- A group of independent experts is meeting Thursday to discuss what is likely to be the first coronavirus vaccine available in the US.
- The US Food and Drug Administration convened the advisory committee to vet Pfizer’s COVID-19 shot.
- The panel will ultimately vote “yes” or “no” to whether the FDA should green-light the shot.
- Even if the advisory group votes in favor of OK’ing the vaccine, the FDA still has the ultimate authority to make the regulatory decision on its own. The agency typically follows the advice of these expert panels but it isn’t required to do so.
- Healthcare and science reporters Andrew Dunn and Hilary Brueck are covering the meeting. Follow along this live blog for their updates on what’s happening.
- For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.
Evan Fein, a participant in Pfizer’s vaccine trial, said he believes the vaccine should receive emergency use authorization (EUA) immediately to help save lives.
“An EUA must be granted and must be granted tonight,” Fein said during an hour-long session for public comment Thursday afternoon. “Most Americans will take the vaccine voluntarily, as long as we’re honest, don’t talk down to them, and treat them like autonomous adults.”
Fein said he received his first shot in a Pfizer study more than five months ago, on July 1.
“I think I got a real vaccine, and not a placebo,” Fein said, noting he felt “mild” effects afterwards, including a fever, chills, and pain where his shot was injected the second time.
He said he was impressed with the study’s follow-up, with calls from doctors and researchers. “Nothing felt rushed, and I never felt like a guinea pig,” he said.
He’s not worried about long-term side effects, either:
“It’s been more than five months now since my first shot, and I can happily report that there are none,” Fein added. “I’ve helped out my older parents, I’ve gone to work in person, and I’ve exercised in small groups, and I haven’t gotten COVID-19.”
Given the emergency posed by the pandemic, Fein said “the burden of proof is on those who don’t want to authorize the vaccine,” calling it “immoral and unethical” to not allow healthcare workers and first responders who want the shot to get it.
Fein compared the pandemic’s devastation to another American tragedy: the terrorist attacks on Sept. 11, 2001. He noted the daily death toll from the virus now exceeds the number of lives lost on 9/11.
“In the words of Todd Beamer, let’s roll,” Fein concluded, referring to the famous last words of a passenger on one of the hijacked flights.
11:10 AM: The CDC wants to text you to see if the vaccine is safe in the real world
Dr. Nancy Messonnier, a top Centers for Disease Control and Prevention official, told the committee that continuing to monitor the vaccines for safety and effectiveness as they are rolled out to the public is a “top priority” of the US government.
There’s a range of monitoring systems to keep tabs on the shots, both new and old.
One new system, called V-SAFE, will follow people after they get the shots with text messages and web-based surveys. But to be useful, Messonnier, said, people will need to opt-in to V-SAFE and participate.
“We really need people to sign onto this program to give us the best data possible,” she told the committee.
The federal government is also rolling out another new tracking program tailored for long-term care facilities, built in partnership between the National Institutes of Health, Brown University, and Genesis HealthCare. It will monitor roughly 35,000 long-term care residents at 250 facilities across the US, Messonnier said. Nursing homes are expected to be prioritized to receive the shot.
Messonnier said that vaccine efficacy may turn out to be different in the real world, when millions of people are getting shots, than it was in clinical trial conditions. Already, two patients have had allergic reactions to the vaccine in the UK. There were no allergy issues in Pfizer’s trials of more than 44,000 individuals in six countries.
10:26 AM: CDC scientist gives grim update on pandemic’s impact in US, highlighting the urgent need for a vaccine
Aron Hall, chief of the respiratory viruses branch at the CDC, gave a grim update on the current state of COVID-19 in the US.
Hall’s update is particularly jarring given the optimistic progress with vaccines. In total, more than 14.8 million people in the US have had confirmed coronavirus infections, resulting in more than 280,000 deaths, he said.
The pandemic is raging like never before in the US. The April peak was driven by spread in New York City, and a July surge came from the southern US. But Hall noted cases have been rising again since September, with the sharpest increases in the past couple months. More than 3,000 people died from COVID-19 in the US yesterday — a new record.
The committee must weigh the benefits, and consequences, of approving the vaccine in this context. The pandemic’s devastation isn’t news to anyone, but Hall’s presentation shows just how desperate the need for a vaccine is right now.
9:45 AM: The committee is an impressive mix of more than 20 virologists, doctors, and leading public health experts. There’s one lawyer and one competing pharmaceutical maker in attendance too.
Some of the more prominent committee members from the world of medicine include:
- Dr. Eric Rubin, an infectious-disease specialist and editor-in-chief of The New England Journal of Medicine.
- Dr. Paul Offit, a top vaccine expert at the University of Pennsylvania who co-invented the rotavirus vaccine.
- Dr. Cody Meissner, chief of the pediatrics infectious disease division at Tufts University School of Medicine.
- Dr. Stanley Perlman, a virology professor from the University of Iowa who has been studying coronaviruses for nearly four decades.
Dr. Paula Annunziato, who works in vaccine research at Merck is the non-voting industry representative, and Sheldon Toubman, a lawyer from New Haven, is attending as a consumer representative. He often works as a legal aid lawyer for low-income families.
9:04 AM: As meeting gets underway, FDA reveals the question of the day.
The expert panel is now underway, virtually, starting with opening remarks and introductions led by the committee’s chair, Arnold Monto, a professor of epidemiology and global public health at the University of Michigan.
These meetings typically take quite a while — finishing by 5:15 p.m. is more a goal than a hard stopping point. The most interesting discussion usually comes close to the end of the day, when the committee is allowed to have a free-flowing dialogue ahead of the big vote. On today’s agenda, that should start around 3:10 p.m.
The FDA committee will only vote on one yes-or-no question at the end of the day:
“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?”
New documents released just now show the FDA wants the panel to also weigh in on a couple of hot topics. First, what should researchers do with trial volunteers who received a placebo shot? There’s a difficult tradeoff between the benefits of following those people for long-term data at the cost of withholding an effective vaccine and exposing them to the pandemic.
Secondly, the agency is asking the group to discuss if they see any gaps in the plans to evaluate the safety and effectiveness of the shot going forward.
9:01 AM: FDA boss Stephen Hahn says “we intend to act quickly” after today’s meeting.
The head of the FDA told NBC’s Savannah Guthrie he will listen to the advisory committee’s discussion today, but ultimately, it’s up to him and the FDA’s in-house scientists to decide whether to approve or reject the Pfizer vaccine for emergency use in the US.
And, he hinted that the agency may already be leaning towards a favorable decision for Pfizer’s shot, saying “our initial assessment is that this is a vaccine that does meet our criteria.”
“We have the advisory committee to get outside opinions about this,” commissioner Hahn said Thursday morning on TODAY.
“We think it’s very important for transparency. We’re the only regulatory agency in the world that has a public vetting of the data. But we’ll make that decision. Our scientific experts will make that decision.”
Hahn also suggested that official decision could come as soon as this evening, shortly after the committee’s vote:
“We’ll have to see what the scientific and medical discussion is today. But our plan is to take their recommendations into account for our decision making and make a decision shortly thereafter. Again, it really depends upon the complexity of the issues discussed, but we intend to act quickly.”
8:00 AM: 7 unanswered questions we expect answers for today.
The advisory committee meeting is set to begin one hour from now, at 9 a.m. ET, with a very full agenda slated to last until 5:15 p.m.
Unlike many FDA advisory committee meetings, the pros and cons of the vaccine aren’t likely to stir much debate, given the scale of the coronavirus outbreak across the US right now. It’s widely expected that the committee will recommend the vaccine should receive emergency use authorization — teeing up the FDA to officially OK the vaccine to go into arms across America in the coming days.
We’ve already seen lots of data about this vaccine, both in what Pfizer initially described in November about the shots’ efficacy, and in far more detail through independently-vetted briefing documents released Tuesday by the FDA. Those documents showed FDA scientists making the case that Pfizer’s vaccine had no major safety concerns, and was overwhelmingly protective — 95% effective at preventing symptomatic COVID-19.
Even so, the devil is often in the details. Some of the most interesting debates we expect today will be on nuanced topics, with this group of virologists, vaccine experts, and biostatisticians digging deep to get the full picture about what we know — and don’t know — about this shot.
Here are seven of the most burning questions we are most eagerly looking forward to (hopefully) hearing some answers to today:
- How much protection do people get after their first shot? Data released Tuesday suggested one Pfizer shot was about 50% effective at preventing COVID-19 in the 21-day period until people got their second (booster) shot. If that partial protection is legit, that would be a valuable benefit to know when immunizing people. Although experts have stressed it will still be essential to get the second dose for the more robust, 95% protection.
- How durable is the protection? Given that Pfizer’s earliest coronavirus vaccine trials only started a few months ago, we probably won’t know how long Pfizer’s vaccine protection typically lasts, but the committee can unearth any new information they’ve discovered about waning immunity. Is the trial showing any signs that participants who’ve had the vaccine for several months now are losing their protection? Or is it still too early to tell?
- Does the vaccine also prevent transmission to unvaccinated people? The Pfizer vaccine trial was designed to measure if the shots prevent people from getting symptomatic disease, the kind of coronavirus that might prompt a fever, cough, or more serious issues. The results are an unambiguous success on that front. But that doesn’t necessarily mean the vaccine can stop people from being infected. If vaccinated people can still be asymptomatic carriers, unknowingly spreading the virus to others who have not yet been vaccinated, that would have big public-health consequences. Is there any data to suggest one way or the other whether the shot provides so-called ‘sterilizing immunity’?
- What happens to the placebo group now that we know the shot works? Half of the roughly 40,000 volunteers in Pfizer’s trial got a placebo shot (aka no treatment) and they still don’t know they’re walking around vaccine-free. Keeping the study blinded allows researchers to continue to gather valuable information — particularly in figuring out the durability of the vaccine’s protection. But it poses an ethical conundrum as well. When should the placebo group be offered the real vaccine, particularly if it’s known to be very safe and effective? The committee is likely to have thoughts on what should happen next.
- Is there enough data on really old people to classify the shot as fully safe for them? We’re not talking about the 55-plus seniors group, but people in their 80s and 90s. With nursing homes being a top immunization priority, this is a relevant population to make sure will be safe to vaccinate. Data released Tuesday showed 860 people in Pfizer’s trial (out of more than 21,000 participants worldwide) were over the age of 75, with the oldest person being 89 years old. Is that a rigorous enough experiment to satisfy the committee and OK this shot to be rolled out to nursing homes across the nation?
- What can we learn from the non-responders? Some of the most valuable insights may be gleaned from people who got Pfizer’s vaccine and still got sick. Fortunately, there weren’t a lot of them. Just one volunteer on the active arm registered a severe case of COVID-19 (compared to nine severe cases who were given the placebo) and there were eight cases of COVID-19 overall who got Pfizer’s shot (compared to 162 in the placebo group). Can that handful of cases tell us something we don’t know about who may or may not respond poorly to this vaccine?
- What about allergic reactions? UK health regulators have warned that people with a history of severe allergic reactions shouldn’t get Pfizer’s shot, after two adverse events were observed in the British rollout. Is there a suitable explanation from Pfizer for why that may be a case, particularly given this vaccine was developed using messenger RNA, a new technology platform? And will this expert panel make a similar recommendation in restricting who should get the shot?