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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). 

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COVID-19

German health agency expects number of Covid ICU patients to rise

The Covid pandemic is continuing to cause problems around Germany, with concerns that the number of patients needing treatment will rise in the coming weeks.

German health agency expects number of Covid ICU patients to rise

In its weekly Covid report, the Robert Koch Institute (RKI) said that confirmed infections appeared to be rising in some German states, and falling in others.

But experts warned that the situation remained tense, with many infections not reported. 

Therefore, in the coming weeks, “hospitalisations, an increase in intensive care treatment and deaths are to be expected, especially among the elderly”, said the RKI.

People over the age of 80 “continue to be most affected by severe courses of the disease”, the experts said in their report. 

The incidence of infections is continuing to rise for this age group, and the number of outbreaks of Covid-19 in medical treatment facilities as well as in old people’s and nursing homes is going up.

READ ALSO: Which Covid rules are likely to return to Germany in autumn?

The number of patients with Covid-19 being treated in intensive care units (ICUs) is also rising slightly. In the previous week, the number was reported to be around 1,330. And on Thursday July 28th, 1,550 people were in ICUs in Germany with 484 receiving ventilation treatment, according to the DIVI intensive care register. 

The number of deaths in connection with the virus is currently around just over 400 per week. The RKI says this trend is a plateau.

When it comes to the overall picture of Covid in Germany, the RKI said there was a “sideways movement rather than a decreasing trend”.

Last week, the nationwide 7-day incidence decreased slightly compared to the previous week. The overall picture shows falling incidences in most western German states and Berlin, with incidences still rising slightly in the other eastern German states and Bavaria.

The RKI estimates there’s been a total of 800,000 to 1.5 million people with Covid (who also have symptoms) in the past week alone in Germany.

Last week experts warned that they expected the Covid situation to get worse in the coming weeks as many schools in Germany return after the summer break.

READ ALSO: Germany’s summer Covid wave set to get worse

The Omicron sub-variant BA.5, which has dominated in Germany since mid-June, has almost completely displaced other variants. It accounts for 89 percent of samples in the past week, the RKI said.

Health Minister Karl Lauterbach warned people against underestimating getting Covid again.

The SPD politician pointed out that it was very easy to become infected with BA.5 – even for those who were infected with a previous type.

He warned that many could become seriously ill or die, plus there’s the risk of picking up Long Covid.

“Therefore, we have to solve the problem not by constant infection, but by better vaccines,” Lauterbach said.

‘Call things as they are’

Lauterbach, meanwhile, defended himself against his choice of words when describing the possibility of a new dangerous Covid variant emerging in autumn. 

In an interview with Bild newspaper in April he said: “It is quite possible that we will get a highly contagious Omicron variant that is as deadly as Delta – that would be an absolute killer variant.”

He was slammed for his dramatic choice of words. 

This week Lauterbach said: “I use few vocabulary that is apocalyptic. But sometimes you have to call things as they are.”

If there were a virus that linked the contagion of the BA.5 variant with the severe course of a Delta variant, “that would be a killer variant”, he maintained.

But he stressed that he had “not said that such a variant is definitely coming, but that we have to be prepared for such a variant”.

READ ALSO: German Health Minister calls on under 60s to get next Covid jab

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