[ad_1]
BERLIN (AP) – The European Medicines Agency will convene a meeting on December 29 to decide whether there is enough data on the safety and efficacy of the COVID-19 vaccine developed by Pfizer and BioNTech for approval, the regulator said on Tuesday. .
The agency also said on Tuesday that it could decide as early as January 12 to approve a rival COVID-19 vaccine developed by Moderna Inc.
German pharmaceutical company BioNTech and its U.S. partner Pfizer said earlier Tuesday that they had asked the regulator for expedited conditional approval of their coronavirus vaccine, concluding the ongoing review process they began with the agency on October 6.
The move comes a day after rival Moderna said he was asking US and European regulators to allow the use of his COVID-19 vaccine.
BioNTech said if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020. The companies said last month that clinical trials with 44,000 participants showed the vaccine to be 95 effective. %. The effectiveness rate in particularly vulnerable older groups was over 94%, they said.
In a statement, the European medicines regulator said it had already started a “continuous review” of the Moderna vaccine based on laboratory data previously submitted by the company and would now assess data on how this vaccine triggers an immune response and its safety. enough for wide use across Europe.
The agency said that “if the data is strong enough to conclude on quality, safety and efficacy,” then it could approve the Moderna vaccine at a meeting scheduled for January 12.
BioNTech and Pfizer have already submitted an emergency approval request with the US Food and Drug Administration and UK regulator MHRA, as well as ongoing submissions in other countries including Australia, Canada and Japan.
“We have known from the start of this journey that patients are waiting and we are ready to ship doses of COVID-19 vaccine as soon as potential authorizations allow,” Pfizer chief executive Albert Bourla said in a statement. .
BioNTech has said it is ready to ship vaccine stocks to where they are needed when the Amsterdam-based agency or the FDA approves the vaccine.
“Depending on how the authorities decide we can start delivering within hours,” BioNTech COO Sierk Poetting said.
The top European Union official said around 2 billion doses of potential COVID-19 vaccines have been secured for the 27 countries in the bloc, with the first deliveries expected to start before the end of the year.
European Commission President Ursula von der Leyen said EU countries have started working on their vaccination plans and logistics to deliver tens of millions of doses across the bloc, a major challenge for the EU.
“If all goes well, the first European citizens could already be vaccinated before the end of December,” said Von der Leyen. “And it will be a huge step forward in our normal life. In other words, I just wanted to say that there is a light at the end of the tunnel.
The Commission, the EU’s executive arm, has entered into agreements to purchase doses with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer and CureVac.
Von der Leyen, however, urged EU citizens to remain “disciplined until we finally achieve an appropriate vaccination to eradicate this virus”.
Germany’s Science Minister said on Tuesday that the same safety standards were applied in the approval process for coronavirus vaccines as for other drugs and that this would be essential to achieve the widest possible public acceptance. for COVID vaccination.
Anja Karliczek cited the fact that Europan regulators plan to hold a public hearing on December 11 regarding BioNTech and Pfizer’s request for approval.
Speaking to reporters in Berlin, Karliczek stressed that the vaccine will be voluntary and that authorities will work hard to educate the public about possible side effects that a small percentage of recipients might experience after vaccination, such as headaches, exhaustion and fever.
Marylyn Addo, a doctor at UKE Hospital in Hamburg who is involved in trials of a rival vaccine, said the rapid development of a vaccine was the result of huge efforts by scientists, funding early and experience with previous vaccines.
___
Cheng reported from London and Petrequin reported from Brussels.
___
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