Perri Nena Smith
Loyola University Chicago School of Law, JD 2021
As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.” When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.
What it takes to be FDA approved
FDA approval is a five-step process which includes Discovery and Development, Preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. Within Step 4, FDA review, approval is also provided, where the FDA determines that the product is safe and effective for its intended use. Upon approval, the drug can be marketed, even though monitoring steps or other issues may still need to be resolved. The FDA approval of drugs, medical devices, and food additives are required by federal law, but some cosmetics and dietary supplements can be marketed without FDA approval. Unapproved products are sought by the FDA and pulled off the market. However, the FDA does permit the use of unapproved drugs if:
- “the drug is subject to an open drug efficacy study implementation program proceeding,
- health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condition,
- there is insufficient supply of an FDA-approved drug.”
The emergency use of unapproved drugs can become FDA authorized after the HHS secretary makes an emergency declaration.
Emergency Use Authorization-FDA authorized
During public health emergencies, such as the global pandemic we find ourselves in now, the FDA is allowed to make available FDA-regulated products through Emergency Use Authorization. This is not the first time the FDA authorized medical products (including vaccines). The FDA terminated or revoked authorizations for other diseases, including the Zika virus in 2016-2017, Ebola virus in 2015, Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in 2013-2015, H1N1 in 2010, and Anthrax Vaccine Adsorbed in 2005.
The authorization of the products is allowed when four statutory criteria are met:
- There is a serious or life-threatening disease or condition,
- Evidence that the product may be effective,
- The “may be effective” standard is lower than the effectiveness standard of an FDA approved product
- The risk benefits analysis weighs the benefits against the risk, and
- There is no adequate, available, or approved alternative.
Compliance with FDA approved and authorized drugs
The FDA section of Inspections, Compliance, Enforcement, and Criminal Investigations enforce FDA compliance. This section issues three different types of compliance manuals: compliance programs guidance manuals (“CPGM”), compliance policy guidelines, and regulatory procedure manuals (“RPM”). The CPGM is intended for FDA personnel to evaluate compliance with the FDA laws. The CPGs guide the FDA staff and the industry of FDA policy on regulatory issues related to FDA laws or regulations. The RPM is also intended for FDA personnel to evaluate procedures for the regulatory environment.
Failure to comply with FDA regulations can result in an FDA warning letter. The letter identifies the violation and expresses the need that the violation to be corrected. Additionally, this section can recall a product if the FDA determines it violates the law. A recall or pending recall product is submitted in the FDA’s enforcement report and classified by three health hazards classes or not yet classified (pending recall). Within the CPGs, the agency warns that any drug marketed without their approval is subject to enforcement action without any other warnings.
The decision to pause the authorized Johnson and Johnson/Janssen vaccine
As with FDA-approved products, the FDA still monitors the authorized products for issues, requiring monitoring and reporting of adverse events. The most recent showing of adverse events for an authorized product was the Johnson and Johnson/Janssen vaccine. On April 13, 2021, the Centers for Disease Control and Prevention (“CDC”) and FDA paused the J&J vaccine due to the reported six U.S. cases of a rare and severe blood clot. A combined effort from the CDC and the FDA will review data and investigate the adverse effects to make a decision, but the J&J vaccine will be paused until this is complete. The federal agencies are taking extra precautions for the authorized vaccine even though they mentioned the effect is extremely rare. As of April 23, 2021, the resumed use of J&J vaccine is permitted in the U.S.
The hesitant potential vaccine takers can see that while it is a lower standard of effectiveness for the FDA authorized products, the FDA and other federal stakeholders are continually monitoring the product and will pause products that they deem too risky. The FDA still monitors for compliance with the regulations and monitors for any potential issues for emergency authorized products as well as approved products.