This week instead of an overview of the COVID news of the week, we are focusing on one very important event that took place yesterday in Washington, DC. The US Food and Drug Administration held the long-anticipated Vaccines and Related Biological Products Advisory Committee, or VRBPAC meeting (it’s pronounced VER-Pack, by the way). The day-long meeting was online like many of our gatherings in this pandemic time and pulled in a range of experts not to look at data or information from specific vaccine trials, but to question the process and procedures put into place by the FDA to ensure science-based not political decisions on eventual vaccines.
 
Ahead of the meeting Science’s Jon Cohen tweeted, “Speaking as a veteran of the FDA's vaccine advisory committee meetings—who, ahem, often struggles to stay awake—it's telling that @HelenBranswell and others are doing stories about the upcoming meeting before it has even happened.” Branswell wrote in STAT ahead of the meeting, “Nothing extraordinary is expected to happen…. But the very convening of the meeting is a reassuring sign that the Food and Drug Administration, which relies on VRBPAC for advice, plans to do what it usually does: Make decisions based not on political timetables but on data that show whether new vaccines are safe and effective.”
 
The outsized interest in this science-focused, wonky meeting—thousands of people watched online—comes from the politicization of the COVID vaccine research process by the current US administration.  As USA Today reports the “meeting featured excruciatingly detailed presentations by FDA and Centers for Disease Control and Prevention on what's known about COVID-19 and what requirements must be met for a vaccine to be approved.”
 
Going into the meeting it was relatively clear that there would be no “October surprise” vaccine approval, but the meeting was a chance for the public to hear more about what FDA’s plans for review of vaccines would be, for outside experts to question that process and for the FDA to clarify how the process will work.
 
The Wall Street Journal reports FDA “officials gave fresh assurances Thursday that COVID-19 vaccines will undergo rigorous testing before being made widely available—a message they underscored in a meeting with outside medical experts aimed at bolstering the agency’s credibility. Only those vaccines that are demonstrated to be safe and effective’ will be licensed by the FDA, said Marion F. Gruber, director of the FDA’s Office of Vaccines Research and Review.”
 
FDA Commissioner Hahn tweeted after the meeting: “We understand the importance of being as transparent as possible about the work we do, including how the FDA will make decisions regarding #COVID19 vaccines.
 
Politico reported yesterday that “Infuriated by the FDA’s defiance in a showdown over the Trump administration’s standards for authorizing a coronavirus vaccine, health secretary Alex Azar has spent recent weeks openly plotting the ouster of FDA chief Stephen Hahn…. Earlier this month, Hahn ended a lengthy standoff over the rules under which the FDA would grant emergency authorization for a vaccine by flouting the White House and ordering their publication. The move won widespread praise from the nation’s public health community. But it angered Azar and others who viewed it as the latest in a recent pattern of Hahn breaking with the broader administration in an effort to bolster his own reputation, current and former officials said.”
 

 
STAT reports, “There are serious signs the Food and Drug Administration is getting cold feet over the notion of issuing emergency use authorizations to allow for the widespread early deployment of COVID-19 vaccines. Instead, it appears the agency may be exploring the idea of using expanded access—a more limiting program that is typically used for investigational drugs—in the early days of COVID vaccine rollouts. Whereas a few weeks ago the agency’s concern was to protect against the possibility that unproven vaccines would be pushed out prematurely due to pressure from President Trump, now the fear is that early authorization of vaccine could squander a one-time chance to determine how well the various vaccines work and which work best in whom.”
 

 
The Pharmaletter reports, “Further issues discussed included the need for more data on duration of protection and whether the vaccine protects against mild or asymptomatic COVID-19, or just moderate and severe disease. Clearly, if the vaccine fails to protect against the milder cases, people who are vaccinated may still transmit the disease to others.
 

Politico reports, “In the runup to the vaccine meeting, at least one company—Pfizer—questioned whether clinical trials should continue unaltered if a shot gets emergency authorization from the FDA. Pfizer wants to be able to dose willing placebo patients with the shot if it is cleared for emergency use. But federal officials argue that could stall all ongoing coronavirus vaccine trials—making it harder to find concrete answers to justify full approval. FDA has already told vaccine manufacturers that they must follow at least half of their patients for two months before filing for that authority, a bar lower than approval…. Following trial participants after a vaccine authorization is critical, said CDC’s Stephanie Schrag, an epidemiologist who studies respiratory diseases. If the FDA allows emergency use of a vaccine before a trial is over, experts may not know how long or how well the shot protects people. Plus, real-world factors—things like getting people in for their booster shot—could impact how effective a shot is outside of controlled trials.”
 
The New York Times reports, “Several of the experts said that they believed the agency should ask the companies to wait for more safety data. They said the agency’s current guidelines, which require two months of safety data after a volunteer has received the last dose of a vaccine, were not good enough. Collecting longer-term data would allow them to evaluate potential risks, such as whether immunity to the virus wanes after a few months, or whether rare side effects emerge.”
 

 
Medpage Today reports on a presentation on the Reagan-Udall Foundation’s "’listening sessions’ on vaccine hesitancy. These indicated that the public harbors concerns about the speed of the process, as well as distrust of government and the healthcare system. Some committee members seemed to share their skepticism. Members of the public are ‘probably not going to have an appetite for anything short of the rigorous process we're used to seeing,’ said Hayley Altman-Gans, MD, of Stanford University Medical Center. ‘This is not going to be enough for this particular vaccine.’ Archana Chatterjee, MD, of Rosalind Franklin University in North Chicago, said that she thought safety needed to be the top priority, even before effectiveness. ‘Whatever products are put on the market under whatever mechanism" should be safe. Then you get to effectiveness.’"
 
Politico reports on the Reagan-Udall data that “Deep-set mistrust was apparent in responses submitted by people of color, who said that African Americans are treated differently by doctors and that people of color feel like "guinea pigs" because of an unethical history of medical experimentation.”
 
For more on the meeting check out #VRBPAC on twitter. AVAC live tweeted highlights during the meeting. And if you want to relive the day all 8 hours and 50 minutes are online here. Read AVAC’s comments ahead of the meeting and our director Mitchell Warren’s public statement delivered at the meeting. Additional public comments, including from our partners at AIDS Action Baltimore and the Treatment Action Group, are here.
 
For more on COVID vaccines check out our vaccine pipeline cheat sheet and regulatory approval primer for vaccine advocates. You can also visit the COVID Advocates Advisory Board website for more information and ways to get involved.