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As we noted below, the FDA advisory committee’s vote was not without dissent.
Four of the 22-voting member panel voted against issuing an emergency authorization, after a late debate about whether to remove 16- and 17-year-olds from the authorization.
Some experts argued the data on this subgroup was “thin” and that the panel should recommend further study. But others said the safety and efficacy data to date was enough for emergency use, not least because this group is unlikely to get the vaccine for months because of supply constraints.
“We have clear evidence of benefit and all we have on the other side is theoretical risk,” said Dr Paul Offit, a vaccine expert at Philadelphia Children’s Hospital.
Another major concern for the panel was how to continue blinded placebo-controlled trials if the FDA issues an emergency authorization, as it is expected to. That is because once an emergency authorization is issued, it would be unethical to keep trial participants from finding out whether they received a placebo, and ultimately getting the vaccine.
If the FDA follows the panel’s recommendation and grants emergency approval, the US would be the third country in the world to have authorized the use of the Pfizer/BioNTech vaccine in the broader public behind the UK and Canada, and it will be the most populous country to do so.
In more data on the vaccine released in the New England Journal of Medicine on Thursday, Pfizer and BioNTech said the vaccine was 95% effective in a randomized controlled trial of more than 43,000 people. An accompanying editorial in the journal described the vaccine’s development as a “triumph” for science.
“Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year,” wrote Dr Eric J Rubin, the editor-in-chief of the journal, who co-authored the editorial.
The vaccine uses messenger RNA technology to introduce the body to the spike protein found on the outside of the coronavirus to provoke an immune response. It requires two doses, administered three weeks apart.
Scientists are still studying how long the vaccine will protect people, the safety and efficacy of the vaccine in children and pregnant women, and the rate of asymptomatic disease in vaccine recipients.
The FDA could approve the vaccine for emergency use at any time after the advisory committee meeting, and the Trump administration is pushing for speedy approval. But the FDA must signal it is giving safety and efficacy concerns due consideration. Vaccines in general have a higher bar for approval than many medicines, because they are given to healthy adults.
FDA panel approves Pfizer vaccine
Today so far
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Let’s go through some of the details of the vaccine being considered by the US Food and Drug Administration’s (FDA) vaccine advisory committee.
- The FDA advisory panel is considering whether to recommend the vaccine for emergency use authorization, often called EUA. That would allow the vaccine to be distributed to the public, but is a lower bar than full approval and only valid during the public health emergency – in this case the Covid-19 pandemic.
- Supplies will be very limited at first. The US Centers for Disease Control and Prevention (CDC) has already recommended the first people to receive the vaccine – health workers and long-term care residents.
- The vaccine appears highly effective. According to data published in the New England Journal of Medicine on Thursday, the vaccine appears to be 95% effective in preventing Covid-19 a trial of more than 43,000 people. The study looked at a two-shot regimen.
- The vaccine is a messenger RNA vaccine, which provokes immunity by introducing the immune system to the spike protein on the coronavirus.
- The trial was a randomized, placebo-controlled observer-blinded trial that split participants evenly between people who received two shots of a placebo, and two shots of the vaccine – currently called “BNT162b2”.
- The study looked specifically at people 16 years and older. In future studies, Pfizer intends to look at vaccine safety and efficacy in children as young as 12.
- Side effects included headache, fatigue and fever, which resolved within a couple days. The government intends to use several surveillance programs to collect information on side effects, called “adverse events”, for years after the vaccine is distributed. It will also begin a surveillance study on healthcare workers specifically.
- The FDA recommended continued surveillance for Bell’s palsy, or facial paralysis. There is no current evidence that the vaccine causes facial paralysis, but four cases among vaccine recipients in the trial.
- The FDA found only one possible serious adverse effect related to the vaccine, which was a shoulder injury. Other serious adverse events, such as a case of appendicitis, were found not to be unrelated to the vaccine.
- Trial participants were followed for a median of two months after they received either the vaccine or a placebo. Most adverse vaccine reactions take place within six weeks.
- Scientists are still studying how long immunity lasts, a concept known as “durability”, and the rate of asymptomatic disease in people who receive the vaccine.
- There is very little data on safety and efficacy in pregnant and lactating women, but there is also no evidence it is harmful to pregnant women or the fetus. For that reason, FDA officials suggest pregnant women should discuss the vaccine with their healthcare provider, when it becomes available to them.
- The panel is expected to recommend an emergency use authorization, and the FDA is expected to grant emergency use rights. The New England Journal of Medicine, which published Pfizer’s results today, called the new vaccine a “triumph” of science.
More than 100 female leaders in the Native American community and entertainment industry have signed on to a letter calling on Joe Biden to nominate congresswoman Deb Haaland as interior secretary.
“As women who have worked to protect our democracy and advance the promise of this country, we are hopeful and relieved that you will be leading us into a bright future,” the letter says.
“It is in this spirit that we, Native American women and Indigenous peoples’ allies, write to urge you to appoint Congresswoman Deb Haaland as Secretary of the Department of the Interior.”
Among those who have signed on to the letter are singer Cher, actress Kerry Washington and feminist activist Gloria Steinam.
If nominated and confirmed, Haaland, a progressive congresswoman from New Mexico, would be the first Native American to lead the interior department.
“We believe it is critical at this time for the first Native American to serve in the President’s Cabinet, so we can begin to shift the focus back to caring for future generations and returning to a value system that honors Mother Earth,” the letter says. “We believe that person is Congresswoman Deb Haaland.”
Progressive groups have pushed for Haaland’s nomination, but some Democratic leaders have expressed hesitation about pulling another House member into Biden’s cabinet, given the party’s very narrow margin in the chamber after last month’s elections.
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An advisory committee to the US Food and Drug Administration (FDA) is currently hearing testimony from Pfizer, which is arguing the agency should should approve its Covid-19 vaccine on an emergency basis.
At the hearing, experts are now questioning Pfizer about the data it has provided, and tire kicking is expected to continue through the afternoon. But some key themes are already emerging.
- Pfizer has developed a vaccine that appears highly effective in Phase II/III trials, but those results need to continue to be monitored in the real world for both efficacy, the length of immune protection (durability) and long-term safety. To do this, the CDC has amped up several vaccine monitoring programs, and is taking a whole government approach.
- The data presented by Pfizer clearly still has skeptics – as was evident during the public comment period. But even experts well known for their criticism of the FDA, such as Dr. Sidney Wolf of the nonprofit group Public Citizen, were in support of distributing the vaccine to the public on an emergency basis.
- Pfizer plans to apply for full approval of the vaccine in April 2021, after six months of monitoring of participants. But it faces a hurdle in keeping trial participants enrolled, many of whom may want to know whether they received a placebo, and then obtain the vaccine themselves.
- Perhaps the most important takeaway from the hearing is the underlying reason the vaccine is being considered – the pandemic is “essentially out of control” in the US, according to Pfizer’s senior vice president of vaccine research and development, Dr. Kathrin Jansen. “Modeling from the CDC shows that a vaccine with high efficacy can save many lives. However, the pandemic vaccine must be introduced before the peak of cases will impact.”