Do Astrazeneca’s problems and the government’s Plan B with Pfizer put the Italian vaccination campaign at risk?



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It is the third day in a row that Italy has fought with a new weapon in hand. The doses of the anti-Covid vaccine, Pfizer-BioNtech, continue to be injected throughout the country, in a scenario of enthusiasm that for now, however, is not yet the mirror of a definitive victory. In the next supply changeover, which must guarantee compliance with the phases set out in the vaccination plan, there is the racehorse that Italy has decided to focus on since last summer and that for that very reason does not cease to arouse fears. In fact, almost the 60% the doses planned for the first three months of 2021, 40 million Throughout 2021, the same ones on which Esperanza’s statement a few hours ago confirmed the expectations set:

«If AstraZeneca also reaches the finish line immediately, others will be added within the first quarter 16 million dose. Final result: already on April 1 we could have 13 million of vaccinated, thus reaching phase 1 of the plan “

Minister Speranza says well, all this could happen “if» Astrazeneca would immediately reach the goal. A conditional that, despite the passage of the months, must still be maintained today, in the setting of an experimentation that has proven to be anything but serene.

The documents presented to the European regulatory body are still being examined, in a dynamic of delays and commitments that once again do not promise the Oxford vaccine a reassuring process. Phase 1 of which Speranza speaks, and which is the one that would lead to seeing the first epidemiological effects of the administration with 13 million of people vaccinated, would therefore depend on Italy’s commitment to a candidate vaccine that for the moment would seem to be really effective only for a certain category of population. The statements of the last hours of the CEO Pascal Soriot on the most encouraging data of the Oxford vaccine – perhaps based on a green light also from the United Kingdom – now contribute to give some more hope to the Italian bet. A challenge the government has repeatedly risked losing permanently in recent months.

Because Astrazeneca looked like the winning horse

Easier to transport and less expensive. Two certainly not secondary elements in light of the difficult logistics that Pfizer doses have forced us to do these days. Unlike the American formula, you need your own -70 degrees to be stored safely and effectively, Astrazeneca vaccine can be kept at refrigerator temperature for at least 6 months. A factor that on paper would facilitate both transport and storage worldwide. Moderna doses will also be able to withstand the temperature of a refrigerator, but not more than 30 days. Regarding costs, then the advantage is quite evident, we are talking about figures ranging from 1.78 euro to 2.80 euro per dose against i 12 euros Pfizer vaccine and me 14.68 Modern vaccine, currently the most expensive of all.

Because today it may not be

The AZD1222 vaccine was developed jointly by the University of Oxford and their company. to enlarge Vaccitech with the viral vector technique. They used a virus similar to SARS-Cov-2 but not aggressive, to which they were glued genetic information capable of alerting the body’s immune response. In May 2020, the British company AstraZeneca received a major grant from the American Advanced Biomedical Research and Development Authority (BARDA), of which the Phase 3 study was an integral part. However, the promising resources put in place have repeatedly undermined expectations, during undoubtedly complex experimentation:

  • The first hitch, resolved in a few days, had occurred due to side effects considered serious in a volunteer undergoing administration. The trial was quickly stopped and then resumed.
  • Second hitch, this is more relevant both in terms of scientific risks and in terms of time. The 90% effectiveness announcement published on November 23 was the result of a luck mistake. A small number of trial participants would have accidentally received a smaller amount of vaccine than expected, which would unexpectedly be more protected. Consequence: the scientific community together with the EMA (European Medicines Agency) wanted to see more clearly when requesting more data and documents from the company, which also caused delays in the roadmap of the entire national vaccination plan. Now the scenario of a commitment to Emma herself is yet another proof of a complexity that is far from being resolved.
  • Third hitch: the best result of the formula (at 90%) was found exclusively among minors 55, ensuring efficacy in older people only in 70%.

This is why Ema is thinking of authorizing Astrazeneca only in the administration of under 55. Better than nothing, it would be said in difficult moments like those of a fight against an unknown virus. It is not enough, if the winning weapon on which a whole strategic plan has been programmed, gets stuck at the most decisive moment.

Engagement with Ema: the failure of excluded categories undermining the Plan

One of the latest developments is that of a solution halfway between Ema and Astrazeneca in order to guarantee approval for the Oxford formula as well. The authorization of the European regulatory body could only apply to those under 55 years of age, a category in which the candidate vaccine appears to be effective in 90%, unlike overs. A trick that only half comply with the Italian vaccination plan, now in need of certainty and few clauses.

The condition of minors under 55 that Ema would like to impose is certainly not a detail to which to turn a blind eye, but rather a factor that would compromise freedom of movement and therefore coverage of the population yet to be vaccinated. A problem that would be worth it First for the elderly, but not only. Among the most fragile categories that could largely fall into the range of over 55in fact, there would also be health workers.

80% coverage. How realistic are Hope’s numbers?

The epidemiological evolution of the virus has now accustomed us to speaking in terms of phases. Even in vaccines, the government plan recognizes 2 different He passed: the first provides 13 million of people vaccinated with the first concrete signs of epidemiological impact in the registered figures. The second phase involves 40 million of vaccinated that at that time, according to the government, would allow the achievement of herd immunity, with the80% necessary coverage. Exact hope:

“According to the contract plan in the first quarter we should receive 8.7 million of doses produced by Pfizer and 1.3 millions produced by Moderna. Total, 10 million dose, corresponding to 5 million of vaccinated people, since with a booster two doses are needed per person “.

However, they were also expected for the first quarter of which Speranza speaks. 16 million of Astrazeneca doses, an arrival that the optimism of the minister alone will not be able to guarantee. The same goes for the others 24 million scheduled in the second trimester. A full authorization will be required, without compromising age groups and categories. It goes without saying that even the “clause” for those under 55 years of age, foreshadowed by Ema for the green light, could put Speranza’s roadmap in phase 1 in difficulty. On an obviously numerical level but also of contagions, excluding from the administration the categories widely recognized as being at higher risk, the elderly and some of the health personnel.

The silent B planes

According to an indiscretion reported by The messenger, the Italian government would move to buy more 18 million dose, probably from Pfizer. If confirmed, the news of an alternative purchase strategy already in place for Astrazeneca, would suggest a very different climate to that of optimism about the success of the vaccination plan, spread in recent days. On the idea of ​​a plan B, the emergency commissioner Domenico Arcuri also exposed himself weeks ago to the possibility of requesting more doses from Moderna, the most expensive vaccine currently among all those available or pending testing. Now the rumors seem to fall on the cheaper Pfizer.

Speranza, for her part, expressed her opinion on the non-particular need for an alternative plan for delayed doses. Days ago, on the subject, Sanofi had said: “With the doses we expect from all other companies, even without Sanofi, Italy should have sufficient coverage.” Even Sanofi itself, like Astrazeneca, would have been the company to bet more on the number of doses agreed. But in this case, hope for a recovery has now been lost, the offer will not arrive before June 2021.

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