The White House attempted to block the federal Food and Drug Administration from publishing stringent new guidelines governing the emergency release of a coronavirus vaccine, fearing the safety rules could delay approval until after the upcoming election, according to a recent report in the New York Times. President Donald J. Trump has repeatedly promised a vaccine will be available this year. Many public health experts worry that this and other reported interventions in the government’s pandemic response by elected officials and political appointees will undermine public confidence in both the vaccine and other health precautions in ways that will render them less effective.
In an interview with Harvard Law Today, Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, says that political interference in the FDA’s process for ensuring that a vaccine is both safe and effective “opens the door to a public health disaster.” Shachar earned her J.D. at Harvard Law School and her Master’s in Public Health at the Harvard T.H. Chan School of Public Health.
Harvard Law Today: The pandemic has been marked by conflicting guidance from the White House, federal agencies and different states. Who is responsible for dealing with a national public health emergency?
Carmel Shachar: We have a federal system in which certain responsibilities lie with the federal government, and everything else devolves to the states. Historically, responsibility for the health and welfare of the people belonged to the states. But over the last century, we’ve really moved away from that model. So, for example, the FDA regulates drugs. And especially in the last decade or so, with the Affordable Care Act, the federal government has become actively involved in promoting public health goals, particularly preventative care.
The pandemic has tested the parameters of federalism as they apply to public health. Back in April and March, for instance, a lot of states were really scrambling to buy PPE [personal protective equipment] for hospitals and physicians. And there were arguments about whether the federal government should have been buying and coordinating and sending everything out, whether the states should be able to purchase independently, and in some cases, who ultimately should take responsibility for coordinating resource allocation. This is in addition to the political push and pull in which some states were much more aggressive about implementing public health requirements, such as mask mandates and shutting schools and businesses down. But vaccine development is an area in which it’s really appropriate for the federal government to be a leader.
HLT: The Food and Drug Administration is in charge of vaccine approvals. What does that process look like and can people trust it?
Shachar: The FDA, in many ways, is the gold seal. FDA-approved means it’s safe and effective. The FDA has worked really hard to walk the fine line between getting devices and drugs that address COVID to people, while also trying to avoid getting snake oil out on the marketplace. The primary mechanism by which they do this is emergency use authorization. Because the whole process of getting regular FDA approval can be quite lengthy, emergency use authorizations enable them to be more nimble in cases of a serious or life-threatening disease or condition. If, based on the scientific evidence that’s available, it’s reasonable to believe that the potential benefits might outweigh known and potential side effects, and there is no alternative on the marketplace, the FDA can approve drugs or devices on an emergency basis.
In the case of COVID, an emergency authorization can be used to get a vaccine out there very quickly. And there are four or five candidates already in phase three trials, enrolling up to 60,000 people. So, it’s quite possible somebody one will be far enough along in their vaccine trials this fall to apply for an emergency use authorization. When the FDA reviews a vaccine, it relies on an outside panel of independent scientific experts called the Vaccines and Related Biological Products Advisory Committee to recommend whether approval should be granted.
HLT: Can the FDA override the independent committee’s recommendations?
Shachar: The committee’s decision is nonbinding, so the FDA could choose to disregard it, but that happens very rarely. They are required to meet publicly, so you can see their deliberations, view whatever clinical trial data has been submitted, and even comment on the product under consideration. So, the good thing is that we’ll all know what’s going on.
The most obvious example of the FDA acting against a similar committee’s recommendation came in 2004 when the agency chose not to approve the emergency contraception drug, Plan B, despite the science clearly saying that it was safe for over-the-counter use. The fact that the recommendation was rejected made it controversial.
If the committee recommends against whatever vaccine they’re considering, I think that would get really challenging politically, because the FDA is under a lot of pressure to not hold up any vaccines.
But it would also be incredibly unusual for the FDA to go against the committee’s recommendation. So, if I’m the FDA commissioner, I’m praying that whatever makes it to this committee gets their seal of approval.
HLT: What happens once a vaccine is approved? Who decides how and to whom is it distributed?
Shachar: The CDC [Centers for Disease Control and Prevention] is responsible for recommending who should get vaccines, and who should get priority access to vaccines. This would include standard language you see with flu shots: ‘If you’re over this age or under this age, or you’re a pregnant woman, you’re at higher risk and should get this type of flu shot.’ Those guidelines will affect how the vaccines are allocated by the health care system. A physician’s office, for instance, might flag its vulnerable patients and really push to get them vaccinated before offering it to others.
Like the FDA, the CDC has a public advisory committee—the Advisory Committee on Immunization Practices—composed of outside experts. They determine which groups should be flagged as priority groups for vaccine allocation. This is going to be incredibly important, because there’s not going to be enough vaccines to go around for a really long time. At best, it’s probably going to take over a year to get the vaccines to everyone. I expect people who are at risk, essential workers, and health care workers will get vaccinated first.
This summer, the National Academies [of Sciences, Engineering and Medicine] also established a committee charged with creating a framework for the fair allocation of COVID vaccines. Unlike the FDA and CDC committees, the National Academies’ new group is not required to be open and public. I don’t have a clear sense of which committee’s recommendations would be taken by the CDC in the case of a disagreement between the two. One might say we should prioritize people with disabilities because they tend to be more medically vulnerable. Another might say we should prioritize people by health status and aim to keep the healthiest people healthy. I don’t really know how that kind of disagreement might be resolved.
And whatever vaccine allocation plan the CDC comes up with, I would be shocked if the White House didn’t play a role in the final decision. And what the White House is willing to approve is, I think, a big question mark. That’s why having the advisory committees be public is so important. If the White House and CDC ultimately come out with a very different distribution plan than what the committee advised, I think a lot of questions will be raised about the involvement of politics.
HLT: Given the criticism over its handling of the pandemic, including allegations of political interference in the work of public health agencies, how does the Trump Administration build enough public confidence to make the vaccine successful?
Shachar: People have different reasons for being skeptical of vaccines. Let’s start with someone like me, who’s generally pro-vaccine, but is maybe worried that a vaccine would have been prematurely rushed to market. For those people, I think the strategy would be to use the principles of government transparency that we’ve already baked into the system to publicize how this committee got to a place of voting ‘yes’; to discuss the underlying evidence; maybe to push manufacturers to reveal more data than they might otherwise; and to make the information accessible to the average person who might not have a Ph.D. in immunology.
For people who are already skeptical of vaccines in general, I think that’s going to be a tougher sell. Mandating a vaccine and providing education are two sides of the same coin. The best vaccine campaigns work on using all of the tools. Massachusetts could, for instance, say the vaccine is required for those who want to enroll their child in school. States could also make it mandatory for certain categories of workers, such those delivering healthcare, which is already standard practice. But we might also say, ‘If you’re a grocery store worker, you are very public facing, and so you also need to get a vaccine.’ Individual employers might also require everyone who comes to their workplaces to get vaccinated, which might cause some employment law issues as people push back.
But at the same time, we’ll need to have education campaigns that say to people, ‘This vaccine is safe and effective. Here’s the data. It’s important for you to get this because you might survive COVID, but your grandmother surely won’t. We can’t reopen restaurants or bars until enough people get vaccines. So, do your part and get vaccinated.’ If you just rely on mandates, you’ll get so much pushback. The great historical example occurred in 19th century England, when really strict smallpox vaccination requirements led to riots.
HLT: What is your take on the report in the New York Times about the White House blocking new FDA vaccine guidelines?
Shachar: Without being in the White House, it is hard to say exactly what is going on. But reports like the one in the New York Times suggesting that the administration is preventing its regulatory experts from carrying out their duties to the best of their judgement will undermine confidence in any vaccine that is approved. Every administration has career regulators and political appointees working together, potentially with different priorities. Every administration shapes the initiatives and actions coming out of the administrative agencies to harmonize with their political goals and motivations. But when the political influence runs directly contrary to what experts consider best practices, that is alarming.
Even more so in the case of what will be a widely administered vaccine. We want to minimize harmful side effects and to ensure that people are confident enough in a vaccine to get it. We want to make sure it actually prevents people from getting COVID. Preventing the FDA from determining what is the minimal length of time and evidence it needs to determine that a vaccine is both safe enough to administer to virtually all Americans and actually stops the spread of COVID opens the door to a public health disaster. We need to get it right the first time we approve a COVID vaccine or people will suffer.
HLT: How many people need to get vaccinated to reach herd immunity?
Shachar: I’ve heard that you generally want between 60 to 80% of the population to be immune, either because they’ve had the disease before or because they’ve been vaccinated. It varies depending on how infectious the disease we’re talking about is. In this case, COVID is fairly infectious, although not as infectious as, say, measles.
I can’t give you a percentage for the vaccine, because some of it is dependent on factors about COVID that we’re still figuring out, such as how many asymptomatic carriers there are. The other issue is that we don’t know what the vaccine will look like. If we give the vaccine to 100 people and 100 people develop full immunity, then that’s very straightforward. In that case, if we need 80% of the population to be immune, we need to vaccinate about 80 out of every 100 people. But many vaccines don’t confer 100% immunity on everybody. It may be that the COVID vaccine is effective in 60% of the people who get it. In that case, we’ll need to essentially overshoot— vaccinate far more than 80% of people—in order to end up with 80% immunity.
HLT: Who will pay for the vaccine? The government, health insurers?
Shachar: I think that there’s going to be a really interesting discussion about who’s going to need to pay for it. Is this so important to public health that the government should just foot the bill and everybody will get access to this free of charge? Or should insurers foot the bill, which might be financially challenging for them? And if the insurers are responsible, not every American has health care coverage. What do you do about the people who are uninsured or underinsured or falling through the cracks? In other words, are we going to treat this as a run-of-the-mill vaccine in terms of payment and delivery, or are we going to say this is akin to the New Deal or World War II, a public good that the government needs to deliver to every citizen? To put it in historical context, when the polio vaccine came out in 1955, federal funds were appropriated to help states and local governments pay for the vaccine and distribute it to vulnerable children. So, there is precedent for having the government pay for access to life-saving, revolutionary vaccines.
HLT: Beyond COVID, it seems like the credibility of the FDA, CDC and the entire public health infrastructure had taken a hit. How does it recover so it can effectively combat the next crisis, whatever that may be?
Shachar: The important thing is to combat that perception that these agencies are too closely tied to the political agenda, whoever is president. And doing that would mean thinking very carefully about who should lead the CDC, who should be FDA commissioner, and making sure there’s somebody who is very well respected and credentialed. I think also allowing them to be the public faces of the government response when there is an outbreak would be really helpful. A lot of CDC and FDA officials have not been allowed to be as public as they might have wanted to be. Because – according to news reports – everything must be cleared through the White House, the public health officials are not available for big interviews or high-profile TV moments. And I think that is a mistake from the public trust perspective. You want to have people who are seen as doctors and scientists out there saying, ‘Here is what we’re doing. And we’re doing it because we have a panel of experts talking to us.’ Or, ‘We’re doing it because of this data and this study.’ That is important to combat the idea that they’re being guided by what elected officials believe they need to stay in office.