European Medicines Agency recommends BioNTech-Pfizer Covid-19 vaccine for authorisation in EU

The European Medicines Agency (EMA) said on December 21 that it had recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent Covid-19 in people from 16 years of age.

“EMA’s scientific opinion paves the way for the first marketing authorisation of a Covid-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails,” the agency said in a statement.

EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation.

This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens, the EMA said.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, Executive Director of EMA. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU member states.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”

A very large clinical trial showed that Comirnaty was effective at preventing Covid-19 in people from 16 years of age, the EMA said.

The trial involved around 44 000 people in total. Half received the vaccine and half were given a dummy injection. People did not know whether they received the vaccine or the dummy injection.

Efficacy was calculated in over 36 000 people from 16 years of age (including people over 75 years of age) who had no sign of previous infection.

The study showed a 95 per cent reduction in the number of symptomatic Covid-19 cases in the people who received the vaccine (8 cases out of 18,198 got Covid-19 symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got Covid-19 symptoms). This means that the vaccine demonstrated a 95 per cent efficacy in the clinical trial.

The trial also showed around 95 per cent efficacy in the 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. The high efficacy was maintained across genders, racial and ethnic groups.

Comirnaty is given as two injections into the arm, at least 21 days apart.

The most common side effects with Comirnaty were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever, the EMA said.

The safety and effectiveness of the vaccine will continue to be monitored as it is used across the member states, through the EU pharmacovigilance system and additional studies by the company and by European authorities, the agency said.

In a statement last week, the EMA said that it would hold a special meeting on January 6 on the assessment of the marketing authorisation application for Moderna’s mRNA-1273 Covid-19 vaccine.

(Photo: Brian Hoskins)

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