Obligation of vaccines, Ema’s slowdown: “The ok only in 2023”. The emergency plan to cut times

Obligation of vaccines, Ema’s slowdown: “The ok only in 2023”. The emergency plan to cut times
Obligation of vaccines, Ema’s slowdown: “The ok only in 2023”. The emergency plan to cut times

The only tool to put pressure on those who are not yet vaccinated will be the green pass, to be extended like wildfire to more categories of workers, starting with those in direct contact with the public, up to extension in the private sector. . For the mandatory nature of the vaccine, aired by Prime Minister Mario Draghi, hoped for by many experts but conditioned by the green light of the regulatory agencies, we have to wait. Not weeks, months if it’s okay, years if it’s worse.

Unfortunately, the good intentions of politics collide with the times of science. Ema, according to a high-level source reported to the Journal, “will give the green light to the authorization for the complete trade of Pfizer and Moderna vaccines, as if they were normal drugs, in a couple of years”. So, in 2023. The obstacle to overcome stems from the times that the manufacturers have agreed to conclude the clinical trial of the vaccine. Pfizer, which produces the most popular vaccine in the world and the favorite of Italians, is committed to concluding the phase 3 study in about 28 months. And the company confirms. When asked by the Journal, he replied that “since the phase three study provides for the follow-up of the participants for two years, for its closure we are talking about 2023”. Modern, on the other hand, for the end of her studies, anticipates the competitor by one year: December 2022. But her vaccine is not very widespread in Europe, and in any case the times remain long. Paradoxically, they could exceed the duration of the current pandemic. However, the clinical trial must respect its times. And the European regulator will take the time to transform “conditional authorization”, which is currently granted to Pfizer and Moderna, into “full authorization,” granted by assessing the risks and benefits on comprehensive data provided by the companies. Which cannot be submitted before the end of phase 3.

It looks like the cat chasing its own tail. How to get out? In Amsterdam, they look for ways out to avoid these delays. According to internal sources, the experts are trying to understand if the timing can be drastically shortened and offer a complete assessment with the data already in the possession of the institution which, at present, are still partial. The turning point could only happen when Ema believes that in the next few months it has obtained abundant data to take the final step. In this case, the final ok could be brought forward even by months but only if, as stated in Ema, “all production problems will be solved”. But Pfizer, rattles off mind-boggling numbers. The pharmaceutical giant has shipped more than 1.3 billion doses all over the world (over 485 million in the European Union) and by the end of the year it expects to produce up to 3 billion, which could become 4 billion in 2022. Currently, the doses have been sent to more than 120 countries with over 280,000 shipments, whose deliveries, in 99.9% of cases, have met all the established parameters. The power of this diffusion also seems a guarantee of the goodness of the product. In the US, emergency approval has been abandoned for a couple of weeks. In the EU, the criteria are different. The vaccine has already been authorized, making a preliminary but sufficient assessment to define the risk-benefit ratio. For full consent, however, complete data is required. But, if it is true that the clinical study will end in 2023, it is also true that this product has already been “tested” on millions of people around the world from which broad-spectrum studies can be obtained. Will this be enough for Ema to drastically cut times? And then, what do these long-term data add to what we already know?

Faster, even if not imminent, the timing for the authorization of the third dose dedicated above all to the immunosuppressed and the elderly. Pfizer announces that data supporting a third dose have already been submitted to the US FDA and “in the coming weeks” intends to submit this data to EMA and other regulators around the world. Only after this formal submission will Ema be able to approve the use of the third dose and indicate the categories to which it should be administered, but not without first having thoroughly analyzed the data provided by the company.

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