COVID-19 Pill Paxlovid No Longer Authorized in US for Emergency Use

Wolfgang Rattay/Reuters/Illustration

Paxlovid that was previously authorized for emergency use in the United States is no longer approved under that authorization and must be returned to the manufacturer, according to the U.S. Food and Drug Administration (FDA).

However, this change does not affect the availability of the drug for patients suffering from COVID-19 symptoms. Instead, the FDA’s update completes the transition to full approval of the antiviral medication prescribed to treat mild-to-moderate COVID-19 in adults and children aged 12 and older weighing at least 40 pounds.

From Emergency Use to Full FDA Approval

Paxlovid, which contains the antiviral medications nirmatrelvir and ritonavir and was developed by Pfizer, first entered the market on Dec. 22, 2021, after the FDA issued an emergency use authorization (EUA) for the drug. The medication’s New Drug Application (NDA) was approved on May 25, 2023.

To obtain full FDA approval, a medical product manufacturer must demonstrate that the drug is safe and effective, that its benefits outweigh any risks, that all labeling is appropriate, and that all manufacturing methods preserve the drug’s identity, strength, quality, and purity, according to the FDA.

Laws necessitate different levels of evidence proving a drug’s or medical product’s effectiveness before the FDA can grant approval.

How the EUA Process Works

The FDA grants emergency use authorization in case of emergencies. During emergencies or potential emergencies, the FDA can grant an emergency use authorization (EUA) to allow access to medical products that may be used when no other adequate, approved, and readily available options exist, among other criteria.

“Congress developed the Emergency Use Authorization—or EUA for short—as a way for the FDA to respond quickly to public health emergencies,” Rear Admiral Denise Hinton, the FDA’s chief scientist, in an FDA podcast.

EUAs are used to facilitate quicker availability of medicines, diagnostic tests, and other vital medical products that could aid in responding to a public health crisis.

The EUA approval process differs from the thorough FDA approval process. Under an EUA, the FDA provides authorization based on the best available evidence at the time, indicating the safety and efficacy of a medical product or medicine without waiting for all the information typically required for full approval.

Although the federal agency may lack comprehensive data to grant full approval, it weighs the risks against the benefits to public health and safety.

COVID-19 Vaccines Still Under EUA Authorization

During the pandemic, the FDA issued more than 400 emergency use authorizations (EUAs) for products like COVID-19 tests, treatments, and vaccines.

Many vaccines remain under EUA authorization. The Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines were all initially authorized through the EUA process.

“The public can be assured that COVID-19 vaccines authorized through an EUA have undergone a thorough evaluation of their safety, effectiveness, and manufacturing quality,” Ms. Hinton said. “Vaccine manufacturers provide the agency with safety and effectiveness information from their clinical trials.”

The FDA states that before approving vaccines through the EUA process, clinical vaccine makers and the agency must investigate the efficacy and safety of COVID-19 vaccines. Such vaccines must undergo at least three phases of studies to provide information on their effectiveness and safety for the general population.

Additionally, the FDA and the U.S. Centers for Disease Control and Prevention continue post-authorization vaccine safety monitoring to continuously assess the safety of COVID-19 vaccines, according to the agency.

Any issues are reported through systems like the Vaccine Adverse Event Reporting System, the Vaccine Safety Datalink, the Biologics Effectiveness and Safety Initiative, and Medicare claims data.