Vaccines, the EMA grants definitive authorization

Covid mRNA vaccines are about to acquire definitive authorization from the EMA (European Drug Authority), coming equated to normal drugs and thus silencing the most extreme criticisms that portray them as dangerous experimental potions or serums.

So far, the Covid mRNA vaccines developed by BioNTech / Pfizer (Comirnaty) and Moderna (Spikevax) have obtained an authorization toso-called “conditional” marketingwhich must be renewed annually. From today, as the daily health information online newspaper reports, Quotianosanità.it, there is something new.

The CHMP (Committee for Medicinal Products for Human Use), EMA’s Committee for Medicinal Products for Human Use, has recommended converting the marketing authorizations for the aforementioned Covid vaccines from “conditioned” to “standard”. This change implies a significant change and presumably simplification for the pharmaceutical companies in question.

From the moment of authorization, BioNTech / Pfizer and Moderna had to present the results of the clinical trials ongoing and provide additional data on the quality of their vaccines in view of increasing production. Well, according to the CHMP, the trials and further studies “have provided reassuring data on key aspects such as the effectiveness of vaccines in preventing severe Covid. In addition, the companies provided any additional data required on the pharmaceutical quality of the vaccines. Taking into account the totality of efficacy and safety data available, resulting from the wide use of these vaccines, specific obligations are no longer considered fundamental for the benefit / risk ratio (of the products), which paved the way for the transition from a ‘marketing authorization conditional on a standard’.

After the second annual review procedure, due to the conditional authorization, the CHMP has just suggested converting the marketing authorizations from “conditioned” to “standard”. This procedure affects all existing and forthcoming Comirnaty and Spikevax vaccines, including Comirnaty Original / Omicron BA.1, Comirnaty Original / Omicron BA.4 / 5, Spikevax bivalent Original / Omicron BA.1, which have recently been approved .

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

Andrea Gebbia, September 16, 2022

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