Category: Covid-19 Vaccine

The important lesson is that people want to know that someone they respect recommends the vaccine. This could be a national political figure, but people are most likely to respond to local leaders, especially family doctors and local nurses, communications experts said. They may also listen to ministers, family members and celebrities. For those who, like Harris, trust science and Dr. Fauci, it could be a scientist. Philip Massey, a health communications expert at Drexel Universitys Dornsife School of Public Health, said public health officials should be talking with groups like Black Lives Matter activists about vaccines.

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Once a COVID-19 vaccine is here, there will be a new challenge: Convincing people its safe - The Philadelphia Inquirer

Harris says she would absolutely take a vaccine if it was recommended by public health professionals, but not if only President Trump says to. USA TODAY

The global effort to develop a COVID-19 vaccine has been apriority since the coronavirus pandemic started. Seven months into the U.S. outbreak,vaccine candidatesare facing skepticismby some in the general public and various elected officials.

Leading health officials, such as Dr. Anthony Fauci, have maintained that a vaccine likely won't be widely available until mid-2021. Meanwhile, President Donald Trump haspromiseda vaccine before Election Day, prompting the Democratic vice presidential candidate Kamala Harris to accuse Trump of politicizingthe vaccineand to question its safety, noting that she would take it only if the health experts said it was safe.

The effectiveness and safety of a COVID-19vaccine is not the only thing people are worried about. Vaccine conspiracy theories that originated in anti-vaxxer communitieshave thrived anew in the COVID-19 era, including claims that the vaccine wouldimplant microchipsor that it will be mandatory for every American.

Apost from from Before It's News, a website that allows anyone to contribute,which was shared 38,00 times as of Oct. 15furthers the conspiracy theory of a mandatory vaccine, witha headline reading, "The Government Has Released Their Initial Plans to Force a Vaccine on Everyone."

The postalso says, "Three potential vaccines are currently in Stage 3 trials in the United States and could be ready in weeks," citing Trump.

USA TODAY reached out to the site's Facebook page for comment.

We'll look at thetwo claims here:Will a vaccine be mandatory? And, what does the development and distributiontimeline really look like?

According to the Centers for Disease Control and Prevention, the general cycle for the development of a new vaccine has six stages:exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing and quality control.

The global prioritization of finding a COVID-19vaccine has shortened the timeline of its development, which for a regular vaccinewould usually take years. However, vaccine developers and institutions like the CDCare following existing protocols to ensure the vaccine's safety and effectiveness.

As of Oct. 15, according to the World Health Organization,42 vaccine candidates are in clinical evaluations and 156are in preclinical evaluations.

16-year-old Katelyn Evans gets the first of two shots as part of a trial testing Pfizer's COVID-19 vaccine in minors.(Photo: Cincinnati Children's Hospital)

The postfrom Before It's News cites a Sept. 15 commentfrom Trump where he saida vaccine could be ready in a "matter of weeks."On Oct. 5, Trump said vaccines would be ready "momentarily."However, scientists disagree.

On Sept. 16, Dr. Robert Redfield, director of the CDC, said that while an effective vaccine could be developed before the end of this year, it won't be available to the general public until the second or third quarter of 2021.

Speculation about mandatory vaccinations for COVID-19 started spreading on social media from the moment scientists began talksabout developing a vaccine.

There is no evidence to support the claim that a COVID-19 vaccine will be mandatory for the entire population.

The post in question cites a COVID-19 vaccineinterim playbook from the CDC, which was created in partnership with theU.S. Department of Health and Human Services and the U.S. Department of Defense.The postmisinterprets and misrepresents the content of the playbook, whichdoes not state that everyone will be required to get a COVID-19 vaccine.

The playbook lays out the plan to effectively distribute the vaccine first to healthand essential workers andvulnerable groups before increasing accessto the general public.

At an August town hall hosted by Healthline, Fauci said the coronavirus vaccine won't be mandatory in the United States, adding that people have a right to refuse it.

I dont think youll ever see a mandating of vaccine, particularly for the general public," Fauci said.

Fauci also said some industries may mandate the vaccine for employees, such ashow the National Institutes of Healthmandates the flu vaccine for its workers. That also is in the playbook.

According to the CDC, "State laws establish vaccination requirements for school children ... . All states provide medical exemptions, and some state laws also offer exemptions for religious and/or philosophical reasons."

Additionally, the U.S. OccupationalSafety and Health Administration took the position that employers canrequire staff to take vaccines, like the flu vaccination.

In general, employers can mandate vaccines for their staff.However, according to the National Law Review,this practice does have limitations and is not always recommended.

Like the exemptions that exist for school vaccine requirements, similar exemptions can also be appliedto workerswho have a reasonablebelief that a medicalconditionmay result inillness or death, according to OSHA.

If someone refuses the vaccine in the general public, then theres nothing you can do about that, Faucisaid. You cannot force someone to take a vaccine.

The claims in the post have been rated FALSE. The claim that a vaccine will be ready within weeks, while stated by the president, has been consistently contradicted by public health officials who say a vaccine likely won't be ready by Election Day, nor would it be available to the general public before the middle of 2021. There is alsono evidence to support the claim that the coronavirus vaccine will be mandatory for the general public.

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Fact check: COVID-19 vaccine won't be ready in weeks, nor mandatory - USA TODAY

Still, its fair to say that most of the general public assumes that the whole point of the current trials, besides testing safety (box 1), is to see whether the vaccine can prevent bad outcomes. How do you reconcile that? The BMJ asked Zaks.

History shows many examples of serious adverse events from vaccines brought to market in periods of enormous pressure and expectation. There were contaminated polio vaccines in 1955, cases of Guillain-Barr syndrome in recipients of flu vaccines in 1976, and narcolepsy linked to one brand of influenza vaccine in 2009.1819

Finding severe rare adverse events will require the study of tens of thousands of patients, but this requirement will not be met by early adoption of a product that has not completed its full trial evaluation, Harvard drug policy researchers Jerry Avorn and Aaron Kesselheim recently wrote in JAMA.20

Covid-19 vaccine trials are currently designed to tabulate final efficacy results once 150 to 160 trial participants develop symptomatic covid-19and most trials have specified at least one interim analysis allowing for the trials to end with even fewer data accrued.

Medscapes Eric Topol has been a vocal critic of the trials many interim analyses. These numbers seem totally out of line with what would be considered stopping rules, he says. I mean, youre talking about giving a vaccine with any of these programmes to tens of millions of people. And youre going to base that on 100 events?8

Great uncertainty remains over how long a randomised trial of a vaccine will be allowed to proceed. If efficacy is declared, one possibility is that the thousands of volunteers who received a saline placebo would be offered the active vaccine, in effect ending the period of randomised follow-up. Such a move would have far reaching implications for our understanding of vaccines benefits and harms, rendering uncertain our knowledge of whether the vaccines can reduce the risk of serious covid-19 disease and precluding any further ability to compare adverse events in the experimental versus the placebo arm.

Itll be a decision well have to take at that time. We have not committed one way or another, Modernas Tal Zaks told The BMJ. It will be a decision where FDA and NIH will also weigh in. And it will be probably a very difficult decision, because you will be weighing the benefit to the public in continuing to understand the longer term safety by keeping people on placebo and the expectation of the people who have received placebo to be crossed over now that it has been proved effective.

Very simply, he replied. Number one, we have a bad outcome as our endpoint. Its covid-19 disease. Moderna, like Pfizer and Janssen, has designed its study to detect a relative risk reduction of at least 30% in participants developing laboratory confirmed covid-19, consistent with FDA and international guidance.2122

Number two, Zaks pointed to influenza vaccines, saying they protect against severe disease better than mild disease. To Moderna, its the same for covid-19: if its vaccine is shown to reduce symptomatic covid-19, it will be confident it also protects against serious outcomes.

But the truth is that the science remains far from clear cut, even for influenza vaccines that have been used for decades. Although randomised trials have shown an effect in reducing the risk of symptomatic influenza, such trials have never been conducted in elderly people living in the community to see whether they save lives.

Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths.23 Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality (box 2).26

A vaccine that has been proved to reduce the risk of symptomatic disease by a certain proportion should, you might think, reduce serious outcomes such as hospital admissions and deaths in equal proportion.

Peter Marks, an FDA official with responsibility over vaccine approvals, recently stated as much about influenza vaccination, which only prevents flu in about half the people who get it. And yet thats very important because that means that it leads to half as many deaths related to influenza each year.24

But when vaccines are not equally effective in all populations the theory breaks down.

If frail elderly people, who are understood to die in disproportionate numbers from both influenza25 and covid-19, are not enrolled into vaccine trials in sufficient numbers to determine whether case numbers are reduced in this group, there can be little basis for assuming any benefit in terms of hospital admissions or mortality. Whatever reduction in cases is seen in the overall study population (most of which may be among healthy adults), this benefit may not apply to the frail elderly subpopulation, and few lives may be saved.

This is hard to evaluate in the current trials because there are large gaps in the types of people being enrolled in the phase III trials (table 1). Despite recruiting tens of thousands, only two trials are enrolling children less than 18 years old. All exclude immunocompromised people and pregnant or breastfeeding women, and though the trials are enrolling elderly people, few or perhaps none of the studies would seem to be designed to conclusively answer whether there is a benefit in this population, despite their obvious vulnerability to covid-19.

Adults over 65 will be an important subgroup that we will be looking at, Modernas Zaks told The BMJ. That said . . . any given study is powered for its primary endpointin our case covid-19 disease irrespective of age.

Al Sommer, dean emeritus of the Johns Hopkins School of Public Health, told The BMJ, If they have not powered for evidence of benefit in the elderly, I would find that a significant, unfortunate shortcoming. He emphasised the need for innovative follow-up studies that will enable us to better determine the direct level of protection immunisation has on the young and, separately, the elderly, in addition to those at the highest risk of severe disease and hospitalisation.

One view is that trial data should be there for all target populations. If we dont have adequate data in the greater than 65 year old group, then the greater than 65 year old person shouldnt get this vaccine, which would be a shame because theyre the ones who are most likely to die from this infection, said vaccinologist Paul Offit.8 We have to generate those data, he said. I cant see how anybodythe Data and Safety Monitoring Board or the FDA Vaccine Advisory Committee, or FDA decision-makerswould ever allow a vaccine to be recommended for that group without having adequate data.

I feel the same way about minorities, Offit added. You cant convince minority populations to get this vaccine unless they are represented in these trials. Otherwise, theyre going to feel like theyre guinea pigs, and understandably so.

Originally posted here:

Will covid-19 vaccines save lives? Current trials aren't designed to tell us - The BMJ

Li Shurui didnt hesitate. Faced with putting his life on hold indefinitely or the risk of catching COVID-19 by returning to university in the U.K., the 22-year-old business student decided to roll up his sleeve and receive an experimental coronavirus vaccine.

Two injections of CoronaVac made by SinoVac (otherwise known as Beijing Kexing Bioproducts) cost 2,000 rmb ($300) at the private Taihe Hospital in the Chinese capital. The treatment still hasnt passed final (Stage 3) clinical trials but is already being offered to the public on a first come, first served basis. Anyone can turn up, pay their money and get the jab. Li says hundreds were queuing to get immunized at the same time as him.

Im a little worried about side effects but more worried catching the virus overseas, Li tells TIME. But I havent had any problems from the jabs so far.

Its not just the CoronaVac vaccine on offer in China. An unofficial vaccine rollout is gathering pace despite the warnings of international public health experts. In September, state-owned SinoPharm revealed that hundreds of thousands of Chinese had already taken its experimental COVID-19 vaccines as part of a state initiative to protect frontline health workers and officials traveling to high-risk nations. In the eastern manufacturing hub of Yiwu this week, hundreds of people queued for a $60 dose of CoronaVac.

Read more: We Will Share Our Vaccine with the World. Inside the Chinese Biotech Firm Leading the Fight Against COVID-19

This is insane, Adam Kamradt-Scott, associate professor specializing in global health security at the University of Sydney, says of Chinas gung-ho vaccine rollout. It is just unsound public health practice. We have previous examples of where vaccines that have not gone through sufficient clinical trials have demonstrated adverse reactions with long-term health consequences.

As the coronavirus pandemic approaches its 11th month, with over 40 million cases and 1.1 million deaths globally, longing for a miracle cure becomes more desperate. But the consequences of a vaccine misstep could also be dire. In 1976, a rushed campaign to immunize millions of Americans against swine flu subsequently resulted in a small proportion developing chronic fatigue syndrome and helped spark the modern anti-vaxxer movement. Handing out a pre-approval vaccine without sufficient monitoring of efficacy and health of participants risks stoking public misinformation.

Read more: How an Election-Year Vaccine Rollout in 1976 Backfired

Whats more, since COVID-19 cases are so low in China, Stage 3 trialswhen the vaccine is given thousands to see how many become infected, compared with volunteers who received a placebocan only be conducted overseas. There have also not been any challenge trials where scientists deliberately expose vaccinated volunteers to the virus to test immunity. (Although controversial, such trials are about to go ahead in the U.K.)

But its not just China thats getting ahead of itself. U.S. President Donald Trump has put enormous public pressure on regulators and pharmaceutical companies to make a vaccine available in time for the American election. On Oct. 16, Pfizer revealed it may begin rolling out its vaccine for emergency use in the U.S. by late November. Moderna has a similar timeline for emergency use, though cautions widespread vaccine distribution may not happen until the spring.

The difference in China, however, is that the virus has been largely contained domestically. The country reported only 14 cases on Wednesday, all imported. It seems there is no need to get a vaccine in China, says the student Li. After all, the pandemic has little impact on life in China now; even masks are not mandatory here anymore.

So why is China so aggressively rolling out vaccines? For the Beijing government, the fight against the pandemic has become a PR battle to drown out international criticism about its early mishandling, coverup and silencing of whistleblowers. Instead, China wants to rebrand itself as a source of vital PPE and, ultimately, a solution the crisis. Chinas National Health Authority projected Chinas COVID-19 vaccine production capacity will reach 610 million doses annually by the end of 2020. SinoPharms boss says his firm alone may be able to produce more than 1 billion doses next year.

Read more: Inside the Unprecedented Scramble to Immunize the World Against COVID-19

Sinovac has promised to supply 40 million CoronaVac doses to Indonesia by March 2021. So Paulo Governor Joo Doria said Brazils federal government had also agreed to buy 46 million doses of CoronaVac, one of at least five vaccines undergoing stage 3 trials in the country, which has the worlds third highest infection tally.

The first results of the clinical study conducted in Brazil prove that among all the vaccines tested in the country, CoronaVac is the safest, the one with the best and most promising rates, Doria told reporters Monday.

Of course, China is not alone in craving the PR benefits. On Aug. 11, Russian President Vladimir Putin unveiled what was ostensibly the worlds first COVID-19 vaccine, which he said had already been administered to his daughter. The trade nameSputnik 5, after the groundbreaking Soviet satelliteleaves no doubt at the national pride wrapped in its development. But it was tested on only 76 people38 in Phase I and 38 in Phase II trialsand hadnt even entered phrase 3 trials. The vaccine hasnt stopped COVID-19 from spiking to record levels in the country this month.

My gut reaction is that this is Chinas attempt to claim international prestige by being first to rollout a widespread vaccination program, says Kamradt-Scott, the Australian global health expert. Unfortunately, I just see politics at play here rather than public health.

Correction, Oct. 22:

The original version of this story incorrectly stated that Beijing Kexing Bioproducts and SinoVac are separate companies. They are the same.

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Write to Charlie Campbell at charlie.campbell@time.com.

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You Can Now Get a COVID-19 Vaccine in China. That Might Not Be a Good Thing - TIME

Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020.

Dado Ruvic | Reuters

LONDON The development of a Covid-19 vaccine may not be enough to prevent the coronavirus from becoming endemic, infectious disease experts warn, suggesting a better way for people to proceed would be to learn to live with the virus.

Dozens of candidate vaccines are in clinical evaluation, according to the World Health Organization, with drugmakers and research centers scrambling to help bring an end to the pandemic.

More than 41 million people have contracted the virus worldwide, with 1.13 million deaths, according to data compiled by Johns Hopkins University.

Many governments, too, have sought to help the Covid-19 vaccine race by providing funds to allow companies to scale up manufacturing even before drugs have been approved.

Dr. David Heymann, who led the WHO's infectious disease unit during the SARS epidemic in 2002-2003, believes some governments may be over-reliant on the development of a vaccine at a time when effective communication, diagnostic testing and outbreak containment activities are all critically important tools.

"The difficulty right now is that in many countries, they are looking forward to a vaccine which may or may not come, which may or may not be effective in the short or long term, and they are looking at possible therapeutic (options) which could solve many of the problems," Heymann said Wednesday during a webinar for think tank Chatham House.

"But, that's not a good way to proceed at present. We have to learn to live with the pandemic."

The U.K.'s chief scientific advisor, Patrick Vallance, told the National Security Strategy Committee in London earlier this week that Covid-19 was likely to become as endemic as the annual flu.

This means the infection rate of the coronavirus, like other coronaviruses, will eventually stabilize at a constant level so that the virus becomes present in communities at all times.

Vallance also said that creating a vaccine from scratch took 10 years on average. The fastest vaccine ever developed was for mumps, and it took more than four years.

A man plays guitar under a empty Bethesda Terrace in Central Park in New York City on October 19, 2020. New York City is planning to set up mass vaccination sites once Covid-19 vaccines become available vetted by an independent state panel, Governor Andrew Cuomo said on October 18, 2020.

TIMOTHY A. CLARY | AFP via Getty Images

"One of the scenarios for this virus is that it does become endemic and it looks at present like that is going to happen just like it happened four previous times when there was an emergence of a coronavirus into human populations that became endemic," Heymann said, referring to the four common human coronaviruses.

"I think the answer is that, yes, this will become endemic," he continued. "We shouldn't just be trying to suppress this virus out of existence or trying to suppress it to a level that's unrealistic. We have to be able to suppress it to a level where it causes minimum damage while at the same time entering a country and becoming endemic."

When asked how people can learn to live with the pandemic, Heymann replied: "Individuals must know how to do their own risk assessments, as they do for sexually transmitted infections, as they do for tuberculosis, as they do for other infections."

"They must do their own risk assessments and understand what measures they can take to prevent themselves from becoming infected and to prevent others from becoming infected," he said. "It's all about people understanding that this virus, if it is destined to become endemic, will become endemic no matter what we do. But we can slow that to a certain level that causes less disruption in our societies and lesser death."

Commuters wearing a face mask or covering due to the COVID-19 pandemic, walk past a London underground tube train at Victoria station, during the evening 'rus hour' in central London on September 23, 2020.

TOLGA AKMEN | AFP via Getty Images

To protect yourself, the WHO recommends that people keep a distance of at least 1 meter (yard) from others, and disinfect frequently touched surfaces. It also advises cleaning hands thoroughly and often, and for people to avoid touching their eyes, mouth and nose.

"We know now that we are going to have to start living with this virus in a more chronic way really, in the long term," said Dr. Olivia Tulloch, CEO of Anthrologica, a leading research-based specialist in applied anthropology in global health.

During the webinar, Tulloch said people across many countries, particularly in the Northern Hemisphere, had been living with strict restrictive measures imposed on their daily lives for several months, with no sign of them ending anytime soon.

"And so, people feel fatigue and confusion and frustration to do with the measures that are being directed at them," she continued. "We are putting a lot of resource into the science of vaccines but, in terms of social science, we have got a huge amount of work to do."

It will also be important to understand the mechanisms that would be necessary to address those with a "high degree of hesitancy" if and when a vaccine becomes available, Tulloch said.

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'Learn to live with the pandemic': Physicians warn that a vaccine may not prevent Covid from becoming endemic - CNBC

The global hunt for a COVID-19 vaccine for kids is only just beginning, a lagging start that has some U.S. pediatricians worried they may not know if any shots work for young children in time for the next school year. (Oct. 21) AP Domestic

After school Thursday, 12-year-old Abhinav pushed up his T-shirt sleeve and looked down as a needle pierced his left shoulder.

The Ohio boy is one of the first children allowed to receive a vaccine designed to protect against COVID-19. His father, Sharat, also joined the trial.

After months of testing its COVID-19 candidate vaccine in adults,Pfizer recently lowered the age of participation to 16, aiming to include at least 3,000 older teens. On Thursday, Cincinnati Children's Hospital inaugurated an even younger group, vaccinating its first two middle schoolers.

Pfizer is the only one of the leading drug companies to allow minors into a vaccine trial.

Some pediatric vaccine experts say drugmakers and federal regulators should wait until the vaccines have been proven safe and effectivein adultsbefore moving to children.

12-year-old Abhinav is one of the first children to join a COVID-19 vaccine trial. He got his shot on Oct. 22 at Cincinnati Children's Hospital, the same day as his father Sharat also joined the trial.(Photo: Courtesy Cincinnati Childrens)

"If I were part of the FDA I would certainly want to be very convinced about the safety of a vaccine before I approved its use in children," Dr. Cody Meissner a pediatric infectious disease expert at Tufts Children's Hospital said Thursday at a public meeting of an advisory panel to the U.S. Food and Drug Administration. "The pattern of disease is very different in children, and lumping them in with adults would cause me some discomfort."

But Dr. Barbara Pahud, director of research in the infectious diseases department at Children's Mercy Hospital in Kansas City, Missouri, said it's immoral not to get kids into trials as soon as possible.

"We should not allow children to die," she said. "That's our job as pediatricians to make noise and make sure people are noticing."

Although most children recover well from COVID-19, they can pass the virus to their parents, teachers and grandparents, so it's important to get them vaccinated, said Dr. Robert Frenck Jr., director of the Vaccine Research Center atCincinnati Childrens Hospital Medical Center.

Last week, Frenck dosed his first minor with the Pfizer vaccine, and Thursday marked the first younger volunteer.

At least 500,000 American children have contracted COVID-19 this year, Frenck said, and probably a lot more. "We're not necessarily identifying all the times when the younger ones are transmitting to parents and grandparents," he said.

Less than 1% of those children ended up hospitalized, Meissner said, so any vaccine given to children has to meet a high bar for safety to outweigh any risks.

"I worry that the vaccines ... in genetically predisposed children may elicit a very troublesome reaction," said Meissner, a member of theFDA advisory panel that met for eight hours Thursdayto discuss COVID-19 vaccine development.

But Pahud noted more than 100 children many who were previously healthy have died from COVID-19. That's nearly as many as died in the last year from the flu, which saw a particularly deadly year. Others have developed a dangerous immune overreaction.

Pahud said COVID-19 is as dangerous for children as other illnesses they are vaccinated against, not counting the risk infectious children present to adults. After the pneumococcal vaccine was introduced in children, for example, doctors were pleasantly surprised to see rates of pneumonia fall.

With COVID-19, she said, "we might have more impact in herd immunity and transmission than we know."

Another reason to test children, Pahud said: once a vaccine is approved for adults, some parents will have their children get it, even without federal approval. Absent a trial in children, there's no way to know if that will be safe, she said, adding that she wishes such studies had started long ago. "We're severely behind," she said.

Vaccination has focused on adults so far, in part because they are more likely to suffer ill effects from the virus, but also because that's how vaccines are usually rolled out. Even vaccines aimed at babies are tested first in adults to make sure they're safe, Frenck said.

While adolescents are generally given an adult dose of a vaccine, Frenck said younger children may need a lower dose, which needs to be worked out during clinical trials.

Pfizer hasn't released any details of its roll out other than to say it plans to assess success with one age group before moving down to the next.

Frenck said he's seen very few side effects so far from the vaccine developed by Pfizer and German company BioNTech. Most recipients are convinced they got the placebo, as half the trial participants will, because they have so few side effects, he said.

Some people experienced fatigue, muscle or joint aches or a fever for a day or two, but nothing serious enough to stop participants from going to work."Based on all that safety data, I'm not concerned about moving into adolescents," Frenck said. "I think their immune system and their size is basically going to see the same results."

16-year-old Katelyn Evans gets the first of two shots as part of a trial testing Pfizer's COVID-19 vaccine in minors.(Photo: Cincinnati Children's Hospital)

It's urgent to start clinical trials in children, he added. "With something that has turned our world upside down, it gives you even a stronger reason of why you want to test now," he said.

Pfizer has not released a timeframe for the study of adolescents, but Pahud said testing in teens and kids will take longer than in adults, because of parents' hesitancy to expose their children to unproven vaccines.

Children who are Black or Latino, like their parents, are more likely to suffer the worst effects of COVID-19, Pahud said, so they should be prioritized in any vaccination effort. "It's a population we need to pay attention to," she said.

Katelyn Evans, 16, decided to volunteer for the vaccine trial because she wanted to be part of the solution. "The more people they have and the more data they have, the sooner they can help people," she said.

Last week when she got her shot, Katelynclosed her eyes asthe needle went in, but said it didn't really hurt, and she hasn't had any side effects since.

During the pandemic,Katelyn, a high school junior,has beenable to continue with her coursework, though her school switches every week or so from everyone in person to half the students coming two days a week and half the other two.

But COVID-19 has robbed the active teen from drama club, mock trial, math club, choir where she proudly sings alto and running cross country.

The sooner there's a vaccine, the sooner life can get back to normal, Katelyn said, adding that she's hoping to convince her cousin and some friends her age to join in the trial. "They need hundreds more people to get the data they need."

Pahud said her own 12-year-old daughter asked several months ago why she couldn't get vaccinated. "That's not fair," she said when Pahud told her children weren't yet included in trials.

Pahud said she's also hearing a lot of fear from parents worried their child will have one of the rare,bad cases of COVID-19. If nothing else, Pahudsaid, a vaccine should be able to stem some of that fear.

And if teachers are no longer afraid of being infected by their students, they should be more willing to reopen schools, which will help all kids and families, regardless of their COVID-19 status.

"We're never going to get back to normal without having a vaccine available for children," she said.

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Pfizer has expanded its COVID-19 vaccine trial to include teens. Some say it's risky. Others argue it's necessary. - USA TODAY

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First up, host Sarah Crespi talks with Staff Writer Jon Cohen about some tricky ethical questions that may arise after the first coronavirus vaccine is authorized for use in the United States. Will people continue to participate in clinical trials of other vaccines? Will it still be OK to give participants placebo vaccines?

Next, producer Meagan Cantwell talks with Bert Weckhuysen, a professor at Utrecht University, about a process for taking low-value plastic like polyethylene (often used for packaging and grocery bags) and upcycling it into biodegradable materials that can be used for new purposes.

This weeks episode was produced with help from Podigy.

Listen to previous podcasts.

About the Science Podcast

Download a transcript (PDF).

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Early approval of a COVID-19 vaccine could cause ethical problems for other vax candidates, and 'upcycling' plastic bags - Science Magazine

WASHINGTON Across the hundreds of pages of plans that state officials sent to the Centers for Disease Control and Prevention on distributing and tracking the yet-to-be-approved COVID-19 vaccines, there are more questions so far than answers on how exactly vaccine programs will be carried out.

Yet states will be on the front lines for a far-reaching vaccination initiative expected to cost in the billions, as the nation registers more than 8.3 million COVID-19 cases and 221,000 deaths. The federal government still has not done its part either, with additional vaccine funding stalled as Congress and the White House extend months-long talks over a new relief deal.

A review by States Newsroom of a dozen state plans found, for example:

And how exactly will states ensure that their residents return for the second dose of whats expected to be a two-part vaccine? Officials in Ohio and other states say theyre working on it, through a combination of PR campaigns, postcards, text messages and help from the providers that will be administering those shots.

States are emphasizing that the initial documents they filed last week are just that: Drafts that will be updated repeatedly as it becomes clearer which vaccine is likely to make it through the approval process first and as the CDC releases more guidance on who should be prioritized for the initial doses.

Some, including Pennsylvania and Minnesota, have so far declined to publicly share their draft plans, citing the need for further revisions and feedback from the CDC.

It is important to understand that this plan will be continuously enhanced and adjusted to the various needs during each vaccine distribution phase, said Maggi Mumma, a spokeswoman for Pennsylvanias Department of Health. It is better to look at this as a framework.

CDC deadline

The initial state plans for the massive logistical undertaking were due to the CDC on a fast timeline, only a month after the administration released its initial COVID-19 vaccination playbook. As those plans were being filed, the National Governors Association sent a long list of questions to the Trump administration, seeking more details on what states can expect when it comes to vaccine distribution, tracking and additional money to pay for those efforts.

We need to answer these questions before the vaccine is available so that we are ready to go and no one is caught flat-footed when the time comes to vaccinate people, New York Gov. Andrew Cuomo said in a public statement accompanying those questions.

CDC officials did not respond to requests seeking copies of the state plans. The dozen drafts that States Newsroom obtained from state governments followed the federal template, detailing when they began working on their vaccine plans, who is involved, and how theyre beginning to enroll providers that will administer the vaccine.

Vaccination experts say theres some logistical precedents for states to follow from past public health crises, including the H1N1 outbreak in 2009, when it comes to initial planning steps.

But the coronavirus pandemic and the vaccines currently in the trial phase also have a slew of unique challenges, including strict storage requirements that may involve keeping each vaccine dose at ultra-cold temperatures of -60 to -80 degrees Celsius.

The storage question is a particularly thorny one, with state officials lacking details so far on how many doses they can expect, the allotment in each shipment, how quickly those doses will need to be used, and the allocation amounts to an unknown number of providers.

Faced with the daunting problem of finding enough dry ice or cold-storage facilities to store the vaccine, some states are planning to ship vaccines directly to facilities where they can be used within the days-long time frame before doses expire, said Claire Hannan, executive director of the Association of Immunization Managers.

That approach has its own hurdles, she added, such as ensuring each location can schedule vaccine clinics that will use the doses fast enough but also do so while following social-distancing and other precautions.

Thats a real challenge for rural areas, Hannan said, adding that North Dakota has said it plans to repackage doses into smaller allotments, an approach that requires close tracking to ensure that the cold temperatures are maintained.

Rural areas also may face technological challenges: Arizonas draft plan mentions that the National Guard is preparing to help with internet connectivity issues in rural communities that will need reliable internet access in order to do real-time reporting on how many vaccines are being administered.

Who gets the vaccine first?

The CDCs Advisory Committee on Immunization Practices will issue guidance to states on which residents should get priority for whats expected to be a limited initial batch of doses, but that panel wont finalize its criteria until a vaccine is approved.

In the meantime, the National Academies of Sciences, Engineering, and Medicine has outlined four phases, with high-risk health care workers and first responders in the first phase, along with those who have high-risk underlying conditions and older adults living in long-term care facilities.

The second phase covers other older adults; those living in congregate settings like jails or homeless shelters; and critical workers in high-risk settings. The third phase includes children, young adults and workers in certain other industries; and the fourth phase would cover anyone else.

Many states cited those proposed phases, with some tweaking the categories to reflect regional needs.

Colorados draft mentions agricultural and ski-industry workers among those to be targeted in the congregate-housing category. New Yorks proposal includes five phases, and a matrix to prioritize both groups of people and areas of the state where there is a higher prevalence of COVID-19 cases.

Billions needed

Few of the state plans include estimates on how much the vaccine efforts will cost.

Virginias plan does identify a range of projected costs, including $71 million to local health districts running vaccination clinics; $40 million for administering payments to health care providers and managing claims from the uninsured; $3 million for public education efforts; and $3.4 million for supplies like syringes, needles, and bandages.

CDC director Robert Redfield told Congress recently that states may need $6 billion; the Association of State and Territorial Health Organizations and the Association of Immunization Managers sent a letter to federal lawmakers requesting $8.4 billion.

The CARES Act, the massive coronavirus relief bill approved last spring, provided just a fraction of that figure, allocating $200 million for state vaccine efforts.

Negotiations on additional coronavirus relief funds have stalled in Congress, with a wide gap between the $500 billion proposal from Senate Republicans that failed to advance on Wednesday and the $2 trillion plan that House Speaker Nancy Pelosi has been negotiating with Treasury Secretary Steve Mnuchin.

Without agreement on Capitol Hill, states wont see additional money flowing as they attempt to prepare for a vaccine that could be approved as soon as next month.

The idea that theyre not going to get additional funding, I mean, its just crazy, Hannan said. These plans would just be a wish list if they dont get additional funding.

Laura Olson covers the nations capital as a senior reporter for States Newsroom, a network of nonprofit outlets that includes NC Policy Watch.

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States struggle to draft COVID-19 vaccine plans while in the dark on details, funding - The Progressive Pulse

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The remarkable aspect was that the transition occurred during the COVID outbreak and that the company showed positive revenues and earnings during that time, avoiding the heavy losses that have plagued some of its competitors. Hoeghs EPS has varied quarter to quarter over the past two years, but the Q2 numbers were in-line with the long-term average, and the Q3 outlook, to be reported next month, is in the same range.Steady earnings usually mean a steady dividend, and HMLP delivers. The company has a 6-year history of dividend reliability, and the payment, of 44 cents per common share, has been held stable through 2020. The $1.76 annualized payment gives an impressively high yield of 15.5%. This is more than 7x the average found among S&P listed dividend payers.Liam Burke, of B. Riley FBR, counts himself as a fan. He writes, Despite near-term decline in global LNG consumption caused by the coronavirus, there is solid underlying demand for LNG, which is estimated to grow by more than 3% to 5% annually until 2030, which sets the stage for consistent demand for high return floating storage and re-gasification units (FSRU) beyond current contract periods. We continue to believe in the long-term strength of the LNG market and HMLP's underlying charters despite the inherent counter-party risks created by a near-term decline in LNG consumption related to COVID-19.Burke rates HMLP shares a Buy, and his $17 price target indicates confidence in a 45.5% upside potential. (To watch Burkes track record, click here)Overall, Wall Street has given HMLP 3 Buys and 1 Hold recently, for a Strong Buy consensus rating. The average price target is $13.67, suggesting a 19% upside from the current trading level of $11.41. (See HMLP stock analysis on TipRanks)Hess Midstream Operations (HESM)Next up on todays list of dividend champs is Hess Midstream, a player in the US oil and gas industry. Hess provides infrastructure services for gathering, processing, storing, and transporting both crude oil and natural gas products in the Bakken formation of North Dakota.Production companies have kept the product flowing despite the coronavirus, which is one reason for the low prices in the oil markets but it has also kept the midstreamers in demand. Hess has benefited from the continuing need for its technical knowledge of pipeline network, and the result has been that, while much of the oil industry had to retrench recently, Hess saw only modest losses in revenues while earnings remained in-line with their 2-year recent history. Second Quarter EPS was 29 cents; that was lower than Q1, but higher than 4Q19.Hess has turned its steady earnings to shareholders advantage, with a dividend that has been increased every quarter for the past 2 years. The last payment, sent in August, was 44 cents per common share. This gave a yield of 9.86%, strong by any standard.JPMorgan analyst Tarek Hamid says of Hess, The unique pricing model underpinning core profitability remains unmatched and further helps to eliminate (to an extent) DAPL uncertainty overhang relative to peers. Longer-term growth prospects could come in the form of asset level acquisitions and potentially a framework tied to Hesss GOM position, but management has conveyed a conservative approach with respect to corporate M&A HESM will burn cash this year, though our modeling indicates a flip to FCF generation in FY21 on lower capital intensity and higher y/y profitability.To this end, JPMorgan rates HESM an Overweight (i.e. Buy) along with a $23 price target. This figure suggests a 40% upside for HESM shares in the months ahead.Overall, this stocks Strong Buy consensus rating is supported by 4 Buys and 1 Hold. Shares are selling for $16.46, and the average price target of $19.75 indicates a 20% upside potential. (See HESM stock analysis on TipRanks)To find good ideas for dividend stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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What to expect from the FDA's COVID-19 vaccine meeting today - Yahoo Finance

Issued on: 22/10/2020 - 22:53

More than four out of 10 French people would bereluctant to get a vaccine for Covid-19 should one become available, a new study has found. FRANCE 24 spoke to apublic health expert who says the government should commit to transparency and listening to medical professionals to help ease the roll-out of any future inoculation plans.

In a survey of global public acceptance of a Covid-19 vaccinepublished in the scientific journalNature Medicinethis week, researchers found that 41.11 percent of French citizens indicated they would be reluctant or even refuse to be vaccinatedif one were to become available. Only Poland and Russia expressed less willingness to get inoculated.

Thisrejection comes as no surprise to Lucie Guimier, a public health expert at Institut Franais de Gopolitiqueand author of a report on the geopolitical consequences of vaccine scepticism.

FRANCE 24: Do the results of the study surprise you?

Lucie Guimier: Theres nothing surprising about these results. It would be wrong to categorise these respondents as "anti-vaxxers because were talking about a vaccine that isstill in the process of being developed and for which we will have little or no time for hindsight or perspective. In general, it takes about 10 years to develop a vaccine before it is ready for the market. So these are legitimate concerns awave of mistrust regarding a Covid-19 vaccination is to be expected.

Even in the context of apandemic, laboratories should not rush a vaccine to market that has not been sufficiently studied or that would have adverse effects on parts of the population. This would only add to the crisis we are already experiencing and would generate even more mistrust of the authorities.

The reaction of the French to the vaccine will also depend on how the government manages this campaign and communicates its message. Many questions remain unanswered: How will these vaccines be made available to the population? Who will be included in the debate? Will there be sufficient stocks?

F24: How can the authorities gain the population's confidence?

LG: To limit this mistrust, in my opinion, all health professionals doctors, nurses, midwives, etc should be included in the debate, because these medical professionals inspire much more confidence among patients than government representatives. If we don't succeed in including them in this vaccination campaign and listen to them, it will be difficult to raise awareness.

F24: Could greater transparency on health policies also play a role?

LG: Health researchers have been hammering on about this for years. More transparency is absolutely essential. We must not hide behind simplistic arguments or take a paternalistic tone by just saying, "Get vaccinated". And although the French public health system is already trying to raise awareness on this issue, it isnot an easy task.

The problem is, when faced with people who refuse to be vaccinated, the more we arguethe more likely they are to view this as justification that the state has somehidden agenda that its aboutcollusion between the pharmaceutical companies and the political elites, that sort of thing. We knowthat this minority of anti-vaccine people will be very difficult to convince.And the efforts at persuasionmust, above all, reach those who are sceptical or hesitant.

F24: Is the mistrust of vaccines more prevalent in France than elsewhere?

LG: Not necessarily. The history of vaccinations has always been marked by protest movements, but each country has its own particularities, which depend on the historical context and the ideology underlying the health systems.

For example, China's view of public health is not the same as in some other countries. China (which hasa vaccine acceptance rate of more than 80 percent, according to the study)is a state with a communist system and a strong public health culture. Vaccination policies are implemented there without major reluctance or pushback. On the other hand, one of the particularities of France could be that, when it comes to health, the French expect a lot of the state while also being very critical when it intervenes.

France has also had some unique experiences with vaccines. Many still remember the winter of 2009-2010, when the H1N1 vaccination campaign was rolled out very rapidly. Around 60 cases ofnarcolepsywere subsequently recorded in the country, which wasnot a small number. Obviously, these undesirable effects have left an impression on people.

But while the anti-vaccine discourse is very voluble, and has even gained strengthor fused with the anti-mask movements in some parts of the world, their impact remains limited in France. One only has to look at the current shortage of the flu vaccine in pharmacies to see this.

F24: Does mandatory vaccination seem like a legitimate option?

LG: Introducing a mandatory vaccination policy for Covid-19 seems very difficult to me the state would meet with enormous opposition. We saw this in 2018, when the government extended the list of mandatory vaccinations for children. This was met with a lot of mistrust fromsome people.

When we see that some people are already reluctant to wear masks, imposing a mandatory vaccination policy which is more intrusive would seem to be extremely complicated.

Even if the state would prefer everyone to be vaccinated, the question remains whether we could do it, logistically. But afirst step would be to make it mandatory, or strongly recommend, for the most fragile sections of society, such as the elderly or the otherwise vulnerable.

This article has been translated from the original interview in French.

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In France, 'mistrust of a Covid-19 vaccine is to be expected' - FRANCE 24 English