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“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 ”. 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 vaccine updates have on protecting people from contagion and severe disease evolution in the fall and winter, and how long the coverage could last,” he added. .
From Omicron variants new wave in the EU
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 Covid-19 cases in many countries in the EU as the Omicron BA.4 and BA.5 variants are highly transmissible,” Cavaleri said. For this reason and based on current projections, EMA itself said it expects the two sub-variants of Omicron “to 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, in reference to the Covid pandemic, the head of the strategy for Ema’s vaccines explained that “even people between 60 and 79 years old and medically vulnerable people of any age should receive a second booster dose of vaccine ”, especially“ if infection rates increase ”. The April recommendation for people over 80, he added, “remains valid: they should receive a second booster vaccine,” he then reiterated.
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Cavaleri also spoke of bivalent vaccines. “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,” he 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”, he added, confirming that “vaccines that 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 to approve “in September” vaccines adapted 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 children. 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 come to a conclusion very soon, we can expect it to happen after the summer break,” he said, confirming that data evaluation has just begun for Pfizer-BioNTech as well. and the opinion should arrive “in early autumn”.