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The Dialog: What Does Full FDA Approval for a COVID Vaccine Imply If It's Already Authorised for Emergency Use?

Approximately 30% of unvaccinated American adults say they are waiting for official approval of the currently approved emergency COVID-19 vaccines by the U.S. Food and Drug Administration. This approval is expected in the next weeks to months. But what has to happen for the FDA to move from emergency approval or EUA to full approval?

From the Associated Press: Fauci's hopeful COVID-19 vaccine will receive full FDA approval within weeks

I'm a pharmacist who trains other pharmacists, healthcare providers, and students on why, when, and how vaccines are given. Emergency approval, while streamlining the approval process to make the vaccine available to the public more quickly, follows a rigorous process that the FDA requires to ensure the vaccine's safety and effectiveness. The difference is that more time has passed and more data is available for review when a company applies for full approval.

EEA and full approval share similar first steps

For both emergency approval and full approval of COVID-19 vaccines, the FDA initially requires initial safety studies on a small number of people. Here researchers document any potential adverse events or side effects that the vaccine may cause. Researchers are also determining the safest and most effective dose of the vaccine.

Once the vaccine has been determined to be safe and an optimal dose has been identified, researchers will conduct larger studies to see how well it works in a controlled environment where some people receive the vaccine while others receive a placebo.

It is important to note that the number of people who participated in the initial COVID-19 safety studies were similar to those in the safety studies of other commonly used vaccines, including vaccines for tetanus, diphtheria, whooping cough, and meningitis. Over 43,000 adults attended Pfizer's early stages
PFE,
+ 2.62%
BioNTech
BNTX,
+ 0.88%
clinical study, over 30,400 in Modernas
MRNA,
-0.42%
and over 44,000 in Johnson and Johnson & # 39; s
JNJ,
+ 0.60%.
Half of the participants in each study received a vaccine while the other half received a placebo.

Where EUA and full approval differ

From this point forward, emergency approval and full FDA approval for COVID-19 vaccines will follow different clinical trial requirements.

For emergency approval, the FDA requires that at least half of the participants in the original studies be observed for at least two months after vaccination. This is because the vast majority of vaccination-related side effects occur right after vaccination.

Companies are working on coronavirus booster vaccinations as some early studies suggest that antibody levels to Covid-19 decrease over time, making boosters more necessary. We examine what this means for the individual consumer. Illustration: Laura Kammermann / The Wall Street Journal

However, for full FDA approval, participants in the original studies must be followed up for at least six months. Reviewers look at data from the same study participants but collected over an extended period of time. All adverse events are investigated.

The manufacturer must also provide more detailed manufacturing plans and processes, as well as a higher level of oversight and inspections. All of this significantly lengthens the verification process.

Both Pfizer and Moderna began their ongoing filings for approval in the FDA's "Fast Track" process to expedite review. This allows companies to submit portions of their regulatory filings to the FDA for review once they are complete.

Full FDA approval would likely initially only apply to the same age groups tested in the original emergency approval. This means the vaccine is likely to be approved first for people aged 16 and over for Pfizer and 18 and over for Moderna. Continuous filing would allow the vaccine to be approved for younger groups as more data become available.

Different deadlines, same strict requirements

Full FDA approval is a milestone that can help build trust with vaccines that are hesitant about vaccine safety. But the real test of the vaccine came when it first received emergency approval. Then the researchers identified most of its potential side effects and demonstrated its ability to protect against serious illness.

Jennifer Girotto is currently an Associate Clinical Professor of Pharmaceutical Practice at the University of Connecticut. Her main areas of activity are vaccinations and pediatric infectious diseases. Dr. Girotto does not work for, advise, own or fund any companies or organizations that would benefit from this article, and has not disclosed any relevant connections beyond their academic appointment

This comment was originally published by The Conversation. What does full FDA approval of a vaccine do if it's already emergency approved?

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