EMA revealed when anticovid vaccines adapted to new variants will be approved

The head of the Strategy for Biological Health Threats and Vaccines of the European Medicines Agency (EMA), Marco Cavalieri, stated at a press conference that the body plans to approve vaccines against covid-19 adapted to Ómicron and other variants in September.

“Our priority is to ensure that the adapted Covid-19 vaccines are approved by September at the latest, so that they are ready for the rollout of the new vaccination campaigns in the European Union in the autumn. This would allow manufacturers to adjust their production lines accordingly,” said the EMA member.

“Clinical trials of the adapted vaccines must show that they are superior to the current licensed covid-19 vaccines against Omicron and other variants,” Cavalieri added.

In addition, the European agency pointed out that the main candidates for these adapted vaccines are those of the Moderna and Pfizer/BioNTech laboratories. “We are working with all the manufacturers of the vaccines that are currently approved, but it is no mystery that mRNA vaccines are way ahead of the race, which is why we are primarily working with Moderna and Pfizer/BioNTech. ”, he clarified.

Second reinforcement in people over 80 years of age

On the other hand, the EMA announced the advisability of approving a second booster of the Covid-19 vaccine in the population over 80 years of age. “It is too early to consider the use of a fourth dose, or second booster of mRNA vaccines in the general population; however, those over 80 years of age could benefit from a second booster, given the higher risk of severe Covid-19 for them,” Cavalieri said.

As for people who have received vaccines from different laboratories (for example, AstraZeneca in the first dose and Pfizer/BioNTech in the second), Cavalieri has advanced that precisely the Pfizer/BioNTech vaccine can be used as “a heterologous booster” .

In addition, during the press conference it was announced that the EMA has begun to evaluate a request for a booster dose in people over 18 years of age for ‘Vaxzevria’, the AstraZeneca vaccine. In this sense, the regulatory agency has also begun to evaluate a request from Moderna to extend the use of ‘Spikevax’ to children from 6 months. “It is the first request for this very young age group”, Cavalieri assured.

Regarding the Novavax vaccine, Cavalieri has reported that the EMA is currently evaluating the data to make a recommendation for use in youth ages 12-17.

Finally, the head of the EMA Biological Health Threats and Vaccines Strategy warned that, despite the fact that the contagion situation has stabilized in Europe, “The pandemic is not over” and has urged “remain vigilant”, while calling for vaccination, both primary and booster.

“Nearly half a million lives of people aged 60 or over have been saved in Europe thanks to vaccination,” he recalled, although he warned of the need to increase the number of the immunized population. “Only 50 percent of Europeans are fully vaccinated and have booster doses. And up to 15 percent of European citizens over the age of 18 have not received a single injection of the Covid-19 vaccine″, she concluded.

With information from Europe Press

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