Thread by @LizSzabo

It's the day you've all been waiting for. An @fdagov advisory committee will evaluate @Pfizer's covid-19 vaccine and recommend whether to issue an emergency authorization. Watch here or follow this tweet thread.

Officially, this is a meeting of the @fdagov's Vaccines and Related Biological Products Advisory Committee, or #VRBPAC. They are independent experts, not government employees, who are asked to scrutinize vaccine data and make recommendations.
fda.gov/advisory-commi…

Although the @fdagov commissioner listens to the advisory committee, he is not legally required to follow its recommendations. @SteveFDA committed early on to convene this committee to show process wasn't political.

When @Pfizer applied for emergency use of its vaccine, it sent stacks of paper to @fdagov. Here's a summary. file:///C:/Users/LSzabo/OneDrive%20-%20Kaiser%20Family%20Foundation/Documents/VRBPAC-12.10.20-Meeting-Briefing-Document-FDA.pdf

@Pfizer also filed this report summarizing its vaccine results. #vrbpac file:///C:/Users/LSzabo/OneDrive%20-%20Kaiser%20Family%20Foundation/Documents/VRBPAC-12.10.20-Meeting-Briefing-Document-Sponsor.pdf

Here's the agenda for today's vaccine advisory board meeting on covid-19 vaccines. #vrbpac fda.gov/media/144231/d…

People submitted more than 300 public comments on the @Pfizer vaccine candidate. You can read them here. beta.regulations.gov/document/FDA-2… #vrbpac

@Pfizer's vaccine data was published today in the @NEJM nejm.org/doi/pdf/10.105…
as well an an outside commentary. nejm.org/action/doSecur…
#vrbpac

The @fdagov expects @Pfizer to continue monitoring its vaccine safety and efficacy even after it's authorized. #VRBPAC

Dr. Doran Fink of the @fdagov said the agency would like the clinical trial to continue as long as possible, without unblinding volunteers or offering the real vaccine to the placebo group, b/c this provides the strongest data. #vrbpac

The @fdagov can revoke the emergency use authorization for a covid-19 vaccine, based on new information on safety, effectiveness, manufacturing quality or the end of the emergency. #vrpac

Dr. Peter Marks of the @fdagov released this statement today: content.govdelivery.com/accounts/USFDA… #vrbpac

Dr. Doran Fink notes that even if the @fdagov issues an emergency authorization for a covid-19 vaccine, it's still considered experimental. It will be officially experimental unless/until the FDA formally approves it and issues a license. #vrbpac

Dr. Aron Hall of the @cdcgov shows how the agency tracks covid-19 trends. #vrbpac

More data on huge racial disparities in covid-19. #VRBPAC

Age is the strongest risk factor for in-hospital death from covid. Other important risk factors are being a male, being immunosuppressed and have kidney disease. #vrbpac

Severe obesity is a huge risk factor for hospitalization with covid-19. #vrbpac

Nearly half of hospitalizations involve residents of nursing homes. Dr. Hall notes that the @cdcgov has prioritized nursing home residents. #vrbpac

Health care personnel make up a smaller number of those hospitalized w/ covid-19. But the @cdcgov prioritized health care workers for early vaccination in order to keep health system operating, avoid having nurses/doctors stay home from work for 2 weeks to quarantine. #vrbpac

The number of covid-19 cases is likely 2-7x higher than reported. So 2.4 million hospitalizations and 55 million total infections. Still, less than 10% of population in average state have been infected. #vrbpac

@DrNancyM_CDC is describing how the @cdc will monitor vaccine safety. #VRBPAC

Although the @Pfizer trial involved +40K volunteers, there are still lots of questions that will need to be answered after the vaccine is given to millions of people. Is it as effective IRL as in a trial? What if people get a late 2nd dose? How long does protection last? #VRBPAC

@DrNancyM_CDC said post-authorization studies should measure whether the vaccines works as well as expected in health care workers and nursing home residents. "We expect those studies to start immediately." #VRBPAC

Dr. Anita Patel of @cdcgov says all vaccines will be ordered through the CDC's vaccine ordering system. #vrbpac

Here are @DrNancyM_CDC's slides fda.gov/media/144327/d…

Here are Dr. Anita Patel's slides from the @cdcgov fda.gov/media/144328/d… #vrbpac

Shipping/distributing @Pfizer vaccines presents challenges. The minimum order is 975 doses, which may be more than some rural clinics can handle. Vaccines must be kept at -75 degrees. #vrbpac

What should happen to trial volunteers given the placebo, once the vaccine is being widely distributed? Should they have the chance to get the real vaccine, given how effective it is? Is that more important than continuing to get randomized data from the trial? #vrbpac

Investigators are not obligated to provide immediate vaccination to placebo patients, says Dr. Steven Goodman of Stanford "Trial participation is not considered a reason for jumping the queue." #vrbpac

Placebo-controlled trials might not be unethical. But are they infeasible? People might not want to remain in the trial if they are eligible for covid-19 vaccine outside the trial. #vrbpac

Some members of the placebo group may decided to stay in the trial, even if vaccines become available. But others will demand vaccine. If they don't get it, this could make it harder to recruit participants in future trials. #vrbpac

To allow placebo recipients in the trial to get the full benefits of the vaccination, researchers could switch to a "crossover" trial. So the vaccine group gets the placebo, and the placebo group gets the vaccine, but they don't know which. So it remains blinded. #vrbpac

Dr. Steven Goodman presents compromise choice that allows researchers to get some scientific data on vaccines but still allows placebo patients to eventually get vaccine through the trial, so they won't leave the trial altogethe. #vrbpac

Dr. Steven Goodman said trial participants given placebo shouldn't "jump the queue" to get a vaccine before other people at greater risk/higher priority. So, a healthy young person in the study shouldn't get vaccine B4 an elderly nursing home resident. #vrbpac

Here are Dr. Aron Hall's slides from @cdcgov about covid-19 outbreak. fda.gov/media/144330/d… #vrbpac

Here are slides from Dr. Doran Fink of @fdagov, discussing what the agency requires in order to issue emergency authorization for covid-19 vaccine. #vrbpac fda.gov/media/144329/d…

@fdagov advisory committee discussing a thorny issue. How do you conduct future covid-19 trials after first vaccines are authorized? There are at least 6 vaccines in pipeline. Would you enroll in placebo-controlled trial if you could just get vaccine from your doctor? #vrbpac

Here are slides from Kathrin Jansen, SVP of @Pfizer, who will speak later this afternoon. #vrbpac fda.gov/media/144325/d…

The @fdagov's vaccine advisory committee is now taking public comment. Speakers get 3 mins each.

Diana Zuckerman of the @NC4HR says the randomized, controlled trial of the covid-19 vaccine need to continue and that 2 months is too short. Says there weren't enough severe cases to "conclude anything." No long-term care patients included in study. #vrbpac

Diana Zuckerman of the @NC4HR says people in the placebo group should not be allowed to jump the queue. And off-label use (giving vaccine first to celebrities) shouldn't be allowed. #vrbpac

Dr. Peter Doshi said he wants the full trial data to be made available, whether an EUA is issued or not. #vrbpac

Newest speaker is Evan Fein, who participated in the @pfizer trial. Says he wants to reassure public on the vaccine. #vrbpac

Speaker Evan Fein said this vaccine trial wasn't rushed. Instead, he thinks other vaccine trials are unnecessary slow due to bureaucracy. He wants the vaccine approved tonight. "Let's roll." #vrbpac

@angie_rasmussen speaks about how serology testing could help us understand how the vaccine works. #vrbpac

@angie_rasmussen says blood tests can tell us if vaccinated people were infected after getting both shots. Blood tests can also help us understand duration of protection from vaccines. #vrbpac

Dr. Sidney Wolfe of @PublicCitizen said he agrees with an EUA for @pfizer.

Public speaker Kim Witczak notes the trial found 100% efficacy in Blacks, but the number of Blacks is too small to be reliable. Wants process to be open. Doesn't want to end the blinded trial, b/c we would lose longer-term data. #vrbpac

Public speaker Lynda Dee supports an EUA but wants more data on the risk of death and reproductive harm. Says the fact that only 120 ppl with HIV included in vaccine trial is "abysmal." Supports a blinded crossover study after vaccine is authorized. #vrbpac

Public speaker @DrPeterLurie agrees with @fdagov about the lack of serious adverse events and that side effects shouldn't block authorization. However, he wants more study of risk of Bell's palsy and hypersensitivity in vaccine recipients. #vrbpac

Public speaker @DrPeterLurie says placebo group patients should be offered real vaccine as soon as their age/demographic group is eligible for vaccine. For example, ppl under age 65 in trial shouldn't be vaccinated ahead of nursing home residents. #vrbpac

Public speaker @DrPeterLurie says consumers need to be warned that the @Pfizer vaccine can cause non-serious but annoying adverse reactions (fever, chills, body aches) that can cause them to miss a day of work. @khnews covered this: khn.org/news/article/t…

Nissa Shaffi of @ncl_tweets calls on @fdagov to continue post-marketing surveillance to detect any potential problems, such as the allergic reactions seen to @Pfizer vaccine in the UK. #vrbpac

Public speaker Julie Omohundro says vaccine should be made available through expanded access programs, not EUA. #vrbpacp

Dru West argues that vaccine should be released "cautiously" and "slowly" and exclude populations that haven't been studied, such as frail elderly people and pregnant women. Wants long-term research on people who are vaccinated. #vrbpac

Public speaker Sarah Christopherson of @TheNWHN notes that indigenous Black Americans have been hesitant about taking covid-19 vaccine. Adverse effects from vaccine (1-2 days of fever, chills, etc.) could be "quite alarming" to people, so education is key. #vrbpac

Kathrin Jansen of @Pfizer is speaking to the @fdagov vaccine advisory committee. #vrbpac fda.gov/media/144325/d…

@Pfizer vaccine will require 2 doses, three weeks apart. Its vaccine targets the spike protein, says Kathrin Jansen. #vrbpac

Kathrin Jansen of @pfizer: mRNA vaccines can be boosted repeatedly if needed.

Kathrin Jansen of @pfizer notes that mRNA vaccines stimulate memory T-cell production. #vrbpac

"The mRNA vaccine is non-infectious and cannot cause disease," said @pfizer's Kathrin Jansen. #vrbpac

@Pfizer's Kathrin Jansen says the company looked at several possibilities before settling on the current covid-19 vaccine. #vrbpac

The @fdagov just posted Dr. Steven Goodman's slides related how to proceed with vaccine trials if the agency grants emergency authorization. fda.gov/media/144354/d… #vrbpac

@pfizer describes its two phase 1 studies. American study included people up to age 85. #vrbpac

@pfizer notes that its covid-19 vaccine caused some volunteers to develop pain in their arms, fever and chills. None of these reactions were "serious" in that no one went to the hospital. But you could miss a day of work and feel really rotten for 1-2 days. #vrbpac

@pfizer said the study's data and safety monitoring board continues to meet and review study. #VRBPAC

@pfizer is collecting data from vaccine study for two years. #VRBPAC

@Pfizer executive said some vaccine volunteers experience fever and chills after their injections, but that these are no worse than those seen in other unlicensed vaccines. (The shingles shot also causes these symptoms.) #vrbpac

Younger people had more vaccine reactions than older people, @pfizer said. Fever lasts about day. #vrbpac

Six deaths were recorded, with four in placebo group. #vrbpac

All of these presentations are being posted as they're given on the FDA web site. #VRBPAC fda.gov/advisory-commi…

Trial patients with these symptoms were tested for covid-19. Vaccine had 95% efficacy #vrbpac

Here's the vaccine efficacy by racial/ethnic breakdown. #VRBPAC

Efficacy in severe disease was high, although the number of severe cases was small. This may have been a healthier-than-average group that wore masks and socially distanced well. #vrbpack

@pfizer says its vaccine provides good protection from severe covid-19 disease. #vrbpac

@Pfizer's sound has cut out, but here are the slides. #VRBPAC

@pfizer vaccine is 95% effective at preventing covid-19 disease, and even with the margin of error, it's at least 90% effective. #vrbpac

@pfizer plans to apply for regular approval next year. Right now, it's just applying for emergency authorization, which has a lower standard. #VRBPAC

@pfizer plans to vaccinate people in the placebo group of the trial and is talking to @fdagov about how to do this. Volunteers can remain blinded if they wish. Study will continue for 24 months no matter what. #vrbpac

@Pfizer will conduct "real world" studies to get much more detailed information on vaccine efficacy. #vrbpac

@Pfizer is applying for emergency authorization in people over age 16. #vrbpac Company plans additional studies in younger children and pregnant women, who weren't included in the study.

A vaccine is needed more than ever, says Kathrin Jansen of @pfizer, given that 3,000 Americans are dying of covid-19 a day and the fact that 55,000 people could die each month this winter. #vrbpac

@drpauloffit asks @Pfizer if there was "volunteer bias" in the study. People in the study had a very low rate of disease. Were they healthier than average, maybe exposed to lower doses of virus? That could make their response to vaccine better than the general public's. #vrbpac

The @fdagov is now presenting its review of the @pfizer vaccine.

Volunteers in @pfizer trial are followed for two years for adverse reactions. #vrbpack

Here's the @fdagov's Susan Wollersheim's report. fda.gov/media/144337/d… #vrbo

Efficacy data by subgroup #vrbpac

Younger patients had more pain in their arms after vaccination than older patients. #vrbpac

Some serious events occurred more in vaccine group than placebo group, although @fdagov notes that the rates of Bell's palsy are the same as those in the general population. #VRBPAC

Although vaccine trial excluded women who knew they were pregnant at the start of the study, some women did become pregnant during the study. #VRBPAC

The vaccine appeared to offer some protection after just one dose, but that data is limited bc most people received two dosese. #VRBPAC

Another slide about how @fdagov and @cdcgov and other agencies will track safety. @vrbpac

@fdagov says they're monitoring the anaphylactic reactions reported in UK closely. #vrbpac

The @fdagov advisory committee is give questions to discuss and a question on which to vote. @vrbpac

Sheldon Toubman, an attorney and consumer representative, notes that trial data is 26 days old and wants an update, particularly on severe disease. Right now, he doesn't feel the evidence on severe disease is strong enough to judge efficacy #vrbpac

@drpauloffit asks @pfizer for more details about UK patients with allergic reactions. "There are 10s of millions of people who carry Epi pens who are going to believe now that they can't get this vaccine. That's a lot of people." #vrbpac

@drpauloffit: "You’re talking about 10s of millions of people who are not going to get this vaccine due to the comments today from the U.S. and the U.K. This is not doing die until we have better data." #vrbpac

@drpauloffit urged @pfizer to settle the issue of severe allergic reactions by conducting a trial in which the vaccine is given to people w. known egg allergy and known peanut allergy, under careful controls to provide emergency treatment if needed #vrbpac

@drpauloffit is worried about comments from the UK, where officials said no one w/ history of severe allergic reactions should take the vaccine, will create the *perception* that it's not safe for anyone w/ allergies. #vrbpac

Kathrin Jansen of @pfizer says animal data suggest that the covid-19 vaccine prevents infection, not just symptoms. No answer to this question yet in humans. #vrbpac

Kathrin Jansen said @pfizer is planning to see if vaccine prevents infection altogether, as opposed to an infection that causes symptoms. #vrbpac

Dr. Mark Sawyer said he's more comfortable authorizing a vaccine for people 18 and up, given that there is much less data on 16- and 17-year-olds. #VRBPAC

Panelist notes there aren't many Native Americans in the study, either, but no one proposes authorizing it for everyone except American Indians. Another panelists notes that American Indians have high rates of disease but kids don't. #vrbpac

"It's not a question of when do you know everything, but when do you know enough?" says @drpauloffit. "We have clear evidence of benefit but only theoretical risk." #vrbpac He supports statement as written.

And the vote is in. The @fdagov advisory committee has voted 17-4-1 to recommend that the agency grant an emergency use authorization (EUA) for the @Pfizer vaccine for people over age 16. 17 yes, 4 no, 1 abstained. #VRBPAC

The vote breakdown is the Dr. Cody Meissner abstained (he wanted to authorize vaccine for age 18 and up). No votes came from Dr. Archana Chatterjee, Dr. David Kim, A. Oveta Fuller and one other. Sorry, can't read my own handwriting! It was fast. ;--)

If an +8 @fdagov vaccine advisory meeting wasn't enough, don't worry. They're meeting again in one week, on Thursday 12-17, to scrutinize vaccine trial data from @modernatx. fda.gov/advisory-commi…

And just a reminder: The @Fdagov committee that met today are independent expert advisors, but their vote it not binding. Although the FDA commissioner usually follows its recommendations, he doesn't to. Look to @SteveFDA for the final word on this vaccine.

End of thread!