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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. https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee
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 https://www.fda.gov/media/144231/download
People submitted more than 300 public comments on the @Pfizer vaccine candidate. You can read them here. https://beta.regulations.gov/document/FDA-2020-N-1898-0036/comment #vrbpac
@Pfizer's vaccine data was published today in the @NEJM https://www.nejm.org/doi/pdf/10.1056/NEJMoa2034577?articleTools=true
as well an an outside commentary. https://www.nejm.org/action/doSecureKeyLogin?uri=https://www.nejm.org/doi/full/10.1056/NEJMe2034717%3fquery=RP&uuid=228864&dateTime=202012200000&key=NoX%2BNa4fOCkAszaJT62pYC5phmIkfXGGh%2BvqNeib414%3D
#vrbpac
as well an an outside commentary. https://www.nejm.org/action/doSecureKeyLogin?uri=https://www.nejm.org/doi/full/10.1056/NEJMe2034717%3fquery=RP&uuid=228864&dateTime=202012200000&key=NoX%2BNa4fOCkAszaJT62pYC5phmIkfXGGh%2BvqNeib414%3D
#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: https://content.govdelivery.com/accounts/USFDA/bulletins/2b081a3 #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
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
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
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 https://www.fda.gov/media/144327/download
Here are Dr. Anita Patel's slides from the @cdcgov https://www.fda.gov/media/144328/download #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. https://www.fda.gov/media/144330/download #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 https://www.fda.gov/media/144329/download
@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 https://www.fda.gov/media/144325/download
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
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: https://khn.org/news/article/time-to-discuss-potentially-unpleasant-side-effects-of-covid-shots-scientists-say-yes/
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 https://www.fda.gov/media/144325/download
@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.
"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. https://www.fda.gov/media/144354/download #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 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 https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement#event-materials
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 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
