EU medicines agency gives green light to second Covid-19 vaccine

EU medicines agency gives green light to second Covid-19 vaccine
Moderna vaccine has been given green light by the EMAAFP
The European Medicines Agency has given its approval to the Moderna Covid-19 vaccine, paving the way for it to be rolled out across the EU.

On Wednesday the European Medicines Agency (EMA) announced it had approved the Moderna vaccine in the fight against Covid-19.

It follows approval last month for the Pfizer-BioNTech vaccine that is in the process of being rolled out across the EU.

The final authorisation for the Moderna vaccine will need to be granted by the EU Commission.

Commission chief Ursula von der Leyen described the announcement as “good news”.

“Now we are working at full speed to approve it and make it available in the EU,” she added.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.

The approval also clears the vaccine for use in Norway and Iceland, which are signed up to the EU's procurement scheme.

 

The vaccine will help governments across the EU battle against Covid-19 infections which have remained high throughout December and forced many countries to introduce further restrictions.

Background

COVID-19 Vaccine Moderna is given as two injections into the arm, 28 days apart. The most common side effects with COVID-19 Vaccine Moderna were usually mild or moderate and got better within a few days after vaccination.

A very large clinical trial showed that COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age. 

The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. 

 

The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial.

Since November 9th, four manufacturers have announced that their vaccine is effective: Pfizer-BioNTech, Moderna, the British alliance AstraZeneca-University of Oxford and the Russian state institute Gamaleia.

These announcements are based on phase 3 clinical trials that involve tens of thousands of volunteers. 

The scientific journal The Lancet confirmed on December 8 that AstraZeneca's vaccine was 70 percent effective on average. 

The FDA confirmed the Pfizer-BioNTech vaccine at 95 percent efficacy with Moderna claiming 94.1 percent for its drug. Russia claims a 91.4 percent efficacy for its Sputnik V vaccine.

The AstraZeneca-Oxford vaccine is the least expensive at around €2.50 per dose. The vaccines from Moderna and Pfizer/BioNTech have a logistical handicap, as they can only be stored over the long term at very low temperatures (-20° Celsius for the former, -70°C for the latter). 


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