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updated 10:20 AM UTC, Dec 13, 2023

Pfizer/Biontech Covid Vaccine Approved By European Regulator

21 December 2020. The Guardian: Europe’s medicines regulator has approved the use of the Pfizer/BioNTech vaccine against coronavirus, paving the way for inoculations to get under way across Europe within the next few days.

A number of EU countries including Germany, France, Austria and Italy have said they plan to start vaccination programmes for their most vulnerable groups from Sunday, after the US and UK began vaccinating earlier this month.

The Amsterdam-based European Medicines Agency (EMA) brought forward its decision on the jab from its planned date of 29 December after pressure to accelerate the process from several EU members states, including Germany.

“I am delighted to announce that the EMA scientific committee met today and recommended a conditional marketing authorisation in the EU for the vaccine,” the agency’s head, Emer Cooke, told an online press conference.

“Our scientific opinion paves the way for the first marketing authorisation in the EU,” she said. “It is a significant step forward in the fight against this pandemic that is causing suffering and hardship.”

The agency’s clearance is known as a conditional marketing approval. It is valid for 12 months and can be renewed annually. After further checks it is likely to be converted into full marketing authorisation valid for five years.

The EMA’s verdict was followed by final approval from the European commission later on Monday.

Preparations for the vaccine rollout come as a highly infectious new strain of the coronavirus discovered in Britain caused disruption across the region, with nearly 20 EU countries suspending travel links with the UK.

Cooke said there was “no evidence” that the Pfizer/BioNTech vaccine would not work against the new variant.

European governments are enlisting medical students, retired doctors, pharmacists and soldiers for an unprecedented inoculation programme that will initially target frontline healthcare workers and elderly residents of care homes.

Most national vaccination schemes will not reach the general public until the end of the first quarter of 2021 at the earliest.

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