UPDATE - EU medicines regulator OKs Pfizer/BioNTech vaccine

UPDATES WITH MORE DETALS, CHANGES HEADLINE, DECK

By Busra Nur Bilgic Cakmak

ANKARA (AA) - The European Medicine Agency (EMA) on Monday gave conditional approval for the COVID-19 vaccine developed by BioNTech and Pfizer to be used in the European Union.

“I'm delighted to be here and to announce that EMA Scientific Committee met today and recommended a conditional marketing authorization in the EU for the vaccine developed by BioNTech and Pfizer,” Emer Cooke, the EMA executive director, said in a news conference.

Cooke said the clinical trials showed the vaccine was effective at preventing COVID-19 in people from 16 years of age and the EMA’s scientific opinion paves the way for the first marketing authorization of a COVID-19 vaccine in the EU, "with the corresponding safeguards, controls, and obligations.”

“It will be valid in all 27 member states at the same time, and it provides them with a firm scientific foundation for the rollout of their vaccination programs, and a continuing framework for control and supervision of the vaccines,” she added.

For the vaccine to be distributed across the member states, the European Commission must approve the EMA’s decision.

EU Commission President Ursula von der Leyen said on Twitter that the EU Commission will act fast and make a decision later tonight.

BioNTech and Pfizer will also require to submit a follow-up data on their vaccine for the next year.

The EU will start vaccination on Dec. 27, several weeks after the UK and the US.

- Safety of vaccine

Harald Enzmann, the chairman of the Committee for Medicinal Products for Human Use, said in the news conference that it is still unclear whether those vaccinated can infect people, so he recommended that those vaccinated should wear masks and keep the distance from others.

He also said the number of pregnant women in the clinical trials were in single digits, so using vaccine on pregnant women should be decided case by case evaluating their exposure and risk.

For side effects of the vaccine, Sabine Straus, the chairperson of EMA’s Safety Committee, said that more than 80,000 people vaccinated during clinical trials and side effects are similar to those of other vaccines, such as pain at the injection site, tiredness, headache, muscle and joint pain or fever.

There was very small number of people that developed allergic reactions and people will be monitored for 15 minutes after the vaccination.

-Possible side effects

A statement from the EMA said, “although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated.”

The vaccine showed 95% efficiency during the clinical trials which also included “participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index ≥ 30 kg/m2,” according to the agency.

“The high efficacy was maintained across genders, racial and ethnic groups,” the agency noted.

- New variant of COVID-19

For the vaccine’s effectiveness on the new strain of COVID-19 discovered in the UK, EMA said Pfizer/BioNTech vaccine is likely to offer protection.

“We think that even if we don’t have yet full confirmation, it is very likely that the vaccine will retain protection also against this new variant,” said Marco Cavaleri, the head of Biological Health Threats and Vaccines Strategy.