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The body designated to approve i Vaccines for COVID-19 in the UK (the Medicines and Healthcare Products Regulatory Agency – MHRA) seems to always be one step ahead of the European Medicines Agency (EMA). After having anticipated it about twenty days for the preparation BNT162b2 (Tozinameran) developed by the pharmaceutical giant Pfizer in collaboration with the German biotechnology company BioNTechApproval for emergency use of the vaccine was also a surprise AZD1222 (or ChAdOx1), developed by the biopharmaceutical company AstraZeneca in collaboration with the Jenner Institute ofOxford University and the Italian company of Pomezia Advent-Irbm. Incredibly, the green light from the United Kingdom came 24 hours after the EMA’s communication of the extension of the deadline for the approval of the same drug, for lack of Clinical data communicated by AstraZeneca and for not submitting the application, as specified by the deputy director of the European agency Noel Wathion.
In light of these premises, one would think that the British committee that is in charge of evaluating vaccines applies less rigorous controls than the EMA, which is “satisfied” with less rigorous tests. Or that in some parts of London they are much faster and better at doing evaluations, but they are definitely not very credible hypotheses, considering the authority of the European Medicines Agency. The fact that AstraZeneca has filed different clinical data with the MHRA and the EMA is also difficult to imagine, considering the need to have as many safe and effective vaccines as possible as early as possible. SARS-CoV-2 coronavirus. It is no coincidence that some sources – as LaStampa reported – even speak of a “political” and unscientific issue behind the two-speed approval process for the vaccine.
A few days ago, the chief executive of the British-Swedish pharmaceutical company Pascal Soriot told the Sunday Times that his team of scientists had found the “formula”Suitable for efficacy comparable to Pfizer vaccines and Modern, which travels about 95 percent. Effectiveness is one of the thorniest issues related to AZD1222, given that the maximum result obtained and documented (equivalent to about 90 percent) was the result of an error in experimentation, as admitted by the company itself. In practice, during Clinical studies some patients received one half dose instead of one full dose in the first injection, and at the end it was found that half a dose plus a full dose was significantly more effective than two full doses.
Just this “catch” Dose me experimentation methodology it would be behind the delay in approval by the EMA, which it could only grant in several weeks. As Professor Francesco Broccolo, a virologist at the University of Milan Bicocca, specifies to ANSA, the lengthening of the times “does not seem to refer to problems related to safety, but rather to the efficacy evaluated with a non-linear protocol, as some data are obtained with a dose followed by a second variable administered, or half a dose by mistake followed by a complete dose. ”In this way – adds the expert – not all subjects were subjected to withdrawal at the same time, giving rise to an element of difficult to interpret the actual percentage of effectiveness. ”However, apparently, this experimental peculiarity has not prevented the United Kingdom from approving the vaccine anyway, whose administration should begin already on January 4 (London has already put 100 million in the farm dose).
According to Dr. Carlo Centemeri, pharmacologist at the Giovanni Lorenzini MI-NY Medical Foundation, although the safety and the tolerability of the AstraZeneca-Oxford-Irbm vaccine, the data related to the trial procedure would make it “very difficult” to approve the EMA at the end of January, so it could even take a few months before approval, as specified by the scientist to ANSA. Meanwhile, Boris Johnson rejoices at the “extraordinary result of British science”, while the European Union has taken cover by reserving another 100 million doses of the Pfizer vaccine. This delay of AZD1222 has a significant impact on the vaccination campaign in our country, considering that it had reserved many doses of AstraZeneca. Therefore, we will have to confidently await the approval of the EMA and then of the AIFA.
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