EMA Approves Covid-19 Vaccine

Lifestyle & TravelHealth ♦ Published: December 21, 2020; 19:50 ♦ (Vindobona)

The European Medicines Agency (EMA) recommended the approval of a Covid-19 vaccine developed by BioNTech and Pfizer. Ultimately, the European Commission granted approval and the first vaccine will be used on December 27. Further Covid-19 vaccinations are awaiting approvals in the upcoming weeks.

The EU approved the first Covid-19 vaccine developed by BioNTech and Pfizer. / Picture: © Flickr / Tim Reckmann (CC BY 2.0)

The European Medicines Agency (EMA) recommended granting conditional marketing authorization for the vaccine "Comirnaty" developed by BioNTech and Pfizer to prevent Covid-19 in people aged 16 and older.

The EMA's scientific opinion paves the way for the first marketing authorization of a Covid-19 vaccine in the EU by the European Commission, with all associated safeguards, controls and obligations.

Austria's Health Minister Rudolf Anschober:

"This is very good news! A total of 1 million doses will be delivered by BioNTech in the first quarter, of which about 230,000 will be delivered in the first four weeks. We will then start vaccinating the elderly and nursing homes with these doses."

He added:

"After that, we still expect the market approval of Moderna at the beginning of January, and then a delivery of this vaccine of 200,000 doses in the first quarter. And after that, market approval of the vaccine from AstraZeneca in February. Of that, 1.2 million doses will be delivered in the first quarter."

The EMA Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of Comirnaty and concluded that sufficient robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorization.

This should provide a controlled and robust framework to support EU-wide vaccination campaigns and protect EU citizens, according to Anschober.

"Due to the excellent cooperation of all experts, it was possible to issue a positive opinion for the first mRNA vaccine Comirnaty in the EU this year. Even the news from the UK that there is a new viral variant will not diminish the success of the vaccine, because the immune response that the vaccine elicits is directed against several features of the virus, individual mutations should therefore not have a dramatic effect," said Dr. Christa Wirthumer-Hoche, head of the Medical Market Supervisory business area in Austria in an initial reaction to the positive news from Amsterdam.

A very large clinical trial has shown that the vaccine effectively prevents Covid-19 in people 16 years and older.

The trial involved a total of about 44,000 people. Half received the vaccine and the other half received a placebo. People did not know whether they received the vaccine or the placebo´.

Efficacy was calculated in more than 36,000 people 16 years and older (including people 75 years and older) who had no evidence of previous infection.

The study showed a 95% reduction in the number of symptomatic Covid-19 cases among people who received the vaccine (8 of 18,198 cases had Covid-19 symptoms) compared with people who received a sham injection (162 of 18,325 cases had Covid-19 symptoms). This means that the vaccine showed 95% efficacy in the clinical trial.

The study also showed about 95% efficacy among participants at risk for severe Covid-19 disease, including those with asthma, chronic lung disease, diabetes, high blood pressure, or a high body mass index. High efficacy was also maintained across gender, race, and ethnic groups.