European regulator to decide Dec. 29 on Pfizer’s COVID-19 vaccine

The first patient enrolled in Pfizer’s COVID-19 vaccine clinical trial at the University of Maryland School of Medicine.
The first patient enrolled in Pfizer’s COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore.
(University of Maryland School of Medicine)

The European Medicines Agency will meet Dec. 29 to decide if there are enough data about the safety and efficacy of Pfizer’s COVID-19 vaccine for it to be approved, the regulator said Tuesday.

The agency also said it could decide as early as Jan. 12 whether to approve a vaccine candidate developed by Moderna.

Pfizer and its German partner, BioNTech, said earlier Tuesday that they had asked the regulator for expedited, conditional approval of their vaccine, to conclude the rolling review process they initiated with the agency Oct. 6. The companies said last month that clinical trials with 44,000 participants showed the vaccine — currently named BNT162b2 — to be 95% effective. The efficacy rate in particularly vulnerable older age groups was more than 94%, they said.


In a statement, the EU medicines regulator said it had also 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 Jan. 12.

Moderna had said Monday that it was asking U.S. and European regulators to allow emergency use of its COVID-19 vaccine.

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BioNTech and Pfizer have already submitted a request for emergency approval with the U.S. Food and Drug Administration and the British 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 authorizations will allow us,” Pfizer Chief Executive Albert Bourla said in a statement.


BioNTech said it stands ready to ship stockpiles of vaccines where they are needed once the Amsterdam-based European Medicines Agency or the FDA approves the vaccine.

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

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The European Union’s top official said that 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 member nations had 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.... There is a light at the end of the tunnel.”

The commission, the EU’s executive arm, has deals allowing it to purchase doses of vaccines being developed by Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica, BioNTech-Pfizer and CureVac.

Germany’s education and research minister said Tuesday that the same safety standards were being applied in the approval process for COVID-19 vaccines as for other drugs and that this would be key to gaining the widest possible public acceptance for immunization against the disease.

Anja Karliczek cited the fact that Europan regulators plan to hold a public hearing Dec. 11 on the approval request submitted by BioNTech and Pfizer.

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