Covid Emma: Towards approval of annual influenza vaccines

The confirmation came from Marco Cavalieri, head of vaccine strategy for the European Medicines Agency (EMA). “Depending on the data we receive, we may be able to move toward an influenza vaccine-like framework that does not require clinical data to be submitted before the annual update is approved. He emphasized that discussions among experts are ongoing.

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“Depending on the data we receive, we may be able to move toward a framework similar to an influenza vaccine that does not require clinical data to be submitted before the annual update is approved. Discussions among experts are ongoing.” These are the words of the Head of Vaccine Strategy at the European Medicines Agency (EMA), Marco Cavalieri, who has assessed the situation in relation to the Covid vaccination campaign in the European Union. “We will need real evidence to understand the impact of vaccine updates on protecting people from infection and severe disease development in the fall and winter, and how long coverage can last,” he added.

Variants of Omicron new wave in the EU


Covid, so Omicron 5 changes the epidemic for infection and hospitalization

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 variants BA.4 and BA.5 are highly transmissible,” Cavalieri said. For this reason and based on current forecasts, the EMA itself said it expects the two Omicron sub-variables to “will become dominant in Europe likely to replace all other variants by the end of July”.

The second supporter for more than 60 in case of increasing cases

Given the current epidemiological situation, referring to the Covid epidemic, the head of the Ema Vaccines Strategy explained that “even people aged 60-79 and medically at risk persons of any age should receive a second booster dose of the vaccine”, in particular “if” Infection rates have increased. He added that the April recommendation for people over 80 “still applies: they should receive a second booster vaccine,” and then reiterated.

Enhanced with a bi-strain vaccine that increases the level of protection


Covid vaccine, fourth dose: Who should do it now and how to book

Cavalieri also spoke about bivalent vaccines. “Preliminary data from clinical trials suggest that adaptive mRNA vaccines that include a strain of the Omicron variant can increase and extend protection when used as a booster,” he said. He added that a bivalent mRna vaccine that combines two strains of SARS-CoV-2, “one of which is the Omicron strain, appears to provide a broader immune response,” stressing that “vaccines that include other variants can also be considered for use as a booster if clinical trial data shows an appropriate level.” of a tie against Omicron and other variables of concern.” He then reiterated that the authority is working to approve “in September” adaptive vaccines against Covid-19. The expert noted that the agency “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 vaccination approaches in Europe. And to tackle potential new waves of Covid-19 infection.”

In the fall, opinion about vaccinations for children under five

Then the final specifications relate to a Covid vaccine for children. Indeed, Cavalieri concluded, the EMA should report its opinion on the Moderna and Pfizer-BioNTech vaccine for children aged 6 months to 5 years, “in early fall.” “We are already evaluating the Spikevax Moderna vaccine application and we really hope to have a conclusion very soon, and we can expect that to happen after the summer break,” he said, stressing that the evaluation of the data has just begun for Pfizer-BioNTech like ok .. and the opinion should come” in early autumn.

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