By Daniel R. Lucey M.D., MPH, FIDSA
COVID-19 vaccine availability will be accelerated by receiving U.S. Food and Drug Administration emergency use authorization as opposed to the longer approval and licensure process. No unlicensed new vaccine candidate has ever received an EUA. For this reason and others, too many Americans may not trust the safety of the vaccines enough to accept them. As a result, United States businesses and institutions will be less likely to reopen as widely as needed in 2021.
The following four steps can build trust in these vaccines.
First, before the end of September the FDA should make public its new detailed guidance on emergency use authorization for COVID-19 vaccines. Thus, public discussion could occur before any company files for an EUA for their COVID-19 vaccine candidate. FDA Commissioner Dr. Stephen Hahn, tweeted Sept.11 a link to an FDA document that states:
“The FDA also intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA”.
Second, FDA should make public online its Vaccine Advisory Committee meetings each and every time they are convened to discuss COVID-19 vaccine candidates. Briefing documents provided by FDA to this independent advisory committee prior to these meetings should also be made public at least two days before these meeting.
As a good precedent, on Oct. 22 FDA will convene a public meeting of its Vaccine Advisory Committee to discuss general issues regarding COVID-19 vaccine candidates. Notably, FDA states that no specific vaccine candidate will be discussed Oct. 22nd.
Third, companies should not submit an EUA request to the FDA until safety data after the second dose for the initial 30,000 persons in the vaccine trial has been provided to the FDA. Trust in Covid-19 vaccines is first and foremost an issue of safety, rather than efficacy. Stopping a trial early at one of the interim analyses, based on criteria for efficacy being met but without essential safety data following the second dose of the vaccine, will not build trust in the safety of that vaccine.
Fourth, by Oct. 1 a comprehensive public education campaign about COVID-19 vaccines should begin across the wide spectrum of communities in America. Information must be provide by trusted members of mainstream and diverse communities in America. These explanations must include dialogue. They will take time. The Oct. 22 FDA advisory committee meeting should incorporate discussion of this outreach to American communities.
These four steps are feasible and straightforward. Their implementation will help build trust and acceptance of COVID-19 vaccines across communities in America.
Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee.He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus here since Jan. 6.