Covid, Ema: towards the ok to annual vaccines as for the flu

The confirmation came from the head of vaccine strategy of the European Medicines Agency (EMA), Marco Cavaleri. “Depending on the data we receive, we may be able to move towards a vaccine-like framework for influenza that does not require the submission of clinical data prior to approval of the annual update. Discussions between experts are ongoing, ”he stressed

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“Depending on the data we receive, we may be able to move towards a similar picture flu vaccines, which does not require the submission of clinical data prior to approval of the annual update. Discussions between experts are ongoing ”. These are the words of the head of the vaccine strategy of the European Medicines Agency (EMA), Marco Cavaleri, who took stock of the situation regarding the anti-Covid vaccination campaign in the EU. “We will need real evidence to understand the impact that updating vaccines has on protecting people from contagion and the severe evolution of disease in autumn and winter, and how long the coverage could last, ”he added.

From Omicron variants new wave in the EU

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Covid, so Omicron 5 is changing the pandemic for infections and hospitalizations

Among other things, the expert confirmed the new wave of infections. “We are seeing a new wave of cases COVID-19 in many countries in the EU as the Omicron BA.4 and BA.5 variants are highly transmissible, ”Cavaleri reported. For this reason and based on current projections, the EMA itself said it expects the two sub-variants of Omicron “Become dominant in Europe probably completely replacing all other variants by the end of July”.

Second booster for over 60 if the cases increase

Given the current epidemiological situation, with reference to the pandemic of Covid, the head of EMA’s vaccine strategy explained that “people between 60 and 79 and medically vulnerable people of any age should also receive a second booster dose of the vaccine”, especially “if infection rates rise ”. The April recommendation for people over 80, he added, “remains valid: they should receive a second vaccine recall ”, he then reiterated.

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Cavaleri also spoke of vaccines bivalent. “Preliminary data from clinical trials indicate that adapted mRNA vaccines incorporating a strain of the Omicron variant can increase and extend protection when used as a booster,” she said. The bivalent mRna vaccines that combine two Sars-CoV-2 strains, “one of which is an Omicron strain, seem to offer an even broader immune response”, she added, confirming that “the vaccines which include other variants could also be considered for use as a booster if clinical trial data show an adequate level of neutralization against Omicron and other variants of concern. ” And reiterating, then, that the EMA is working for the approval “in September” of adapted vaccines against Covid-19. The Agency, the expert underlined, “is working closely with the European Center for Disease Prevention and Control (ECDC), the European Commission and national public health authorities to identify the best approaches to vaccination in Europe. and address potential new waves of Covid-19 infections “.

In autumn, the opinion on vaccines for children under 5

A final specification then concerns the anti-Covid vaccine for the little ones. In fact, the EMA should report its opinion on Moderna and Pfizer-BioNTech vaccines, for children aged 6 months to 5 years, “in early autumn”, concluded Cavaleri. “We are already evaluating the request for Moderna’s Spikevax vaccine and we really hope to reach a conclusion very soon, we can predict that it will happen after the summer break,” he said, confirming that also for Pfizer-BioNTech the evaluation of the data has just started and the opinion should arrive “in early autumn”.

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Covid, Ema: towards the ok to annual vaccines as for the flu


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