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Covid-19 vaccine: European regulator to decide on Dec 29

Berlin - European Medicines Agency meeting to assess data about safety and efficacy of the vaccine.

The European Medicines Agency will convene a meeting on December 29 to decide if there is enough data about the safety and efficacy of the Covid-19 vaccine developed by Pfizer and BioNTech for it to be approved, the regulator said Tuesday.

The agency also said Tuesday it could decide as early as January 12 whether to approve a rival Covid-19 vaccine developed by Moderna Inc.

The German pharmaceutical company BioNTech and its U.S. partner Pfizer said earlier Tuesday that they had asked the regulator for speeded-up, conditional approval of their coronavirus vaccine, concluding the rolling review process they initiated with the agency on October 6.

The move comes a day after rival Moderna said it was asking U.S. and European regulators to allow the use of its 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 is 95 per cent effective. The efficacy rate in particularly vulnerable older age groups was more than 94 per cent, they said.

In a statement, the EU medicines regulator said it had already begun a “rolling review” of the Moderna vaccine based on laboratory data previously submitted by the company and would now assess data on how well that vaccine triggers an immune response and whether it is safe enough for broad use across Europe.

The agency said that “if the data are robust enough to conclude on quality, safety and effectiveness", then it could approve the Moderna vaccine at a meeting scheduled for January 12.

BioNTech and Pfizer have already submitted a request for emergency approval with the U.S. Food and Drug Administration and the U.K. regulator MHRA, as well as rolling submissions in other countries including Australia, Canada and Japan.

“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Covid-19 vaccine doses as soon as potential authorisations will allow us,” Pfizer’s chief executive Albert Bourla said in a statement.

BioNTech said it stands ready to ship stockpiles of vaccines where they are needed when the Amsterdam-based agency or the FDA approve the vaccine.

“Depending on how the authorities decide, we can start delivering within a few hours,” said BioNTech’s chief operating officer, Sierk Poetting.

The European Union’s top official said around 2 billion doses of potential Covid-19 vaccines have been secured for the bloc’s 27 nations, with the first deliveries likely to start before the end of the year.

EU Commission President Ursula von der Leyen said EU nations have started working on their vaccination plans and on the logistics for delivering tens of millions of doses across the bloc, a major challenge for the EU.

“If everything goes well, the first European citizens might already be vaccinated before the end of December,” Von der Leyen said. “And it will be a huge step forward toward our normal life. In other words, I just wanted to say there is a light at the end of the tunnel.”

The Commission, the EU’s executive arm, has secured deals allowing 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 till we have reached finally a vaccination that is appropriate to eradicate this virus.”

Germany’s science minister said Tuesday that the same safety standards are being applied in the approval process for coronavirus vaccines as for other drugs and that this would be key to gaining the widest possible public acceptance for Covid immunisation.

Anja Karliczek cited the fact that European regulators plan to hold a public hearing on December 11 about the approval request by BioNTech and Pfizer.

Speaking to reporters in Berlin, Karliczek stressed that the vaccine will be voluntary and that authorities will work hard to inform the public about "possible side effects" that a small percentage of recipients might experience after immunisation, such as headaches, exhaustion and fever.