Pfizer has asked US for “full approval” of its vaccine: what may change

WASHINGTON.- Pfizer lab and German biotech company BioNTech became the first companies to ask to the United States Food and Drug Administration (FDA) for full approval of its coronavirus vaccine for use in people 16 years of age and older. The vaccine is currently being administered to adults in the United States under an emergency use authorization granted last December..

The approval process requested by the companies will likely take months, according to the newspaper. The New York Times.

The companies said in a statement Friday that they had submitted their clinical data, including six months of information on the safety and efficacy of the vaccine, to the FDA. They plan to send additional material, including information on how the vaccine is made, in the coming weeks.

“We are proud of the significant progress we have made since December in delivering vaccines to millions of Americans, in partnership with the US government,” said Dr. Albert Bourla, CEO of Pfizer, in the statement. “We look forward to working with the FDA to complete this ongoing submission and support its review, with the goal of securing full regulatory approval for the vaccine in the months to come.”he added.

As of Thursday, more than 134 million doses of the vaccine had been administered in the United States, according to the Centers for Disease Control and Prevention (CDC). Full approval would allow Pfizer and BioNTech to market the vaccine directly to customers.

It could also make it easier for businesses, government agencies and schools to require vaccinations. The Equal Employment Opportunities Commission said in December that employers could demand vaccinations, and legal experts generally agreed.

Many companies are reluctant to demand vaccines, especially when they only have emergency clearance, which is designed to be temporary. Some institutions, such as the University of California and California State University systems, have said they will only do this after a vaccine has been fully approved.

Full approval could also prompt the US military, which has had low acceptance of Covid-19 vaccines, to demand doses for the military.

If the FDA grants full approval, it this could help increase confidence in the vaccine. The vaccination rate has slowed in the United States in recent weeks, and a recent national survey indicated that the majority of people in the country who planned to receive vaccines had already done so.

Too The agency is expected to issue an emergency clearance for the use of the Pfizer-BioNTech vaccine in boys aged 12 to 15 next week.. The companies said that plan to apply for emergency clearance for children ages 2-11 in September.

Moderna plans to seek full approval for its vaccine this month, the company said in its quarterly earnings call on Thursday.

The New York Times

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