Emergency Use Authorization vs. FDA Approval

With the Pfizer COVID-19 vaccine recently receiving its FDA approval for those aged 12 and older, some people may be wondering what this means for the Moderna and Johnsons & Johnson versions, as well as why these vaccines were distributed and administered prior to FDA approval.

In order to understand why the government was able to authorize the COVID-19 vaccine months before receiving FDA approval, it is important to distinguish between the terms emergency use authorization (EUA) and FDA approval.

Emergency Use Authorization

In almost every case, the only way a medication or medical device can be used by general consumers is to go through an FDA approval. This is to protect the public and to ensure that there are benefits to the product's use and that benefits outweigh the risks or side effects.

However, in the case of public health threats, the FDA can help speed up the availability and use of medical countermeasures (MCMs), which exceptionally benefit the public during a public health emergency. It is also important to note that EUAs are only considered when there are no pre-existing alternatives to treat the condition or disease.

With more than 89 million cases of COVID-19 in the U.S. since the pandemic first began, as of this writing, the coronavirus quickly became an infectious disease that posed a serious threat to the health and well-being of Americans.

The person in charge of approving emergency use authorizations is the Secretary of Health and Human Services. The agency is in charge of evaluating the risk of certain conditions and diseases. If they deem emergency use authorizations appropriate, the FDA can then authorize unapproved medical products or unapproved uses of previously approved medical products.

However, these products are only temporarily approved if they are used to diagnose, treat, or prevent the specific diseases or conditions that warranted the EUA.

The main reason why the government allows EUAs is that FDA approval takes a long time to review and approve a new medication, vaccine, or medical device. In most cases, that is a good thing because it provides security in knowing that new medical products have been rigorously tested in clinical trials. However, in the case of a disease such as COVID-19, waiting for full FDA approval would put the population in a situation where the disease could continue to run rampant with no check on its spreading power and no treatment for those who contracted it.

FDA Approval

When a drug, device, or treatment has received FDA approved, it means that it has gone through a rigorous testing process. Through this process, the FDA has successfully determined that the benefits provided by the medical product outweigh any known and potential risks for the population intended to use the product.

This offers some explanation on why as of July, 8 2022 the COVID-19 vaccine approval is only for ages 12 and up, while those in the age range of 6 months – 11 years old can still receive it under an EUA. The FDA, so far, is still evaluating the vaccines safety and efficacy for full approval for younger age groups.

Accelerated Approval

There is something called accelerated approval, which is different than an EUA. While an EUA is a product that has not gone through the complete approval process, medical products that go through accelerated approval still have to pass all the steps that every other product that has been FDA approved must go through. However, they are pushed to the “front of the line” so they can go through the process faster because clinical trials show a compelling treatment benefit that addresses and unmet need or substantially improves upon existing treatments.

This is standard for promising treatments of serious or life-threatening conditions or diseases, such as COVID-19. It may seem like the COVID-19 vaccine did not have to go through as rigorous of an FDA approval process since it was approved relatively quickly following production. However, it simply became a high priority for everyone working at the FDA and was able to go through each step right away.

The COVID-19 vaccine is not the only product that has been put through an accelerated approval. Many targeted cancer-fighting drugs and antiviral drugs used to treat HIV/AIDS have achieved FDA approval by through accelerated approval, as well.

Additional Approaches

In addition to accelerated approval, there are other approaches that a company can request when applying for FDA approval. It is important to note that these options are only meant for drugs and treatments aimed at serious conditions where time is truly of the essence.

Fast Track

With promising animal or human data, companies can request the fast-track approach. This facilitates the development and review of drugs meant to treat a serious condition with an unmet medical need. FDA will review the request and make a decision within 60 days based on whether the drug fills an unmet medical need in a serious condition.

Breakthrough Therapy

This approach provides similar benefits as the fast-track approach. However, it is meant for drugs that are intended as a treatment for a serious condition and current results show a significant improvement over existing therapies. Similar to Fast Track, FDA will respond to Breakthrough Therapy designation requests within 60 days of receipt of the request.

Priority Review

The FDA typically takes action on an application within 10 months, but they instead act within six months with priority review. This approach is meant for drugs and treatments that intend to significantly improve the treatment, diagnosis, or prevention of a serious condition.

The COVID-19 Vaccine

So, while the COVID-19 vaccine was authorized for distribution under EUA, it was still undergoing FDA approval, which has now been achieved. If the vaccine was deemed to have side effects that outweighed any perceived benefits at any point in the FDA approval process, it would have lost its EUA. Instead, the FDA deemed the vaccine safe to distribute -currently for those ages 12 and up- and gave its stamp of approval.

It can be concerning when new products are quickly put to widespread use, but the FDA and the Secretary of Health and Human Services are diligent in ensuring that only products with promising clinical trials are allowed for emergency use and eventual FDA approval.

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