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The approval from the European Medicines Agency paves the way for EU countries to start mass vaccination campaigns within a week.
The European Union medicines regulator has given conditional approval for the coronavirus vaccine developed by Pfizer-BioNTech for use throughout the block, paving the way for inoculations to start within a week.
Following a closed-door expert meeting, the European Medicines Agency (EMA) announced on Monday that it was authorizing the vaccine produced jointly by the US pharmaceutical giant and its German partner for use in the elderly over 16 years old.
“It really is a historic scientific achievement,” said Emer Cooke, the agency’s chief. “This is an important 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. USA and UK, where vaccinations started earlier this month.
After getting the green light from the EMA, the final step is the approval by the European Commission, which is expected to be granted later on Monday.
“Now we are going to act quickly. I expect a decision from the European Commission by this evening, ”Commission chief Ursula von der Leyen wrote on Twitter. She had already targeted the start of vaccinations over the period from December 27 to 29.
Monday’s developments came following the identification of a new, highly infectious strain of the novel coronavirus in the UK.
The discovery sparked chaos across Europe and beyond, with several countries severing travel ties with the UK, disrupting trade.
EMA officials told a press briefing that the vaccine was very likely to work against the new strain of virus.
Step Vaessen of Al Jazeera, reporting from Amsterdam, said there had been growing pressure within the EU to get Pfizer-BioNTech approved “as soon as possible”.
“But despite the pressure, the EMA said its entire decision was based on science and there were no political considerations,” she said.
The pandemic hits Europe
The COVID pandemic has killed around 470,000 Europeans to date and is accelerating during the winter months, crushing economies.
Many governments have imposed stricter restrictions on households in an attempt to curb a second wave of infections and avoid overloading health systems.
Doctors, retired doctors, pharmacists and soldiers are being drafted into a European vaccination campaign of unprecedented scale.
A phased approach means frontline healthcare workers and elderly nursing home residents are prioritized, with most national programs reaching the general public only by the end of the first quarter of 2021 at the earliest.
The objective of the EU27 is to reach 70% coverage of its 450 million inhabitants.
The EMA had begun an ongoing review of preliminary data from Pfizer’s trials on October 6 with the goal of speeding up an approval process that typically takes at least seven months.
The EMA authorization, initially granted in the form of a conditional marketing authorization (CMA), is valid for one year and can be renewed each year. It can be converted into a standard marketing authorization after further data checks.
This would be valid for five years, but can be renewed for unlimited validity.
The process took longer than the lightning-fast emergency clearance given by the UK, the first Western country to approve a COVID-19 injection.
Scientists are still waiting for longer-term follow-up data to see how long the immunity from the Pfizer-BioNTech and other pioneering vaccine lasts and whether there are any rare or serious side effects.
Final testing of the Pfizer-BioNTech jab is still ongoing. More information on the effectiveness of the vaccine in children, in addition to its effects in pregnant women.
The vaccine is not made with the new coronavirus itself, which means there is no chance anyone can catch it from shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the enriched protein on the surface of the virus.
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