The Times Australia
The Times World News

.

What does full FDA approval of a vaccine do if it's already authorized for emergency use?

  • Written by Jennifer Girotto, Associate Clinical Professor of Pharmacy Practice, University of Connecticut

Thirty percent of unvaccinated American adults[1] say they’re waiting for the COVID-19 vaccines currently authorized for emergency use to be officially approved by the U.S. Food and Drug Administration. That approval is expected within the next few weeks to months[2]. But what has to happen for the FDA to advance from emergency use authorization[3], or EUA, to full approval?

I’m a pharmacist[4] who trains other pharmacists, health care providers and students on why, when and how to administer vaccines. Emergency use authorization, while streamlining the regulatory process so the vaccine is more quickly available to the public, still follows a rigorous process[5] the FDA requires to ensure vaccine 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.

All vaccines undergo five stages to ensure their safety and efficacy before approval.

EUA and full approval share similar first steps

For both emergency authorization and full approval, for COVID-19 vaccines, the FDA first requires initial safety studies[6] on a small number of people. Here, researchers document potential adverse events, or side effects, that the vaccine may cause. Researchers also determine the safest and most effective dose of the vaccine.

Once the vaccine is determined to be safe and an optimal dose identified, researchers will create larger studies to ascertain how well it works in a controlled setting where some people are given the vaccine while others are given a placebo.

It is important to note that the number of people who participated in the initial COVID-19 safety studies was similar to that in the safety studies of other commonly used vaccines, including vaccines for tetanus, diphtheria, whooping cough and meningitis[7]. Over 43,000 adults participated in the early phases of the Pfizer BioNTech[8] clinical trial, over 30,400 in Moderna’s[9] and over 44,000 in Johnson and Johnson’s[10]. Half the participants in each study were given a vaccine, while the other half were given a placebo.

Where EUA and full approval differ

From this point on, emergency use authorization and full FDA approval for COVID-19 vaccines follow different clinical study requirements.

For the emergency use authorization[11], the FDA requires at least half of the participants of the original studies to be followed for at least two months post-vaccination. This is because the vast majority of vaccine-related side effects occur right after vaccination[12].

Full FDA approval, on the other hand, requires participants in the original studies to be followed for at least six months[13]. Reviewers look at data from the same study participants but collected over a longer period of time. All adverse events are examined. The manufacturer must also provide more detailed manufacturing plans and processes, as well as a higher level of oversight and inspections. All of this adds significantly more time to the review process.

Vaccine vials lined up in front of the FDA and Pfizer BioNTech logos Full FDA approval involves reviewing more data after a longer observational period. SOPA Images/LightRocket via Getty Images[14]

Both Pfizer[15] and Moderna[16] began their rolling submission for approval in the FDA’s “Fast Track” process[17], designed to speed up review. This allows the companies to submit portions of their approval application to the FDA for review as they’re completed.

Full FDA approval will likely apply initially to only the same age groups that were tested in the original emergency use authorization. This means that the vaccine will likely be approved first for people ages 16 and up for Pfizer and 18 and up for Moderna. Rolling submission will allow approval of the vaccine for younger groups as more data becomes available.

Different timelines, same rigorous requirements

Full FDA approval is a milestone that may help build confidence among the vaccine hesitant about the safety of the vaccines. But the true test of the vaccine came when it first gained emergency use authorization. Then, researchers identified the majority of its potential side effects and proved its ability to protect against severe disease.

[Like what you’ve read? Want more? Sign up for The Conversation’s daily newsletter[18].]

References

  1. ^ Thirty percent of unvaccinated American adults (www.kff.org)
  2. ^ few weeks to months (www.nytimes.com)
  3. ^ emergency use authorization (www.fda.gov)
  4. ^ pharmacist (scholar.google.com)
  5. ^ rigorous process (www.fda.gov)
  6. ^ initial safety studies (www.fda.gov)
  7. ^ tetanus, diphtheria, whooping cough and meningitis (doi.org)
  8. ^ Pfizer BioNTech (doi.org)
  9. ^ Moderna’s (doi.org)
  10. ^ Johnson and Johnson’s (doi.org)
  11. ^ emergency use authorization (www.fda.gov)
  12. ^ occur right after vaccination (www.verywellhealth.com)
  13. ^ followed for at least six months (www.fda.gov)
  14. ^ SOPA Images/LightRocket via Getty Images (www.gettyimages.com)
  15. ^ Pfizer (www.pfizer.com)
  16. ^ Moderna (investors.modernatx.com)
  17. ^ “Fast Track” process (www.fda.gov)
  18. ^ Sign up for The Conversation’s daily newsletter (theconversation.com)

Read more https://theconversation.com/what-does-full-fda-approval-of-a-vaccine-do-if-its-already-authorized-for-emergency-use-165654

Times Magazine

Understanding ITIL 4 and PRINCE2 Project Management Synergy

Key Highlights ITIL 4 focuses on IT service management, emphasising continual improvement and value creation through modern digital transformation approaches. PRINCE2 project management supports systematic planning and execution of projects wit...

What AI Adoption Means for the Future of Workplace Risk Management

Image by freepik As industrial operations become more complex and fast-paced, the risks faced by workers and employers alike continue to grow. Traditional safety models—reliant on manual oversight, reactive investigations, and standardised checklist...

From Beach Bops to Alpine Anthems: Your Sonos Survival Guide for a Long Weekend Escape

Alright, fellow adventurers and relaxation enthusiasts! So, you've packed your bags, charged your devices, and mentally prepared for that glorious King's Birthday long weekend. But hold on, are you really ready? Because a true long weekend warrior kn...

Effective Commercial Pest Control Solutions for a Safer Workplace

Keeping a workplace clean, safe, and free from pests is essential for maintaining productivity, protecting employee health, and upholding a company's reputation. Pests pose health risks, can cause structural damage, and can lead to serious legal an...

The Science Behind Reverse Osmosis and Why It Matters

What is reverse osmosis? Reverse osmosis (RO) is a water purification process that removes contaminants by forcing water through a semi-permeable membrane. This membrane allows only water molecules to pass through while blocking impurities such as...

Foodbank Queensland celebrates local hero for National Volunteer Week

Stephen Carey is a bit bananas.   He splits his time between his insurance broker business, caring for his young family, and volunteering for Foodbank Queensland one day a week. He’s even run the Bridge to Brisbane in a banana suit to raise mon...

The Times Features

Metal Roof Replacement Cost Per Square Metre in 2025: A Comprehensive Guide for Australian Homeowners

In recent years, the trend of installing metal roofs has surged across Australia. With their reputation for being both robust and visually appealing, it's easy to understand thei...

Why You’re Always Adjusting Your Bra — and What to Do Instead

Image by freepik It starts with a gentle tug, then a subtle shift, and before you know it, you're adjusting your bra again — in the middle of work, at dinner, even on the couch. I...

How to Tell If Your Eyes Are Working Harder Than They Should Be

Image by freepik Most of us take our vision for granted—until it starts to let us down. Whether it's squinting at your phone, rubbing your eyes at the end of the day, or feeling ...

Ways to Attract Tenants in a Competitive Rental Market

In the kind of rental market we’ve got now, standing out is half the battle. The other half? Actually getting someone to sign that lease. With interest rates doing backflips and ...

Top Tips for Finding the Ideal Block to Build Your Home

There’s something deeply personal and exciting about building your own home. You’re not just choosing paint colours or furniture, you’re creating a space that reflects your lifes...

The Home Buying Process Explained Step by Step

Buying a home is a thrilling milestone, but it can also feel like navigating a maze without a map. With paperwork, finances, and decisions at every turn, understanding the home-b...