The full results of clinical trials of the Covid-19 vaccine developed by the American-German alliance Pfizer-BioNTech were published on Thursday, December 10, in the New England Journal of Medicine, the top-rated medical journal in the United States.
The scientific journal mentions in an editorial a “Triumph”, while a committee of experts convened by the Food and Drug Administration (FDA) began Thursday to publicly examine the data of the vaccine, with the aim of recommending or not its authorization of marketing.
The manufacturers themselves published the results in press releases on Nov. 18, and on Tuesday the FDA released its own detailed summary of the results on the vaccine’s efficacy and safety. Thursday’s publication confirms the very high efficacy: vaccinated people had a 95% lower risk of contracting Covid-19, the disease caused by SARS-CoV-2; and efficacy was similar regardless of age, gender, ethnicity, weight or presence of pathologies.
The study also confirms the safety of the vaccine. Adverse effects – such as pain around the injection site in the arm, fatigue and headaches – are common, but no serious safety concerns were noted in the clinical trial, which has so far recruited 44 000 people, half of whom received the vaccine and the other half a placebo.
The vaccine not recommended in the United Kingdom in case of serious allergies
However, the British health authorities still chose to advise against, Wednesday, the administration of the vaccine from Pfizer and BioNTech to people who have had in the past“Significant allergic reactions”.
The first country to authorize this vaccine, the United Kingdom began a massive vaccination campaign on Tuesday, aimed for the moment at caregivers and the elderly. However, two people prone to allergies, to the point of always carrying adrenaline on them, reacted badly to the first injections. “Two people who had serious allergic reactions reacted badly”, revealed Stephen Powis, medical director of the National Health Service for England, before concluding that they “Are recovering well”.
Therefore, the UK medicines agency, MHRA, issued a recommendation not to vaccinate people ” having a history of a significant allergic reaction to vaccines, drugs or food (such as anaphylactic reactions or those who have been advised to wear an epinephrine injector) ”.
Caution in the United States
Some 800,000 doses of this vaccine, out of the 40 million ordered by the government, will be administered initially in the United Kingdom. Despite the haste to put it on the market, “We did not cut” on safety, had assured Tuesday the boss of Pfizer, Albert Bourla, during a virtual round table in Geneva.
On Wednesday, a senior American official announced that if the vaccine was authorized in the United States in the coming days, the same recommendation would undoubtedly be made. “As in the UK, it is likely that the vaccine [sera déconseillé] to people who have known severe reactions, until it is understood exactly what happened ”, said Moncef Slaoui, appointed by Donald Trump to coordinate the development of a vaccine against Covid-19.
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