Alerts

COVID-19 Vaccine: Approval or Authorization?

Alerts / December 15, 2020

On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19).

An EUA differs from an approval in that the statutory standard to receive an EUA is lower than the standard to receive approval. Sponsors may seek approval of medical products at any time. For an EUA, there must be some condition or event to rationalize emergency use of a medical product. Importantly, receiving an EUA does not mean that a product is FDA “approved.” An EUA allows for the temporary marketing of a medical product during an emergency (the COVID-19 public health emergency, in this case). For continued marketing after the COVID-19 public health emergency ends, manufacturers will need to receive a full approval or clearance from the FDA.

Emergency Use Authorization

First, the secretary of Health & Human Services (HHS) must make a declaration that circumstances exist justifying an EUA. This EUA declaration may be based on various factors. Here, the secretary of HHS on Feb. 4, 2020, determined that a public health emergency exists that has a significant potential to affect national security or the health and security of United States citizens living abroad, and then issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products.

Second, once the EUA declaration is issued, the FDA may authorize the emergency use of an unapproved product or an unapproved use of an approved product. Four statutory criteria guide the FDA’s issuance of an EUA: 1) serious or life-threatening disease or condition, 2) evidence of effectiveness, 3) risk-benefit analysis and 4) no alternative, as described in more detail below. For the FDA to authorize an EUA, the EUA declaration must reference a chemical, biological, radiological, or nuclear (CBRN) agent that can cause a serious or life-threatening disease or condition. Drugs or medical devices that may be considered for an EUA are those that “may be effective” to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a CBRN agent identified in the HHS secretary’s EUA declaration. The “may be effective” standard is a lower bar than the standard used for traditional FDA approval and is based on a totality of scientific evidence available. The FDA also considers the risks and benefits of the drug or medical device. In doing so, the FDA weighs the known and potential benefits of the product when used to diagnose, prevent, or treat such disease or condition against the known and potential risks of the product, taking into consideration the material threat posed by the CBRN agent, here COVID-19. Lastly, there must be no adequate, approved and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. After considering all four conditions, the FDA may statutorily issue an EUA. For more detail on the EUA process, see our previous alert, FDA Emergency Use Authorizations (EUAs): Cutting Regulatory Red Tape for COVID-19.

Approval

The approval standard for vaccines follows the approval standards of biologic license applications (BLAs). The approval and clearance standards for drugs and medical devices differ from the standards for biologics, but the standards are likewise more robust than the standards for an EUA. For biologics and the COVID-19 vaccine, the product, the manufacturing process, and the manufacturing facilities meet applicable requirements to ensure continued safety, purity and potency. When the FDA evaluates BLAs, safety means the relative freedom from harmful effects, direct or indirect, when a product is prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time. Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances. Potency is interpreted to mean the specific ability or capacity of the product, as indicated by appropriate laboratory tests, to yield a given result (including effectiveness).

Next Steps for EUAs

With the FDA issuing the first EUA for a COVID-19 vaccine, we anticipate additional EUAs in the upcoming weeks. BakerHostetler is experienced in submitting EUA requests for In Vitro Diagnostic Products, Personal Protective Equipment and Related Medical Devices, Ventilators and Other Medical Devices, or Drug and Biological Products. Now that a vaccine is authorized, we may soon be rounding the curve of the pandemic. EUA holders should begin to consider product planning and life cycle implications for EUA-authorized products post-emergency. Now is the time to consider submitting applications for approval and clearances of medical products for continued marketing once the public health designation for COVID-19 is removed.

Authorship Credit: Lee Rosebush, Lindsay Holmes and Marc Wagner

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