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What accelerated COVID-19 vaccine development means for safety

Some of the federal government’s top health officials are suggesting a vaccine for COVID-19 could be released in less than two months. The move would be made through a special emergency authorization of the Food and Drug Administration. But the accelerated speed of the process is also raising questions. Amna Nawaz reports and talks to Dr. Michael Mina of Harvard’s School of Public Health.

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  • Judy Woodruff:

    Some of the federal government's top health officials are suggesting a vaccine for COVID could be sent out in less than two months. It would be done through a special emergency authorization of the Food and Drug Administration.

    But, as Amna Nawaz tells us, the accelerating speed of this process is raising questions.

  • Amna Nawaz:

    That's right, Judy.

    In fact, the CDC confirmed it has notified public health officials in all 50 states and five large cities to prepare for potential vaccine distribution. That would be for some higher-risk people as early as late October or early November.

    But there are a number of concerns about developing and distributing a rushed vaccine, especially when the president himself has been promising one.

    Dr. Michael Mina is assistant professor of epidemiology, immunology and infectious diseases at Harvard's School of Public Health. He's also a member of the Center for Communicable Disease Dynamics.

    He joins me now from Boston.

    Dr. Mina, thanks for being with us.

    We should point out to people, the normal vaccine process takes years. It's been dramatically accelerated during the pandemic. And the firms that are developing a vaccine are already in phase three of the trials, which is the final phase before they are supposed to seek FDA approval.

    So, how would an emergency authorization change the timeline and the process?

  • Michael Mina:

    Well, essentially, what happened is, having the emergency use authorization as the goal to actually get this vaccine approved gives the FDA and gives the manufacturers of the vaccines quite a bit more room to accelerate the overall design and study of these.

    So, what we have seen, for example, is an overlapping of the different phases, phase one, phase two and phase three, that normally don't overlap in nearly the same way that we have seen.

    And this has compressed the time window considerably, by years, essentially, to actually get this vaccine, potentially over the first hurdle, to get it out into the public domain.

  • Amna Nawaz:

    But with an emergency authorization, does it reduce the number of hurdles it has to go through? Does it lower the standards in any way?

  • Michael Mina:

    Well, ideally, it would not lower the standards, nor necessarily reduce the actual — the overall hurdles that it needs to get through.

    It certainly allows for the evaluation to be accelerated in many ways. Now, of course, there's been concerns about whether or not it might be getting approved too quickly and sort of rushed through. And that is not necessarily a function of the EUA in this case. It's — that might be more — those concerns are really being driven, I think, more from some of the confusion that's happened at the political level.

    But the EUA is still intended to keep safety first and foremost, try to evaluate for efficacy as well as possible before these vaccines really get out to market.

  • Amna Nawaz:

    So, if you're further accelerating the process, what are the potential risks of that?

  • Michael Mina:

    Yes, well, the risks certainly are to — if these are not necessarily recruiting and evaluating as many people as they might otherwise look at, what we are concerned with, for example, as we're talking about safety, is that phase one and two are really designed around safety, to make sure that people aren't getting harmed by the vaccine.

    We didn't see any real serious safety signals during phase one and two of this, but these were also — these were accelerated. And there is a chance that, when these really move out to phase three and then out to post-market, we could end up seeing what we have been think of as kind of fringe effects.

    What happens at the edges of the distribution? If you have a bulk of people, for example, getting slight fevers, there's always a concern that in a rare number of people that those fevers could become more serious in terms of adverse effects.

    And so we haven't really had the protocols set up and the time to really rigorously evaluate those pieces. So that is a risk, I would say.

  • Amna Nawaz:

    Let me ask you about some of the higher-risk communities that they say the vaccine could be deployed to first.

    We know that the front-line health care workers, essential workers, national security people also among the high-risk groups so far. You can talk about Black and brown communities and Native Americans. We know they have been disproportionately affected in the pandemic.

    You look at the COVID-19 death rate, it's higher for Latinos, higher for Native populations, more than two times higher for Black Americans than for white Americans.

    Is there a concern that the government will have trouble convincing these communities that have already lost faith in them for failing to help them during the pandemic, convincing them to willingly accept a vaccine?

  • Michael Mina:

    I think there's a lot of concern around that.

    The vaccine, unfortunately, has been polarized. And this certainly is — it's been polarized by politics. The whole virus and our response to this virus has become polarized.

    And I think any time we're infusing so much divisiveness into what needs to be a concerted effort, in this case, to keep people healthy, to suppress the virus from transmitting at the population level, to get people to trust that the FDA and the CDC and the federal government are doing their due diligence to keep people safe, whether it's from the virus or from the vaccine, I am — it's not surprising that there is so much concern and confusion that's abounding in the general public.

  • Amna Nawaz:

    Dr. Mina, before we go, I want to ask you to address a claim the president himself has made and now others are picking up.

    There is this idea that the COVID-19 death toll is overstated that is now circulating, that hospitals are misreporting COVID-19 diagnoses for reimbursement incentives. Is there any evidence or truth to that?

  • Michael Mina:

    No, this is all misunderstanding, whether intentional or unintentional.

    These — it is very common. By the time somebody dies from an infection, many things can go wrong during that course in the hospital. And so it's actually very rare that, when somebody dies in a hospital, that they have a single cause of death necessarily written on their death certificate.

    And so this piece of information has kind of been picked up and completely misconstrued. For example, somebody dying of COVID who also has diabetes, for example, well, we know that diabetes is a risk factor for severe infections with COVID, but you still are dying of this virus, even if you have diabetes.

    So, diabetes will make its way onto the certificate perhaps, but it's not the thing that's killing you. So, I think that this has been, unfortunately, another piece that's been politicized. It's been taken up by people who want to project a message that this virus isn't something to take seriously.

    And that is — it's an unfortunate state of affairs that we are even having to have this conversation.

  • Amna Nawaz:

    And we appreciate the clarification.

    That is Dr. Michael Mina from Harvard's School of Public Health.

    Thanks so much for your time.

  • Michael Mina:

    Well, thanks very much.

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