The head of the U.S. Food and Drug Administration says it’s critically important that a diverse population enrolls in clinical trials for a COVID-19 vaccine.
Some health care providers have expressed concern around ensuring equitable participation in clinical trials, as the virus has disproportionately impacted minorities in the U.S.
“We know from medicine and science that different groups could respond differently to vaccines,” FDA Commissioner Dr. Stephen Hahn said in an interview with The Tribune.
“Our stance on this is that we want the people who are on the clinical trials to represent all of America so that when we look at the data at whatever point in the future, those data are representative of the entire population.”
He said the trials must include representation of minorities, the elderly and people who have diseases that put them at risk for COVID-19 complications including diabetes, heart disease, hypertension and obesity.
“We’ve spent a lot of time clarifying this and communicating this to the people who are running the trials but also looking very closely at their enrollment and frankly pushing folks to make sure that they are redoubling their efforts to ensure diversity,” said Hahn, who was appointed to his post in December.
He said the FDA is committed to being as transparent as possible in authorizing a potential COVID-19 vaccine. The agency is analyzing the data from clinical trials from manufacturers and developers of potential vaccines.
Four U.S. Phase 3 trials of coronavirus vaccines are underway, each involving tens of thousands of participants.
“Those trials give us a reading on the effectiveness of the vaccine. What I mean by effectiveness is — the prevention of someone getting COVID,” Hahn said.
“They allow us to get a very good reading, not only of the effectiveness but the safety.”
Moderna, the first company to start U.S. clinical trials of the COVID-19 vaccine, announced Thursday that it finished enrolling all 30,000 of its participants. The company also said 20% of the participants are Latino and 10% are Black.
Hahn said the FDA is one of the few regulatory agencies in the world that actually looks at the raw data of a clinical trial.
“Our scientists analyze it on their own and come to their own conclusions. So we’re independent of anything a company or anyone else could conclude,” he said.
“We’ve been really clear about what we need to see around safety and effectiveness — that we have promised that these are the criteria that we are going to use and that we’re not going to cut corners and that we intend to be very public about our assessment of it and we will keep to that pledge,” Hahn said.
He said the agency wants a COVID-19 vaccine to be at least 50% effective.
“Of course, we’d love to see a vaccine that is even more effective and we’re hoping that is what comes from the clinical trials, but our approval will be based upon that assessment of 50% efficacy and we intend to be transparent about what the data shows,” he said.
To assess safety concerns, the FDA has requested that 50% of those who receive a potential vaccine during a clinical trial be monitored for at least two months.
“Our scientists have looked at past approvals of vaccines and have determined that two months is the period of time when we see the vast majority of side effects of a vaccine,” Hahn said.
“If there was to be an authorization of a vaccine, we would put in place a very strict program of following people who receive a vaccine. As the number of people increase who get the vaccine, we want to make sure that we are not seeing anything different than what we saw in the clinical trial,” he said.
“We will be putting a lot of effort and resources into that because we want to continue to ensure that a vaccine is safe.”
On Thursday, the FDA’s Vaccine and Related Biological Advisory Committee hosted the first in a number of virtual public meetings on COVID-19 vaccines. The committee is made up of independent advisers who will determine whether COVID-19 vaccines are safe and effective.
“I think that it is very important for people to know that this public airing of the data and the questions by independent scientists outside of the agency is a very important component of it and I believe helps in terms of competence because it is not just one group looking at it — it’s multiple sets of eyes and that is critical in science and medicine,” Hahn said.