What impact will the US FDA VRBPAC's first meeting have on the approval of the new crown vaccine?

The Composition and Function of the Advisory Committee on Vaccines and Related Biological Products The Advisory Committee on Vaccines and Related Biological Products (VRBPAC) is an advisory committee of external experts convened by the FDA.
VRBPAC's membership is made up mostly of experts and doctors from different specialties who are responsible for evaluating vaccine applications and making recommendations to the FDA when it reviews whether to approve a new vaccine.
current VRBPAC includes 20 members.
include a number of infectious disease specialists, paediatricians, and biostatists.
committee also includes a representative of the biopharmaceutical industry (currently Dr. Paula Annunziato, Vice President of Clinical Research for merca East Vaccines), although pharmaceutical industry representatives do not have the right to vote when the committee decides.
committee also includes a representative of the consumer.
committee members are required to undergo a "conflict of interest" check before each VRBPAC meeting.
the meeting, several committee members would not attend the meeting because of their involvement in the on-the-job clinical trial of vaccines, so the FDA added several interim members to complement the committee.
VRBPAC members will discuss in their first meeting related to the new crown vaccine? By browsing the draft meeting schedule published by the FDA on its official website, VRBPAC will discuss a number of issues related to vaccine development, approval, distribution, such as clinical factors to consider when approving a new crown candidate vaccine EUA application, as well as chemical, manufacturing and control (CMC) factors;
, awarding the new crown candidate vaccine, EUA, remains one of the fastest ways to bring the vaccine to the public.
month, the FDA issued guidelines for the authorization of emergency use of COVID-19 vaccines, setting out a range of requirements for the efficacy, safety and CMC data that candidate vaccines need to prepare when submitting EUA applications.
e.g., in terms of clinical data, the FDA requires that "data from Phase 3 studies should include a mid-range follow-up time of at least 2 months after completing a complete vaccination program to help provide sufficient information to assess the risk characteristics of the vaccine's benefits."
on safety, the FDA says safety data should include safety data for at least 3,000 vaccinators who are followed up for at least a month after completing their vaccination program.
hope to see at least five serious cases of COVID-19 in the placebo group to address concerns about vaccine-related enhanced respiratory diseases.
committee meeting, VRBPAC members could present their views on the guidelines, including those proposed by the FDA.
committee meeting also provided the FDA with an opportunity to hear the views and reflections of outside experts on specific issues.
, for example, the FDA said in the EUA guidelines that it wants vaccine developers to continue blind follow-up to Phase 3 clinical trials after obtaining EUA and continue to collect safety and efficacy data in blind situations.
However, from an ethical point of view, during the COVID-19 pandemic, should clinical trial subjects who received a placebo be told that they were not vaccinated, giving them the opportunity to get a new crown vaccine and be protected? However, if exposed after obtaining EUA, it may affect the collection of subsequent safety and efficacy data in the placebo group and the comparison with the vaccine group.
is a difficult decision that requires weighing the ethics of clinical research and the need to maximize the collection of information about vaccine candidates.
VRBPAC members can provide valuable insights into the FDA on such thorny issues.
VRBPAC's first meeting will begin at 10 a.m. EST on October 22 and is expected to last a full day.
the FDA's Biological Products Review and Research Center (CBER) will broadcast the conference process live online.
: s1. FDA Briefing Document Vaccines and Related Biological Products Advisory Committee Meeting October 22, 2020. Retrieved October 20, 2020, from .2 Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Draft Roster. Retrieved October 20, 2020, from s.3. Why this week's meeting of an FDA advisory panel on Covid-19 vaccines. Retrieved October 20, 2020, from the As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines. Retrieved October 20, 2020, from s.5 Roster of the Vaccines and Related Biological Products Advisory Committee. Retrieved October 20, 2020, from.