BERLIN (AP) – EU drugs agency said on Tuesday it could take another four weeks to decide whether to give its first approval for a coronavirus vaccination, even as US and UK authorities continue to go green. set a goal before Christmas.
The European Medicines Agency plans to convene a meeting by December 29 to decide if there are enough safety and efficacy data on the vaccine developed by Pfizer and BioNTech to be approved, the regulator said. The agency also said it could decide as early as Jan. 12 whether to approve a shot of rival rival American pharmaceutical company Moderna Inc., which was filed with U.S. and European regulators this week.
If its vaccination is approved, German-based BioNTech says it could start using it in Europe before the end of 2020 – but that seems rather ambitious, given that the EU Commission will usually have to stamp the regulator’s decision. Nevertheless, the regulator also left open the possibility of bringing forward the meeting date if data arrives faster.
The date of approval will now be later than some European countries had hoped. Germany, which has given BioNTech € 375 million ($ 450 million) to develop the vaccine, is preparing to start immunizing people from mid-December.
On Tuesday, German, French and Dutch officials warned that vaccination programs would probably only start at the end of the year.
“Based on the information we have received in recent days, we have to assume that the approval will only take place around the anniversary,” said German Health Minister Jens Spahn.
“It moved because some studies obviously need to be submitted a little further,” he said. – Importantly, be prepared.
His remarks were echoed by French President Emmanuel Macron and Dutch Health Minister Hugo de Jonge, who said authorities in these countries were working to start vaccinating people in the first week of January.
“For the general public, this will not be a vaccination policy,” Macron said at a news conference at the Presidential Palace in Ellysee.
BioNTech and Pfizer said clinical trials have shown that their vaccine is 95% effective. The two companies have already submitted data to the U.S. regulators and Great Britain, and approval may come from them first.
Hospitals in England have been told they will receive their first dose of Pfizer shot as early as December 7 if they receive OK, the Guardian and the Financial Times wrote. Scientific advisers from the U.S. Food and Drug Administration will hold a public meeting on Dec. 10 to review Pfizer’s request to allow the vaccine to be used urgently, and a decision may be made soon after.
British regulators are also evaluating another vaccine developed by researchers at Oxford University and AstraZeneca.
Whichever regulator acts as soon as possible would give its first approval to a COVID-19 vaccine that has been rigorously tested in tens of thousands of people in studies that meet common scientific standards.
Worldwide, any country that has a drug regulatory agency must issue its own approval for any COVID-19 vaccine, although countries with weak systems generally rely on the World Health Organization for veterinary treatment of admissions. In the EU, countries generally accept EMA approval for vaccines and medicines, unless there is a specific issue that the country wants to investigate further.
More successful vaccinations will be needed to end the pandemic in Europe and the United States, which has killed more than 1.4 million people worldwide so far.
Many other vaccines are already being developed worldwide. Russia and China they began giving recordings of locally developed vaccines and selling them to other countries before publishing safe and effective evidence of the vaccines from advanced studies.
Even after vaccines are approved, manufacturers and regulators monitor how well they are received by patients to determine the frequency of less common side effects that can only occur if millions have been immunized. While vaccines submitted for approval so far appear to prevent people from becoming ill, it is still unclear whether people are being prevented from passing the virus on to others in its entirety – and crucially.
And officials warn that while some may be vaccinated in the coming weeks, it will take many months to shoot billions of people worldwide, or two if a reminder is needed, which means people will be well on their way to antiviral measures. for next year.
Authorities and drugmakers have pledged to work together to begin making the first recordings as soon as approval comes in, be it in the United States or Europe.
“Depending on how the authorities decide how we can start shipping within a few hours,” said Sierk Poetting, Chief Operating Officer of BioNTech.
About 2 billion doses of potential COVID-19 vaccine were provided to the 27 nations in the bloc on Tuesday, according to a top EU official, with the first deliveries likely to begin before the end of the year.
“It will be a huge step towards our normal lives,” said Ursula von der Leyen, President of the EU Commission. “In other words, I just wanted to say there’s light at the end of the tunnel.”
Von der Leyen, however, encouraged EU citizens to remain “disciplined until we finally get a vaccine that is adequate to eradicate this virus”. As infections and hospitalizations have increased in Europe in recent weeks, many countries have tightened their restrictions. Some of these measures are starting to take effect, but there are concerns that family reunions at Christmas could lead to a new peak.
Cheng reported from London and Petrequin reported from Brussels. Writer Kirsten Grieshaber of Mike Corder in Berlin and The Hague, the Netherlands, contributed to the report.
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We have updated this story to correct that Pfizer and BioNTech have requested quick approval of their vaccine, not an emergency license.