Europe’s medical agency reviews safety of 2 coronavirus vaccines

The European Medicines Agency said it would convene a meeting on Dec. 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 agency also said Tuesday it could decide as early as Jan. 12 whether to approve an experimental COVID-19 vaccine developed by Moderna Inc.

Read more: Moderna says coronavirus vaccine 94.1% effective, requests U.S., Europe approval

In a statement, the EU medicines regulator said it had already begun a “rolling review” of the vaccine based on laboratory data previously submitted by Moderna and would now assess data on how well the 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 vaccine at a meeting scheduled for Jan. 12.

On Tuesday, German pharmaceutical company BioNTech and its U.S. partner Pfizer said they have submitted an application for speeded-up, conditional approval of their coronavirus vaccine with the European Medicines Agency.

The two companies said Tuesday that the submission, which occurred Monday, completes the rolling review process they initiated with the agency on Oct. 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.

Click to play video 'Hospitals packed as COVID-19 deaths surge across Europe' 2:13 Hospitals packed as COVID-19 deaths surge across Europe

Hospitals packed as COVID-19 deaths surge across Europe – Nov 19, 2020

The companies said last month that clinical trials with 44,000 participants showed the vaccine had an efficacy rate of 95 per cent. The success rate in particularly vulnerable older age groups was more than 94 per cent, they said.

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 in 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’s chief executive Albert Bourla said in a statement.

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 immunization.

Anja Karliczek told reporters in Berlin that the EMA will be holding a public hearing on Dec. 11 on the approval request by BioNTech and Pfizer.

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.

READ MORE: Canada ‘in the top 5’ on list to receive coronavirus vaccines 1st, minister says

“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 two billion doses of potential COVID-19 vaccines have been secured for its 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.”

Click to play video 'Coronavirus: BioNTech chief says vaccine approval possible in mid-December' 1:42 Coronavirus: BioNTech chief says vaccine approval possible in mid-December

Coronavirus: BioNTech chief says vaccine approval possible in mid-December – Nov 18, 2020

Karliczek, the German science minister, 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 immunization, such as headaches, exhaustion and fever.

Marylyn Addo, a doctor at Hamburg’s UKE hospital who is involved in the trials for a rival vaccine, said the rapid development of a vaccine was the result of enormous efforts by scientists, early funding and experience from previous vaccines.

© 2020 The Canadian Press

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