5 things you need to know about FDA and COVID-19 vaccines

There was no clear bombshell in the first meeting of an FDA advisory committee dedicated to COVID-19 vaccines. There were, however, several conclusions. 

Known as the Vaccines and Related Biological Products Advisory Committee (VRBAC), the meeting yesterday provided an overview of the steps medical and government authorities are taking to approve COVID-19 vaccines. 

Here are five key points from the meeting:

1. The government won’t mandate vaccines

The group also stressed that the federal government cannot mandate vaccines. “Mandates have been shown to increase coverage in some settings, but the federal government would not be mandating use of these vaccines,” said Dr. Amanda Cohn, chief medical officer at CDC’s National Center for Immunization and Respiratory Diseases. “Organizations, such as a hospital with licensed products, do have the capability of asking their workers to get the vaccine.” But in the context of an emergency use authorization, individuals will have “the right to refuse the vaccine,” Cohn said.   

The panel also discussed the need for a COVID-19 vaccine in settings such as nursing homes, prisons and medical facilities.

2. Data-based approach to COVID-19 vaccine approval comes with challenges

The panel stressed the need for scientific rigor in the development of vaccines for the novel coronavirus. The prospect of gathering data from populations such as individuals with comorbidities, the elderly in addition to pregnant and nursing women, however, is generally limited, panelists acknowledged. 

There’s a need to recruit “individuals who reflect the pandemic — in particular, individuals who are at risk of severe COVID,” said Dr. Hilary Marston, a medical officer with the National Institute of Allergy and Infectious Diseases.

There is also a dearth of COVID-19 vaccine trial data involving children. The Pfizer trial is unique in its enrollment of individuals as young as 12 years old. Most trials typically start at the age of 18.  

The panel recommended that trials continue if a vaccine is granted emergency use authorization. Pfizer, Johnson & Johnson and the trade group BIO have asked for clinical trial guidance from FDA in the event a vaccine becomes available. In particular, officials at the companies worry that attracting trial participants will become difficult if they realized they might receive a placebo. Prior guidance from FDA stated that the agency “does not consider availability of a COVID-19 vaccine under EUA, in and of itself, as grounds for stopping blinded follow-up in an ongoing clinical trial.”

If FDA grants emergency use of a vaccine before a clinical trial is completed, however, the prospect of determining how long the vaccine is effective could be difficult. 

3. Concerns about the lack of trial diversity

Moderna’s clinical trial for a COVID-19 vaccine hit a snag earlier this year for failing to recruit sufficient numbers of minority patients. The company is not alone. Several COVID-19 trials have struggled to recruit from diverse communities.

4. Risk of COVID-19 vaccine-induced enhanced disease is a concern

There is no proof that a vaccine for the novel coronavirus could exacerbate a COVID-19 infection rather than guard against it. But scientists have observed antibodies can occasionally worsen infections in a number of virus families. Researchers, for instance, have observed antibody-dependent disease enhancement with the dengue virus.

5. Panelists are mindful of a vaccine-wary public

The nation’s top infectious disease expert, Dr. Anthony Fauci, recently lamented that there is growing mistrust among the public in the government’s steps to combat the pandemic. “It’s the elephant in the room,” he said in a video posted by the watchdog group the Project on Government Oversight. 

The acting chair of the VRBAC Arnold Monto stressed the importance of transparency.

Several panelists in the VRBAC meeting stressed the need to build public trust in vaccines.

“We need to ensure the trust of the covid-19 vaccine and vaccines in general,” said Dr Doran Fink, a deputy director at FDA’s Center for Biologics Evaluation and Research division. “Widespread deployment of a weakly effective COVID-19 vaccine could result in more harm than good,” he added.