Category: Covid-19 Vaccine

AstraZenecas COVID-19 vaccine road to approval has been anything but smooth.Announcingin Marchamid-Aprilsubmission for U.S. approval, that timeline has been pushed back to mid-May,with the company citing the massive dataset as the cause.

"There's a lot more data than just a Phase III study and so we're working as fast as we can to pull it all together and submit," said MenePangalos, executive vice president ofBioPharmaceuticalsR&D at AstraZeneca.

CEO PascalSoriotreassured in a first-quarter results briefing there is no issue with the data, its merely the size causing this speedbump.

From the beginning, AstraZeneca promised to sell its COVID-19 vaccine without profit. But sales havent kept up with the costs, resulting in a hit to earnings.Earnings from vaccine sales have been nowhere near the companys best-sellerTagrisso, acancerdrug, reported over $1.1 billion in sales for the same quarter.Vaccine sales for the first quarter came in at$275million, a paltry amount when comparedto the multibillion-dollar sales anticipated for Pfizer and Moderna.

Johnson& Johnson reported $100million in sales for its vaccine this quarter, having also pledged to sell its vaccine at cost. Pfizer and Moderna made no such forbearance of profit, expecting $15 billion and $18.4 billion in revenue, respectively, from sales of COVID-19 vaccines.

Developing a safe and effective vaccine at breakneck speed to stop a global pandemic is no small task. When the pandemic first began,over 100 vaccine candidates began the race to development.That list has been whittled downover the year as efforts have been abandoned.

Currently, just three COVID-19 vaccines are approved for use in the U.S., with AstraZeneca hoping to be the fourth.The vaccine is already approved for use in at least 78 countries.

With close to 240 million doses of eitherthe Pfizer-BioNTech, Moderna and J&J vaccines already administered in the U.S., itsbecoming likelythe AstraZenecashotsoriginallyintended tobe suppliedto the countryunder government contractare not needed. However, an approval by the FDAwould provide amuch-neededboost to confidence in the vaccine,as its faced multiplequestion-raisingsetbacks through the past months.

The Biden administration haspromisedto make the 60 million doses earmarked for the U.S. available to the rest of the world, pending a quality review.

Former Biden-team advisorEzekielEmanuel, oncologist and professor at the University of Pennsylvania, explained the importance of FDA approval for AstraZenecas vaccine, even if its not used in the U.S.

We need this vaccine out there helping the world, Emanuelsaid. If it were not authorized, that would be a blow to the whole world, not just the U.S.

The AstraZeneca shot is much cheaper than rival vaccines, as well as easier to transport and store. The companys initial pledge for three billion doses this year were primarily being supplied for poorer countries that cant transport or afford the pricier, cold storage vaccines.

The AstraZeneca shot reputation has taken a few hitswithreportsthat information provided by the company on its clinical trials was outdated and provided an incomplete view of efficacy data.

The biggest hit to confidence has been the suggested link between the AstraZenecavaccine and blood clots.Quebec just reportedCanadas firstblood clot death in a woman whohadreceived the vaccine.

"We just had our first patient who has died of a thrombosis, cerebral thrombosis, following vaccination from AstraZeneca," Dr. Horacio Arrudatolda news conference Tuesday."This is an event that is rare. We knew that it might happen.

Although the AstraZeneca vaccine has been linked to blood clot cases in the Europe and UK, the cases are still rare. Health authoritiesstillbelieve thebenefits of the vaccine far outweigh the lowrisk of blood clot.

More here:

AstraZeneca Hits Another Bump in the Road to COVID-19 Vaccine Approval in the US - BioSpace

The US vaccination campaign is entering a new phase, marked by excess supply of shots. And public-health experts, bioethicists, and doctors are debating whether or not mandating the COVID-19 vaccine would be helpful or harmful.

The arguments for and against mandates are shaping up to be a signature element of this next phase of the immunization campaign, as the key challenge in reaching herd immunity shifts from supply to demand. And experts are split on whether or not it's time to start enacting such requirements, as much of the nation continues to re-open and relax public-health restrictions.

Amid the debate, a small smattering of businesses and organizations are already requiring the shot, including a New York restaurant, a factory in Louisville, Kentucky, and a large health system in Houston. More than 100 colleges and universities have said they will require the shot for students and staff to return to campuses in the fall.

Overall, in conversations with five bioethicists, doctors, and public-health experts, Insider found an array of opinions on mandates. The most ardent backers say they should be rolled out now. Other supporters say they make sense in the next few months. Other experts warned the mandates are a heavy-handed approach that will be harmful at this stage in the rollout. There should be more in education and outreach to hesitant groups before requiring the shot, they say.

Art Caplan, a bioethicist at New York University, said he hopes more groups will follow the mandate track.

"Why are we still battling vaccine hesitancy with one hand behind our back?" Caplan told Insider. "Let's start to move a mandate through populations that are posing risks to others."

To do this, Caplan wants action at multiple levels, including the federal government, state governments, and private organizations. For example, a state legislature could insist its state police force be immunized. A private hospital could adopt a policy on its own, similar to the way many healthcare organizations require the flu shot .

In Caplan's view, mandates would help maintain the pace of vaccination, which has fallen dramatically over the past few weeks.

The rate of adults in the US getting their first dose peaked in early April at nearly 2 million per day. Now, that pace has dropped by nearly 50%, to about 1.1 million daily.

About 55% of adults in the US have received at least one dose, with 38% fully immunized, according to the Centers for Disease Control and Prevention. People on the fence about the shot would be nudged to roll up their sleeve. Ultimately, mandates would leave the US better prepared against the threat of another wave of illnesses and deaths, Caplan says.

Not all experts agree. Dr. Tia Powell, director of the Montefiore-Einstein Center for Bioethics, told Insider that mandates are the wrong strategy and will be harmful.

"It's expedient. It feels efficient," Powell said. "But I think it's really shooting yourself in the foot in the long run, particularly for any matter dealing with public health."

"The lack of trust in medicine and government is a critical issue right now," she added. "This will really light that problem on fire if you're forcing people to take the vaccine who are uncomfortable and frightened about it at the expense of losing their job."

As the unsettled debate heats up, some businesses and organizations are already rolling out requirements, tethering employment to someone's vaccination status. Job postings ranging from a sommelier at an upscale restaurant in New York to an assistant at the Boys & Girls Clubs in San Francisco are requiring vaccination, The Wall Street Journal's Chip Cutter reported.

Mandates could also skirt around some of the more troubling concerns around the idea of so-called vaccine passports, or digital apps that could allow businesses like a theater, sports stadium, or concert hall to verify the vaccination status of their customers. Vaccine passports have become a heavily politicized topic, with critics arguing it is an invasion of privacy and allows people to be tracked. Mandates, unlike passports, would likely be a one-time verification with an employer or specific organization.

Mandates face an array of legal, ethical, and logistical challenges.

Experts widely anticipate that a mandate will eventually wind up in court, challenged by a civil-rights or libertarian group. Advocates like Caplan and Dr. Robert Wachter, chair of University of California, San Francisco's medical school, said they're confident mandates would legally prevail.

In general, employers can require vaccination, providing some exemptions for medical and religious reasons. Mandates aren't unheard of. Many healthcare systems require the flu shot. Basic vaccinations, like against measles, are required for children in many states to attend school or daycare. Even then, these mandates aren't foolproof and have brought controversy. Small-scale measles outbreaks have still happened recently in the US. Parents can typically claim a range of religious or medical exemptions to avoid the requirement for their children.

A common argument against enacting mandates now is the COVID-19 vaccines are not fully approved medicines. US regulators issued emergency use authorizations for the shots developed by Moderna, Pfizer-BioNTech, and Johnson & Johnson. An EUA provides regulators with more flexibility during a crisis than the standard pathway of approval.

"If it is fully approved, I'm a lot more comfortable with it," said Andrew Noymer, an associate professor in population health and disease prevention at University of California, Irvine.

For now, Noymer said groups should be doing more educational work to convince hesitant people.

"I think mandates are for when you've exhausted all approaches that make people feel like stakeholders," Noymer said. "It's heavy-handed, and I think we need to exhaust all avenues of encouragement before we go to mandates."

Caplan and Wachter don't buy the argument on waiting for full approval. Both experts rebuffed the notion that these vaccines should be treated like experimental medicines, citing the fact that more than 140 million Americans have already gotten at least one dose.

"If you're not sure that it should be out there, then what are we doing?" Caplan said. "Of course we're sure this is a safe and good thing to do: we're vaccinating millions."

Waiting until full approval is a "quasi-argument," Wachter said, given the results from the rollout show these vaccines to be extremely safe and protective.

"The evidence on the vaccines after having been administered to more than 100 million people in the United States, the evidence is as clear as it's going to be that they are breathtakingly effective," Wachter said.

Some experts also see ethical challenges for mandates today. Powell, the bioethicist in New York, said such requirements needlessly lean on the force of authority, threatening to further politicize public health.

"We haven't earned the right to come in and enforce," she said. "It's lazy and it's arrogant and I don't think we should do that."

Stefanie Friedhoff, a professor of the practice in health services, policy, and practice at Brown University School of Public Health, said ""there's absolutely a role for mandates to play."

But she also said that how they are rolled out and communicated with the public is crucial in gaining support. In particular, she said people should still have time to make the decision. Forcing them into vaccination may stoke distrust, particularly among people of color who have a deservedly rocky history in trusting the medical system.

"In the long run, we need the mandates. They are important and they get people over the hill," Friedhoff said. "But in this current moment, we have these overlapping issues and it's not just the EUA. It includes the overall respect for some people will take a little bit of time to get to that decision and to give them the chance to trust the healthcare system in new ways. That's where I think a mandate has the potential to backfire."

Ultimately, even for proponents of mandates, the logistical hurdles are daunting. There's no federal system to authenticate that someone has gotten a vaccine. People get paper cards from the Centers for Disease Control and Prevention after getting the shot, but those can be easily forged. Scammers already sell fake cards online. A mandate would be tough to enforce if it's difficult to validate someone's vaccination status.

"To me, I don't think the legal issues are problematic. I don't find the ethical issues particularly problematic now that vaccine is available for everyone," said Wachter. "Right now, it's mainly a matter of can we come up with a trustworthy system. We should have started on it six months ago, but we didn't, so now we got to scramble."

If those logistics can be figured out, Wachter said vaccination mandates will be close to a no-brainer for many employers and organizations.

"By and large, the benefits of not only moving the entire community toward herd immunity but creating a workplace where everyone feels that it is safe to be there far outweigh the downsides," he said.

Even as the debate goes on, mandates are happening at some organizations, including Houston Methodist Hospital.

The 26,000-worker health system became the first major health system to require the shot so far. Every employee needs to provide proof of vaccination by June 7. Workers need to apply for medical or religious exemptions by May 3. For those that still choose not to get vaccinated and don't have an exemption, they will be suspended without pay and eventually fired.

Jennifer Bridges, a nurse at Houston Methodist, is planning to sue the hospital over the requirement. "All we're asking is: just more time," she told KHOU11, a local TV news station.

There about 3,000 employees holding out on getting the vaccine, Houston Methodist CEO Dr. Marc Boom said, defending the policy even in the face of legal threats.

"We're never going to make anybody take the vaccine," he told KHOU11. "But at the end of the day if they choose not to take the vaccine there are many other places they can work."

More health systems could follow soon. Houston's Memorial Hermann Health System is also planning on mandating the shot for workers, CNN reported on April 26. That organization has yet to set a firm deadline for getting the shot.

Wachter said he's particularly surprised that so few healthcare organizations have implemented requirements.

"I don't think it's a close call anymore," he said. "Someone working in an environment surrounded by people at high risk of getting very sick and dying have an ethical obligation to be vaccinated."

Healthcare systems may be fretting about the politics and pushback from some employees, Wachter said. It's likely a handful of workers would quit an organization over such a mandate. Still, Wachter said he's imploring healthcare systems to step up, particularly as some colleges and businesses are ahead in requiring vaccination.

One surprising element is far more colleges have said they will require vaccination than hospitals and health systems. That could lead to a bizarre dynamic this fall, UCI's Noymer said, when college kids need to get the shot but not necessarily most doctors or nurses.

"If your local state U is requiring it of their freshmen, it's a good question why your local hospital isn't requiring it of a respiratory tech or a doctor," he said. "I think things will come to a head in the fall, when you have literally dozens of colleges and universities requiring it for returning students but not your local hospital. That seems weird."

Dr. Francis Collins, the head of the National Institutes of Health, said he wouldn't disagree with private groups mandating the vaccine.

Collins said Sunday on Meet the Press that once "we no longer have this block about it being emergency use" groups could be more assertive in encouraging or requiring the shot.

For now, Collins is only encouraging, not mandating, vaccination within the NIH, he said.

See original here:

Should the COVID-19 vaccine be mandated in US immunization campaign? - Business Insider

But that's a drop in the bucket.

The US has bought or contracted to buy more than 1 billion doses of coronavirus vaccines. That's enough to vaccinate the US population at least twice, with plenty left over.

Medical ethicists told CNN the US has a moral duty to share those doses with other countries. That's especially true, they said, now that the pandemic is relatively under control in the US while countries like India have been overwhelmed by the virus.

"I do believe that the US is obligated to share vaccines with other countries," said Keisha Ray, an assistant professor and bioethicist at UTHealth McGovern Medical School in Houston, "especially those countries we might consider poorer countries or what we call underdeveloped countries."

Arthur Caplan, director of the Division of Medical Ethics at NYU's Grossman School of Medicine, agreed. He said the US was "ethically obligated" to share vaccines, pointing to the "horrific death toll and hospitalization tsunami that's taking place in many countries."

"Morally," he said, "we have to help."

It's a question of when -- not if

From an ethical perspective, everyone should have access to protection from Covid-19, Kathy Kinlaw, associate director for Emory University's Center for Ethics, told CNN.

She said many countries lack vaccine access because of the "diminished purchasing power for healthcare in general, but also for Covid-19 treatments and vaccines."

"I think the United States is definitely in a position where we should be sharing, absolutely," she said. "It's a matter of timing -- I think that's one real issue here."

The US is not simply obligated to share vaccines by virtue of its resources, Ray said. Wealthier countries like the US have historically benefited by hindering other countries, she said, whether through government relations or colonialism.

"We've gone to other poorer countries, taken their resources, and we've built our wealth on the backs of their resources," she said. "And we've left them in a position that now they can't care for themselves."

"Now we are in a position to give back, we are in a position to go there and help these countries," she said, like "paying our debt."

All three agreed it was right for the US to control its virus outbreaks before sharing vaccines. The pandemic is still an issue in the US, Ray said, but conditions have improved greatly.

"When you look at the US and global distribution of vaccines, you have to first ask, is the US in a position to help other people? That means it won't be of detriment to its own people, in this case Americans," she said. "So do we have the resources to share with other countries who are really struggling with the Covid pandemic? And simply put, right now, the answer is yes."

Caplan likened it to the rule for airplane oxygen masks that flight attendants describe prior to takeoff: "Put your own mask on before you assist others."

"You need to stabilize your own nation before you assist others," he said. "And I think we're there. I think we're getting there now."

US supply is outpacing demand

One factor in deciding to release extra vaccines is the issue of supply and demand -- specifically, that the former will soon outstrip the latter in the US, Kinlaw said. And that could mean it's time to start shipping spare doses overseas, she said.

"Once this happens," the report said, "efforts to encourage vaccination will become much harder, presenting a challenge to reaching the levels of herd immunity that are expected to be needed."

The US needs to continue to address vaccine hesitancy at home and be responsive to peoples' concerns, Kinlaw said. "But certainly there could be a point where there are people who will not take the vaccine and we have extra vaccine in this country, in which case it should be used and shared."

Data from the US Centers for Disease Control and Prevention shows that 30% of the US population is fully vaccinated. Experts like Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have estimated the US needs between 70% and 85% of the country to be immune -- either through vaccination or prior infection -- to reach herd immunity.

But even without reaching that crucial threshold, the US has enough vaccines to share with other countries, experts said.

"The world's wealthiest nations have locked up much of the near-term supply," wrote Dr. Krishna Udayakumar and Dr. Mark McClellan, health experts at Duke. "At the current rate vaccines are being administered, 92 of the world's poorest countries won't vaccinate 60% of their populations until 2023 or later."

Ray told CNN the main issue in the US is not one of supply. It's vaccine access for poor communities, rural communities and communities of color -- particularly those that are Black and Latino -- and lingering hesitancy, largely among White and conservative populations.

"That is an education, a public outreach and an access issue," she said. "We have other hurdles that are not supply hurdles. So we do have the supply to help other countries."

Global herd immunity will benefit everyone

It's not just the right thing to do.

The US and the world stand to benefit, especially if it wants to prevent further spread of the coronavirus and the emergence of new variants, the ethicists said.

"If you don't get these hotspots under control outside the US, they're going to come back, likely with new, dangerous strains that may undermine our vaccines," Caplan said. "It's both prudent to do it and ethical to do it."

Kinlaw also emphasized the importance of herd immunity not only in the US, but globally.

"Epidemiologically, we should be working to suppress the virus and to decrease transmission and decrease the continue evolution of the virus and the variants," she said. "That is going to be beneficial to every single person."

But vaccinations everywhere could also present economic benefits, Kinlaw said, allowing people to travel more freely and conduct business around the world.

"Beyond just doing what is just, we can look at it practically," said Ray, "and we can't have a country as large as India and as important to the global economy as India not producing the goods that we have come to rely on them for."

There are plenty of questions that will also have to be addressed when the US shares vaccines, Caplan said, like, "Who goes first? What do you do within the country? Is it too late and better to send medicine rather than vaccine?"

He pointed to the need to ensure a country that receives doses from the US is distributing them fairly and to vulnerable individuals.

"One of the ethical challenges is, are we going to insist on fair distribution within those countries? Or are we just going to give them vaccine and let them give it to the military and elite?" he said.

"It sounds nice to say we're going to aid others, but its simplistic, because some governments are corrupt," he said. "Some governments have no distribution plan other than to give it first to their own leaders, rather than to those in need."

CNN's Maggie Fox contributed to this report.

See the original post:

The US secured 1 billion doses of Covid-19 vaccines. Medical ethicists say it should share with other countries - CNN

His arm was a signal of his second COVID-19 vaccination, and that he was soon to be protected from the virus thatd so severely hit so many of his family members, even taking the life of his mother last year.

You get the second dose, probably feel (bad), but guess what, we got it done. So I love it, Towns said. Im excited to be fully vaccinated finally. Ive said it before and will say it again, I think its important for all of us to get vaccinated if we want to see life come back to normal. We all gotta make the sacrifice and make the effort to go get the vaccine.

Towns, his teammates and many other members of the Timberwolves organization took such measures this week.

Its kind of a relief. Little bit of excitement at the same time, it allows you to get back to normal as we move towards our threshold here, Timberwolves coach Chris Finch said. We can start operating with less constraints. Offseason scheduling and all that kind of stuff will be a little easier to manage. Thats whats most important, so were all looking forward to that.

Timberwolves forward Jarred Vanderbilt admitted he was a little skeptical about the vaccine at first, but ultimately decided to get the shot.

Once I got it, I felt good about it, not only for me, but for the people around me, Vanderbilt said. I was trying to make a safer environment for all of us. I feel good about it. It was a little bit of a sigh of relief.

Finch said it was a mixed bag of side effects between those who got the second dose.

Some guys felt it, some guys were OK, Finch said. Nobody was reporting anything untoward (Saturday) at shootaround.

Everyone was good to go for Saturdays contest against New Orleans.

Me personally, Im good right now, Vanderbilt said. I felt it a little bit (Friday). A little headache and a little body ache.

The Timberwolves winning streak has intoxicated its most loyal fans, but sports books are yet to buy into the teams success.

Minnesota was a hefty underdog in both of its games against Utah, was a narrow favorite against Houston the worst team in the league and was an underdog again at home Thursday against Golden State.

But the Wolves won all of those games. And theyd beaten New Orleans in each of their prior two meetings this season. So logic would suggest Minnesota would be a favorite Saturday at Target Center against the Pelicans, a fringe playoff team.

Nope, Minnesota was a four-point underdog.

See the article here:

Timberwolves relieved to get second dose of COVID-19 vaccine - Duluth News Tribune

ST. PAUL, Minn. (WXOW) - Numbers released Saturday by theMinnesota Department of Healthshow that over 45 percent of residents throughout the state have had at least one dose of the COVID-19 vaccine.

MDH figures as of Thursday, the most recent data available, show that 50.5 percent of all Houston County residents have received the first dose. 43.4 percent of the county's population is finished with the vaccine series. 94.9 percent of those 65 and over have had at least one dose of the vaccine according to MDH.

Winona County has had 44.9 percent of its population get at least one dose, while 39.3 percent have completed the vaccine series. 87.1 percent of those 65+ have had at least one dose of the vaccine.

Overall, the figures show 1,938,241 people or 34.8 percent have completed the vaccination series according tothe state's vaccination dashboard.

Among the total population, MDH said 2,556,515 persons, or 46 percent, have received a first dose of the vaccine.

RELATED: Find local vaccine and vaccination information here

In figures released Saturday, the Minnesota Department of Health Services reported 10 new deaths from COVID-19 in Minnesota.

To date, a total of 7,154 people have died from COVID-19 in Minnesota, the Department reported. MDH said 4,370 of those who died were residents of long-term care or assisted living facilities.

State health officials also reported in its update that another 1,723 people have tested positive for COVID-19 in Minnesota. The cases were tested through a combination of PCR and antigen tests.

Winona County reported three new cases. Houston saw one new case while Fillmore County had two. For a list of how many cases have been reported in each countyclick here.

A total of 577,524 people have tested positive for COVID-19 in Minnesota, including 41,456 health care workers, MDH said. Health officials said 39,054 of the state's cases were reported through positive antigen tests, rather than PCR tests, so they are considered "probable cases."

Health officials said 555,214 of those who tested positive for COVID-19 in Minnesota no longer need to be isolated.

MDH also reported that the total number of tests completed in the state is 9,270,547. The Department reported that about 4,039,525 people have been tested for COVID-19 in Minnesota, noting that some people get tested more than once.

MDH also said a total of 30,344 people have been hospitalized with COVID-19 in the state to date. This includes 6,180 patients who have been hospitalized in the ICU.

Continue reading here:

Minnesota Update: Over 45 percent of residents have started the COVID-19 vaccination series - WXOW.com

JACKSONVILLE, Fla. Half of the adults in the United States have now received a COVID-19 vaccine but the race to get people vaccinated is not over yet.

In Jacksonville, a COVID-19 vaccine event will be held each weekend with no appointments necessary. Read on for the vaccine event happening soon.

On Sunday, May 2 a COVID-19 vaccine event will be held at the Webb Wesconnett Library.

This story will be updated with the latest one-day vaccine information as soon as it becomes available.

Follow this link:

This weekends one-day COVID-19 vaccine sites - ActionNewsJax.com

Heres what you need to know about taking allergy medicines before getting the COVID-19 vaccines  The Philadelphia Inquirer

More:

Heres what you need to know about taking allergy medicines before getting the COVID-19 vaccines - The Philadelphia Inquirer

NEW DELHI In hopes of taming a monstrous spike in COVID-19 infections, India opened vaccinations to all adults Saturday, launching a huge inoculation effort that was sure to tax the limits of the federal government, the countrys vaccine factories and the patience of its 1.4 billion people.

The worlds largest maker of vaccines was still short of critical supplies the result of lagging manufacturing and raw material shortages that delayed the rollout in several states. And even in places where the shots were in stock, the countrys wide economic disparities made access to the vaccine inconsistent.

Only a fraction of Indias population will be able to afford the prices charged by private hospitals for the shot, experts said, meaning that states will be saddled with immunizing the 600 million Indian adults younger than 45, while the federal government gives shots to 300 million health care and front-line workers and people older than 45.

So far, government vaccines have been free, and private hospitals have been permitted to sell shots at a price capped at 250 rupees, or around $3. That practice will now change: Prices for state governments and private hospitals will be determined by vaccine companies. Some states might not be able to provide vaccines for free since they are paying twice as much as the federal government for the same shot, and prices at private hospitals could rise.

Since state governments and private players compete for shots in the same marketplace, and states pay less for the doses, vaccine makers can reap more profit by selling to the private sector, said Chandrakant Lahariya, a health policy expert. That cost can then be passed on to people receiving the shots, increasing inequity.

There is no logic that two different governments should be paying two prices, he said.

Concerns that pricing issues could deepen inequities are only the most recent hitch in Indias sluggish immunization efforts. Less than 2% of the population has been fully immunized against COVID-19 and around 10% has received a single dose. Immunization rates have also fallen. The average number of shots per day dipped from over 3.6 million in early April to less than 2.5 million right now.

In the worst-hit state of Maharashtra, the health minister promised free vaccines for those ages 18 to 44, but he also acknowledged that the shortage of doses meant immunization would not start as planned on Saturday. States say the paucity of shots is one reason why immunizations have declined.

India thought the worst was over when cases ebbed in September. But mass gatherings such as political rallies and religious events were allowed to continue, and relaxed attitudes on the risks fueled a major humanitarian crisis, according to health experts. New variants of the coronavirus have partly led the surge. Deaths officially surpassed 200,000 this week, and the true death toll is believed to be far higher.

The countrys shortage of shots has global implications because, in addition to its own inoculation efforts, India has promised to ship vaccines abroad as part of a United Nations vaccine-sharing program that is dependent on its supply.

Indian vaccine makers produce an estimated 70 million doses each month of the two approved shots the AstraZeneca vaccine made by the Serum Institute of India and another one made by Bharat Biotech.

The federal government is buying half of those vaccines to give to states. The remaining half can then be bought by states and private hospitals to be given to anyone over 18, but at prices set by the companies.

The federal government is buying shots at 150 rupees each, or $2. The Serum Institute will sell the shots to states at 300 rupees each, or $4, and to private players at 600 rupees each, or $8. Bharat Biotech said it will charge states 400 rupees, or less than $5.50 for a shot, and private players 1,200 rupees, or more than $16.

By comparison, the European Union paid $2.15 per dose for the AstraZeneca vaccine. The company says that price is discounted because the EU contributed to the vaccines development.

The strain is mounting on the Serum Institute, which in addition to being Indias main supplier is also a critical supplier of the U.N.-backed initiative known as COVAX, which more than 90 countries are depending on. The institute paused exports in March.

The urgent demand for vaccines in India is bad for the rest of the world, said Ravi Gupta, a professor of clinical microbiology at Cambridge University.

Some experts warned that conducting a massive inoculation effort now could worsen the surge in a country that is second only to the United States in its number of infections more than 19.1 million.

Theres ample evidence that having people wait in a long, crowded, disorderly queue could itself be a source of infection, said Dr. Bharat Pankhania, a senior clinical lecturer specializing in infectious diseases at Britains University of Exeter. He urged India to first stop the circulation of the virus by imposing a long, sustained, strictly enforced lockdown.

Pankhania cautioned that immunization efforts alone would not help immediately stem the current spike of COVID-19, since shots only start to bear fruit in about three months time. Vaccination would help prevent future waves of infection, he said.

India is also importing shots from the Russian makers of Sputnik V. The first batch was due to arrive Saturday. Another 125 million doses of Sputnik V will be distributed by an Indian pharmaceutical company later this year.

Given the urgent need for vaccines, some experts said rationing available doses is critical.

Vaccines need to be delivered to the areas with the most intense transmission, Gupta said, explaining that vaccines should be used as emergency control measures in specific regions of India rather than offering doses to all adults across the subcontinent.

Pankhania said the widely seen images of Indian virus patients gasping for air and smoke billowing from makeshift funeral pyres should spur rich countries to share their vaccines more freely. He criticized the approach taken by many Western countries that are attempting to vaccinate all citizens, including younger people at low risk, before sharing any doses.

It is better globally to immunize all the (vulnerable) people that need to be protected rather than to immunize entire populations in only some countries, Pankhania said.

Visit link:

India begins widespread COVID-19 vaccination to all adults - New York Post

Doctors said simply receiving the COVID-19 vaccine could be stressful enough to trigger a change in menstruation, but the vaccine itself has nothing to do with it.

SEATTLE A lot of women have said their menstrual cycle changed after receiving the COVID-19 vaccine, but is there actually any relationship between the two?

To verify and answer the burgeoning question, we consulted with Dr. Lora Shahine, an endocrinologist and fertility specialist who is also an associate professor at the University of Washington.

"I have read the social media posts," Shahine told KING 5. "I have had some patients that have asked me and said, 'my cycles are a little bit heavier, or a little bit off schedule after the vaccine."

Stories in the New York Times and Chicago Tribune have helped fuel the fire online, but as the doctor who co-authored the op-ed in the New York Times wrote: So far, theres no data linking the vaccines to changes in menstruation.

Still, when a researcher seeking participants for a definitive study tweeted about the topic, it got hundreds of responses, with many women saying they were late.

But doctors said menstrual cycles can change for numerous reasons, including diet, exercise, illness and more. The Mayo Clinic lists additional possibilities, including pregnancy, breastfeeding and premature ovarian failure.

"It's OK to be concerned, to ask questions, but it's not unusual to have a cycle that's disrupted or a little bit heavier, said Shahine. There are so many things that have to communicate, as far as hormones and our immune system, in order to have regular, predictable menstrual cycles. We can have a cycle thrown off by traveling or a really stressful event. So, I'm really not surprised that people are having a change after getting their vaccine. I don't want people to worry."

In other words, simply receiving the COVID-19 vaccine could be stressful enough to trigger a change in menstruation, even though the vaccine itself has nothing to do with it.

Ive been fighting the rumors that the COVID vaccine causes infertility for a few months now, explained Shahine. This is just the next rumor that we are going to fight and hopefully ease their worries, and help people get the vaccine to help us end this pandemic."

In the end, we can verify there is no proof that the COVID-19 vaccine affects menstrual cycles.

Read the original:

VERIFY: Did your menstrual cycle change after the COVID-19 vaccine? Heres what doctors have to say - KING5.com

Debate has raged over which provides better protection against COVID-19 natural infection or vaccine injection?

Sorry Dr Fauci and other fearmongers, new study shows vaccines and naturally acquired immunity DO effectively neutralize COVID variants. Good news for everyone but bureaucrats and petty tyrants! tweeted a combative Kentucky Sen. Rand Paul in March.

A large-scale study by UC Irvine researchers may definitively settle this debate. They found that, yes, natural infection provides protection, but mRNA vaccines like Pfizer and Moderna kick natural immunitys butt in protecting against COVID-19.

Our results show that the nucleic acid vaccines in use in this setting are remarkably effective at elevating (antibody) levels against SARS-CoV-2 antigens, says the study, posted April 20. The level and breadth of protection induced by these mRNA vaccines is much greater than that induced by natural infection.

Indeed, after the second mRNA shot, vaccinated people had antibody levels up to 10 times higher than what was found in convalescent plasma from people who recovered from natural infection, the researchers found.

Added bonus: The mRNA vaccines also allow the immune system to recognize other novel coronavirus strains, offering hope that vaccination will be effective against emerging virus variants that are circulating around the world, they said.

This is a pretty spectacular thing, said Philip L. Felgner, director of UC Irvines Vaccine Research and Development Center and Protein Microarray Laboratory and Training Facility, who was one of the researchers. Its not just doing something for a relatively small group of patients with uncommon disease here were talking about saving the whole world.

The mRNA vaccines eclipsed natural infection at one very specific task: recognizing the precise piece of the virus spike protein that binds to and infects healthy cells.

The spike protein is big, Felgner said. And in natural infections, the virus manages to hide this vital receptor so the immune system doesnt see it. And if the immune system doesnt see it, it cant develop antibodies to it.

When a person gets infected they develop an immune response, but its not against this most important part, Felgner said. So the virus can evade the immune response that we develop, and thats really favorable for the virus. It means it can go on out and propagate in the world, mutate itself more, make more variants.

But that doesnt happen with mRNA vaccines. The mRNA instructs the body to manufacture the piece of the spike protein with this otherwise-hidden receptor which allows the body to produce antibodies to it.

Since vaccination induces a more robust immune response than natural exposure alone, those whove recovered from COVID may benefit from getting vaccinated, the paper found.

Outside experts were buoyed by the findings.

I was hoping for this, and it was reflected in developmental animal data. But to actually see it work is amazing, said Dr. Brigham C. Willis, senior associate dean for medical education at the UC Riverside School of Medicine, who was not involved.

This represents a huge step forward in our ability to combat emerging and existing diseases. This new technology is so powerful. Now we can produce vaccines against a huge variety of disease that were heretofore impossible, and incredibly fast. The fact that it produces immunity much higher and more broadly against these difficult and mutating pathogens is huge. It will be very simple to produce boosters that include variants.

It should also be exciting in the next couple of years, as I imagine we will now be able to produce effective vaccines against a variety of things we could not before the common cold, perhaps flu, maybe even other things, Willis said.

George Rutherford, a professor of epidemiology and biostatistics at UC San Francisco who also was not involved in the research, said, Vaccine-induced immunity provides much, much higher levels of neutralizing antibody, at least in the medium term.

The study must be peer-reviewed, Felgner said, and clinicians and public health officials should use the data to inform patients and public health policy.

Researchers are measuring how long vaccine-induced immunity lasts to guide the timing of future booster shots and theyll compare the immune responses induced by different types of vaccines, such as mRNA (Moderna, Pfizer) and adenovirus delivery systems (Johnson & Johnson, AstraZeneca).

In one area of concern, the UCI researchers found that immune-compromised people such as those whove had organ transplants and are on immune-suppressing drugs dont develop high antibody levels after vaccination. We need to discover ways to boost immunity in the immune compromised, Felgner said.

The big takeaway is that mRNA vaccine-induced antibody levels are spectacular and appear rapidly within a few days after vaccination, he said. Only in our dreams we could have imagined a vaccine that could be developed so quickly, works so well, can be manufactured at scale, distributed and administered to billions of people worldwide within months.

But this isnt a scientific miracle, he said. Nucleic acid vaccination was discovered 30 years ago and has been the passion of hundreds of scientists over the decades, backed by billions of dollars of investment, including millions from the National Institutes of Health.

It shows how we make progress in science, Felgner said. Sometimes people complain, Why are we giving all this money to the NIH? A reason is, so we can be prepared like we are today to respond to this outbreak.

The researchers used data from several different studies in Orange County of thousands of people. To detect antibody levels, they used a coronavirus antigen microarray that is the intellectual property of the Regents of the University of California and licensed for commercialization to Nanommune Inc., a private company in which Felgner and several co-authors own shares.

Original post:

Which is better for developing immunity: COVID-19 vaccine or natural infection? - The Mercury News