[ad_1]
BERLIN (AP) – The European Union’s pharmaceutical agency said on Tuesday it might take another four weeks to approve its first coronavirus vaccine, even as US and UK officials continue to target fire green before Christmas.
The European Medicines Agency plans to convene a meeting by December 29 to decide whether there is enough safety and efficacy data on the vaccine developed by Pfizer and BioNTech for it to be approved. The regulator also said it could decide as early as Jan. 12 to approve a rival shot from US pharmaceutical company Moderna Inc, which submitted its request to US and EU regulators this week.
If its vaccine is approved, Germany-based BioNTech has said that use of the vaccine in Europe could begin before the end of 2020 – but that seems ambitious enough, given that the European Commission generally has to approve the regulator’s decision. Nevertheless, the agency has also left open the possibility that the date of this meeting will be brought forward if the data arrives more quickly.
Any approval granted by the European regulator will be conditional on companies submitting additional information to confirm that the benefits of the vaccine outweigh the risks.
The envisaged date would be later than what some European countries had hoped for. Germany, which has given BioNTech € 375 million ($ 450 million) in funding to develop the vaccine, is preparing to start vaccinating people from mid-December.
German, French and Dutch officials on Tuesday warned that vaccination programs are unlikely to begin until the end of the year.
“With the information we have received over the past few days, we have to assume that approval will only occur towards the end of the year,” German Health Minister Jens Spahn said.
“He moved because some studies obviously need a little longer to be submitted,” he said. “What’s important is to be prepared.”
His comments were echoed by French President Emmanuel Macron and Dutch Health Minister Hugo de Jonge, who said authorities in those countries were working to start vaccinating people as early as the first week of January.
“It will not be a vaccination policy for the general public” in the first few months, Macron said at a press conference.
BioNTech and its US partner Pfizer said clinical trials have shown their vaccine to be 95% effective. Both companies have already submitted data to regulators in the United States and Britain, and the approval could come from them first.
Hospitals in England have been told they could receive the first doses of the Pfizer vaccine as early as the week of December 7 if they receive an OK, the Guardian and Financial Times reported. U.S. Food and Drug Administration scientific advisers are holding a public meeting on Dec. 10 to consider Pfizer’s request to authorize emergency use of its vaccine, and a decision could come soon after.
Stephen Evans, a professor at the London School of Hygiene and Tropical Medicine, said that although the main drug regulators all analyze the same data, the decision-making process of the European regulator is slowed down by the bureaucracy of the 27-nation bloc.
He explained that approval at the EMA “requires the cooperation of member states, which each have a say in the authorization of a vaccine.”
UK regulators are also evaluating another vaccine developed by researchers at the University of Oxford and drugmaker AstraZeneca.
The earlier of the three regulators – US, UK or EU – would give the first approval of a COVID-19 vaccine that has been rigorously tested on tens of thousands of people in trials that meet common scientific standards.
Many other vaccines are also in development. Russia and China have even started giving injections of locally developed vaccines and selling them to other countries, but have not published evidence of advanced studies proving the vaccines to be safe and effective.
Globally, each country that has a drug regulatory agency will need to issue its own approval for any COVID-19 vaccine, although countries with weak systems typically rely on the World Health Organization to verify vaccines. In the EU, countries generally accept EMA approval for vaccines and drugs, unless there is a specific issue that the country wishes to investigate further.
Several effective vaccines will be needed to end the pandemic, which is on the rise in Europe and the United States and which has so far claimed more than 1.4 million lives worldwide.
Authorities and drug makers have pledged to work together to immediately begin launching the first plans once approval is received, whether in the United States or Europe.
“Depending on how the authorities decide we can start delivering within hours,” BioNTech COO Sierk Poetting said.
But officials warn that while some people can get a vaccine in the coming weeks, it will likely take years to give the vaccine to billions of people around the world, or two if a booster is needed, which means people will live with some control of the virus. measures at least well in the next year.
While the top three vaccines submitted for approval so far appear to keep people from getting sick, it’s still unclear whether they are preventing people from contracting the virus entirely – and most importantly – passing it on to others.
The top EU official said on Tuesday that around 2 billion doses of potential COVID-19 vaccines had been secured for the 27 countries in the bloc and called the hope of their early approval “a huge step forward. forward to our normal life ”.
European Commission President Ursula von der Leyen, however, urged EU citizens to remain “disciplined until we finally achieve an appropriate vaccination to eradicate this virus”.
Even after vaccines have been approved, manufacturers and regulators will monitor how well they are received by patients to determine the frequency of rarer side effects that may not appear until millions of people are immune.
___
Cheng reported from London and Petrequin from Brussels. Associated Press editors Kirsten Grieshaber in Berlin, Mike Corder in The Hague, The Netherlands, and Sylvie Corbet in Paris contributed to this report.
___
Follow AP’s coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak
___
This story has been updated to correct that Pfizer and BioNTech have requested expedited approval of their vaccine, not emergency use authorization.
[ad_2]
Source link