US FDA grants full approval to Pfizer-BioNTech Covid vaccine

The U.S. drug regulator on Monday granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine that earned emergency-use authorization in December, making it the first to secure such Food and Drug Administration validation as health authorities struggle to win over vaccine skeptics.

The FDA approved the two-dose vaccine for use in people over the age of 16. More than 204 million people in the United States have received the vaccine since it was given emergency authorization, based on data from Sunday.

None of the three COVID-19 vaccines given emergency-use authorization by the FDA - also including those made by Moderna Inc and Johnson & Johnson - had previously received full FDA approval.

Public health officials hope it will convince more unvaccinated Americans that Pfizer's shot is safe and effective.

Vaccine hesitancy among some Americans has hindered the United States response to the COVID-19 pandemic.

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Janet Woodcock, the U.S. Food and Drug Administration's acting commissioner.

Roughly 51% of Americans have been fully vaccinated so far, even as a recent surge of infections spurred by the contagious Delta variant ravages parts of the country with low vaccination rates.

The FDA's approval is based on updated data from the company's clinical trial.

"Based on the longer-term follow-up data that we submitted, today's approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed," Albert Bourla, CEO of Pfizer, said in a statement.

The Pfizer-BioNTech vaccine will now be marketed under the name Comirnaty, the FDA said.

Some U.S. cities including New York and San Francisco have already imposed rules requiring vaccination to dine at restaurants or work in government offices, among other activities.

Taiwan stocks jump on local vaccine rollout
 

Taiwan stocks soared over 2 per cent on Monday, as the island rolled out its first locally developed Covid-19 vaccine, while Indonesian rupiah led gains across Asia on hopes that Covid-19 curbs in its capital Jakarta would not be extended. Currency markets strengthened after Dallas Federal Reserve President Robert Kaplan, among the US central bank's most forceful supporters for starting to reduce support for the economy, said on Friday he may need to adjust that view if the Delta variant slows economic growth materially. (Reuters)