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The key word is always the same: serendipity. A “discovery that happened by chance”, that of the doses of the vaccine against the coronavirus AstraZeneca, which nevertheless runs the risk of blowing up the immunization plan for Italy and other European countries.
AstraZeneca vaccine: the dose error that puts Italy in trouble
Step back. The candidate vaccine developed by AstraZeneca in collaboration with the Jenner Institute in Oxford and the Irbm in Pomezia at first seemed destined to win the race with Pfizer-BioNTech and Moderna: someone announced the development even in September. In mid-November it was announced that the whole world had frozen: the efficacy of the two-dose preparation, according to the company’s experimentation, was “only” 62%, while 90% immunization was achieved with the administration of a first half dose followed by a full dose. An administration that had occurred due to an error in the interpretation of the test documents that had led to a dosage error, subsequently arose thanks to the controls, with a concentration of the active principle in half.
For this AstraZeneca had to restart the experimentation. And the European Medicines Agency (Ema) has announced that it has not yet received the results: in these conditions it is impossible to obtain authorization before the end of January and therefore the distribution could only be postponed until the second half of February. Meanwhile, the company has announced that within a week it will prepare the dossier that will be presented to the EMA with the data from the phase 3 trials, carried out in three countries (Great Britain, Brazil and South Africa) on 24,000 volunteers. These are those published in The Lancet on December 8, which show the case of serendipity: the regimen of one dose plus one dose, 28 days later, has an efficacy of 62%. The half-dose plus one-dose regimen, again 28 days apart, is 90% effective. The new trials are planned in the United States and Italy: 3,000 volunteers will be enrolled in 13 centers. But the start date has not been set, nor has it been decided at what dose the trials will continue.
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40 million doses at risk
The delay creates a problem in the Italian government’s plan for mass vaccination. As you point out today The impression, most of the doses that should arrive in the first quarter of 2021 are precisely those of the antidote developed by the University of Oxford and the Irbm of Pomezia and produced by AstraZeneca.
Italy has reserved, for the next three months, 16 million doses of the AstraZeneca vaccine and 8.7 million of Pfizer-BioNTech, the only one currently approved in the EU. Another 2 million vials are expected to come from Curevac and 1.3 million from Moderna. Overall, for the entire vaccination plan, the government reserved 202 million doses, 53.8 from Johnson & Johnson, 40.3 from Astrazeneca, another 40.3 from Sanofi-Gsk, 30.2 from Curevac, 26.9 from Pfizer and 10.7 from Moderna.
In short, it is clear that the Astrazeneca delay runs the risk of creating more than one problem. A government source explains: “It is obvious that this news generates some apprehension. Let’s see what will happen in the next few weeks, because London still seems ready to go ahead with AstraZeneca. And if they get the go-ahead, an acceleration in the EU is also possible. Otherwise we will have to intensify the purchases of the other vaccines … “
Meanwhile, after the latest Pfizer-BioNTech schedule change, another 470,000 doses should hit 203 active sites by now. In the four weeks of January the average should remain at 470 thousand doses. Then there’s Moderna: the government has bought more than ten million doses and now wants to double them to make up for AstraZeneca’s delay. The problem is that at this stage companies are overwhelmed by requests. Will they be able to produce it on time?
