German pharmaceutical company BioNTech and its US partner Pfizer said early Tuesday that they had asked the European regulator for expedited approval of their vaccine. The companies have said that clinical trials showed the vaccine to be 95 percent effective.
It will take multiple successful vaccines to end the pandemic, which has been on the rise in Europe and the US and has so far killed more than 1.4 million people worldwide. Pfizer and BioNTech have already applied for approval to start vaccines in the US in December. Rival Moderna said on Monday it was asking European and US regulators to allow the use of its vaccine.
British regulators are also evaluating the injection from Pfizer and another from AstraZeneca. There are several other vaccines in development, including in Russia and China.
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 can only appear when millions of people are immunized. While the vaccines submitted for approval so far appear to prevent people from getting sick, it is not yet clear whether they prevent people from contracting the virus completely and, crucially, passing it on to others.
And officials warn that while some people may receive a vaccine in the coming weeks, it will take many months to deliver the vaccine to billions of people around the world, or two if a booster is needed, meaning that the people will live with virus control measures. well into next year.
If its vaccine is approved, BioNTech said its use in Europe could begin before the end of 2020, something difficult but not impossible if approved on December 29. The regulator has also left open the possibility that the date of that meeting be advanced if the data enters faster.
The date of December 29 would be later than expected by some European countries. Germany, which has given BioNTech 375 million euros ($ 613 million) in funding to develop the vaccine, has been preparing to begin immunizing people from mid-December.
Since requests have already been made to US and UK regulators, approval could come from them first, and authorities around the world promise to work with drug makers to launch the first injections within the days, if not hours, of approval.
“We know from the beginning of this journey that patients are waiting and we are ready to ship doses of the COVID-19 vaccine as soon as potential clearances allow us,” Pfizer CEO Albert Bourla said in a statement. .
BioNTech said it is ready to ship vaccine stocks where they are needed when the European agency based in Amsterdam or the US Food and Drug Administration approves the vaccine.
“Depending on how the authorities decide, we can start delivering in a few hours,” said BioNTech COO Sierk Poetting.
The top European Union official said Tuesday that around 2 billion doses of potential COVID-19 vaccines have been secured for the 27 nations of the bloc, with the first deliveries likely to begin before the end of the year.
EU Commission President Ursula von der Leyen said member states have started working on their vaccination plans and logistics to deliver tens of millions of doses across the bloc.
“It will be a big step towards our normal life,” said Von der Leyen. “In other words, I just wanted to say that there is a light at the end of the tunnel.”
Von der Leyen, however, urged EU citizens to remain “disciplined until we finally reach a vaccine that is appropriate to eradicate this virus.” As infections and hospitalizations increased in Europe in recent weeks, many countries tightened their restrictions. Some of those measures are beginning to take effect, but many remain concerned that family gatherings at Christmas could lead to a further increase.
Amid concerns about the safety of vaccines given the tremendous speed with which they have been developed, Germany’s science minister said Tuesday that the same safety standards are being applied in the approval process for vaccines against the coronavirus than for other drugs.
Anja Karliczek said that maintaining the highest standards is key to gaining the widest possible public acceptance for immunization against the coronavirus.
Speaking to journalists in Berlin, Karliczek stressed that the vaccine will be voluntary and that authorities will work hard to inform the public about the possible side effects that a small percentage of recipients could experience after immunization, such as headaches, exhaustion. and fever. The EMA plans to hold a public meeting on December 11 to explain how COVID-19 vaccines are regulated to ensure they work and are safe.
Marylyn Addo, a doctor at the UKE hospital in Hamburg involved in trials of a rival vaccine, said the speed of development of the coronavirus vaccine was the result of enormous efforts by scientists, early funding and vaccine expertise. previous.
– Reported with Associated Press