HAP's Latest News

Pfizer and BioNTech to apply for Full FDA Approval for COVID-19 Vaccine

May 07, 2021

Pfizer-BioNTech has started its application for the full approval of its COVID-19 vaccine with the U.S. Food and Drug Administration (FDA), company officials announced today.

During December, the FDA granted Pfizer-BioNTech an emergency use authorization (EUA) for its two-dose COVID-19 vaccine. The vaccine has been approved for use during the pandemic for people 16 and older. More than 170 million doses have been delivered to date, Pfizer-BioNTech officials said.

“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” Pfizer Chairman and CEO Albert Bourla said in a statement.

Pfizer-BioNTech said the Phase Three clinical trial data indicated its COVID-19 vaccine was about 95 percent effective in preventing severe disease and provided protection against some of the circulating variants, as well.

As part of the FDA’s thorough review process, Pfizer-BioNTech will need to submit pre-clinical and clinical studies to support licensure of the vaccine, manufacturing and facility data, and labeling information.

Moderna is expected to submit its application to the FDA for full approval of its two-dose COVID-19 vaccine, as well.

During a press briefing today, officials with the White House COVID-19 Response Team said they anticipated Pfizer-BioNTech would submit the application for full approval in the coming weeks, and the review from the FDA would take months to complete.

“Given the nature of the pandemic, FDA will move as expeditiously as possible without compromising its gold standard for safety,” White House COVID-19 Response Coordinator Jeffrey Zients said.

As part of its emergency approval, Pfizer-BioNTech is asking the FDA to authorize its COVID-19 vaccine for children between 12 and 15 years old. The FDA and Centers for Disease Control and Prevention are evaluating that request after reviewing clinical data and are expected to make a decision this month.

HAP will continue to follow the progress of the FDA’s clinical review and provide updates to members.

HAP and Pennsylvania’s hospital community encourage everyone who is eligible to sign up to receive the COVID-19 vaccine. The vaccines have undergone a stringent review process and provide significant protection against the virus. Residents can find available appointments online.