Pfizer, BioNTech COVID vaccine gets EU regulatory nod, inoculation to start from Dec 27
Source : Reuters
Amsterdam: Europe's medicines regulator on Monday approved the use of the Covid-19 vaccine developed by U.S. company Pfizer and its German partner BioNTech, putting the EU on course to start inoculations within a week.
European Union countries including Germany, France, Austria and Italy have said they plan to start vaccinations from Dec. 27 as Europe tries to catch up with the United States and Britain, where inoculations began earlier this month.
Having gained the green light from the European Medicines Agency (EMA), the final step is approval by the European Commission, which is expected 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.
Von der Leyen had already targeted the start of vaccinations over the Dec. 27-29 period.
Preparations for the vaccine rollout come as the identification of a highly infectious new strain of the coronavirus in Britain caused chaos across the region, with countries shutting off travel ties with the UK and disrupting trade ahead of the Christmas holiday.
EMA executive director Emer Cooke said it would still take a long time to inoculate the 450 million people of the 27 EU countries.
"Vaccines alone will not be the silver bullet that will allow us to return to normal live, but the authorisation of this first vaccine is definitely a major step in the right direction and an indication that 2021 can be brighter than 2020," she told a news briefing.
EMA officials said it was highly likely the vaccine would work against the new variant of the coronavirus.
"We think that even if we don't have yet full confirmation, it is very likely that the vaccine will retain protection also against this new variant," said Marco Cavaleri, head of biological health threats and vaccines strategy.
The pandemic has killed about 470,000 Europeans 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.
Student medics, retired doctors, pharmacists and soldiers are being drafted into a European vaccination campaign of unprecedented scale.
A phased-in approach means frontline 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% of its 450 million people.
The drugs regulator in Switzerland on Saturday authorised the vaccine for use in people aged over 16.
The EMA had started a rolling review of preliminary data from Pfizer trials on Oct. 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 ultra-fast emergency authorisation given by Britain, the first western country to endorse a Covid-19 shot.
EUROPE'S DRUG TEST
The roll-out will be a test for Brussels' ability to unify Europe amid political pressure to speed up the process and tame the pandemic which has killed more than 1.6 million people globally.
Last week, Germany, France, Italy and five other European states agreed to coordinate the start of their vaccination campaigns.
The EU has ordered 200 million doses of the Pfizer-BioNTech shot, enough to vaccinate 100 million people, paying 15.50 euros ($18.90) per dose.
It will also buy an extra 100 million with a timetable for delivery still to be negotiated.
EMA officials denied any political interference and defended the speed of the approval process.
"The focus was exclusively on the science, there were too many involved of the member states who would look into the science as to allow any political whitewashing or adaption," said Harald Enzmann, chair of EMA's Human Medicines Committee (CHMP).