Europe will not approve the AstraZeneca vaccine in January- Corriere.it

It is unlikely that the European Medicines Agency, EMA, can give the green light to the vaccine. AstraZeneca / Oxford in January.

This was stated by the Deputy Executive Director of the European Medicines Agency, Noel wathion, in an interview with the Belgian newspaper The newspaper.

They have not yet been implemented, he added, noting that more data is needed on the quality of the vaccine. The Authority has currently received only certain information about the vaccine, insufficient even to give a conditional green light to marketing.

A few days ago, talking to him sunday time, the CEO of AstraZeneca had stated that the publication of the new study on phase 3 of vaccine trials would arrive in a few days, that the effectiveness was 95% (in line with those of Moderna and Pfizer-BioNTech) and that The British drug agency, the Regulatory Agency for Medicine and Health, would be ready to authorize the use of the preparation in a very short time. Health Minister Matt Hancock, quoted by Reuters, said AstraZeneca and Oxford had already sent all the necessary data to the British authority. According to UK media, the first doses could be administered as of January 4.

If the delay in the approval by the EMA of the AstraZeneca vaccine were confirmed, it would be news with very significant consequences for the citizens of the European Union and for Italy.

Characteristics of the Oxford-Astrazeneca vaccine

The preparation carried out by the Jenner Institute of the University of Oxford together with AstraZeneca and the Irbm of Pomezia has in fact – compared with the vaccine of Pfizer and BioNTech (already approved by Ema) and that of Moderna (pending approval in Europe) – some advantages.

First of all, the temperature at which it should be stored: a normal refrigerator is enough, at – 4 degrees Celsius, so you do not need special freezers capable of maintaining a temperature of – 70ºC.

Further, the cost of the Oxford vaccine is much lower: AstraZeneca has promised to distribute it at the cost of production, or € 2.8 per dose: 8-10 times less than Moderna and Pfizer vaccines.

The Oxford formula is based on a viral vector, already tested on the occasion of Ebola and MERS in Saudi Arabia. Instead, Pfizer-BioNTech and Moderna work on mRna (messenger RNA) technology and represent a first time in humans, despite having passed all the experiments with great success.

The effectiveness and tests to repeat

In recent weeks AstraZeneca and Oxford had first announced an efficacy of 90%, then they had clarified that this percentage was related to the administration of one and a half doses of the product, and that with two doses the result was lowered to 70%. The results, which spoke of a strong immune response triggered by the vaccine, had been published in The Lancet: the Oxford and AstraZeneca product was the first whose results were certified by a scientific journal.

The product was then subjected to a new trial, after preliminary phase III data had caused more than one perplexity in the international scientific community (as written here).

The consequences for Italy

The lack of approval in January would also have significant consequences for Italy. The government – according to what is stipulated, for now, within the European plan – must receive the following doses of the vaccine:

Pfizer / BioNTech: 26.92 million
Modern: 10,768 million
AstraZeneca: 40.38 million
Johnson & Johnson: 53.84 million –
Sanofi: 40.38 million
CureVac: 30,285 millioni
For a total of 202,573 million doses.

For the moment, as is known, only the first vaccine (Pfizer-BioNTech) was approved by the EMA: doses are reaching all of Europe. The vaccine Modern, approved in the United States and Great Britain, not yet approved by the European Union (It will be in days, January 6) The third vaccine to reach the European market should be that of AstraZeneca, of which Italy has bought many doses. The vaccine Johnson and Johnson not presented yet (I understand that no later than March it should be available, although I think the third phase of experimentation is accelerating and concluding: at the end of January-mid-February we should know some specific dates, he told Open Guido Rasi, former executive director of the European Medicines Agency), as well as those of Sanofi me CureVac. The all-Italian Reithera vaccine in collaboration with Spallanzani (currently one of 65 clinical-phase vaccines that has completed phase 1) could also arrive, perhaps by the summer.

To overcome the slowdown related to the approval of the AstraZeneca vaccine, the European Union has decided to increase the purchase of Pfizer vaccines by 100 million doses: we have decided to take an additional 100 million additional doses of the BioNTech / Pfizer vaccine, already in use to vaccinate Europeans, wrote the president of the EU Commission, Ursula von der Leyen. Then we will have 300 million doses of this vaccine, which has been rated as safe and effective. More vaccines will follow!

Article updating …