Category: Corona Virus Vaccine

She is 31 years old, a pet sitter and former fitness teacher who once ran a half marathon. She was, by most measures, healthy.

When Aguilar got Covid-19 she lost her sense of taste, had mild fevers and muscle weakness. She could barely keep anything down yet gained about 30 pounds. Later, she developed pelvic pain, cystic acne, breast tenderness, headaches, brain fog and extreme fatigue.

It has been months since then, but she says the low energy, chronic pain and brain fog -- long-haul Covid-19 symptoms -- remain and she can't even go for a 15-minute walk without needing a break. She's also now dealing with insulin resistance and taking several medications to keep that and her hormone levels under some control. Her doctor told her she'll likely be dealing with this fallout of Covid-19 for the rest of her life.

More than a year into the pandemic, one study has found that some women are at higher risk for Covid-19 compared to others in their age and sex groups. These women, often young and otherwise healthy like Aguilar, have an underlying condition that isn't mentioned on any Covid-19 comorbidity list: polycystic ovary syndrome, or PCOS.

"PCOS is completely underestimated in its impact. It's sort of seen as some reproductive issue that is not clinically relevant. But this is completely wrong ... Patients need to be seen as a high-risk population," said Dr. Wiebke Arlt, director of the Institute of Metabolism and Systems Research at the University of Birmingham in the United Kingdom.

Despite how common PCOS is, as well as the serious complications it can come with, health experts say the condition has long been overlooked, misunderstood and under-researched, leaving patients to advocate for themselves or even educate practitioners to get treatment. And with very little research looking at whether women with PCOS are at higher risk for more severe Covid-19 or long-term symptoms, some fear the same is happening with public health policy around the pandemic.

"My advice would be to include women with PCOS as ... potentially a high-risk group," said Dr. Katherine Sherif, chief of Women's Health at Jefferson University's Department of Medicine and a leading PCOS expert. But she warned: "We're working in a very large system that is full of silos. Nobody's going to jump up and say, 'Oh, well, don't forget about PCOS.'"

"If Anthony Fauci said, 'you need to look at the high-risk groups like PCOS,' people might pay more attention," she said.

Part of the reason PCOS flies under the radar in general and with regards to Covid-19, according to Arlt and Sherif, is because it is often dismissed as a women's health issue -- an obstacle of the ovary. Over the past year, we've learned about numerous preexisting health conditions that put a person at higher risk for severe Covid-19 illness, but PCOS isn't one of them.

For Arlt, who co-authored the first major study published in February in the European Journal of Endocrinology, the name PCOS is a misnomer. It is not a disorder of the ovary, Arlt said, but a "lifelong metabolic disease" and should be treated as such when assessing Covid-19 vulnerability.

"The higher the metabolic risk is, the higher the risk is to catch Covid-19," Arlt said. "People looked at obesity and Type 2 diabetes and hypertension and heart disease, but they have not looked at PCOS systematically before we did. Because they just don't consider this a metabolic risk factor. That's something that we would like to change."

'Something in PCOS is actually driving this'

Arlt and researchers at the University of Birmingham in the United Kingdom found that women with PCOS had a 51 percent higher chance of confirmed or suspected Covid-19 infection than women without. Using primary care records from January to June 2020, they identified more than 21,000 PCOS patients and a control group of more than 78,000 without, matched for age and location.

Researchers then "wanted to understand if the increased incidence of Covid-19 was only because of PCOS, or was it also because of the underlying risk factors that women with PCOS have?" lead author Anuradhaa Subramanian told CNN. In other words, if a woman has PCOS and Type 2 Diabetes, which one is putting her at increased risk for Covid-19?

Subramanian says the results didn't surprise her. However, "it gave us more confidence... that it's not just about the risk factors associated with PCOS, but something in PCOS is actually driving this," she said.

But because the data was pulled from primary healthcare databases, researchers couldn't look at whether patients with PCOS had more severe or long-term Covid-19 symptoms. What's more, PCOS is not a one-size-fits-all disorder and Covid-19 may or may not have a different impact or risk level depending on the person. There are many questions we don't have definitive answers to yet, says Dr. Anuja Dokras, director of the Polycystic Ovary Syndrome Center at Penn Medicine.

"We need to get this information now that (Covid-19 has) lasted a full year," said Dokras. "It's affecting so many people that it would be good to look back at this literature and just sort it out because these are confounding factors."

Searching for answers

So far, whether people with PCOS have more severe complications from Covid-19 is anecdotal, leaving some women with only speculation about how Covid-19 affects PCOS.

In Aguilar's case, she was diagnosed with PCOS after she was exposed to Covid-19, despite likely having it for years but not recognizing the symptoms. "I had some of these underlying symptoms, my body was able to just manage them to a point for most of my life, and then contracting Covid really just wiped out all of my body's defenses and ability to regulate anything," she said her doctor told her.

But she still doesn't know why or whether her symptoms will ever improve.

Kris Nealon has also spent much of the past year looking for answers.

She was diagnosed with PCOS at age 12, and the disorder has left her struggling with her weight and insulin resistance. These factors, she says, made her concerned that she could have severe Covid-19 symptoms and maybe even require hospitalization. So last summer she did what most have done during the pandemic: She Googled it. She recalled searching "'should I be concerned...insulin resistance COVID?' or 'PCOS COVID?'"

Nealon didn't find answers. She got Covid-19 in October and says her symptoms were mild. But when that turned into muscle and joint pain, extreme fatigue, depression, insomnia and brain fog, she did what was recommended: Talk to her doctor.

In Nealon's case, she spoke to several. Having lived with PCOS more than half her life, she was aware of the complications and wanted to know how this could impact her long-term Covid-19 symptoms.

She says the primary doctor for her long-term symptoms said her only Covid-19 comorbidity was her weight.

"He's been nice and understanding but ... you can see him be like, 'Lady problems, don't worry about it. This is your lungs,'" she said. She told him that PCOS is linked to anxiety and depression and asked if that could be related to Covid-19 fatigue and insomnia. She also asked about her heart, explaining that PCOS and Covid-19 can cause complications.

But aside from suggesting that losing weight might help, Nealon recalled her doctor saying "it had nothing to do with PCOS. He's like, 'no, that's your ovaries and stuff.'"

After Covid-19, Nealon also noticed her PCOS symptoms "went crazy." She says she had extreme pain in her lower abdomen. An ultrasound showed her fallopian tubes "suddenly looked very concerning" and she had an ovarian cyst burst.

She went to her gynecologist, the doctor who first diagnosed her with PCOS, and asked, "Does this have anything to do with (that) I just had Covid?"

She says her doctor told her: "No, there's no literature about that."

And there wasn't. Weeks after Nealon tested positive, Allison Roach and Chitra Gotluru, two medical students at Florida International University, finished their journal article exploring the potentially higher risk women with PCOS have for Covid-19-related morbidity. No data set of patients with both diagnoses existed, they said.

Risk 'obvious but not proven'

People with PCOS often have higher levels of and sensitivity to androgens, male sex hormones. This could "potentially directly affect the susceptibility to COVID-19," Roach and Gotluru wrote. Androgens work as a "gateway," in very simple terms, to let in Covid-19, Roach says.

What's more, it is common for people with PCOS to have chronic inflammation -- an immune system that is in a near-constant state of fighting off harm. Impaired insulin regulation and obesity can lead to a toxic buildup of fatty acid in tissue, known as lipotoxicity, potentially damaging organs.

This can also trigger the secretion of immune-signaling cells called cytokines. While cytokines are a vital part of the body's immune response, too much can cause what's known as a cytokine storm. Adding a Covid-19 infection to that can cause further cytokine secretion, potentially triggering one of these storms and causing the immune system to attack the body's cells, not just the pathogen. And there is research that suggests this can occur "whether you are overweight or not," Gotluru told CNN.

For Jefferson University's Sherif, the risk of more severe Covid-19 symptoms for PCOS patients is "obvious but not proven." Obvious because "If testosterone increases inflammation, and if ... men who are in the hospital with Covid complications and have high testosterone levels, it makes sense that it would put women with PCOS more at risk."

This is not proven, she says, because so little research exists.

Drawing from her own research about PCOS and heart disease, Sherif said, "What's important for people to understand is that this is independent of obesity."

"It's the high insulin and high testosterone that confer their risk for a greater risk for Covid compared to weight matched controls," she said. "So, you have two women who are 100 kilograms. The one with PCOS is more likely to become diabetic or have sleep apnea, or to be sick from Covid."

Without that data, some doctors and researchers say this is something patients with PCOS should be aware of, but not to panic. If you do get Covid-19, it's important to tell your doctor you have PCOS and any medications you're taking, Gotluru says.

"Let your provider know ... that there is research out there that is worrisome about PCOS and you'd like to be careful," she said.

In the meantime, women like Aguilar and Nealon are still searching for answers. Nealon says her doctors still haven't made a connection between the fallout of Covid-19 and her PCOS. She isn't surprised.

"That's what it's like, just with PCOS, let alone adding Covid in," Nealon said. "You go to a doctor with a list of symptoms, and you either get 'you're fat' or 'you're overthinking things.'"

Aguilar says that constantly having to educate people in her life has been exhausting on top of her two new diagnoses.

"A lot of people like to talk about the survival rate is so high and the death rate is so low, but what they're not taking into account is the degree that lives are changing because of illnesses that are popping up from this, or just the long-haul symptoms that are so debilitating," Aguilar said. "It's hard to overcome."

Follow this link:

The women possibly at higher risk for Covid-19 that no one is talking about - CNN

As of May 13, the coronavirus had infected more than 3.9 million children and sent more than 16,000 to hospitals, more than are hospitalized for flu in an average year, according to data collected by the American Academy of Pediatrics. About 300 children have died of COVID-19 in the United States, making it one of the top 10 causes of death in children since the pandemic began.

Here is the original post:

CDC looking at reports of heart problem in a few young vaccine recipients - Chicago Tribune

For more than 400 colleges and universities, it is being billed as the ticket to a normal year on campus: Require all students to be vaccinated for the coronavirus before they can matriculate next fall.

From just one university in March, to a dozen by the first week of April, the trickle has become a tide over the past month depending on just where students are attending school.

In a divided nation, college vaccine mandates are mostly following familiar fault lines. As of this weekend, only 34 roughly 8 percent are in states that voted for Donald J. Trump, according to a tracker created by The Chronicle of Higher Education. Nine of those were added on Friday, when Indiana University and its satellite campuses became rare public universities in a Republican-controlled state to mandate vaccines. Though the 400 campuses are only about 10 percent of the nations roughly 4,000 colleges and universities, experts say the political gap is likely to persist.

With many colleges facing falling enrollments and financial pressure, the decision whether to require vaccinations can have huge consequences. Particularly in Republican-controlled states, college presidents are weighing a delicate equation part safety, part politics, part peer pressure and part economic self-interest.

On weekly conference calls with presidents of other colleges, the subject has become a frequent topic of discussion, said Katie Conboy, the president of Saint Marys College, a private, all-womens college near South Bend, Ind.

College presidents, worried that students might respond to a mandate by enrolling someplace else without one, described a feeling of safety in numbers.

People are waiting for a tipping point, Dr. Conboy said. Theyre not saying, Were going to be out on the leading edge of this, but we are watching and waiting and hoping it will make sense for us.

A total of 15 conservative-led states, including Oklahoma, Nebraska, Kansas, Mississippi and Alabama, do not have a single university that has announced a vaccine requirement.

A mandate is seen as the easiest step to protecting students, and for many colleges, the decision is an easy one especially since many already require other immunizations for the flu or measles, mumps and rubella.

Because the Food and Drug Administration has authorized only the emergency use of the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines, many universities have added a caveat to try to protect themselves from liability. Their mandates are contingent on one of the vaccines obtaining final regulatory approval, but they would allow students to return to campus after receiving any of them.

The vaccine is one of the best things we can do to help us get back to normal life, said Michael V. Drake, a physician and the president of the University of California system.

At the University of Idaho in one of the nations most conservative states, it is also an easy choice not to have mandatory vaccinations. Not a single college in the state has announced a vaccine requirement, and the immunization rate there is among the lowest in the country.

We definitely have political ramifications of things we do as a public institution, and we want to be good partners with our State Legislature and with our Board of Education, said Jodi Walker, a spokeswoman for the University of Idaho.

Public universities and to a lesser extent, private ones in conservative states are feeling the squeeze from all sides, say college officials and experts on academia.

Desperate to reopen successfully, college presidents want as many students as possible to be vaccinated but worry about facing a backlash from conservative state governments. They fear losing funding at a time when many universities have seen a dip in tuition revenue, as well as running afoul of state politicians, whose good will and budget largess they rely on.

May 23, 2021, 3:32 p.m. ET

If you are a public college president, getting on the wrong side of a governor or state legislature can be a career-ending action, said Terry W. Hartle, senior vice president at the American Council on Education.

Even so, Michael A. McRobbie, the president of Indiana University, whose flagship campus is in Bloomington, said he did not feel pressure to decide either way.

Less than 50 percent of the university population has been vaccinated, he said. The medical advisers who were involved in this dont see how we can return to a normal state of affairs without the mandate.

Long before any university had announced its plans for the fall, Nancy Cantor, the chancellor of Rutgerss campus in Newark, remembers getting a weekend call from the universitys chief operating officer, who wanted to know if she would support a vaccine requirement.

One of the first things I thought was, Oh, thank goodness, Dr. Cantor said. We wanted to put our arms around our students.

On March 25, Rutgers became the first major university in the country to announce a mandate, according to university leaders and the tracker.

As a public university, however, requiring immunization was tricky because none of the three vaccines has yet received full licensure.

The Rutgers policy allows some wiggle room, with students able to apply for a religious or medical exemption, a move copied across the country. And vaccination is only required for students, not staff members, a reflection of the legal difficulty of imposing it on employees. Now, about one-third of colleges that have announced a mandate are applying it to both students and employees.

Some university presidents have cited the lack of F.D.A. approval which Rutgers did not include as a prerequisite for its mandate as a compelling reason not to make vaccines mandatory.

I think that those that are in the blue states are not following the law, said Tommy G. Thompson, the University of Wisconsin systems interim president, who previously served in George W. Bushs cabinet as secretary of health and human services, which includes the F.D.A. All those individuals that have mandated it are really on thin ice.

Along with needing to be on the right side of the law, universities are very aware of being on the right side of state politics.

In Florida and Texas, the governors have issued executive orders prohibiting businesses from requiring customers to provide proof of immunization. Whether the same rules apply to schools is not always clear, but the signals from state government are hard to miss.

One of the first colleges in the country to adopt a vaccine mandate was Fort Lauderdale-based Nova Southeastern University, which issued its announcement a week after Rutgers on April 2. That same day, Gov. Ron DeSantis signed the order, cutting off state grants and contracts to local businesses that required customers to provide proof of vaccination.

A month later, the university did a U-turn, rescinding the mandate, presumably because it was seen as conflicting with the new law.

The universitys flip-flop has served as a cautionary tale to other colleges in Republican-led states. In Florida there are currently no campuses that require a vaccine. In Texas, there are only two, both of them private.

But some college presidents in conservative states who have broken with the pack and mandated vaccination are pointing to the particular vulnerabilities of their student bodies.

We are a historically Black college that represents a segment of the population that has been disproportionately affected by this, said Michael J. Sorrell, the president of Paul Quinn College, a private institution in Dallas. Our reality is a very different reality.

Tom Stritikus, president of Fort Lewis College in the mountains of rural Colorado, described how representatives of the nearby Southern Ute Indian Tribe approached the campus to arrange the vaccination of their members who are enrolled at the university. Then, in an effort to create a protective bubble around those students, the tribes medical team went one step further and offered vaccinations to the students roommates and professors.

Seeing that kind of commitment made it easy to announce the requirement for the campus as a whole: Any political blowback we would get, we think its worth it, he said.

For the most part, the colleges choosing to enforce vaccine mandates in states that voted for Mr. Trump are private, name-brand schools not worried about meeting enrollment targets. The list reads like a roster of the most prestigious universities in those states: Tulane University in Louisiana, the University of Notre Dame in Indiana, Vanderbilt University in Tennessee and Duke and Wake Forest Universities in North Carolina.

Most others are still trying to figure out what is best for their students and what is best for them.

Ronald S. Rochon, president of the University of Southern Indiana in Evansville, said many of his students were local in a county where only 38 percent of the population has been fully vaccinated. The university has seen a 2 percent drop in enrollment during the pandemic, he said.

That number tells me something significant about my community, he said of the vaccination rate. Enrollment does not drive all decisions, but I need to be mindful of that element.

Regarding a vaccine mandate, he said there was still time: I have not ruled it out, and I have not ruled it in.

Jack Begg contributed research.

The rest is here:

For Colleges, Coronavirus Vaccine Mandates Often Depend on Which Party Is in Power - The New York Times

If theres one take-home message for the general public about the coronavirus vaccines approved in the U.S., its that they are remarkably effective.

MSU Assistant Professor Morteza Mahmoudi

But Michigan State Universitys Morteza Mahmoudi is raising awareness about an important subtlety: The vaccines developed by Moderna and Pfizer-BioNTech appear to work slightly better for males than for females.

Both vaccines use tiny orbs, or nanoparticles, to deliver their active ingredients to cells in our immune systems. For years, Mahmoudi has been studying how and why nanomedicines therapies that use nanoparticles can affect patients differently based on their sex and he believes this could be a factor with the vaccines.

The Johnson & Johnson vaccine has also drawn attention to sex differences because its rare blood-clotting side effect has affected predominantly female recipients. The J&J vaccine, however, uses modified adenoviruses rather than nanoparticles to help teach our immune systems to fight off the coronavirus. That said, Mahmoudi has shown in earlier work that viruses can transfect the cells of males and females differently.

Now, hes focusing on the nanomedicine component. Hes published three peer-reviewed papers calling attention to the role of sex in nanomedicine studies, both in general and as they relate to coronavirus vaccines.

We need to monitor these sex differences and report them to the scientific community and the public, said Mahmoudi, an assistant professor in the Department of Radiology and the Precision Health Program. It can be very helpful in developing future strategies and as we prepare for future threats.

To develop those future strategies, researchers must better understand what causes patients of different sexes to respond differently to nanomedicines, Mahmoudi said. To that end, Mahmoudi is advocating for systemic changes in how nanoparticles are used and studied in medicine with an article published May 20in the journal Nature Communications.

In the article, he outlines four large challenges in researching the role of sex in nanomedicine performance along with strategies to mitigate them moving forward.

For example, researchers may not have sufficient resources to perform their studies in cells or other samples taken from males and females. Yet these researchers and others may still interpret their results as being equally applicable to all sexes. To prevent this from happening, Mahmoudi is calling for researchers to be more transparent and share sex-specific limitations of studies and conclusions.

We need to be more careful about the science that gets out, Mahmoudi said. Weve witnessed that there has not been a robust consideration of sex in nanomedicine, but we need to consider sex because it is important.

Before the coronavirus pandemic, most of the research interest and funding in nanomedicine had been focused on its use in treating cancer. But nanomedicines performance in this realm has been lackluster. Less than 15% of nanomedicines that have entered clinical trials made it through the final phase and none have proven to be better than the standard of care, Mahmoudi said.

In addition, he said, when nanomedicines are robustly studied in females, its often because the therapies are being studied in diseases that mainly affect females, such as breast and ovarian cancers.

Our analysis of the 41 completed clinical trial studies of therapeutic nanomedicine products revealed that 21 studies were stratified by sex because they concerned pathologies primarily found in females, Mahmoudi said. Of the remaining 20 studies involving 851 males and 430 females, none provided sex-stratified results or indications.

Mahmoudis team detailed these findings and more in an article published online on May 4 in the journal Advanced Drug Delivery Reviews.

Despite their shortcomings in cancer therapies, nanoparticles have been greatly effective in helping provide protection against the novel coronavirus. Yet there is still evidence that the vaccines work differently for males and females.

On the one hand, the vaccines have been really good news for nanomedicine, Mahmoudi said. But we didnt solve the problems that we saw with them in cancer treatments.

To be clear, the differences in vaccine efficacy are small, but they are measurable. In the case of the vaccine developed by the pharmaceutical company Moderna, clinical trials showed it was 95.4% effective at preventing COVID cases for males, compared with 93.1% for females. For the vaccine created by Pfizer and BioNTech, the numbers are 96.4% for males and 93.7% for females.

Both vaccines use nanoparticles based on lipids, which are fatty molecules that form tiny spheres in water, kind of like bubbles. The pharma companies then pack these tiny lipid-based particles with the vaccines active ingredients and essentially use the nanoparticles as delivery vehicles to ship the vaccines payloads to our immune cells.

Working with researchers at Sapienza University of Rome, Mahmoudi designed an experiment to test whether lipid-based nanoparticles could be a reason behind the difference in vaccine efficacy for males and females. The team published its results on May 13 in the journal Molecular Pharmacology.

The team added lipid-based nanoparticles with similarities to those used in the vaccines to blood samples taken from 18 patients, eight male donors and 10 female donors. The researchers then observed how well or how poorly immune cells within the blood adsorbed those nanoparticles. The team found a significant difference between men and women for one cell type called natural killer cells.

This colorized image shows a closeup of a microscopic natural killer cell. Credit: National Institutes of Allergy and Infectious Diseases, National Institutes of Health

These cells are responsible for finding other infected cells cells that are producing the virus and they can kill them, said Mahmoudi. What we found is that natural killer cells respond to lipid-based nanoparticles in a sex-specific manner.

Namely, natural killer cells from female donors took up fewer nanoparticles than natural killer cells from male donors. Based on this model system, then, it is plausible that the immune systems of males and females would respond differently to the vaccine.

But Mahmoudi and his colleagues also showed that the difference could be eliminated by first putting the nanoparticles in a donors plasma, the cell-free portion of their blood sample. Mahmoudi believes this is because proteins in the plasma can bind to the lipid-based nanoparticles, giving the nanoparticle a biological coating or corona.

I think of the corona as acting like a new passport for nanoparticles, it tells the cells how to respond to nanoparticles, he said.

What this suggests, then, is that if there are differences in the vaccines performance based on a patients sex, doctors and researchers should be able to do something about it. But theyll need more research and data to fully understand the cause of and remedies to these differences, Mahmoudi said. Thankfully, though, the data available to the community is growing every day.

The clinical trials were performed with tens of thousands of patients. We know that the differences are there and that we need to monitor them, he said. Now we have millions of people getting the vaccines. Thats millions of data points. We need to go out there and get them.

Go here to read the rest:

Do COVID-19 vaccines care whether you're female or male? - MSUToday

Heres what you need to know:Video

transcript

transcript

Lets get back to life. This shutdown has caused all sorts of damage, damage that were not even aware of. Everybody points to the economic damage, and thats certain. Businesses closed, people lost their jobs, but theres all sorts of other damage that people are not yet understanding, I believe. What did it mean to keep children out of a school, out of school for a year? Effective this Wednesday, were going to adopt the C.D.C.s new guidance and regulations on masks and social distancing for vaccinated people. By the C.D.C. guidance, immunocompromised people, unvaccinated people should continue to wear a mask and social distance. But if you are vaccinated, you are safe. No masks, no social distancing. Were also going to follow the C.D.C.S guidelines that you will still need to wear a mask on public transportation, the subways, the buses, nursing homes, homeless shelters, correctional facilities, schools and health care facilities.

The governors of New York and New Jersey, both Democrats, took major steps on Monday toward fully reopening their states.

Gov. Andrew M. Cuomo said that New York will lift several mask requirements beginning Wednesday, and Gov. Philip D. Murphy said that New Jerseys public school students will no longer have the option to learn remotely starting in September. But Mr. Murphy said in recent days that his state is not lifting his indoor mask mandate for vaccinated residents.

I dont want to get burned, he said at a news conference on Monday. I dont want to go back.

Mr. Cuomos announcement was in accordance with the new guidance for vaccinated people that the Centers for Disease Control and Prevention announced last week. No masks, no social distancing, he said of the policy that will go into effect for vaccinated people on Wednesday.

Masks will still be required in nursing homes, schools, health care facilities and on public transit. Unvaccinated people should continue to wear a mask, he said in a news conference at Radio City Music Hall in Midtown Manhattan.

The move dovetails with the previously scheduled lifting of most capacity restrictions statewide at offices, museums, restaurants and stores on Wednesday. It was significant, however, given the longstanding restrictions imposed on one of the hardest hit cities in the United States. Illinois, Massachusetts and Ohio are among the states that are taking a similar approach to New York. On Monday, however, California said that it is keeping its rule to wear masks in all indoor settings outside of home for four weeks, until June 15.

In addition, New York Citys subway system returned to 24-hour service on Monday. There has been more than one year of overnight closings during the coronavirus pandemic to provide more time to clean and disinfect trains, stations and equipment. It was the longest planned shutdown since the subway opened in 1904.

As of Monday, 52 percent of New Yorkers had received at least one vaccine dose and 43 percent were fully inoculated.

Those in the most crowded public settings must continue to wear masks, Mr. Cuomo said, referring to students at school, public transit passengers and people in homeless shelters.

In New Jersey, some of the largest school districts have not yet reopened to all students, and many families continue to keep their children home.

New Jersey has recorded 1,263 cases of in-school transmission of the virus since schools began to reopen in September, according to the New Jersey Health Department. Less than 1 percent of the states K-12 students and teachers had a coronavirus case linked to in-school transmission, while the positivity rate among the general population was 11 percent.

New York is hosting upcoming N.B.A. playoff games inside Madison Square Garden and the Barclays Center in Brooklyn, where at least 50 percent of seating will be for vaccinated people, Mr. Cuomo said. Masks and social distancing will be required in the section for unvaccinated fans.

Mr. Cuomo said that the Tribeca Festival would return next month and its final night would be held at Radio City Music Hall with full capacity for vaccinated filmgoers and no masks required. The New York City Marathon will return in November at 60 percent capacity, or about 33,000 runners.

The guidance the C.D.C. issued on Thursday said that it was no longer necessary for fully vaccinated people to mask or maintain social distance in many settings. The change set off public confusion and drew objections from some local officials and labor unions, including the countrys largest union of registered nurses. A number of major U.S. retailers have already lifted mask requirements, essentially turning to an honor system that relies on unvaccinated people to keep their masks on in public.

Businesses in New York can still set individual policies and some will require masks. They do not have to do vaccination checks.

They can check, they can ask at the door, they can ask when you are seated at the table, or not, Mr. Cuomo said. There is no mandatory compliance the state is imposing on the private vendors.

The states health department is keeping its recommendation to wear masks indoors where the vaccination status of nearby people is not known. It applies to retail stores, food services, offices, gyms and fitness centers, amusement and family entertainment, hair salons, barber shops and other personal services, among others.

On Monday, CVS and Target said they would no longer require fully vaccinated shoppers to wear masks, except where its required by local laws.

Bryan Pietsch contributed reporting.

transcript

transcript

We need to help fight the disease around the world to keep us safe here at home, and to do the right thing of helping other people. Its the right thing to do. Its the smart thing to do. Its the strong thing to do. In March, we shared over four million doses of our AstraZeneca vaccine with Canada and Mexico. At the end of April, we announced that we would provide another 60 million doses of our AstraZeneca vaccine overseas. Remember, this is the vaccine thats not authorized for use in the United States yet. So were going to be sending it to folks once the F.D.A.s reviewed this, and said its safe. This is all the AstraZeneca vaccine produced in the United States all of it will be sent to other countries. And today Im announcing they will also share U.S.-authorized vaccine doses of Pfizer and Moderna, and Johnson and Johnson, as they become available with the rest of the world as well. These are vaccinations and vaccines that are authorized to be put in arms of Americans and by the end of June, when we will have taken delivery of enough of such vaccines to protect everyone in the United States, the United States will share at least 20 million of those doses, that extra supply, with other countries. This means over the next six weeks, the United States of America will send 80 million doses overseas. Just as in World War II, America was the arsenal of democracy, in the battle against Covid-19 pandemic, our nation is going to be the arsenal of vaccines for the rest of the world. Well share these vaccines in the service of ending the pandemic everywhere, and we will not use our vaccines to secure favors from other countries. Well work with Covax, the international organization set up, and other partners to ensure that the vaccines are delivered in a way that is equitable and follows the science and the public health data.

President Biden, heeding widespread calls to step up his response to the pandemics surge abroad, said on Monday that his administration would send 20 million doses of federally authorized coronavirus vaccine overseas in June the first time he has pledged to give away doses that could be used in the United States.

The donation is another step toward what Mr. Biden promised would be an entirely new effort to increase vaccine supplies and vastly expand manufacturing capacity, most of it in the United States. He also put Jeffrey Zients, the White House coronavirus response coordinator, in charge of developing a global strategy.

We know America will never be fully safe until the pandemic thats raging globally is under control, Mr. Biden said in a brief appearance at the White House. No oceans wide enough, no walls high enough, to keep us safe.

With new cases and deaths plummeting as vaccination rates rise in the United States, the epicenter of the crisis has moved to India and other nations. A growing and bipartisan chorus of diplomats, health experts and business leaders has been pushing the president to do more to end what the AIDS activist Asia Russell calls vaccine apartheid.

Mr. Biden said on Monday that 20 million doses of the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines all approved for domestic use would be sent abroad. That is in addition to the 60 million doses of AstraZenecas vaccine he pledged last month, though those doses are not approved for domestic use and cannot be released until regulators deem them safe.

Hes crossed the threshold into direct donations, said J. Stephen Morrison, a global health expert at the Center for Strategic and International Studies, which teamed up with three other health institutes on Monday to release a plan to ramp up vaccine supply. Thats an important shift.

International health activists want far more.

Donating 80 million doses of vaccines without a plan to scale up production worldwide is like putting a Band-Aid on a machete wound, said Gregg Gonsalves, a longtime AIDS activist.

Those 80 million doses amounted to five times the number that any other country had donated, Mr. Biden said, noting that taking the lead in helping the world beat back the coronavirus was a chance to reassert American authority. And unlike Russia and China, which have sought to use their vaccines as an instrument of diplomacy, the United States will not expect any favors in return, the president said.

We want to lead the world with our values, with this demonstration of our innovation and ingenuity, and the fundamental decency of the American people, Mr. Biden said. Just as in World War II America was the arsenal of democracy, in the battle against the Covid-19 pandemic our nations going to be the arsenal of vaccines for the rest of the world.

Mr. Bidens announcement came not long after a World Health Organization news conference at which the director general, Dr. Tedros Adhanom Ghebreyesus, said that countries with high vaccination rates had to do more to help countries that were being hit hard by the coronavirus, or the entire world would be imperiled.

A growing and bipartisan chorus of foreign policy experts, diplomats, global health advocates and prominent business leaders are pushing President Biden to take a more aggressive stance in combating the international coronavirus pandemic by scaling up vaccine manufacturing and exporting surplus doses.

In two open letters to the president, one released last week and the other early Monday, a string of prominent names urged Mr. Biden to do more.

The first letter came from top executives including Suzanne Clark, the president of the U.S. Chamber of Commerce; former ambassadors including John Negroponte, envoy to Iraq and the United Nations under President George W. Bush; and a former defense secretary, William Cohen, who served President Bill Clinton.

The world has come to rely upon U.S. leadership at times of great strife, Ms. Clark, Mr. Cohen, Mr. Negroponte and the others wrote, adding: Today we have a generational opportunity to mobilize vaccine efforts around the world. Our friends and allies will not forget easily if we sit on surplus stockpiles of the most proven vaccines as their citizens suffer and die.

The second letter, organized by four global health institutes and signed by experts including Mark McClellan, the Food and Drug Administration commissioner under Mr. Bush, called on Mr. Biden to, among other things, name a global coronavirus coordinator and commit to sharing Covid-19 vaccine doses immediately.

Mr. Biden has promised he would restore America as a leader in global health, and the letters indicate that a broad array of leaders in multiple sectors believe he has not gone far enough.

The Biden administration has already committed $4 billion to Covax, the effort by the World Health Organization to get vaccines into the arms of people in disadvantaged nations; pledged to work with Australia, India and Japan to bolster global vaccine supply; and has said it would send 60 million doses of the American supply of AstraZeneca vaccine for global deployment.

On Monday Mr. Biden announced that the U.S. would send an additional 20 million doses of authorized vaccines abroad in June.

We need to help fight the disease around the world to keep us safe here at home, Mr. Biden said.

Those 80 million doses amounted to five times the number that any other country had donated, Mr. Biden said, noting that taking the lead in helping the world beat back the coronavirus was a chance to reassert American authority.

We want to lead the world with our values, with this demonstration of our innovation and ingenuity and the fundamental decency of the American people, Mr. Biden said. Just as in World War II America was the arsenal of democracy, in the battle against the Covid-19 pandemic our nations going to be the arsenal of vaccines for the rest of the world.

To further broaden global supply, Mr. Biden recently announced he would support waiving intellectual property protections for coronavirus vaccines.

But J. Stephen Morrison, a global health expert at the Center for Strategic and International Studies who helped organize Mondays letter, said suspending intellectual property rights would not help without White House leadership. The world is now in great need of high-level engagement that up to now has been conspicuously absent, his letter said.

The pharmaceutical industry opposes waiving the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS, and the letter from the business leaders and ambassadors argued that such a waiver would make little difference and could do harm.

Global health activists, who are strongly in favor of the waiver, said they nonetheless welcomed the business approach. They see clear parallels to their work fighting the global AIDS epidemic.

It shows an unprecedented willingness of pharma and its allies in the private sector to admit what all of us having been saying for months, the private sector alone cannot and will not ensure global vaccine access, James Krellenstein, a founder of PrEP4All, a nonprofit aimed at ensuring universal access to H.I.V. prevention and treatment, wrote in an email message.

It really shifts the burden to the Biden administration, Mr. Krellenstein wrote, adding, When will they act?

Dr. Anne Schuchat, the second-in-command at the Centers for Disease Control and Prevention for the last six years, is leaving the agency, the second time this month that a top official has abruptly announced plans to depart.

Dr. Schuchat, a low-key career C.D.C. scientist, joined the agency as a young epidemiologist in 1988 and eventually helped lead its responses to a number of public health emergencies, including the anthrax attacks of 2001 and the H1N1 flu pandemic in 2009. Deeply respected within the agency, she nonetheless was criticized along with other top officials there at times last year for not pushing back harder at least publicly against pressure from the Trump White House to downplay the coronavirus pandemic.

News of her departure, first reported by Politico, comes as the C.D.C. is facing fresh scrutiny for advising last week that fully vaccinated people could stop wearing masks in most settings. Dr. Rochelle P. Walensky, the C.D.C.s new director, said the guidance was based on research showing that few vaccinated people become infected with or transmit the coronavirus, and that the vaccines appear to be effective against all known variants of the virus.

But the new guidance has caused widespread confusion, as well as concern about whether unvaccinated people would continue wearing masks when no proof of immunization is required.

Dr. Walensky said in a statement that Dr. Schuchat, the C.D.C.s principal deputy director, would leave this summer. I have enormous gratitude for Dr. Schuchats leadership and contributions over three decades, and during this very challenging period for our country, the statement said. I am especially thankful for her invaluable counsel, assistance and support in my transition into this role.

I will remain forever grateful that our paths crossed, even for just a short while, she added.

The announcement came less than two weeks after another top C.D.C. official, Dr. Nancy Messonnier, resigned after many years and roles at the agency, including as its initial lead in responding to the coronavirus.

But while Dr. Messonnier, 55, left to take a job as an executive director at the Skoll Foundation, a philanthropic organization in Palo Alto, Calif., Dr. Schuchat, 61, said she is retiring.

One longtime C.D.C. official, who requested anonymity to discuss personnel issues, said that Dr. Schuchats resignation did not immediately appear to result from any internal disagreement and that she seemed ready after 33 years to step back. But the announcement came as a surprise to many who work there.

In a statement of her own on Monday, Dr. Schuchat who was reported to be the model for Kate Winslets disease detective character in the 2011 movie Contagion said she would be leaving for a retirement that I hope will allow more time for creative passions.

I will be leaving with the greatest respect and confidence in C.D.C.s leadership and staff, and the important work we do, Dr. Schuchat said. I could not be more optimistic about the future of our agency and the prospects for our public health system.

States in the U.S. Northeast, after experiencing spikes in coronavirus infections earlier this year, are reporting significant drops in cases and hospitalizations.

Connecticut, Massachusetts, Pennsylvania and Rhode Island have all reported many fewer cases in recent weeks as more people receive vaccinations. New York and New Jersey have also seen steady declines in cases after struggling to contain the virus earlier this spring.

Reported cases across the United States reached a high in January, and then, as vaccinations accelerated, fell through February and most of March. A much smaller overall surge peaked in mid-April, but has dropped about 32 percent over the past two weeks, according to a New York Times database. Hospitalizations and deaths are also ticking down, even as the pace of vaccinations has slowed in recent weeks.

In Rhode Island, confirmed cases have dropped 48 percent and hospitalizations have dropped 23 percent in the past two weeks. State officials attribute the fall in cases to increased vaccinations.

Its the vaccinations, Gov. Daniel McKee of Rhode Island said, adding that the vaccinations are really our focus right now.

The state announced on Friday that it would adopt the Centers for Disease Control and Preventions new guidelines eliminating most mask requirements for fully vaccinated people starting on Tuesday. Although Mr. McKee expressed concerns that unvaccinated people might stop wearing masks too, he said he hoped the C.D.C.s new guidance would encourage more people to get vaccinated and that it was not a pass for people who have not been vaccinated.

State officials are still worried about the threat of more contagious variants of the virus, he said. And even though Rhode Islands vaccination campaign is ahead of most states, Mr. McKee said that convincing people who were hesitant was still a challenge. About 57 percent of Rhode Islands population has received at least one dose, and 46 percent have been fully vaccinated, according to a New York Times vaccine tracker.

In Pennsylvania, reported cases have dropped 44 percent and hospitalizations have dropped 28 percent in the past two weeks. Cases in the state started to rise in mid-March and continued to climb for weeks before reversing course in late April.

Alison Beam, Pennsylvanias acting secretary of health, said the states vaccination effort had made great strides, which had led to the decreases. About 55 percent of the states population has received at least one shot, and 39 percent have been fully inoculated.

One of our greatest hesitancy strategies is making it really convenient for folks and weve been able to do that by spreading out the vaccine to more of our provider networks more recently because the supply has increased as well, Ms. Beam said.

With the pace of vaccinations falling, the Biden administration has been focused on door-to-door and person-by-person efforts. The Department of Health and Human Services recently started a Covid-19 community corps, a loose group of volunteers, corporations, advocacy groups and local organizations working to vaccinate Americans who may prefer to get their shots by or around people they know.

Ms. Beam cautioned, however, that coronavirus testing had also decreased in the state and she urged people to continue getting tested if they showed symptoms.

Although reported cases are continuing to drop nationwide, public health experts warn that the United States will have to continue aggressively vaccinating its population over the next few months. It is possible that the virus could surge again more widely in fall and winter, when viruses like the flu are typically dominant.

That would be a terrible shame because that will include serious cases and deaths, and thats preventable, said Dr. Sten Vermund, the dean of the Yale School of Public Health.

Sanofi, the French pharmaceutical company, said on Monday that it would move the experimental Covid-19 vaccine it is developing with GlaxoSmithKline into a late-stage trial after the shot produced strong immune responses in volunteers in a midstage study.

The findings are encouraging for a vaccine that has fallen behind in development and has so far disappointed those expecting that it would be crucial in combating the pandemic. If the vaccine can become available in the last three months of this year, as its developers hope, it could still play a central role as a booster shot as well as an initial inoculation in the developing world, where the pace of vaccination is lagging.

The vaccine hit a major setback in December, when its developers announced that it did not appear to work well in older adults and that they would have to delay plans to test it in a Phase 3 trial, the crucial test that will assess the vaccines effectiveness.

But the companies modified the vaccine and in February began testing it in a Phase 2 study that included more than 700 volunteers in the United States and Honduras between 18 and 95 years old. Sanofi said the vaccine did not raise any safety concerns and produced a strong immune response across age groups, a finding suggesting it has been successfully tweaked.

Sanofi announced the findings in a statement and said it plans to soon publish the results in a medical journal.

Sanofi and GSK are much more experienced in vaccine development than a number of their rivals that have already won authorization. The two companies used a more established approach than those deployed in other, more swiftly developed Covid vaccines. Their shot is based on viral proteins produced with engineered viruses that grow inside insect cells. GSK is supplying the Sanofi vaccine with an adjuvant, an ingredient used in many vaccines meant to boost the immune response.

Sanofi and GSKs vaccine was one of six selected for funding from Operation Warp Speed, the Trump administrations effort to accelerate vaccine development. Last summer, the federal government agreed to give the companies $2.1 billion to develop and manufacture the vaccine, in exchange for 100 million doses once the shot was ready.

Sanofi also has supply deals with the European Union and Canada. It has also agreed to supply 200 million doses to Covax, the program to deliver vaccines to middle- and lower-income countries that has been struggling with a shortfall in expected doses. Sanofi has also announced plans to help manufacture the authorized vaccines made by Pfizer-BioNTech, Moderna and Johnson & Johnson.

Sanofi said its Phase 3 trial of its vaccine would begin in the coming weeks and enroll more than 35,000 adult volunteers around the world. It will test two formulations of the vaccine, one aimed at preventing the original strain of the virus and the other aimed at the B.1.351 variant first seen in South Africa that some vaccines appear to be less effective against.

Su-Peing Ng, Sanofis global head of medical for vaccines, told journalists on Monday that the company expected it to be operationally quite challenging to enroll unvaccinated participants in the Phase 3 trial as vaccination coverage increases in many nations. Still, she said, vaccine doses were still scarce in many parts of the world, pointing to Latin America and Asia as places where the company may look to enroll volunteers.

The company said that soon after starting the Phase 3 trial it planned to assess whether its vaccine could boost immune responses in people who had been vaccinated months before with authorized vaccines. Those booster studies are expected to enroll volunteers in well-vaccinated parts of the world, including the United States and Europe.

Sanofi and GSK said last year they were preparing to be able to make 1 billion doses annually. Thomas Triomphe, Sanofis global head of vaccines, said on Monday that the companys production this year, if its vaccine were shown to work, would depend on the worlds needs.

The vaccine, he said, has potential to be a booster of choice for many nations and many different platforms.

CAPE TOWN Facing a resurgent coronavirus and plagued by delays with vaccine supply, South Africa began the second phase of its public vaccination campaign on Monday, opening appointments for people aged 60 or older.

Only about 500,000 people in the country have been vaccinated to date, and most doses have gone to health care workers in a trial involving the Johnson & Johnson vaccine. South Africa is aiming to open vaccinations for people aged 40 or older in July, followed by the rest of the adult population in November.

South Africa has obtained nearly a million doses of the Pfizer-BioNTech vaccine and anticipates receiving around 4.5 million doses by the end of June.

The country has also ordered 3 million doses of the Johnson & Johnson vaccine, but only plans to begin using these in the public rollout following a verification process by international regulatory agencies, including the U.S. Food and Drug Administration.

Its going to change my life, said Zola Bisholo, who was hospitalized with Covid-19 in January, after receiving her first shot of the Pfizer vaccine at a government hospital in the Cape Town suburb of Brooklyn.

With more than 55,000 deaths and some 1.6 million confirmed cases, South Africa has been hit harder by the pandemic than any other nation in Africa. Its most recent wave of infections, in December and January, was driven by a more contagious virus variant, known as B.1.351.

The government has set a goal to vaccinate 5 million people by the end of June, South Africas health minister, Zweli Mkhize, said Sunday. Just over 4,000 people were scheduled to receive vaccines on Monday.

The expanded eligibility comes at a critical phase: South Africa is experiencing a sustained rise in cases, and officials have warned of a third wave in the coming weeks, as the southern hemisphere heads into winter.

Link:

Covid News: New York and New Jersey Make Big Moves to Reopen - The New York Times

Philippines Health Secretary Francisco Duque III administers the China-made Sinovac COVID-19 vaccine to Eileen Aniceto, a doctor at the Lung Center of the Philippines. Maria Tan/AFP via Getty Images hide caption

Philippines Health Secretary Francisco Duque III administers the China-made Sinovac COVID-19 vaccine to Eileen Aniceto, a doctor at the Lung Center of the Philippines.

The Philippines' Health Department says it will no longer allow local governments to announce which brand of coronavirus vaccines will be available at inoculation sites.

The move comes after hundreds of people this week lined up at a site in Manila when they found out the Pfizer vaccine would be given out there.

"What we're going to enforce now is brand agnostic," Undersecretary Myrna Cabotaje told CNN Philippines' The Source.

From now on, only people already in line at a vaccination site will be told which shot they'll get and "if they do not like the vaccines that are given during that time, then they go to the end of the line," Cabotaje said.

On Tuesday, residents lined up outside the Manila Prince Hotel as early as 2 a.m. for a chance to get one of the 900 Pfizer jabs that the local government announced could be given to walk-ins, reports Rappler.com.

Manila Mayor Isko Moreno told CNN Philippines that the preference for the Pfizer vaccine may have been why people chose that specific site out of the nearly 20 in the city.

The Philippines, which has the second-highest COVID-19 infection rate in Southeast Asia, has seven vaccines in its arsenal, but the rollout has been slow. Today less than 1% of the population of 108 million has been fully vaccinated.

China's Sinovac vaccine, which has an efficacy of about 67% according to a recent study done in Chile, makes up the bulk of the doses available in the Philippines. Only about 200,000 doses of the Pfizer vaccine with an efficacy of 95% are available, and none of the vaccine produced by Moderna is available.

Health experts say that people waiting out higher efficacy vaccines, along with rampant misinformation, bad messaging from the government and fresh memories of the troubled 2016 rollout of the dengue fever vaccine DengVaxia that put thousands of children in danger, have contributed to vaccine hesitancy in the Philippines.

Earlier this year, a Pulse Asia survey revealed that 6 in 10 Filipinos did not want to get vaccinated against COVID-19.

View original post here:

Philippines Says People Won't Be Given A Choice Of COVID-19 Vaccine : Coronavirus Updates - NPR

There is major progress on the development of a universal coronavirus vaccine, that could also help protect against some of the common colds, according to experts.

SEATTLE Its the other big news that came out of the White House COVID-19 briefing on Thursday that few people heard about. The news that there is major progress on the development of a universal coronavirus vaccine, according to Dr. Anthony Fauci, the nation's leading infectious disease expert.

It's based on incredibly small proteins that help the body recognize disease called nano-particles. While that may sound like basic vaccine science, this goes beyond that to prevent illness from an entire class of viruses.

And theres a whole host of SARS Co-viruses circulating in bats, that look poised to make the jump to humans. Nobody wants that to happen, said Dr. Neil King, who is an assistant professor of biochemistry at the University of Washington (UW) and works in the school'sInstitute for Protein Design.

Under UW Medicine, King is leading what's officially known as the Design of Broadly Protective Coronavirus Vaccines program. King said there are four classes of coronaviruses, but one, the beta class, is dangerous and has led to the worst pandemic in a century.

Its out of this beta group that comes SARS CoV-2, the virus that causes COVID-19. Nearly two decades ago it was SARS CoV-1, which triggered the SARS threat back in 2002, then the MERS infections a few years later.

Neither became a pandemic like SARS CoV-2, but theyre all related and others could well follow, according to King.

Also in that group, coronaviruses that cause five to 15% of colds, and a vaccine against one could become a vaccine against all beta class coronaviruses.

We use this software called Rosetta, thats been developed here at the U.S. and worldwide, to make up new protein nano-particles and we dial in their structures at the atomic levels. That atom here, that atom there to predictively design new nano-particles that are going to make the best possible vaccine, said King.

He claims the UW's approach to engineering a specific targeted protein is better than isolating and working with existing nano-particles.

King said by designing a specific protein and forming a pattern of those super tiny proteins, it instructs the body to fight off current and future beta coronaviruses through the development of antibodies.

So the immediate priority is to develop a vaccine to protect against known and unknown SARS-like coronaviruses, said King. "Thats what many groups are going after first, and once we get that well go even broader.

Fauci cited work going on at Duke University, as well as tests in non-human primates when it comes to developing this vaccine.

So in monkeys, the nano-particle vaccine completely blocked SARS CoV-2 infection and enlisted higher vaccine immunity protection than current vaccines or with natural infection," said Fauci. "But importantly, what is the crux of this discussion is -- that the vaccine elicited cross neutralizing antibodies against bat coronaviruses, SARS CoV-1, SARS CoV-2 and variants of SARS CoV-2 we are dealing with."

View post:

A universal vaccine for coronavirus and some common colds? Seattle scientists are working on it - KING5.com

Two Heads: Billionaire BioNTech cofounders Ozlem Tureci and Ugur Sahin.

Before the Covid-19 pandemic, Big Pharma had been easing out of the vaccine business for decades. By 2019, the major vaccine makers supplying America had dwindled to a handful of large companiesMerck, Sanofi, Pfizer, and Johnson & Johnson. Because vaccines are only used once or twiceas opposed to medicines that people take dailythey are not profitable. The scale of vaccination programs also invites class action litigation if something goes awry.

The White House needed a whopping amount of money to coax companies to research and test and then produce hundreds of millions of doses. They initially asked for and Congress rapidly appropriated $10 billion. Ultimately, Operation Warp Speed (OWS)the U.S. governments Covid-19 relief programwould dole out $22 billion to Big Pharma.

The amounts of money were the kinds of sums normally seen in the smaller defense budget line items, but were massive for a public health project$2.5 billion to Moderna, $1.2 billion to AstraZeneca, half a billion dollars to Johnson & Johnson, and $1.6 billion to a small company called Novavax. Only Pfizer opted out of ponying up to the trough at firstit didnt want to devote resources to coordinating with the US government on its work.

In July, Pfizer signed a $1.95 billion deal to sell one hundred million doses of its two-shot vaccine to the United States, enough for fifty million people. It would be the first to reach American arms. The price per double shotabout forty dollarsis comparable to the price per shot of the flu vaccine. By February, the government had ordered three hundred million doses from Moderna, with its first shipment of one hundred million priced at thirty dollars per double-shot dosecheaper than Pfizer partly because the United States had forked over nearly a billion dollars to Moderna research. Modernas CEO has said the price per dose will be higher for retail once the government contracts phase out.

Because the project worked, it may well elude financial investigation.

OWS was staffed at every level by pharmaceutical industry executives and their revolving door of allies in the government. They could, if they wished, keep their investments thanks to a special exemption. Brought on as contractors, they were not subject to federal conflict-of-interest regulations in place for employees. OWS advisers with connections and investments had to agree to assign some of their Covid vaccine earnings to the NIHbut they could wait to do so until after their deaths.

Executives at Moderna and Pfizer cashed in on the vaccine, selling shares timed precisely to clinical trial press releases.

OWS was staffed at every level by pharmaceutical industry executives and their revolving door of allies in the government. They could, if they wished, keep their investments thanks to a special exemption. Brought on as contractors, they were not subject to federal conflict-of-interest regulations in place for employees. OWS advisers with connections and investments had to agree to assign some of their Covid vaccine earnings to the NIHbut they could wait to do so until after their deaths.

Former Big Pharma executive Moncef Slaoui sat on the board of Moderna. Thirteen days after the first massive infusion of taxpayer money into its cofferswhich triggered a jump in the companys stock priceSlaoui was awarded options to buy 18,270 shares in the company, according to Securities and Exchange Commission filings first reviewed by Kaiser Health News. Those shares were added to 137,168 options hed accumulated since 2018. He reaped an estimated $8 million when he resigned from the Moderna board.

Among the other known connections between OWS and Big Pharma cash: OWS advisers and Pfizer employees William Erhardt and Rachel Harrigan maintained financial stakes of unknown value in Pfizer, the recipient of a nearly $2 billion HHS contract for one hundred million doses of its vaccine. Richard Whitley, an adviser on the vaccine safety panel, is associated with Gilead, maker of the Covid antiviral agent remdesivir. Adviser Carlo de Notaristefani is connected to Teva, maker of the Trump-approved hydroxychloroquine. Former FDA commissioners Dr. Scott Gottlieb and Dr. Mark McClellan, informally advising the federal response, both have seats on the boards of Covid vaccine developers.

Even more money was raining down on company insiders trading on good-news releases. Executives at Moderna and Pfizer cashed in on the vaccine, selling shares timed precisely to clinical trial press releases.

Timing stock sales like that is neither unusual nor illegal. Columbia Law School economist Joshua Mitts has found that execs in many sectors are up to three times more likely to sell o their company stock on days when their companies announce positive news than on days when negative, neutral, or no news is released.

The Big Shot: Albert Bourla, CEO of Pfizer

On November 9, the day Pfizer announced its more than 90 percent vaccine efficacy, Pfizer CEO Albert Bourla sold more than half of his holdings62 percent. It was a good day to sellthe positive news jacked stock prices 15 percent. Bourla was among seven Pfizer executives who collectively earned $14 million from stock sales in 2020, according to data provided to the Los Angeles Times by Equilar, an executive compensation and corporate governance data firm.

Not to be outdone, Moderna executives made $287 million from timed stock sales in 2020and kept going. In just a few days in late January and February 2021, Moderna CEO Stphane Bancel sold millions of dollars worth of his stock.

The Trump administrations best and brightest Covid solutionthrow public money at private industry with almost no oversight of the contracting procedurewill stand as one of the most audacious efforts in the administrations free market ideological playbook. The full roster of this pharmaceutical windfall club will probably never be revealed.

The pandemic crisis offered a challenge that government might have used to restructure the shareholder model of for-profit medicine, a model that dates to the 1980s and corporate Americas turn toward putting shareholders above the public good. Instead, taxpayer money flowed to a small group of capitalists with almost no strings attached and little transparency. The contracts are redacted, although Freedom of Information Act (FOIA) requests are pending.

As cities across the nation started vaccinating at the end of 2020, the media sought out and hailed some of the researchers as heroes. And they are heroes. But most researchers would not cash in. The NIHs Barney Graham, whose work on molecular protein manipulation is key to the Moderna vaccine, gets paid a government salary. Moderna execs, besides pocketing nearly a billion dollars, will still charge Americans for its vaccine.

Katalin Karik, a Hungarian biochemist whose research was crucial in developing the BioNTech-Pfizer vaccine, doesnt hold the patent for her discovery; the University of Pennsylvania does. BioNTech founders Ugur Sahin and zlem Treci, however, have profited significantly. Today the married doctors (top) are billionaires, among Germanys richest people. They sold their company Ganymed Pharmaceuticals in 2016 for $1.4 billion.

In 2020, the US government spent $18 billion on vaccine research, manufacturing, and logistics and approved two for use at the end of the year: the mRNA-platformed Pfizer and Moderna vaccines. The eleven-month concept-to-emergency-approval process set a record in American vaccine history. Nothing else even came close.

Besides the mRNA vaccines, US taxpayers had bet billions on Johnson & Johnson, Novavax, and AstraZeneca, the British company. Johnson & Johnson and AstraZeneca, like the Chinese and Russian vaccine efforts, were making vector vaccinesa newer vaccine model than the attenuated virus model in vogue since the days of the cowpoxusing virus modified so that it can enter cells, but cannot replicate itself. The vector vaccines use viruses that the body is familiar withusually an adenovirus that causes the common coldto deliver genetic information about specific disease into cells.

A year after Covid showed up in Wuhan, 200 vaccines were in trials or already in usea world record in vaccine history.

In February 2021, Johnson & Johnson reported that its single-shot vaccine, made from an adenovirus carrying Covid spike protein DNA, had a 72 percent efficacy rate. AstraZeneca produced a vaccine also based on a manipulated adenovirus that was already in use in the United Kingdom by February, despite a series of clinical trial mishaps. Novavax, the small Maryland-based company that took $1.6 billion from the US government to produce a protein-based vaccine using material from the soap bark tree as an adjuvant, was bringing up the rear, but promised to have one hundred million doses available in the United States by summer.

By late 2020, a year after Covid showed up in Wuhan, 200 vaccines were in trials or already in use, according to the WHOanother world record in vaccine history. Chinas Sinovac was first out of the gate with its inactivated Covid vaccine in June 2020. Another Chinese company, Sinopharm, started tests in the United Arab Emirates, Morocco, and Brazil during summer and made its first sale to the UAE, which began manufacturing it. By early 2021, the UAE was second in the world (behind Israel) in the percentage of its population that had received a vaccination.

The Chinese vaccine dominated the global market, stepping into a soft power vacuum left by US isolationism and pandemic mishaps. By early 2021, three Chinese vaccines were approved and in use, manufactured by Sinovac, Sinopharm, and CanSinoall either based on the adenovirus model or the attenuated Covid virus. In August, Sinovac announced an agreement to sell forty million doses to Indonesia. In February, Hungary became the first European Union country to approve the Sinopharm vaccine for useafter the European Union faced shortages due to the European Commissions inability to cut a deal quickly with vaccine makers in 2020.

In February 2021, the Russian Ministry of Health reported that a vaccine called Sputnik V, based on the vector platform, had a 91.6 percent efficacy rate. Mexico immediately authorized it for use. Canada, Turkey, and South Korea were all testing their own vaccines, and even Cuba had produced a viable vaccine and was reportedly offering it to tourists. Bharat Biotechs inactivated virus vaccine was approved for emergency use in India. Meanwhile, the Serum Institute of Indiathe worlds largest vaccine-producing factorywas scheduled to manufacture one billion doses of vaccine, mostly for poorer nations.

To be sure, these endeavors did not all meet the standards that Moderna and Pfizer had set. Few in the Western world fully trust official Russian and Chinese numbers about anything. In January 2021, Brazil announced Sinovacs efficacy at 78 percent. A week later, the country revised that to above 50 percentstill high enough to meet WHO goals, but the swing from high to merely adequate efficacy nonetheless gives us pause.

Seven Stories Press

Inevitably, the race to the vaccine took on a nationalistic flavor. In August, Russian president Vladimir Putin announced on national state television that Russias Sputnik V vaccine (named after the USSRs landmark launching of the worlds first artificial satelliteplus a V for vaccine) was quite effective, even though it hadnt made it to a phase three trial. The Brits took to calling the Oxford-developed AstraZeneca shot the English one, and in Germany,

Pfizerwhich received early German fundingwas called the German one with pride.

But the challenge also spawned some intriguing collaborations, suggesting that the virus could inspire the notion of a brotherhood of nations and corporations on the fractious planet. Russia and the United Kingdom, for example, announced they were going to pool their adenovirus vaccines into a single vac- cine, to see if the combination amplified efficacy. GSK, based in Britain, and the French company Sanofi, usually competitors, joined forces, putting their combined Big Pharma financial and manufacturing capacity behind a vaccine. And, in March 2021, the White House brokered a collaboration to manufacture vaccines between Merck and Johnson & Johnson.

The flurry of research and collaboration has even led to scientists not just talking about but being on the verge of testing a pan-coronavirus vaccine made of nanoparticles studded with corona proteins, which would be effective against all coronaviruseseven the one that causes the common cold. Imagine a world without the common cold. Can vanquishing death and taxes be far behind?

Adapted fromVirus by Nina Burleigh,published bySeven Stories Press. 2021by the author.

GetForbesdaily top headlines straight to your inboxfor news on the worlds most important entrepreneurs and superstars, expert career advice, and success secrets.

Read this article:

How The Covid-19 Vaccine Injected Billions Into Big PharmaAnd Made Its Executives Very Rich - Forbes

A Pfizer-BioNTech COVID-19 vaccine vial and syringe. An advisory panel to the Centers for Disease Control and Prevention has recommended that the Pfizer-BioNTech vaccine be administered to children ages 12 to 15. Jaap Arriens/NurPhoto via Getty Images hide caption

A Pfizer-BioNTech COVID-19 vaccine vial and syringe. An advisory panel to the Centers for Disease Control and Prevention has recommended that the Pfizer-BioNTech vaccine be administered to children ages 12 to 15.

The Centers for Disease Control and Prevention recommends that the Pfizer COVID-19 vaccine be given to adolescents ages 12-15.

CDC Director Rochelle Walensky issued a statement saying, "The CDC now recommends the vaccine be used among this population, and providers may begin vaccinating them right away."

An independent federal advisory committee on Wednesday had voted 14 in favor with one recusal to recommend that the Pfizer-BioNTech vaccine be quickly approved for those as young as 12.

Making younger people eligible could open a new front in the fight against COVID-19 as many states follow the recommendation.

Previously, COVID-19 vaccines in the U.S. had been authorized only for people age 16 and older. Pfizer is the first vaccine manufacturer to gain emergency use authorization for younger Americans after it demonstrated in a March clinical trial that its vaccine was 100% effective in preventing COVID-19 in study participants who were ages 12 to 15.

"We're ready," President Biden said in an address Wednesday afternoon. "This new population is going to find the vaccine rollout fast and efficient. As of tomorrow, more than 15,000 pharmacies across this country will be ready to vaccinate this age group."

While publicly waiting for the CDC and FDA authorization process to play out, the Biden administration began quietly laying the groundwork to immediately roll out vaccines to adolescents.

That included aggressively working to sign up pediatricians and family practitioners to begin administering doses to their patients, making sure pharmacies are ready to serve younger patients and reaching out to Medicaid providers, since 40% of the nation's children are insured through the Children's Health Insurance Program.

Notably, a White House official tells NPR, the administration plans to make sure smaller packages of Pfizer vaccines get to doctors' offices as soon as they become available. This has been a significant obstacle, since the Pfizer vaccine is currently delivered just in packages holding nearly 1,200 doses, more than many private practitioners can handle. Pfizer has said it plans to begin shipping smaller packages by the end of this month.

As summer winds down, there will be an additional back-to-school push to reach young people before they return to classrooms. The administration plans to work to have COVID-19 vaccines offered as part of annual physicals and sports physicals that kids and teens are often required to get before school starts.

Panel finds studies support use of the vaccine in adolescents

During a meeting lasting nearly four hours, the advisory committee heard details of studies showing the vaccine prevented COVID-19 in more than 1,000 adolescents in the age range, while 16 cases occurred in those who got a placebo. No serious side effects were reported.

Public health officials, including those from the CDC and the independent advisers on the committee, said the vaccine will further help control the coronavirus pandemic in the U.S. and in other countries that typically follow the U.S. lead. Data presented by the CDC showed that about 20% of COVID-19 cases in the U.S. have been in children and adolescents 17 years of age and younger.

The American Academy of Pediatrics endorsed the move in a statement read during the meeting.

"This is truly an exciting development that allows us to protect a large population of children and help them regain their lives after a really rough year," said AAP President Lee Savio Beers. "As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected. The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated."

Comments from the public during an open session included questions of whether the relatively low risk of serious COVID-19 complications in children justifies the use of the vaccine in this age group before more studies are performed.

The study included more than 2,000 adolescents but was criticized by some public commenters for not being of sufficient size. Commenters also expressed concern that the studies were not sufficient to demonstrate whether there are any long-term effects associated with this or other COVID-19 vaccines.

CDC and Pfizer officials stressed study findings that show the vaccine is extremely safe in this age group, paralleling what has been seen in adults for several months now.

More than 150 million people in the U.S. have received at least one dose of one of the COVID-19 vaccines, with a very low rate of serious side effects.

Authorization comes in time for summer

The authorization and endorsement come in time for many adolescents to get vaccinated before participating in summer activities such as camping and group sports. Efforts to get as many adolescents vaccinated as possible before school restarts in August and September are already underway.

In the pediatric studies, the CDC and FDA evaluated the same two-dose regimen separated by three weeks that is used for people age 16 and up.

While children and adolescents generally have milder symptoms if they contract COVID-19 compared with adults, they can nonetheless pass the coronavirus on to others. That has parents worried about the prospect of schools fully reopening in the fall.

"I think we should be in full school, full in-person school, in the fall," the CDC's director, Walensky, said at a CNBC health summit on Tuesday.

Despite the Biden administration's push to get enough Americans inoculated against COVID-19 to establish herd immunity, the pace of vaccinations in the U.S. has slowed in recent weeks, with many adults opting not to get the shots.

CDC data shows that just over a third of Americans are fully vaccinated, with 46% having received at least one dose. While surveys have shown that only about 46% to 60% of parents have said they plan to have their adolescent children immunized, opening up vaccinations for millions of adolescents would likely get the U.S. closer to the goal of herd immunity.

To aid in persuasion, the White House official says the Biden administration has already held webinars and listening sessions with the American Academy of Pediatrics and numerous education associations.

There will be more sessions this week and into next week, including with the American Camp Association and Indian Health Service providers.

Over the coming days and weeks, there will be TV ads, social media campaigns and events with "celebrities and influencers who have the ability to reach out to teens and their parents." The White House declined to preview who these celebrities might be.

He's not a celebrity by any traditional definition, but U.S. Surgeon General Vivek Murthy is set to host a roundtable discussion with parents next week, aimed at answering questions about the vaccine.

In March, both Pfizer and Moderna launched pediatric trials of their vaccines in children as young as 6 months. Results are expected in the early fall. Neither company has applied to the FDA for emergency use authorization in children younger than 12.

Johnson & Johnson resumed shipments of its one-dose vaccine last month after U.S. federal regulators ended a 10-day pause in administering the vaccine while a potential link to a rare form of blood clot was examined.

The Moderna and Johnson & Johnson vaccines are currently authorized only for adults age 18 and older.

Meanwhile, states had already begun sending the Pfizer vaccine to pediatricians in anticipation of Wednesday's recommendation, according to The Associated Press.

Read this article:

CDC Says Kids As Young As 12 Should Get The Pfizer COVID-19 Vaccine - NPR

WASHINGTON Nearly a year ago, amid concerns about how to prevent transmission of the virus causing Covid-19, scientists were beginning to conclude that rigorous disinfection of surfaces say, fogging them or deep-cleaning with bleach was overkill.

Academics were warning that the risk of so-called fomite transmission was wildly overblown. In the fall, research from Israel and Italy found that the virus couldnt even be cultured from surfaces in hospital infectious disease units. By February of this year, the editorial board of Nature was openly urging the Centers for Disease Control and Prevention to update its guidelines.

The CDC did so last month.

advertisement

That so much time passed before the nations leading public health agency took a stand on an issue that seemed patently obvious to others was puzzling. But it was hardly an isolated incident.

After months of pleas from scientists, the CDC acknowledged last week that Covid-19 can be spread through small particles floating in the air an acknowledgment that came more than a year after some experts began warning that the virus is airborne. Separately, it took three months after Covid-19 vaccines began going into arms before the CDC issued its first attempt at outlining the activities vaccinated people could safely undertake.

advertisement

When the CDC issued new guidelines recently on when people still need to wear masks, the guidelines were seen as so conservative that they prompted a primetime rant on The Daily Show.

I know science is difficult but whos running messaging at the CDC? asked the shows host, Trevor Noah.

Some public health experts are asking the same question. Most experts interviewed for this story say the agency has struggled to take advantage of the latest scientific findings to communicate as rapidly as possible with the American public. And when the guidance is issued, it tends to be overly cautious.

The explanation does not seem to be, as it might have been under the Trump administration, political interference. Rather, there is a certain mentality when it comes to [caution] that I believe has been detrimental, said Leana Wen, an emergency physician and visiting professor of health policy at George Washington University.

Even defenders of the CDCs approach admitted that the agency has been conservative, and at times slow.

I admit it is a conservative approach, and they have historically always been very conservative, said Georges Benjamin, executive director of the American Public Health Association, who largely defended the CDC and insisted that the agency has followed the science.

The CDC did not respond to a request for comment.

The issues facing the CDC arent altogether new. Two former CDC directors, Tom Frieden and Rich Besser, both acknowledged to STAT that the CDC has continually labored to quickly release guidance though, like Benjamin, defended the agency.

In every public health crisis the complaint is made that the CDC is too slow to make recommendations, said Besser, who served as the acting CDC director in 2009. Its an issue that the CDC has always grappled with and will continue to grapple with.

Still, public health officials say the conservative nature of the agencys approach to Covid is a marked departure from how it deals with other major public health issues, like HIV and opioid use disorder.

There, public health officials by and large embrace harm reduction: giving honest advice on how to make risky behaviors safer, rather than discouraging activities altogether. For injection drug use, that means supporting needle exchanges and providing advice on cleaning syringes; for STDs, it means making sure those at outsized risk, like sex workers, have easy access to condoms.

When it comes to Covid-19, the CDC has often stressed simply avoiding certain activities.

Theres still a lot of abstinence-only in their Covid guidances, said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. People somehow kind of walled off what they know about HIV, opioid use, and hep C and we are the worse for it.

Nowhere is the CDCs abstinence-only approach clearer than in its advice on travel.

The evidence has been overwhelming for months: Americans, despite possible risks to themselves and their loved ones, are traveling during Covid-19.

Some 6.8 million Americans traveled via plane around Thanksgiving. The day before Christmas Eve was the busiest day at airports since the start of the pandemic. And by March, airports around the country were regularly serving 1 million travelers daily.

But the CDC repeatedly insisted Americans should not travel. It even discouraged vaccinated people from traveling in March guidance in which it laid out what vaccinated people can and cannot safely do.

It wasnt until April 2 that the CDC changed its stance sort of. The agency issued guidance that day saying fully vaccinated people can travel at low risk to themselves. But CDC Director Rochelle Walensky contradicted the guidelines almost immediately. During a press conference, Walensky said that she continues to advocate against general travel overall.

In every public health crisis the complaint is made that the CDC is too slow to make recommendations. Its an issue that the CDC has always grappled with and will continue to grapple with.

Rich Besser, former acting CDC director

Other CDC guidelines have been panned as unnecessarily restrictive.

The CDCs new guidance on reopening summer camps, for example, recommends that everyone at a camp, including children older than 2 and fully vaccinated adults, wear masks at all times even outdoors except when swimming or eating.

The guidance seemed disconnected from the science, which has continually shown that the risk of catching Covid-19 outdoors is low compared to the risk of indoor transmission. Its also thought that children particularly young children transmit the virus less efficiently than adults, though researchers are still studying Covid-19 dynamics in kids.

Former FDA Commissioner Scott Gottlieb called the guidance byzantine. Libertarian publications are equating it with the government recommending that summer camps treat kids like prisoners. Even Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledged last week that the guidelines certainly are conservative and a bit strict.

The CDC has faced similar criticism over its recent guidelines on when vaccinated and unvaccinated people need to wear masks.

That guidance recommends that vaccinated people continue to wear masks at crowded outdoor events, and at nearly all types of indoor gatherings. The unvaccinated are urged to wear a mask in nearly every situation, except when taking a walk outdoors or at a small gathering with fully vaccinated people.

Experts, like Emory Universitys Carlos del Rio, have criticized the guidance as too timid, and everyone from talk show hosts, like Noah of The Daily Show, to public health experts, like Virginia Techs Linsey Marr, have complained that the guidance, with a color-coded chart attempting to explain when to wear a mask, is too confusing. Even those who vociferously defended the CDC in interviews with STAT admitted that the CDCs masking guidelines could have been clearer.

They were going in the right direction, said Howard Koh, who served as assistant secretary for health during the Obama administration. I expect that future versions of those graphics and recommendations will be simplified and updated sooner rather than later.

Public health officials worry that the CDC is making it harder to beat back the Covid-19 pandemic by issuing guidance that is so timid, and doing it slowly.

Multiple experts told STAT that they fear the CDCs recommendations are becoming irrelevant for most Americans. They worry, too, that guidelines, like the CDCs advice on masking, so seriously underplay the benefits of getting vaccinated that they risk dissuading people from getting a shot in the first place.

It looks like theres still confusion, and what people are wanting from the CDC is more certainty, said Glen Nowak, a 14-year veteran of the CDCs communications department who now teaches at the University of Georgia. Nowak added that people want certainty from the CDC rather than what ifs, and that they want to know if you do believe in these vaccines, why do you show so much trepidation regarding these vaccines?

Even former CDC director Frieden told STAT he believes the CDC needs to be better at emphasizing with how sick and tired people are with restrictions, though he largely defended the CDCs guidelines.

I have sympathy for the CDC, said Frieden, who called making CDC guidance an art and a science that doing so requires an encyclopedic knowledge of the data as well as a sensible way of interpreting the data and applying it to everyday life.

We want simplicity when there isnt simplicity, Frieden added.

Besser, the former acting CDC director, also acknowledged that certain CDC guidelines, including advice on what vaccinated people can safely do, were released later than he would have liked. He attributed the CDCs slowness to a culture in which it gets challenged in settings where the science is incomplete, or settings where the science may not exist at all.

It was one of the biggest challenges that I felt we had, said Besser.

Its clear vaccines are cutting transmission dramatically. But some breakthrough infections still do occur, and researchers are still trying to determine the level of risk posed to others by someone who is infected after vaccination. Some experts, Frieden included, still also worry fomites are a possible mode of transmission, and studies were still being published in peer-reviewed journals late last year claiming fomite transmission is possible, even if its not the dominant mode of transmission.

I still dont like to touch the lobby button of elevators, Frieden said. I think we were too concerned about it last year and I think we may minimize it too much this year.

Defenders of the CDC insist its better for the agency to be cautious than it would be for it to get ahead of the science and then being forced to walk back recommendations.

The CDC wants to avoid making any sweeping new recommendations today that might have to be walked back tomorrow, said Koh. Theyre being extremely cautious and I respect them for that.

But those frustrated with the CDCs approach insist that waiting for more certainly just isnt an option.

If their advice is too disconnected from reality, and if they are too slow, then they make themselves irrelevant, Wen, the George Washington professor said. I understand that theyre in a difficult position. However caution and indecision also comes at a price.

Link:

CDC's slow, cautious Covid-19 messaging seems out of step with moment - STAT