This article about the role of the CDC and FDA concerning COVID-19 vaccines was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.
I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.
So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.
For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor's post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.
The FDA and CDC roles in COVID-19 vaccines
Keep in mind four major actors:
||The Advisory Committee
|Food and Drug Administration (FDA)
||Vaccines and related biological products advisory committee (VRBPAC)
|Centers for Disease Control and Prevention (CDC)
||Advisory Committee on Immunization Practices (ACIP)
The Food and Drug Administration is our regulatory agency for food and drugs. It does many things, but for this purpose, two powers delegated to the FDA commissioner by the Secretary of Health and Human Services (who got them through Congress) are most important.
First, the FDA can grant a biological license application – BLA – to a vaccine that meets some criteria of safety and effectiveness (I summarize those criteria here). Second, the FDA can give an emergency use authorization (EUA) to a product if certain less stringent criteria are met (I summarize those criteria here).
For our purposes, although the contents of the applications and the time and effort needed to review them are very different, the process we are looking at is similar. In the FDA, a dual review, ideally, will happen. FDA personnel in the Center for Biologics Evaluation and Research (CBER), which specializes in biologics – the category vaccines belong to – thoroughly review the request materials. These people have substantial expertise in the matter and their reviews tend to be very detailed.
If the CBER personnel think the request should be granted, they usually submit it to their advisory committee, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which includes a roster of subject matter experts, industry representatives, and consumer representatives. VRBPAC members do not work for FDA as such; they are independent advisors. They do work off materials FDA prepares, though they also have presentations from industry and others in their meetings and get to ask questions.
This happened, for example, when the committee met to discuss the request to give an Emergency Use Authorization (EUA) to Moderna’s vaccine for children 6-17 and for Moderna and Pfizer’s COVID-19 vaccine for children 6 months to 5 years, the committee held two days of hours-long meetings.
The question for the committee was whether the benefits of the vaccines outweigh the risks, and they voted that yes, they do.
FDA does not have to convene VRBPAC and get their advice and does not have to follow their advice. In the end, the decision is FDA’s. But as a matter of public perception, there is a cost to ignoring them (plus, having independent expertise should make for better decisions.
Note that regular drugs – non-biologics – are handled by other parts of the FDA and other committees. This is just about vaccines.
The decision FDA makes under this model is usually whether a product meets the criteria to be allowed on the market. Is it good enough to be given a green light, do the benefits sufficiently outweigh the risks? It's an up/down vote.
In addition to giving initial approval (and setting the conditions for the clinical trials it would accept), FDA continues to monitor products licensed or approved and assure regulatory compliance. Oversight of vaccine safety is done by both FDA and CDC, but for example, monitoring the production of vaccines is only done by FDA.
CDC is the United States expert agency in preventing and handling diseases. CDC is not generally a regulatory agency – it does not directly monitor products or licenses them. It does have some coercive power – like the power to quarantine people or issue orders related to disease prevention.
But about vaccines, its role, for our purpose, is to give guidance to doctors and others about using vaccines. It has another role – it runs a federal benefit program called the Vaccines for Children Program that gives vaccines to many children who are uninsured or underinsured, and during the COVID-19 pandemic, it was also in charge of giving out the vaccines the United States government purchased.
But where people may get confused about the division of labor is that CDC also makes recommendations about how to use the vaccines FDA approved or authorized. To do so, the CDC uses an expert committee, the Advisory Committee on Immunization Practices (ACIP). In this case, CDC personnel appears to be part of the ACIP process, rather than two separate tracks of review — the ACIP works through work groups, and those workgroups seem to always include both the independent experts officially on the committee and regular CDC personnel.
In theory, FDA gives vaccines approval or rejection. The ACIP then recommends how to use them. ACIP’s recommendations do have practical implications: under the Affordable Care Act, insurance companies need to cover vaccines recommended by ACIP, so there is a real effect on access and coverage. But the vaccine is already authorized and approved when it gets to ACIP; ACIP decides where it should go to make the best use of it. In practice, vaccines are unlikely to be shipped without ACIP recommendations, and removing ACIP’s recommendation means the vaccine will likely not be used. This could literally kill a vaccine that is already approved.
ACIP’s recommendations do not become CDC recommendations unless the CDC director accepts them, but although it’s not unheard of, it’s very rare for the director not to follow ACIP’s recommendations.
So, to recap — the FDA approves or authorizes, usually after the vaccine went through both regular personnel review and advisory committee review. CDC recommends (and adjusts recommendations as data comes in), a process that integrates regular personnel and advisory committee personnel.
Let me know if you have questions.