What’s the difference between EUA and full FDA approval?


Q: COVID-19 vaccines have emergency use authorization, but not full FDA approval yet. Does that mean we don’t yet know if they are safe?

A: The three vaccines in circulation in the United States to protect against COVID-19 have been proven to be safe and effective.

Vaccine manufacturers are continuing to gather even more data, and answering questions about how long the protection will last. Public health experts (including us!) hope that the vaccine manufacturers will submit requests to get full FDA approval soon, but in the meantime, large-scale data shows that adverse reactions are exceedingly rare. Translation: The vaccines are safe to receive right now.

✅ We have three vaccines in circulation in the United States right now, from Pfizer/BioNTech, Moderna and Johnson & Johnson. Each of these vaccines are authorized for emergency use, but not yet fully approved by the FDA.

☔ Emergency Use Authorization is meant for situations like the one we’re in right now where there is urgent need to develop diagnostics, therapeutics or vaccines. Although the FDA makes its Emergency Use Authorization decision with a more limited data set, it still does a rigorous review. (For more on EUAs, check out this post.)

⭕ To get a vaccine fully approved by the FDA, a company must show that it is safe and effective in clinical trials AND that it can be manufactured in a consistent and reliable way.

☑️ The first part – the safety and effectiveness – has been proven: In scientific speak, we’d say the three existing vaccines have completed Phase 1, 2 and 3 clinical trials and adverse reactions have been exceedingly rare. In real-world language, using real-world data since mid-December 2020, we can say the vaccines work really, really well.

📊 What’s remaining is for the manufacturing data to be submitted to the FDA for approval … and for more questions to be answered about how long the vaccine’s protection will last, whether there will need to be booster shots and whether these vaccines are effective against the new variants of the virus. Along the way, vaccine makers will continue to collect data from the Phase 3 trial volunteers, and the FDA will continue to evaluate safety and efficacy data in the general public. All this data will be used when the companies apply for FDA approval.

So: Our three COVID-19 vaccines have already been tested on tens of thousands of people in clinical trials, and found to be safe and effective, and millions more have received the vaccines in the last few months, administered under the emergency use authorization, safely receiving excellent protection against COVID-19.

🚀 Full approval is hopefully on the horizon in the coming months, but the delay is because the vaccine manufacturers need to compile the data and submit the request. The delay is NOT based on widespread safety concerns.

While some universities, employers and agencies report they are waiting until the vaccines receive full FDA approval before considering making vaccination mandatory, this need not delay your individual choice to protect yourself and others.

More on Emergency Use Authorization:

March 11 Dear Pandemic Post
UNC Health post on EUA vs. full FDA Approval

On the path to full FDA approval:

What difference would full FDA approval make for COVID-19 vaccines?
Full FDA approval of Covid-19 vaccines could help fight vaccine hesitancy, officials say

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