|Добавлено: 22.12.2020 11:48 Заголовок сообщения: EU greenlights COVID-19 vaccine after agency gives safety OK
|EU greenlights COVID-19 vaccine after agency gives safety OK
The European Union has given official approval for the coronavirus vaccine developed by BioNTech and Pfizer to be put onto the market across the 27-nation bloc
BRUSSELS -- The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech and Pfizer to be used across the 27-nation bloc, raising hopes that countries can begin administering the first shots to their citizens shortly after Christmas.
The EU’s executive commission gave the green light just hours after the European Medicines Agency said the vaccine meets safety and quality standards. Brussels had been expected to take two or three days to endorse the market authorization move.
“As we have promised, this vaccine will be available for all EU countries at the same time, on the same conditions," said European Commission President Ursula von der Leyen. “This is a very good way to end this difficult year, and to finally start turning the page on COVID-19.”
Deliveries of the vaccine are expected to start this coming Saturday, with inoculations beginning across the EU between Dec. 27 and Dec. 29.
Health care workers and other high-risk populations already have started receiving the BioNTech-Pfizer vaccine in Britain and the United States, prompting pressure from European governments for EU regulators to act more quickly than they originally planned.
Harald Enzmann, the head of the European Medicines Agency's expert committee, dismissed any suggestion that political influence had affected the decision.
“The focus was exclusively on the science,” he told reporters. “That was a scientific assessment, full stop.”
The Amsterdam-based EMA is responsible for approving all new drugs and vaccines across the 27 EU member states, Iceland, Liechtenstein and Norway. It is roughly equivalent to the U.S. Food and Drug Administration.
The vaccine has already been given some form of regulatory approval in at least 15 countries.
Britain, Canada and the U.S. authorized the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide, according to a tally by Johns Hopkins University.
Switzerland became the first country Saturday to authorize the vaccine according to the normal licensing procedure. EMA’s conditional market authorization also followed 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.
While many have clamored for the vaccine’s authorization, there have also been concerns in Europe and elsewhere about the speed with which the shot was developed. Normally, vaccines take years to develop and approve, not months.
In a statement last week that appeared to address those concerns, the agency stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the 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 of the vaccine is still ongoing, and more information on whether the shot works in children is needed. EMA experts also said that data on pregnant women is limited, and physicians should decide on a case-by-case basis whether to immunize them.
The vaccine is not made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, it contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
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