Hilary Marston, M.D., medical officer and policy adviser for pandemic preparedness at the National Institute of Allergy and Infectious Diseases, said she and her colleagues are “thrilled” about announcements that at least two COVID-19 vaccines so far have been shown to have an efficacy of over 90% in late-stage clinical trials.
“I don’t think any of us could have hoped for those results,” Marston said during a Nov. 18 interview at the AHCJ Journalism Summit on Infectious Disease. “We are … ready to work with the FDA to get the data to them as soon as possible.”
Pfizer, one of the two vaccine makers, said on Nov. 18 that it has enough safety data to apply for FDA emergency use authorization in the next few days. On Nov. 16, Moderna, the other vaccine maker, said it too has promising data and expects to file for regulatory approval soon.
The requests for approval will launch an intense regulatory review process. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will publicly review Pfizer’s clinical trial data.
“That was a really important move that the FDA took, to decide that the VRBPAC would do these public meetings and look at the data in a transparent manner,” Marston said. “I hope that will help to build confidence.”
A majority of Americans ― about 58% ― say they would be willing to be vaccinated against SARS-CoV-2, the virus that causes COVID-19, but there are many who are hesitant or say they won’t get vaccinated. That presents a considerable challenge to ending the pandemic.
Building public confidence in these and the other COVID-19 vaccines in development will take a “multi-pronged” approach that includes journalists reporting extensively about the vaccine approval process’s rigor and scrutinizing the regulatory process and clinical trial data, Marston said.
“Health journalists have a tremendous role to play in that, particularly in emphasizing the multiple aspects of review that these vaccines will go through and the robust evaluation that they have already been through,” she said. “Check our work every step of the way and see what we are doing.”
For those who worry that drugmakers may have cut corners during the clinical trial phase, Marston noted that all of the COVID-19 trials have been overseen by the independent Data and Safety Monitoring Board and the Centers for Disease Control and Prevention (CDC). The FDA will continue to monitor the vaccines’ safety after approval and as they are administered more widely to the public.
“It’s really important to keep hitting the fact that these were very carefully designed trials, that we took the potential for any one player to influence out of the system,” Marston said. “Even if an industry player or someone wanted to influence it more, they wouldn’t be able to because there is that independent data and safety monitoring board.”
Roll out of the vaccine will begin with specific high-risk populations, such as those who work in patient care or senior citizens living in nursing homes, and will expand from there, she said. The CDC will be in charge of overseeing the distribution of the vaccines and be drawing upon lessons learned from the H1N1 flu pandemic in 2009., she said. Further, health officials are prepared for the challenges of having to store vaccines at very low temperatures. To get the vaccine to hard-to-reach communities, the CDC will partner with pharmacy store chains and federally qualified health centers, she said.
However, Marston warned that the public should not expect the vaccines to end the COVID-19 pandemic quickly. Everyone still needs to wear masks, practice hand hygiene and continue to practice physical distancing to prevent infection.
“It is imperative that we all understand that for the foreseeable future, we are looking at a combination COVID-prevention situation, and that is one where we do not put everything on vaccines,” she said.
“I think it has to be about stories,” she said. “A lot of people won’t be moved, in their individual situation, by statistics, but I think those stories of weddings, of family gatherings, just having a small dinner party and the reverberations weeks afterward are the most moving on the individual level.”
Check out this recent AHCJ tip sheet on covering COVID-19 vaccines. Registration for the Journalism Summit on Infectious Disease is available through Nov. 19 and gives registrants access to recordings of all four days of sessions, which began Nov. 16.
Also see this video of AHCJ’s Nov. 18 interview with NIH Director Francis Collins.