FDA gives full approval to Pfizer vaccine

The full authorisation will address reservations harboured by people who refused to be vaccinated citing EUA granted to all Covid-19 vaccines available in the US thus far.

The top US health agency on Monday granted full approval to Pfizer-BioNTech’s two-shot mRNA Covid-19 vaccine, making it the first for the United States. It will now retail as Comirnaty.

The move will allow the company to retail the vaccine more freely, through pharmacies and also advertise it. (Reuters)

Janet Woodcock, the acting head of the US Food and Drug Administration (FDA), called the approval a “milestone”. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency-use authorisation (EUA) as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the agency requires of an approved product,” she said.

The full authorisation will address reservations harboured by people who refused to be vaccinated citing EUA granted to all Covid-19 vaccines available in the US thus far. The move will allow the company to retail the vaccine more freely, through pharmacies and also advertise it.

Pfizer-BioNTech’s Covid-19 vaccine was the first to be used in the US - it had been rolled out already in the UK and Canada - after the FDA granted it EUA on December 11, 2020 for people 16 years of age and older.

The Pentagon has said that it will require service members to receive the Covid-19 vaccine, now that the Pfizer vaccine has received full approval.

Pentagon spokesman John Kirby said on Monday that US defence secretary Lloyd Austin is making good on his vow earlier this month to require the shots once the FDA approved the vaccine. Kirby said guidance is being developed and a timeline will be provided soon.

In a memo on August 9, Austin said he’d seek US President Joe Biden’s approval to make the vaccine mandatory no later than mid-September, or immediately after the FDA’s nod, “whichever comes firs.”.

Booster dose lowers infection risk: Israel

A third dose of Pfizer’s vaccine has significantly improved protection from infection and serious illness among people aged 60 and older in Israel compared with those who received two shots, findings published by the health ministry showed.

The data were presented at a meeting of a ministry panel of vaccination experts on Thursday and uploaded on its website on Sunday. The findings were on par with separate statistics reported last week by Israel’s Maccabi healthcare provider, one of several organisations administering booster shots to try to curb the Delta variant.

With inputs from agencies