March 28, 2024

Pfizer and BioNTech To Apply For Full Approval of COVID-19 Vaccine in the US

The multinational pharmaceutical company Pfizer and its COVID-19 vaccine partner BioNTech have begun a regulatory process to seek complete approval for their COVID-19 vaccine in the US. Both the companies are the first ones in the country to ask for full regulatory approval of the mRNA vaccine for individuals above 16 years. Pfizer’s vaccine was the first to get authorized for emergency use in the country.

The company was granted emergency use authorization (EUA) in December 2020. Since then, both companies have distributed over 170 million doses in the US. Last year, the US Food Drug & Administration (FDA) made it clear that companies applying for EUA of the COVID-19 vaccine should provide two months of safety data. While if the company wants to apply for a full approval license, it needs to submit six months’ data of the vaccine’s efficacy after the second vaccine dosage. In addition to the submission of the Biologics License Application (BLA), both the companies have also submitted an application to expand the existing EUA to include individuals between 12 years and 16 years for COVID-19 administration.

Both the Companies Statement on Seeking License

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Chairman and CEO of Pfizer Albert Bourla in a statement. “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,” he added.

“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said CEO and Co-founder of BioNTech Ugur Sahin. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

Pfizer and BioNTech Collaborates with International Olympic Committee (IOC)

On Thursday, the COVID-19 vaccine makers announced that they have signed a Memorandum of Understanding (MoU) to donate their vaccines to athletes and delegates participating in the Olympic and Paralympic Games Tokyo 2020. According to the press release, Pfizer’s CEO Albert Bourla met Prime Minister of Japan Suga Yoshihide and asked the company can donate Pfizer-BioNTech COVID-19 vaccine to athletes and delegations participating in Tokyo 2020.

“With hundreds of millions of vaccines already administered, and hundreds of millions more to go, Pfizer is committed, together with BioNTech, to doing all we can to help end this pandemic and help return the world to a sense of normalcy,” said CEO Albert Bourla in the press release. “The return of the Olympic and Paralympic Games represents a monumental moment of world unity and peace after a grueling year of isolation and devastation. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”

Pfizer’s CEO Against Patent Waving in the US

The Biden administration said on Wednesday that it will support patent waiving intellectual property protection for COVID-19 vaccines to “expand the vaccine manufacturing and distribution” in the country. Meanwhile, the Director-General of the World Health Organization (WHO) praised the commitment by the US administration to support the waiver decision.

On the announcement, the shares of the COVID-19 vaccine makers tanked, which includes Pfizer and Moderna. The Wall Street Journal reported that Pfizer’s CEO said that ‘It’s so wrong,” pointing out that patent suspension will not ramp up the vaccine production.

Pfizer’s Latest Developments

On May 3, 2021, Pfizer wrote on Twitter that the company is donating medicines worth USD 70 Million to “every public hospital across India” for 90 days free of charge. The medicines include steroids that can reduce inflammation and anticoagulants that can prevent blood clotting and antibiotics that can treat secondary bacterial infections.” It had applied for EUA in India, but revoked its applications in February 2021. According to the reports, legal indemnity and pricing are the two factors that are holding the Indian Government and Pfizer to strike the deal.

On April 28, 2021, the company announced that it has acquired Amplyx Pharmaceuticals. The deal is expected to help Pfizer to expand its product portfolio in the infectious disease segment. In the same month, it said that it will supply 100 Million doses of COVID-19 vaccine to the European Union (EU).