Pfizer-BioNTech vaccine gets EU regulator approval

European Medicines Agency committee recommends conditional approval for drug to be used in Europe

A truck driver holds up an urgent medicines sign as he pulls his truck out of Pfizer Manufacturing in Puurs, Belgium. The European Medicines Agency approved a coronavirus vaccine on Monday. AP

Inoculations against Covid-19 are due to start across the European Union within days after the European Medicines Agency gave approval to the Pfizer-BioNTech coronavirus vaccine.

After a closed-doors meeting on Monday, the EU drug regulator said it was recommending the drug be licensed for use in people over 16 years of age, with some exceptions. The pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

The head of the EU's medicines regulator said it appeared the Pfizer-BioNTech vaccine would protect against a new strain of the coronavirus found mainly in Britain.

"At this moment there is no evidence to suggest this vaccine will not work against the new variant," European Medicines Agency chief Emer Cooke said as she announced approval of the drug.

The decision comes weeks after the vaccine was first granted permission under emergency provisions in Britain and the US. "This is really a historic scientific achievement," Ms Cooke said. "It is a significant step forward in our fight against the pandemic."

The approval needed to be rubber-stamped by the EU’s executive branch on Monday evening.

European Commission President Ursula von der Leyen described it as "Europe's moment". She tweeted that the EMA’s approval was “a decisive moment in our efforts to deliver safe and effective vaccines to Europeans”.

“Now we will act fast. I expect a @EU—Commission decision by this evening,” she said. The EU’s executive arm was expected to require two or three days to approve the EMA’s decision.

Authorities in Germany and several other European countries said they hope to begin vaccinating people on December 27.

“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, the company’s chief executive and co-founder.

“Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help to combat this devastating pandemic.

“We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light."

The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible. The EMA originally set December 29 as the date for its evaluation of the vaccine, but advanced the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.

The vaccine has already been given some form of regulatory authorisation in at least 15 countries.

Britain, Canada and the US authorised it to be used under to emergency provisions, meaning the drug is an unlicensed product but its temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide, according to Johns Hopkins University.

Switzerland became the first country on Saturday to authorise the Pfizer-BioNTech vaccine according to normal licensing procedure. EMA approval also follows the regular process, only on an accelerated schedule and under the condition that the pharmaceutical companies submit follow-up data on their vaccine for the next year.

In a statement last week that appeared to address concerns by some in Europe about the speed of the process, the agency said: “A vaccine’s benefits in protecting people against Covid-19 must be far greater than any side effect or potential risks."

Scientists are still waiting for more long-term follow-up data to see how long immunity from the vaccine lasts and if there are any rare or serious side effects. Final testing is ongoing because more information on whether the drug works in children is needed, in addition to its effects on pregnant women.

The vaccine is not made with the coronavirus itself, meaning there is no chance that anyone could catch it from inoculation. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognise the spiked protein on the surface of the virus.

On the day Britain began its vaccination campaign, authorities told people with severe allergies not to get the inoculation after two people suffered serious allergic reactions, although it is unclear whether the reactions were caused by the immunisation.

The US Centres for Disease Control and Prevention said that as of Friday it had seen six cases of severe allergic reaction out of more than 250,000 administered doses of the BioNTech-Pfizer vaccine, including in one person with a history of vaccination reactions.

BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the bloc’s executive commission chose to buy 200 million, with an option for 100 million more.

The EMA plans to hold a meeting on January 12 to decide if the coronavirus vaccine made by Moderna should be licensed. It has reviews ongoing for a vaccine developed by the University of Oxford and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.