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Moderna asks the US regulator for authorization for a second booster dose

The American pharmaceutical company Moderna asked the Food and Drug Administration (FDA), the regulatory body of the United States, to authorize the administration for those over 18 years of age of a second booster dose of its vaccine against COVID-19 .

Moderna’s request is broader than the one made on Tuesday by US drugmaker Pfizer and its German partner BioNTech, who asked the FDA that approves a second booster dose of the vaccine but only for adults 65 years of age or older.

It’s a statement, modern explained that his request covers all adults because he believes that the health authorities of the United States, such as the Centers for Disease Control and Prevention (CDC), should have “flexibility” to decide together with family doctors who a second booster dose should be given.

The FDA authorized the first booster dose of the Moderna and Pfizer-BioNTech vaccines last November, concluding that the effectiveness of the first two doses declines over time and a booster injection was needed to minimize hospitalizations and deaths.

modern and Pfizer-BioNTech now argue that a second booster dose would allow immunity to the virus to improve again.

In his petitions to the FDAboth companies have alluded to data collected in Israel, which has pioneered the distribution of the second booster dose.

Specifically, Israel is administering this booster injection to those over 60 years of age, immunosuppressed people, and adults with medical conditions, as well as their caregivers and people who may be exposed to the disease.

Apart from considering the requests from Moderna and Pfizer-BioNTech, the FDA has organized a meeting of its external group of experts for April with the aim of evaluating whether it is necessary to carry out an annual immunization campaign against COVID-19, as is done every year. year with the flu.

In addition, that panel will debate whether the booster doses will keep the same formula or whether they will be modified to combat new variants of the virus.

Source: Gestion


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