November 27, 2022

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Corona virus disease. Emma: “With an increase in the incidence of the fourth dose even in over sixty and weak people of all ages.” For approval, new vaccines can be released without clinical data such as influenza

Currently in Italy, only the fourth dose has been given to more than 80 RSA guests and vulnerable people in the 60-79 age group. Meanwhile, preliminary data from clinical trials of vaccines adapted to the Omicron variant indicates that “these can increase and extend protection when used as boosters.” and vAn accini that combines two Sars-CoV-2 strains, one of which is the Omicron strain, appears to present a broader immune response. To them, the picture is similar to influenza vaccines, which do not require clinical data to be submitted before an annual update is approved.

July 07

In the current epidemiological context that is witnessing a new strong increase in the incidence of Covid cases, even people between the ages of 60 and 79 and those at risk of any age should be able to receive a fourth dose of the vaccine. This is the new indication from the European Medicines Agency. Currently, the fourth dose has been offered in Italy only to those over 80s, RSA guests and vulnerable people in the 60-79 age group.

Meanwhile, there is good news from preliminary data for vaccines that have been adapted to the Omicron variant. Clinical studies indicate that “these can increase and extend protection when used as a booster.” Vaccines that combine two strains of SARS-CoV-2, one of which is the Omicron strain, appear to provide a broader immune response.

“Depending on the data we receive, we may be able to move toward a framework similar to an influenza vaccine, which does not require clinical data to be submitted before an annual update is approved. Expert discussions are ongoing. – The EMA Vaccine Strategy Leader explained, Marco CavallerI -. We will need real evidence to understand the impact of vaccine updates on protecting people from infection and severe disease development in fall and winter, and for how long they can last. “

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07 July 2022
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