The European Union drug agency said on Tuesday it may need four more weeks to approve its first coronavirus vaccine, even as authorities in the United States and Britain continue to push for a green light for Christmas.
The European Medicines Agency (EMA) plans to convene a meeting on December 29 to decide whether there is sufficient safety and efficacy data on the vaccine developed by Pfizer and BioNTech to be approved. The regulator also said it could decide on Jan. 12 whether it would approve a rival shot from US pharmaceutical company Moderna Inc, which submitted its request to US and European regulators this week.
If the vaccine is approved, Germany-based BioNTech said the use of the shot could begin in Europe before the end of 2020 – but that seems quite ambitious, as the EU Commission usually has to stamp the regulator’s decision. However, the agency has also left open the possibility that the date of that meeting may be brought forward if data comes in faster.
Any approval granted by the European regulator is conditional on companies submitting additional information to confirm that the benefits of the vaccine outweigh the risks.
The date being viewed now would be later than some European countries hoped. Germany, which has given BioNTech € 375 million ($ 450 million) in funding to develop the vaccine, is preparing to vaccinate people starting in mid-December.
On Tuesday, officials in Germany, France and the Netherlands warned that vaccination programs will probably not start until the end of the year.
“With the information we have received in recent days, we have to assume that approval will not take place until the turn of the year,” said German Health Minister Jens Spahn.
“It has been moved because some studies clearly need a little longer to be submitted,” he said. “What’s important is to be prepared.”
His remarks were echoed by French President Emmanuel Macron and Dutch Health Minister Hugo de Jonge, who said authorities in those countries are working to vaccinate people in the first week of January.
“It will not be a vaccination policy for the general public” for the first few months, Macron said at a news conference.
BioNTech and US partner Pfizer have said clinical trials have shown their vaccine to be 95% effective. The two companies have already submitted data to regulators in the United States and Great Britain, and approval may come first from them.
Hospitals in England have been told they could receive the first doses of the Pfizer injection as early as the week of Dec.7 if they get the OR, the Guardian and Financial Times reported. Scientific advisers to the U.S. Food and Drug Administration are holding a public meeting on Dec. 10 to review Pfizer’s request to authorize emergency use of its vaccine, and a decision could be reached shortly thereafter.
Stephen Evans, a professor at the London School of Hygiene and Tropical Medicine, said that while the main drug regulators will all analyze the same data, the European regulator’s decision-making process is being slowed by the bureaucracy of the 27-country bloc.
He explained that approval at the EMA “requires the cooperation of Member States, each of which has a say in approving a vaccine.”
UK regulators are also reviewing another vaccine developed by Oxford University researchers and drug manufacturer AstraZeneca.
Whichever of the three regulators – US, UK or European – comes first would be the first approval of a COVID-19 vaccine that has been rigorously tested in tens of thousands of people in trials meeting common scientific standards.
Many other vaccines are also being worked on. Russia and China have even begun to administer injections of locally developed vaccines and sell them to other countries, but have not published any evidence from advanced studies showing the vaccines to be safe and effective.
Globally, every country with a drug regulatory agency will have to issue its own approval for any COVID-19 vaccine, although countries with weak systems usually rely on the World Health Organization (WHO) to examine the photos. In the EU, countries typically accept EMA approval for vaccines and drugs unless there is a specific issue that the country wants to investigate further.
Multiple successful vaccines are needed to end the pandemic, which is on the rise in Europe and the US and has so far killed more than 1.4 million people worldwide.
Authorities and drug manufacturers have pledged to work together to roll out the first shots immediately as soon as approval comes in, be it in the US or Europe.
“Depending on how the authorities decide, we can start delivering within hours,” said Sierk Poetting, BioNTech’s Chief Operating Officer.
But officials warn that while some people will get a vaccine in the coming weeks, it will likely be years before billions of people around the world get the chance, or two if a booster is needed, meaning people will live with some virus control. measures at least well into next year.
While the three major vaccines submitted for approval so far appear to prevent people from getting sick, it’s still unclear whether they prevent people from picking up the virus completely – and crucially – passing it on to others.
The top EU official said on Tuesday that about 2 billion doses of potential COVID-19 vaccines have been secured for the 27 countries of the bloc, calling on their swift approval “a huge step forward towards our normal lives.”
However, European Commission President Ursula von der Leyen urged EU citizens to “remain disciplined until we finally achieve a vaccination capable of eradicating this virus”.
Even after vaccines are approved, manufacturers and regulators will monitor how well they are received by patients to determine the frequency of rarer side effects that may only occur when millions are immunized.