AstraZeneca has officially filed an authorization request for his vaccine, developed with the University of Oxford. The evaluation by the European Medicines Agency is expected by January 29th. It would thus be the third vaccine to be conditionally authorized in the European Union after those of Pfizer-BioNTech e Modern. The procedure will obviously be accelerated, usually the checking of documents and the evaluation of quality, effectiveness e safety as well as the indications on the population for which the treatment is authorized, take months.
But the times of the past are incompatible with the health emergency that sweeps Europe in this long and cold winter of pandemic.
It could therefore close by 29 January during the meeting of the Committee for Medicinal Products for Human Use (CHMP), provided that the data presented is sufficiently robust and complete – explains the EMA in a press release – and that any further information requested to complete the assessment is sent in a timely manner. The AstraZeneca vaccine, which at one point last year looked the most promising and then faced a not insignificant series of problems regarding the audience of individuals involved in field trials and to posology, however, it is already used in the United Kingdom, Argentina, India, the Dominican Republic, El Salvador, Mexico and Morocco. As usual, a quick passage to the European Commission and then to Aifa, theItalian drug agency which will detail all aspects, from conservation to administration.
The Commission bought 400 million doses of the AstraZeneca vaccine blindly. Of these, 40 million will go to Italy during the year, 16 of which within the first quarter and 24 in the second. A real breakthrough, considering the bottleneck of supplies and the international rush to grab more and more doses, which could change the course of the infection in our country, despite all the difficulties of the case. There is one though: the AstraZeneca vaccine it should not be authorized for all age groups above 16 or 18 years, as happened for the two discoveries of the American giants already in use. This is a legacy in the mistakes made in clinical trials and beyond involved a few patients over the age of 55 but, in fact, they have concluded the evaluations of immunogenicity and efficacy on a large scale with two different posologies (half dose discovered almost by chance and initial full dose), with complete data, however, only for the least performing combination in immunological terms, around 70%.
This means that from February Italy and other countries could in fact be forced to split the tracks of the vaccination campaign. After the green light, the first vaccine loads will arrive within two weeks, perhaps less. However, if the EMA has authorized its administration only to individuals under 55 years of age it will be necessary to reformulate the vaccination campaign during the course of the work. Limiting ourselves to the first quarter, on the one hand we should continue to cover the older groups, that is, the over 80s and then the over 60s, with only Pfizer and Moderna vaccines, on the other we will have suffered a flood of doses available to younger groups in which, however, most of the categories most at risk fall: teachers, police forces, public transport drivers and obviously people with previous pathologies but younger in age. This would launch a kind of forced but not necessarily ineffective pincer strategy in which, at the same time, we proceed precisely to protect the elderly but also those who live in society more actively and still on the labor market.
There are a few things to keep in mind though. The first is the logistics. The Pfizer vaccine (let’s limit ourselves to that of the Moderna we will have very few doses in the first three months) must be maintained and delivered by protecting a very rigid ultra-cold chain, at around -80 degrees centigrade. It is therefore impossible to administer it in general practitioners’ offices, which would be more able, thanks to their databases and the knowledge of patients as well as to the widespread distribution in the territory, to proceed with a more rapid administration among the elderly who do not reside in assisted residences. The game changer for that phase would have been AstraZeneca, which, however, we may not be able to use, although the EMA guidelines also suggest the opposite outcome: specific population groups, net of the pediatric one, can be excluded from the recommendation of the use of a drug only if you are sure that it is not effective on that range. Otherwise they must be authorized.
So we will be able to find ourselves with an easily distributed vaccine that is also available to general practitioners’ offices it may not be administrable to those subjects that we most need to reach through their dense network of doctors’ offices. For them we may have to continue to use the others, Pfizer and Moderna, for whose administration we will still have to rely on powerful refrigerators for hospitals and local health authorities, thus bringing the elderly who can move into hospitals (by contacting them directly or asking them to book?) and reaching others, for example the disabled, directly at home with the mobile units. One thing is certain: from February the campaign will become much more complex but also faster and with many more doses available.