Full approval soon for Pfizer's Covid vaccine

The Food and Drug Administration has asked Pfizer for more information about its Covid-19 vaccine and expects to give full authorisation for its regular use soon, after it was approved for emergency use on June 24.

Full approval soon for Pfizer's Covid vaccine
Thailand General

Full approval soon for Pfizer's Covid vaccine

published : 24 Aug 2021 at 17:35

writer: Apinya Wipatayotin

A nurse holds a vial of the Pfizer-BioNTech Covid-19 vaccine at an inoculation station in Bang Phli district, Samut Prakan, on Aug 14. (Photo: Somchai Poomlard)

The Food and Drug Administration has asked Pfizer for more information about its Covid-19 vaccine and expects to give full authorisation for its regular use soon, after it was approved for emergency use on June 24.

FDA secretary-general Paisarn Dunkum on Tuesday invited Pfizer to submit the additional information.

This follows the decision on Monday by the Food and Drug Administration of the United States fully authorising the administration of the Pfizer-BioNTech COVID-19 vaccine, known by the trademark Comirnaty, to people aged 16 years old and more.

The US FDA set emergency use as a condition for its administration to people aged 12-15 years.

Dr Paisarn said that if Pfizer now submitted its application for full registration approval in Thailand, his agency could complete the process within 30 days.

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

With the June 24 emergency use approval, the government ordered 30 million doses of the Pfizer vaccine for delivery this year and would buy 50 million more doses next year. It expects the first shipment next month.

The mRNA-based vaccine is regarded by many as the most efficient choice to counter the often deadly SARS-CoV-2 virus, including the Delta strain.

Dr Paisarn said the FDA would first approve the vaccine for people aged 16 years and more. It would be ready to lower the minimum age to 12 years if there was enough evidence to support it, he said.

"The US FDA approved the use on people aged 16 years and more, but still keeps the emergency use condition on children aged 12-15 years. So we will initially follow the same procedure," he said.

With full approval, the Pfizer vaccine will be available directly to hospitals, which will not have to acquire it through any government agency - a condition for Covid-19 vaccines registered for emergency use, Dr Paisarn said.

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