Food and Drug Administration advisory board meetings, though important, usually tend to be events monitored by dozens of corporate representatives, scientists, investors, and patient advocates.
But Next week’s hearing Research on coronavirus vaccines, set against the backdrop of the presidential election 12 days later, could turn on the White House’s response to a pandemic and may be carefully watched at a historic rate.
The agency expects an audience of tens of thousands, even if outside experts convened in remote areas are not required to make specific recommendations for shot approval.
Two experimental vaccines developed by Pfizer and Moderna are approaching the retrieval of data that, if positive, may support emergency approval. The two companies will arguably have nothing to show the FDA in time for the October 22 meeting, but the advisory board still has a lot to discuss.
Late clinical trials Register hundreds of thousands of volunteers in progress. External experts on the advisory board will be asked what additional investigations need to be conducted to assess the safety and effectiveness of the shot. In particular, the discussion can focus on the use of vaccines in under-researched or at-risk populations, the safety assessment of granted emergency permits, and the persistence of the protective effects shown. ..
In an interview, Thomas Russo, Dean of the Department of Infectious Diseases at the University of Buffalo, said, “I hope the vaccine will be given to hundreds of millions of people in the country and billions of people around the world.” Said. “These trials are just a few. What if one in a million or five in a million serious side effects occur?
Advisory board documents, voting questions, and panel rosters are typically published 48 hours before the meeting and date October 20 with additional clues to the FDA’s view of the coronavirus vaccine.
In the meantime, here are five important questions that may be addressed at next week’s meeting:
How is vaccine safety monitored after emergency clearance? After full approval?
The first vaccines that are likely to get an emergency license this fall have at most eight months of safety data across early, mid- and late-stage tests. In these critical studies used to support FDA OK, participants will be followed for up to 4 months if an emergency clearance estimate for November is retained.
Agency leaders specify how much data would be comfortable to authorize vaccines for emergency use. Safety data for 2 months or more For at least half of the trial volunteers. However, the FDA wants to continue its safety assessment to ensure that there are no adverse events that could prompt the withdrawal of authorization. The two-month safety mark set by the institution is based on the knowledge that most vaccine-related adverse events are within that time frame.
In guidance on applying for an Emergency License (EUA), authorities said pharmaceutical companies need to plan to monitor side effects to support continued public use of the vaccine. In addition, the FDA said the EUA issuance is not a reason to stop blind follow-up on safety and efficacy, so vaccine manufacturers need to plan monitoring months or years later. .. Panel expert advisors may be asked to comment on good strategies for ongoing safety follow-up.
How long does immunity last and how is it measured?
One of the major controversies over the SARS-CoV-2 pandemic is how long an infection or vaccine immunity lasts. Patients infected with the coronavirus that caused SARS and MERS showed measurable immune responses ranging from 1 to 3 years.
Still, First confirmed reinfection in US patients This question continues, as reported this week, especially as regulators and policy makers are considering the possibility that a vaccine to prevent COVID-19 may need to be given annually with a vaccine for influenza. This is the most important issue.
Pascal Soriot, CEO of AstraZeneca, who is developing key vaccine candidates Admitted Boosters need to be part of a long-term vaccination strategy. The advisory board may be asked the best way to measure weakened immunity. This should include ways to coordinate data collection to account for volunteers who have withdrawn from the trial to receive the licensed vaccine.
How is the vaccine-induced enhancement of respiratory illness monitored?
One of the biggest concerns of vaccine professionals is the risk that rush testing of coronavirus injections can lead to a condition known as vaccine-induced respiratory disease (ERD). When this happens, the weakened antibodies actually help the virus enter the cells, exacerbating the condition that vaccination intended to prevent.
To distinguish between COVID-19 and ERD, it is necessary to identify biomarkers such as certain types of leukocytes associated with allergic reactions and proteins involved in immune signaling, said the Vaccine Education Center of Philadelphia Children’s Hospital. The director, Paul Ofit, said. Email.
The· FDA guidelines For the purpose of emergency clearance, the occurrence of 5 or more severe COVID-19 patients in the placebo group in the Phase 3 trial alleviates concerns about ERD. On the other hand, more than five vaccinated volunteers will be a sign for researchers to consider the potential of ERD more closely.
Is sufficient data collected for vulnerable groups?
Like most clinical trials, the first coronavirus vaccine study in the United States enrolled primarily white volunteers, excluding more vulnerable groups such as people over the age of 60 and black, Hispanic, and Latin people. did. Early studies also generally first looked at healthy adults under the age of 60 without other illnesses.
However, in order for the vaccine to be effective in controlling the spread of COVID-19, vulnerable groups affected disproportionately by the disease must be protected as well.
With that goal in mind, Moderna recently delayed enrollment in large-scale vaccine research. Secure a larger expression Among those identified as black, Hispanic, or Latin, Pfizer added 14,000 patients to the trial to increase diversity among participants.
In an interview, virologist Larry Corey, co-head of the National Institutes of Health’s COVID-19 Preventive Trials Network, said in an interview, “We have proven that we can effectively register if we are involved with the community.” .. However, “I don’t know anything until I actually see the results. Registration doesn’t end the exam. I need to demonstrate its effectiveness.”
Elderly people and patients with comorbidities are also at high risk of COVID-19 complications, and we are also creating data from groups of interest.
How other populations, such as children and pregnant women, who are excluded from major phase 3 trials will be studied may also be a topic of discussion. Testing vaccines in school-aged children is important given their potential role in community infections, but testing in pregnant women was conducted to study the potential risk of birth defects. need to do it.
Do future vaccine trials need to measure cases of COVID-19, or are immune response data sufficient?
Even if two or three vaccines are approved or approved in the coming months, drug developers will want to improve on their first launch.
However, in such a scenario, enrolling in a study can be difficult for a huge number of volunteers, half of whom could receive a placebo. The FDA’s own guidance on vaccine approval is to clear subsequent vaccines with so-called “surrogate” endpoints, as well-characterized when the first vaccine is approved based on COVID-19 prophylaxis. It states that there may be sufficient benchmarks. Immune response. However, this is only true if the vaccine in question is of the same type as previously approved.
The FDA may seek advice from outside experts on when to use surrogate endpoints, which endpoints to use, and under what circumstances they can support their use.
Ben Fidler contributed to the report.
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