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Pfizer and its vaccine partner BioNTech have launched an application for approval of the COVID-19 vaccine by the Food and Drug Administration.
Pfizer is the first manufacturer of coronavirus vaccines in the United States to request full approval. Like Pfizer, Moderna and Johnson & Johnson were previously approved for use within the agency emergency use permit – a less stringent approval method to support a faster response to a pandemic.
An FDA approval for a vaccine means that the Agency has decided that its benefits outweigh the known risks after reviewing the results of the manufacturer’s testing.
If granted, Pfizer’s full certification would only apply to vaccines for persons over 16 years of age. The vaccine manufacturer is currently applying for an emergency use of COVID-19 for children aged 12 to 15 years.
“We look forward to working with the FDA to complete this incremental submission and support their revision to ensure full regulatory approval for the vaccine in the coming months,” said Pfizer CEO Albert Bourla. Press Release Friday.
CEO of BioNTech, Dr. Ugur Sahin, described the application for FDA approval as “an important cornerstone for achieving long-term immunity of the herd and containing in the future COVID-19.”
“We are pleased to be working with U.S. regulators to seek approval for our COVID-19 vaccine based on our pivotal Phase 3 and follow-up data.”
In this final phase of the clinical trials, Pfizer found that its vaccine was 95% effective against COVID-19, the highest efficacy among vaccines approved for emergency use in the United States.
In order for the FDA to grant approval, Pfizer-BioNTech will need to meet a key requirement: providing follow-up data six months after vaccination.