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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

Covid-19: Are Italian live events at risk of being postponed?

As the infection rate rises sharply across the country, Italian virologists are calling for concerts and festivals to be rescheduled.

Covid-19: Are Italian live events at risk of being postponed?

Italy has seen a large increase in the number of Covid-19 cases in recent days, so much so that a number of virologists across the country are now urging the government to postpone major live events in a bid to curb infections. 

According to a new report by Italy’s independent health watchdog, the Gimbe Foundation, 595,349 new cases were recorded in the week from June 29th to July 5th; a worrying 55 percent increase on the previous week. 

In the same time span, the country also registered a 32.8 percent rise in the number of hospitalised patients, which went from 6,035 to 8,003.  

The latest Covid wave, which is being driven by the highly contagious Omicron 5 variant, is a “real cause for concern”, especially in terms of a “potential patient overload”, said Nino Cartabellotta, president of the Gimbe Foundation. 

As Italian cities prepare to host a packed calendar of concerts and festivals this summer, health experts are questioning whether such events should actually take place given the high risk of transmission associated with mass gatherings.

READ ALSO: What tourists in Italy need to know if they get Covid-19

“Rescheduling these types of events would be the best thing to do right now,” said Massimo Ciccozzi, Director of Epidemiology at Campus Bio-Medico University of Rome. 

The summer wave is expected to peak in mid-July but, Ciccozzi warns, the upcoming live events might “delay [the peak] until the end of July or even beyond” and extend the infection curve.

Antonello Maruotti, Professor of Statistics at LUMSA University of Rome, recently shared Ciccozzi’s concerns, saying that live events as big as Maneskin’s scheduled Rome concert are “definitely not a good idea”. 

The Italian rock band are slated to perform at the Circus Maximus on Saturday, July 9th but the expected turnout – over 70,000 fans are set to attend the event – has raised objections from an array of Italian doctors, with some warning that the concert might cause as many as 20,000 new cases.

If it were to materialise, the prospected scenario would significantly aggravate Lazio’s present medical predicament as there are currently over 186,000 Covid cases in the region (nearly 800 patients are receiving treatment in local hospitals). 

Italian rock band Maneskin performing in Turin

Italian rock band Maneskin are expected to perform at the Circus Maximus in Rome on Saturday, July 9th. Photo by Marco BERTORELLO / AFP

But, despite pleas to postpone the event, it is likely that Maneskin’s concert will take place as scheduled.

Alessandro Onorato, Rome’s Tourism Councillor, said that rescheduling is “out of question” and that “all recommendations from the local medical authorities will be adopted” with the help of the event’s organisers and staff on the ground.

At the time of writing, there is also no indication that the Italian government will consider postponing other major live events scheduled to take place in the coming weeks, though the situation is evolving rapidly and a U-turn on previous dispositions can’t be ruled out.

READ ALSO: At a glance: What are the Covid-19 rules in Italy now?

On this note, it is worth mentioning that Italy has now scrapped all of its former Covid measures except the requirement to wear FFP2 face masks on public transport (though not on planes) and in healthcare settings.

The use of face coverings is, however, still recommended in all crowded areas, including outdoors – exactly the point that leading Italian doctors are stressing in the hope that live events will not lead to large-scale infection.

Antonio Magi, President of Rome’s OMCEO (College of Doctors, Surgeons and Dentists), said: “Our advice is to wear FFP2 masks […] in high-risk situations.”

“I hope that young people will heed our recommendations and think about the health risks that their parents or grandparents might be exposed to after the event [they attend].”

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