Covid-19. What do we know about the Pfizer/BioNTech vaccine adapted to the Omicron variant?

“It was said earlier this year that a vaccine against the Omicron variant would be ready in March. Do you know what it is? »asks Marie-Helene.

It’s quite fair. In January, Pfizer and BioNTech launched the clinical trial of an adapted vaccine against the Omicron variant, in order to evaluate the safety, the tolerance of such a vaccine in healthy adults aged 18 to less than 55 years. . Same thing at Moderna: the American company announced on Wednesday January 26 that it had started clinical trials for a booster dose of vaccine designed specifically against this variant.

On the Pfizer side, the boss of the American laboratory, Albert Bourla, declared in early January that the pharmaceutical giant could be ready to request authorizations for this new vaccine as early as March. On the other hand, no date had been advanced for Moderna.

The question of new vaccines arises all the more so as the number of cases of Covid-19 is on the rise again: with more than 158,000 cases per day. The number of patients remains high, with more than 23,000 people hospitalized as of April 7, even if that of patients in critical care remains contained with just over 1,500 patients in intensive care, according to figures from health authorities.

Read also: Covid-19. Are we moving towards an annual vaccination against the virus?

Where are these clinical trials?

Contacted by West FrancePfizer says research is continuing. About the vaccine adapted to Omicron, the laboratory explains: “We have successfully achieved this and are continuing our research efforts. »

“However, the data is constantly changing and needs to be constantly analyzed. We are moving at the pace of science and since then we have launched new trials to assess the best approach to take, knowing that the BA.2 variant is now the most widespread ”adds the company.

The BA.2 variant is a sub-variant of Omicron, which became the majority in France, between February 28 and March 6, according to information from Public Health France. “The Omicron variant was still circulating almost exclusively on the territory. Its BA.2 sublineage accounted for 92% of sequences as of March 21”note Public Health France, in its epidemiological update of April 7.

Permissions to obtain

Pfizer further specifies that the strategy to be adopted “does not depend solely on Pfizer and BioNTech”. “If these clinical trials are successful, additional discussions will need to take place with regulatory and health authorities so that the data can be reviewed and submitted for approval. »

Because, before it can be injected, the vaccine must first be authorized by the European Medicines Agency (EMA) Going through its Committee for Medicinal Products for Human Use (CHMP). The committee makes recommendations, then the European Commission issues the marketing authorization.

“To date, the EMA has not received a marketing authorization application for a suitable mRNA vaccine developed by Pfizer/BioNTech”indicates the EMA at West France.

The European Agency remains cautious about the development of a new vaccine. “We don’t know yet whether we will need an adapted vaccine with a different composition to fight the Omicron variant,” explains the EMA.

This decision should be coordinated globally and the EMA is reviewing all emerging data and liaising with international regulators to “evaluate the need for an adapted vaccine with a different composition in order to fight against this variant or other variants that may emerge”.

What about Moderna’s vaccine? Contacted, the laboratory did not respond to our requests.

Faced with the rise in Covid-19 cases, France is now offering a new booster dose to people over 60. Until now, this fourth dose was only intended for people over 80 years old. It could be administered six months after the last dose received.

Covid-19. What do we know about the Pfizer/BioNTech vaccine adapted to the Omicron variant?

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