The Haute Autorité de Santé officially confirms the launch on the French market of the anti-Covid vaccine developed by the Pfizer and BioNtech laboratories, renamed Comirnaty® for mRNA.
The vaccination strategy will get off to a good start on December 27 in France
The European Medicines Agency and the European Commission have already validated the product. It is the first vaccine to obtain a ” conditional marketing authorization (MA) in Europe on December 21 “. After relying on the data transmitted by the companies, the HAS decided to implement the vaccine in the vaccine strategy in France. It reveals that the results of clinical studies, which “ have a follow-up of 1.5 months », Demonstrate a 95% efficacy of the vaccine in adults when it is administered in 2 doses spaced 21 days apart. He is ” effective regardless of the age of people (including those over 65), gender, body mass index and possible co-morbidities “.
Are there any side effects?
The health authority also indicates in its report that the side effects linked to the Comirnaty® vaccine are mostly mild: fatigue, headaches, pain at the injection site. Serious adverse health events are rare. The National Agency for the Safety of Medicines and Health Products (ANSM) will monitor and update regularly, based on pharmacovigilance data. HAS may review its recommendations if “Other serious or unexpected side effects occur “.
HAS recommendations
The vaccination campaign will be carried out in three stages. The organization confirms its recommendations for prioritizing the most vulnerable people and those most at risk of Covid-19. The vaccine can therefore be administered to people over 16 years of age and to the elderly. On the other hand, it is neither recommended for pregnant women, unless they present a high risk of severe form, nor for people with a history of allergies. Concerning people who have developed a symptomatic form of the disease, there is no need, for the moment, to vaccinate them systematically. The decision must be taken on a case-by-case basis with the doctor, within a period of at least 3 months after the onset of clinical signs. It is he who will assess the risk-benefit balance. A person who exhibits symptoms should not be vaccinated with the Comirnaty® vaccine.
Additional data expected
The HAS ” insists that the phase 3 trial should be continued in order to have longer-term immunogenicity, efficacy and safety data “. Indeed, several data are still missing to this day, for ” confirm the encouraging results of phase I / II and III clinical studies “. Vaccine efficacy has yet to be demonstrated in people of very advanced age. It could not be evaluated either in young people under 16 years of age or on viral transmission.
