The COVID-19 vaccine can be released within weeks – at least a limited amount of care for cutting-edge healthcare workers. Pharmaceutical companies Pfizer, Moderna and AstraZeneca are leading the COVID-19 vaccine candidates. Several are still under development.
The Food and Drug Administration is responsible for licensing and approving all vaccines in the United States. Widespread use of the vaccine, once given the green light, could provide a way to eradicate the coronavirus epidemic. USA TODAY interviewed FDA Commissioner Dr. Stephen Hahn about how the approval process works, how fast it can go, and how the agency will encourage Americans to give the vaccine..
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How COVID-19 vaccination is authorized
How is COVID-19 used?
Hahn: Companies have the option to apply for a license (or Biologics License Application) or an emergency use license. This is their choice.
What is an Emergency Use Permit (EUA)?
Hahn: An emergency use permit is an authority granted by Congress to the FDA following the 9/11 terrorist attacks to allow countermeasures, treatments, or vaccines to be available earlier than would normally be done during the approval process.
Has the FDA ever issued an emergency license for a vaccine?
Hahn: Yes, for anthrax vaccination (2005).
How is an emergency use permit different from FDA approval
What standards must companies meet in order to obtain a permit for emergency use?
Hahn: The standard used at EUA is that it must be effective in treating or preventing COVID-19 and that the risk / benefit ratio is in favor of authorization.
In the case of vaccinations, this is especially important because, unlike treatments, vaccinations are given to people who are otherwise healthy. There is no COVID-19, so if we look at the risk / benefit ratio … we need to take this into account in its safety and effectiveness. We need to think about this incredibly.
How the FDA evaluates the safety of an emergency-approved vaccine
What can you say to reassure people that an EUA-approved vaccine is as safe and effective as a BLA-approved vaccine, even though there isn’t that much long-term effectiveness data?
Hahn: The security and efficiency expectations of the EUA are very similar to what we expect in a BLA. Our career scientists have been doing this for years; this is their specialty. They will judge science and medicine.
Do COVID-19 vaccines issued under the EUA continue the authorization process and are ultimately fully authorized using a Biologics License Application?
Hahn: Yes. We expect sponsors (vaccine manufacturers) to apply and be invited if EUA or BLA. A BLA is then submitted later or in real time. Of course, we will prioritize the application for an emergency license, but then we will review the standard checks.
How the FDA is trying to encourage people to accept the vaccine
What more could be done to encourage people to get a licensed vaccine? Can you do something as an FDA chief to encourage people to get vaccinated?
Hahn: I was a doctor before I became an FDA commissioner. If you explain something to the patient — if you share it in a transparent way and then do what you say, then — it builds trust. We will follow our process, look at the criteria – we will be transparent about them.
Do you get the vaccine yourself? Either in April or May, when it can become available to the general public, or does it fit into one of the categories that are likely to be accessed sooner, such as front-line health workers?
Hahn: I was clear, I won’t let the agency authorize or approve a vaccine that I don’t want my own family to receive. No one at the FDA wants this to happen.
When it is appropriate for the guidelines to obtain a vaccination, I will receive that vaccination. I strongly urge my family to get it. I trust the FDA staff 100%. If this would increase confidence in the vaccine, I would get the vaccine as soon as it is allowed.
An employer or school can’t require someone to get vaccinated under the EUA, right?
Hahn: Institutions may require individuals to take an FDA-approved vaccine or request an exemption. However, EUA products are still considered as testing activities.
It is possible that some employers or schools may have questions or concerns about a test product that is licensed for emergency use, so we will be as transparent as possible about the data and information used to make the decision. This will help these organizations determine what is best for them.
How long it takes to allow vaccination
The vaccination authorization process has several steps. A company must first contact the FDA. Then the FDA has to go through the application and send it to an external evaluation committee called the Advisory Committee on Vaccines and Related Biological Products (VRBPAC). This committee will meet on Dec. 10 and send the FDA’s comments and recommendations. Only then can the FDA make a final decision on vaccination.
How long should the FDA be consulted after hearing that particular committee?
Hahn: We expect it to be days, but it depends a lot on the complexity of the data and the feedback we get from VRBPAC.
So can it be longer?
Hahn: We can’t predict our process in advance; our scientists must make the decision. We take the time to make the right call.
We want to move fast because this is a national emergency, but we will make sure that our scientists take the time to make the right decisions. It is our job to acquire this right and make the right decision about the safety and effectiveness of vaccinations.
How much paperwork does the EUA require? There used to be so much paper that it came in on wooden pallets. Would you give us a metric?
Hahn: These applications are very complex. This is thousands of pages of information that our scientists have to go through. …
The FDA is one of the few, if not the only, regulatory agencies in the world to examine raw data in a clinical trial. We refer to it as a line. We analyze the data, we have expertise in this, we have been doing this for years. That’s why it takes time because it’s very complicated.
This is another issue that I think should bring great comfort to the American people: These scientists will break the number. We have biostatists, we have scientists. Not only do we accept the conclusions of our sponsors – we also come to our own conclusions.
How many people work for the FDA on COVID-19 vaccines?
Hahn: We have a review team that we set up and meet regularly. There are hundreds of people in the groups who study biological materials and products, and for many of them, they devote their time to these (vaccine) applications. And we bring all the staff we need throughout the agency.
How the FDA monitors the safety of vaccines
Will surveillance end if a vaccine has been approved?
Hahn: We set up systems to monitor the safety and efficacy of approved vaccinations to ensure our robust safety assessment.
How long does the FDA follow these vaccines to see how long they are effective?
Hahn: For at least two years, and probably longer.
How much will the public know about their vaccination decisions?
Hahn: That’s something to learn from the pandemic – increased transparency helps people trust the process. Our expectation is to write something for everyone to see what we publish online. Our goal is to make this understandable to the majority of Americans.
This article originally appeared in the U.S. MA: COVID-19 Vaccine Responses: What FDA Commissioner Hahn Says About Safety