science

Vaccines, EMA gives final permission

Covid mRNA vaccines on the verge of obtaining final authorization from the EMA (European Medicines Authority), coming Equivalent to regular medication Thus silencing the fiercest criticism portraying them as dangerous experimental potions or serums.

To date, the Covid mRNA vaccines developed by BioNTech/Pfizer (Comirnaty) and Moderna (Spikevax) have been licensed.The so-called “conditional” marketingwhich must be renewed annually. From today, as reported by the daily online health information newspaper, Quotianosanità.it, there is something new.

The Committee on Medicinal Products for Human Use, the EMA’s Committee on Medicinal Products for Human Use, has recommended converting the marketing authorizations for the above-mentioned Covid vaccines from “conditional” to “standard”. This change involves a significant change and a supposed simplification of the pharmaceutical companies involved.

From the moment of licensing, BioNTech/Pfizer and Moderna had to present clinical trial results It is ongoing and provides additional data on the quality of their vaccines in light of increased production. Well, according to the CHMP, the additional trials and studies “provided reassuring data on key aspects such as the efficacy of vaccines in the prevention of severe Covid. In addition, the companies provided any additional data required on the pharmaceutical quality of the vaccines. Taking into account the totality of available efficacy and safety data , resulting from the widespread use of these vaccines, the specific commitments are no longer considered essential for the benefit/risk ratio (for products), paving the way for the transition from “standard conditional marketing authorization”.

After conducting the second annual review, due to the conditional authorization, the CHMP has just proposed the transfer of marketing permits From “conditional” to “standard”. This action affects all current and upcoming Comirnaty and Spikevax vaccines, including the recently approved Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4/5, and Spikevax bivalent Original/Omicron BA.1.

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As with any regular medication, the EMA explains that the two mRNA vaccines will also continue to be closely monitored. Any new data will be immediately evaluated and any action necessary to protect patients will be taken.

Andrea Gibbia September 16, 2022

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