SHARE
COPY LINK

COVID-19

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

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.

EU medicines agency gives green light to second Covid-19 vaccine
Moderna vaccine has been given green light by the EMAAFP

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). 

Member comments

Log in here to leave a comment.
Become a Member to leave a comment.

TRAVEL NEWS

Covid face mask rule on flights in Europe set to be eased

The mandatory EU-wide mask requirement for air travel is set to be dropped from Monday, May 16th, but airlines may still require passengers to wear masks on some or all flights

Covid face mask rule on flights in Europe set to be eased

Europe-wide facemask rules on flights are set to be ditched as early as next week in light of new recommendations from health and air safety experts.

The European Union Aviation Safety Agency (EASA) and European Centre for Disease Prevention and Control (ECDC) dropped recommendations for mandatory mask-wearing in airports and during flights in updated Covid-19 safety measures for travel issued on Wednesday, May 11th.

The new rules are expected to be rolled out from Monday, May 16th, but airlines may still continue to require the wearing of masks on some or all of flights. And the updated health safety measures still say that wearing a face mask remains one of the best ways to protect against the transmission of the virus.

The joint EASA/ECDC statement reminded travellers that masks may still be required on flights to destinations in certain countries that still require the wearing of masks on public transport and in transport hubs.

It also recommends that vulnerable passengers should continue to wear a face mask regardless of the rules, ideally an FFP2/N95/KN95 type mask which offers a higher level of protection than a standard surgical mask.

“From next week, face masks will no longer need to be mandatory in air travel in all cases, broadly aligning with the changing requirements of national authorities across Europe for public transport,” EASA executive director Patrick Ky said in the statement. 

“For passengers and air crews, this is a big step forward in the normalisation of air travel. Passengers should however behave responsibly and respect the choices of others around them. And a passenger who is coughing and sneezing should strongly consider wearing a face mask, for the reassurance of those seated nearby.”  

ECDC director Andrea Ammon added: “The development and continuous updates to the Aviation Health Safety Protocol in light of the ongoing Covid-19 pandemic have given travellers and aviation personnel better knowledge of the risks of transmission of SARS-CoV-2 and its variants. 

“While risks do remain, we have seen that non-pharmaceutical interventions and vaccines have allowed our lives to begin to return to normal. 

“While mandatory mask-wearing in all situations is no longer recommended, it is important to be mindful that together with physical distancing and good hand hygiene it is one of the best methods of reducing transmission. 

“The rules and requirements of departure and destination states should be respected and applied consistently, and travel operators should take care to inform passengers of any required measures in a timely manner.”

SHOW COMMENTS