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Safe and effective. To be approved, a vaccine must meet these two prerequisites. There is no question about the first point: that of Oxford and AstraZeneca is not dangerous at all. Regarding efficacy, however, the different drug agencies have been divided: if for the London Health and Medicine Regulatory Agency the percentage of coverage (estimated at 62%) is sufficient to be useful against Coronavirus infection . , for the EMA (European Medicines Agency) things are more complicated.
At the moment there are only two countries in the world that have given the green light to the AstraZeneca vaccine: the United Kingdom, in fact, and Argentina. The first to break the ice on the Oxford vaccine was the Mhra, which yesterday morning, December 30, gave the green light before the Ema, as has already happened with the Pfizer / BioNTech serum. According to the European body, there are still aspects to be clarified about the English University vaccine, produced in collaboration with the Irbm of Pomezia. On the other hand, the UK drug agency itself has granted a so-called “temporary authorization”, by which it reserves the right to revoke authorization at any time in the event of new unconvincing data.
The dose
The main problem is related to the percentage of effectiveness compared to the doses. During the months of experimentation, the researchers mistakenly administered only half a dose (0.5 ml) to 2,000 volunteers: the error revealed that by halving the dose, infection coverage increased from 62% until the 90%. According to the EMA, AstraZeneca should have repeated the study on all 40 thousand people involved in the research before it could be approved. For the UK, however, the certainty about the safety of the product and the hope of reaching a good part of the population in any case was enough to give the go-ahead.
Currently, both Ema and Mhra agree that there is insufficient data to approve the administration of only half the dose. But for the British, this does not mean that the AstraZeneca vaccine can remain, even, that is, administered in full doses according to the protocol, an important and safe ally in developing immunity in a not inconsiderable percentage of citizens. And this is also because, by extending the duration between the first administration and the next as much as possible (and thus indirectly exploiting the advantages discovered by the error), the British government intends to cover the weakest subjects as much as possible.
The duration of protection
The second unknown refers to the duration of protection. On this, the British agency was clear: “We still do not know how long immunity against Covid-19 will last.” In light of the various differences of opinion, it is worth wondering which of the two strategies is the more correct: the EMA, which prefers to wait for clearer data on efficacy before leaving, or the MHRA, which claims exploit the potential of the vaccine as much as possible at a particularly difficult time for health (yesterday there was 50,023 new infections and almost mille deaths in the UK). According to Walter Ricciardi, former president of the Higher Institute of Health and consultant to the Minister of Health, in the UK “they are certainly more pragmatic, but the political pressures in a country fighting an increase in infections should not be underestimated.”
Cover image: EPA / OXFORD UNIVERSITY / JOHN CAIRNS /
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