FDA urges Pfizer to submit vaccine info

FDA urges Pfizer to submit vaccine info

The Food and Drug Administration (FDA) is asking Pfizer for more information about its Covid-19 vaccine, saying it expects to give full authorisation for its use soon.

The agency had authorised Pfizer's Covid-19 vaccine for emergency use on June 24.

FDA secretary-general, Paisarn Dunkum, yesterday invited Pfizer to submit additional information on the vaccine, so the agency can authorise its general use.

The move followed Monday's decision by the United States' FDA to fully authorise the use of the Pfizer-BioNTech Covid-19 vaccine, known by its trade name Comirnaty, on people aged 16 years old and older.

The agency also endorsed its administration to individuals aged 12-15 in emergency cases.

In its statement, the US FDA said it reviewed data from 44,000 samples before it approved its general use.

The mRNA vaccine, which will now be marketed under its brand name, was found to be 91% effective in preventing Covid.

The approval is hoped to encourage more US citizens to get the vaccine, as its safety and efficacy have been guaranteed by relevant authorities.

Dr Paisarn said if Pfizer submits its application for general use in Thailand today, his agency could complete the process within 30 days.

"We have a team that is ready to read the 40,000-page report [on the vaccine] to consider its quality, safety and efficacy within 30 days," Dr Paisarn said.

"That's what we did to the 10,000-page report they sent in when we were considering the emergency approval [of the vaccine].

"If approved, it will be for general use, like the avian flu vaccine, that hospitals can purchase directly from suppliers," he said.

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