Covid-19: why AstraZeneca’s vaccine should not be approved right away in Europe and the United States

The vaccine race continues. The British Medicines Agency (MHRA) gave the green light, Wednesday, December 30, to the one developed by the Anglo-Swedish firm AstraZeneca, in partnership with the University of Oxford, making the United Kingdom the first country in the world to authorize it. According to the British media, this new vaccine – based on the adenovirus technique and therefore much less difficult to handle than messenger Arn vaccines – could be deployed in the country as of next Monday, well before Europe and the United States, where the marketing authorization from the health authorities should wait until January, perhaps even February.

Too small and imprecise clinical trials

Last November, AstraZeneca announced that its vaccine was 70% effective, or even more in some cases. A test group in the United Kingdom of less than 3,000 people had indeed been mistakenly injected with half a dose of the vaccine as the first dose. In their case, AstraZeneca had assured that the vaccine was effective up to 90%, a figure comparable to those of Pfizer-BioNTech and Moderna.

But the results of these clinical trials are disputed, not only because the test group that fell victim to the AstraZeneca error was very small, and without a patient over the age of 55, but also because the vaccination protocol – two full doses and not one and a half – had not been observed. The British Medicines Agency itself has rejected the vaccine’s 90% efficacy rate: according to them, this is rather linked to the time between the injection of the two doses, which was more than six months for some people in the test group of 3,000 people, compared to three months usually, which would have boosted the immune response, reports The Guardian.

A study by the medical magazine The Lancet, the data of which is available to all researchers, has since confirmed the AstraZeneca vaccine’s 70% effectiveness rate, and the UK Medicines Agency does plan to inject two full doses. AstraZeneca boss Pascal Soriot announced last Saturday to the British Sunday Times newspaper that the group had found “the winning formula and how to achieve efficiency which, with two doses, is high like that of others”.

Americans suspicious of omission on stop testing

Despite these precautions, the European and American drug agencies are still waiting before authorizing this vaccine. The first said in a statement Wednesday that “additional scientific information on issues related to the quality, safety and efficacy of the vaccine is deemed necessary to strengthen the rigor required for a conditional marketing authorization.” At EU level, the vaccine approval process is also slower than in the UK, where Pfizer and AstraZeneca vaccines have been authorized following an emergency authorization process, while the European Agency of the drug favors a conventional or accelerated procedure.

The United States are also waiting for more data, but the American authorities are also scalded by a communication failure from the pharmaceutical group. On September 6, the New York Times reports, AstraZeneca suspended clinical trials of its vaccine after a British patient developed a case of transverse myelitis, a rare neurological disorder. “A serious side effect likely to be related” to the injection of the vaccine, details The Lancet, but the only side effect as serious discovered on the more than 20,000 participants in clinical trials.

Two days later, AstraZeneca spoke by conference call with U.S. health officials in hopes of getting their green light for the vaccine. The Anglo-Swedish group, however, informed them of the temporary cessation of testing once the information was released in the press, according to the New York daily. Stephen Hahn, the head of the American Medicines Agency (FDA), was “stunned” by this omission, even though the United States contributes a billion dollars to the development and manufacture of this vaccine.

An essential vaccine to vaccinate as many people as possible

The AstraZeneca vaccine is however crucial to the vaccination campaign in Europe as in the United States, which respectively ordered 400 million and 300 million doses. Its manufacturing method makes it

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