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Following clearance from the US FDA, the Food and Drug Administration, the vaccine Moderna will soon also arrive in Europe. “It will certainly be evaluated by EMA, the European regulatory agency in January,” anticipates the virologist. Giorgio Palù, new president of Aifa, the Italian drug agency. The doses of Moderna would thus be added to those of Pfizer Biontech. “The EMA will give the go-ahead on December 21, then the practice should transition to the European Commission only on a formal level – Palù specifies – Aifa will take a look, but it is a centralized negotiation, the funding has already been allocated, for what we can give the authorization already on December 22 at the latest ».
Professor Palù, with the arrival of the Moderna vaccine, can we immediately count on a more impressive number of doses?
Health Minister Speranza, with the approval of Parliament, has already ‘reserved’ the purchase of more than 200 million doses of all the vaccines that will be produced, except of course those from China or Russia, because they are not subject to scrutiny from recognized regulatory bodies. Therefore, given that almost all vaccines except one in two doses, will potentially be available to more than 100 million Italians.
Are there particular differences between the two vaccines?
“Moderna vaccine is easier to store and therefore to distribute, it can even be stored at 4 degrees for a few days and then at -20 degrees. The studies presented also showed that there is a good immune response even in elderly subjects. It has also been proven, although not in many subjects, that the vaccine is capable of preventing infection, creating the conditions to sterilize immunity, which is essential to block transmission from person to person. Both vaccines have an efficacy of around 95% and this is an extraordinary fact.
Based on some recent studies, it appears that Sars-Cov-2 has several mutations. Will the vaccines already produced still be effective?
‘This virus certainly mutates, but it does so much less than other RNA viruses such as influenza, HCV and HIV. A reassuring fact in this regard is the observation, made in preliminary studies carried out in volunteers, that the antibodies induced by vaccination also neutralize circulating viruses carrying mutations with respect to the original strain. In any case, this aspect, as well as the duration of the immunity acquired with the vaccine, must be evaluated later with the start of mass vaccination ”.
Could vaccination coverage not be effective for everyone?
“To protect even the unvaccinated from infection, the vaccine must be administered to around 65% -70% of the population, to obtain so-called herd immunity, a goal that is difficult to achieve quickly. In any case, the effectiveness of the vaccines will be evaluated over time. Not everything could be verified with the acceleration due to the pandemic. Never before has a vaccine been produced in ten months. Consider that Moderna had already performed a first vaccination setup 10 days after the Chinese published the Sars-Cov-2 genome sequence. ‘
What could be the side effects?
“Both vaccines can cause local reactions, such as redness, pain at the injection site, or non-serious systemic effects such as fever, asthenia, myalgia, arthralgia. Very rarely very serious effects have been observed. It is good that people who have suffered significant allergic manifestations are followed by their doctor. The side effects should be known to everyone and Aifa has specifically created a vigilance commission. I would like to emphasize that the advantage for those who get vaccinated is very considerable compared to the risks of side effects, especially for the elderly who are currently the most exposed to lethal consequences, as we unfortunately see daily.
Last updated: 22:24
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