EU regulator approves Pfizer-BioNTech COVID vaccine

The European Union’s medicines regulator has given its conditional approval for the coronavirus vaccine developed by Pfizer-BioNTech to be used across the bloc, paving the way for inoculations to start within a week.

Following a closed-door expert meeting, the European Medicines Agency (EMA) on Monday said it was authorising the vaccine jointly produced by the American pharmaceutical giant and its German partner for use in people aged above 16.

“This is really a historic scientific achievement,” said Emer Cooke, the head of the agency. “It is a significant step forward in our fight against the pandemic.”

EU countries including Germany, France, Austria and Italy have said they plan to start vaccinations from December 27 as Europe tries to catch up with the United States and the United Kingdom, where inoculations began earlier this month.

Having gained the green light from the EMA, the final step is approval by the European Commission, which is expected to be granted later on Monday.

“Now we will act fast. I expect a European Commission decision by this evening,” Commission head Ursula von der Leyen wrote on Twitter. She had already targeted the start of vaccinations over the December 27-29 period.

Monday’s developments came on the back of the identification of a highly infectious new strain of the novel coronavirus in the UK.

The discovery has sparked chaos across Europe and beyond, with several countries shutting off travel ties with the UK, disrupting trade.

EMA officials told a news briefing that it was highly likely the vaccine would work against the new virus strain.

Al Jazeera’s Step Vaessen, reporting from Amsterdam, said there had been mounting pressure within the EU for the Pfizer-BioNTech to be approved “as soon as possible”.

“But despite the pressure, the EMA said their whole decision was based on science and that there were no political considerations,” she said.

Pandemic hammers Europe

The COVID pandemic has killed about 470,000 Europeans to date and is picking up pace in the winter months, crushing economies in the process.

Many governments have imposed tighter restrictions on households to try to curb a second wave of infections and avoid overwhelming healthcare systems.

Medics, retired doctors, pharmacists and soldiers are being drafted into a European vaccination campaign of unprecedented scale.

A phased-in approach means front-line healthcare workers and elderly residents of care homes are being prioritised, with most national schemes not reaching the general public until the end of the first quarter of 2021 at the earliest.

The goal of the 27-member EU is to reach coverage of 70 percent of its 450 million people.

The EMA had started a rolling review of preliminary data from Pfizer trials on October 6 in an effort to speed an approval process that usually takes at least seven months.

The EMA clearance, initially granted as conditional marketing approval (CMA), is valid for one year and can be renewed annually. It can be converted into a standard marketing authorisation after further data checks.

This would be valid for five years but can be renewed for unlimited validity.

The process took longer than the ultrafast emergency authorisation given by the UK, the first Western country to endorse a COVID-19 shot.

Scientists are still waiting for more long-term follow-up data to see how long immunity from the Pfizer-BioNTech vaccine and other frontrunners last and if there are any rare or serious side effects.

Final testing of the Pfizer-BioNTech jab is still continuing. More information on whether the shot works in children is needed, in addition to its effects in pregnant women.

The vaccine is not made with the novel coronavirus itself, meaning there is no chance anyone could catch it from the shots. 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.