The Centers for Disease Control and Prevention sent notices to states last week alerting them to prepare for a coronavirus vaccine as soon as late October or early November. Election Day is Nov. 3.
There’s concern that any vaccine may not be fully tested and safe for distribution, and that even if it is, even a hint of political motivation will erode trust in it.
The CDC’s announcement referred to two candidates labeled Vaccine A and Vaccine B. The requirements for their distribution align with the two vaccines which are furthest along in the trial process, one from Modera and the other from Pfizer.
“I'm not sure which one is A or B. But we certainly are one of the vaccines in contention to deliver on a Nov. 1 date, and we're still working very hard to achieve that goal,” says Dr. Bill Gruber, Pfizer's senior vice president of vaccine clinical research and development.
Pfizer says they have 23,000 people enrolled, with up to 30,000 scheduled to participate in the trial, which is in late Phase 3. Fifty percent of participants receive the vaccine and 50% receive a placebo, he says.
Gruber says so far, recruitment has gone well and the vaccine’s safety profile in the current phase is “very similar” to what Pfizer saw in their Phase 1 trials. The trials are blinded, which means researchers don’t know who is receiving the vaccine versus the placebo.
But one looming question remains: Will it be ready for mass distribution as soon as two months from now?
While Gruber doesn’t have a surefire answer, he says their bottom line is making sure the vaccine is “safe and well-tolerated” among all else. Pfizer will be working in cooperation with the Food and Drug Administration to make sure all safety guidelines are met, he says.
“We are obviously very keen to follow the guidance and rules of the FDA and our decisions about how the vaccine would be licensed would be done in concert with them,” he says. “I've been very pleased at the collaboration that has existed with the FDA.”
Editor’s Note: A Here & Now producer’s spouse is a participant in the Pfizer coronavirus vaccine trial.
On the results from Phase 3 so far
“First of all, our highest priority is demonstrating that the vaccine is safe and well-tolerated. And even though we're, of course, blinded to the results, and as you said, half the individuals enrolling in the trial receive vaccine and half receive placebo, the reactions that we're seeing after vaccine are very similar to what we saw in Phase 1. So the vaccine looks to be that it will likely be well tolerated and safe.
“The other thing that we do is that everybody who enrolls in the trial either receives in a blinded fashion two doses of the vaccine or two doses of placebo. And once that's done, we monitor them to see if they actually acquire circulating COVID-19 or circulating Sars coronavirus 2 that produces COVID-19. So we're watching to see if they catch the virus in the community. And then we use that information to determine are there fewer numbers of individuals that catch the virus or receive the vaccine or not? Now, how do we do that? We obviously have to remain blinded during the early phases of the trial until we get to the end, but we might have efficacy early. And so we have what's called a data monitoring committee, and some people refer to it as a data safety and monitoring board, who have the ability to look in an unblinded way independent of us — we have no idea. And at particular time points in the trial, they can say you do not have to go any further with this trial. You've already shown efficacy and you have sufficient safety to actually declare success.”
On potential side effects or long term impacts: A Here & Now producer’s husband, who is a doctor, is participating in the trial and experienced severe vertigo, nausea, diarrhea, headache for several days. He still thinks it's important to be in this trial and he has faith in this vaccine, but says it would be irresponsible and ethically wrong to release it before the trials are completed.
“I think, again, our goal is to obviously do our very best in collaboration with regulatory authorities to assure a safe and effective vaccine. I think all of us that are working in this area need to follow the rules. The rules were designed to protect the safety of individuals. For our part, we very closely monitor the nature of reactions to the vaccine.
“And again, let me express my appreciation for your colleague's husband for participating in this trial. As we're very appreciative of all the individuals who see fit to participate, because, of course, we can't guarantee ahead of time that the vaccine will be effective. But we do monitor safety very closely, not only for the short term but this study is designed to follow these individuals out to two years. That's both so that we can monitor longer-term potential safety outcomes, but also so that we can determine how long protection might last.”
On whether he trusts the government regulatory authorities and people making this decision
“Yeah, let me be clear. Again, our approach is no different than we would take for any other vaccine in terms of following the rules that the FDA has required. The FDA has, you know, provided guidance in terms of the size of a safety database that's required to release a vaccine based on just the safety component. We absolutely plan to follow those rules. Pfizer is very supportive of the FDA's approach to safety.
“I can't speak to the politics beyond the FDA but that the nature of what we choose to do is to follow the FDA rules. And, you know, I'm hopeful that that will be the basis for licensure. The FDA is going to actually hold at least one meeting, maybe more, that is actually going to set the ground rules for what's going to be required that I understand is going to occur toward the end of October. And I think that should be the basis for any sort of decision making as to whether a vaccine is considered safe enough and demonstrates efficacy sufficient either for emergency use authorization or to potentially be licensed.”
On whether he’s confident that health centers across the country could build the infrastructure needed to store Pfizer’s vaccine, which requires refrigeration, in time
“Yeah, I think, you know, obviously that's part of the reason we and everybody in this field has been working closely with the CDC and other entities that will be responsible for figuring out how to deliver vaccine. And yes, there's no question that it is more challenging the circumstance where you have to maintain vaccine in a frozen state.
“... We may have to think differently about how we manage vaccination in a pandemic setting. And I'm old enough to have experienced what was referred to as Sabin on Sunday where, you know, I lined up along with other children and adults to receive live poliovirus vaccine at my school. So for pandemic planning, I think we need to think carefully about how we would provide vaccines at site. We've identified ways to maintain the cold chain and the packaging so we can deliver vaccine to site that would be stable and could be delivered to individuals.”
On how he feels about the possibility of having a coronavirus vaccine
“Oh, I'm feeling very optimistic. Obviously, I can't promise success, but the recruitment has gone well. We're still on target to deliver a potential efficacious vaccine if all goes incredibly well. And we have high efficacy in the timeframe that you mentioned at the beginning of this report. So I'm feeling quite good.
“I really think the platform that we're using, the RNA vaccine platform, offers some advantages in terms of providing the right type of immune response that should prove efficacious against COVID-19. And we're on path that we don't have to be in suspense for much longer. I'm thinking that we will start learning things as soon as October into November. And hopefully, if the vaccine is efficacious, we'll be able to declare success and also prove to the public that the risk-benefit in terms of the safety profile favors the population receiving this vaccine.”
Correction: Pfizer says they have 23,000 people enrolled in their Phase 3 trial, not 30,000, which is how many are scheduled to participate. The correct number has been updated on the digital article. We regret the error.
This segment aired on September 3, 2020.