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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

Return of the health pass? How France plans to tackle new wave of Covid cases

With a sharp rise in reported cases in recent weeks, France appears to be in the middle of a new wave of Covid infections - so what measures are the government taking to control it?

Return of the health pass? How France plans to tackle new wave of Covid cases

Recorded case numbers in France are now over 50,000 a week, and have been since the beginning of June – this is a long way short of the 350,000 weekly cases recorded in January but still the highest since May and representing a steady an increase of 57 percent on the previous week.

Hospital admissions are also on the rise – standing at 707 admissions on Friday, June 24th compared to 400 daily admissions just two weeks earlier.

So what is the French government doing about it?

Since March, almost all Covid-related restrictions have been lifted in France – the health pass is no longer required for everyday activities such as visiting a bar or going to the gym and face masks are now merely advised in all indoor locations. Only hospitals and other health establishments such as nursing homes still have mandatory rules on face masks and health passes.

For international travel, fully vaccinated arrivals from most countries – including the UK, US and the whole of the EU – need only to show proof of vaccination, while unvaccinated travellers need to show proof of a recent negative Covid test – full details HERE.

Health pass

A proposed bill from the health ministry that was leaked to French media talks about re-imposing some form of pass sanitaire (health pass) to get numbers under control.

Some caveats to add here is that the document is only a proposal at this stage and the government has explicitly rules out – for the moment – reintroducing the vaccine pass. The health pass can be used to show either proof of vaccination or a recent negative Covid test, so it is less restrictive for the unvaccinated.

The document suggests re-introducing a health pass for travel – both to and from France – not for everyday activities like going to a café.

Testing and contact tracing

The bill also proposes extending the software involved in contact tracing and the Covid testing programme until March 2023, although this is described as a ‘precaution’.

Testing remains available on a walk-in basis at most French pharmacies and by appointment at health centres and medical labs. Tests are free for fully-vaccinated residents of France who have a carte vitale. Those are only visiting France, who are not registered in the French health system or who are not vaccinated have to pay – prices are capped at €22 for an antigen test and €54 for a PCR test.

READ ALSO How tourists in France can get a Covid test

Masks

The government’s Covid vaccine adviser Alain Fischer told France Info that he was in favour of making face masks compulsory on public transport again and said it is ‘being discussed” at government level.

At present masks are not required, but are recommended, especially on busy services where it is impossible to practice social distancing.

Epidemiologist Pascal Crépey said: “In crowded trains, the risk of being in the presence of infected people is high. It would be a good idea for the population to wear the mask, to protect especially the most fragile and avoid massive infection rates.”

Local measures

French local authorities also have the power to impose certain types of restrictions if their area has a particularly high rate of infections.

At present, none have done so, but Nice mayor Christian Estrosi has spoken in favour of possibly bringing back the vaccine pass over the summer.

Second booster shots

A second booster shot of the Covid vaccine is now available to all over 60s and anyone who has a long-term medical condition or who is otherwise at risk from Covid.

It is recommended that the government increase public messaging advising those in high risk groups to get the second booster shot. The medical regular HAS has advised combining second booster shots with the seasonal flu vaccine campaign in September and October.

France is not, at present, considering widening the campaign to the entire popular, but the EU’s vaccine commissioner Thierry Breton says that if necessary, there would be enough doses to cover the whole population.

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