ARCHIVED - EMA approves Pfizer coronavirus vaccine for use within Europe

The European Commission also gave its approval this evening.

- The European Medicines Agency gives the green light to Comirnaty, the vaccine from Pfizer and BioNTech 

- Vaccinations will begin next Sunday the 27th in Spain and the rest of the European Union.

On Monday afternoon the European Medicines Agency (EMA) gave its approval for marketing the Pfizer and BioNTech vaccine for people over 16 years of age within the European Union.

EC approval of the vaccine followed shortly afterwards on Monday evening.

This is the first covid vaccine to be approved in the European Union "with all the safeguards, controls and obligations that it implies," according to the statement issued by the EMA, and vaccinations will begin next Sunday the 27th in all member states, including Spain. "Our rigorous evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets the necessary quality standards," said EMA Executive Director Emer Cooke. "However, our work does not end here. We will continue to collect information and analyze data on the safety and effectiveness of this vaccine to protect people who receive it in the EU," added Cooke.

The vaccine, which will be marketed under the name Comirnaty, had already been approved in the United Kingdom and the United States, where the first of the two necessary doses has already begun to be inoculated into the population, 21 days apart.

Pfizer and BioNTech began sending data on their clinical trials to the EMA on October 6th, seeking to speed up an approval process that usually lasts for about a year and that, given the health situation, has been reduced to just three months.

On November 18th, Pfizer released preliminary results of clinical trials of its vaccine, based on the innovative messenger RNA technology, which yielded encouraging 95% effectiveness data. The next vaccine to be evaluated by the EMA for approval will be Moderna, which is now available in the United States. The European regulator is scheduled to meet on January 14th to evaluate it.

EMA Executive Director Emer Cooke also said on Monday that: "at the moment there is no evidence" that the Pfizer and BioNTech vaccine will not work against the new strain of the coronavirus detected in the United Kingdom. "At the moment we can say that there is no evidence to suggest that this vaccine will not work against the new variant. But these are issues that must be scientifically evaluated," Cooke said at a virtual press conference.

New variant 'likely to become dominant global strain'
The new variant of coronavirus found in the UK is likely to become the dominant global strain, a scientist advising the government has said.

Prof Calum Semple, a member of the Scientific Advisory Group for Emergencies (Sage) which advises the UK government, said the new strain was infecting many more people in the same amount of time than the previous variant.

Asked whether the new variant would become the dominant strain around the world, he told Sky News:

"I suspect it will, or strains like it will.

"Because the virus has the evolutionary advantage in transmitting more quickly, it will out-compete all the other strains, and so it will naturally do that."