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. Know what it is? »asks Marie-Hélène.

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

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

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

Also read: COVID-19. Are we heading towards an annual vaccination against the virus?

Where are these clinical trials?

contacted by West of France, Pfizer says the investigation is continuing. On the vaccine adapted to Omicron, the laboratory explains: “We have successfully done so and continue our investigative efforts. »

“However, data is constantly changing and must be constantly analyzed. We are advancing at the pace of science and have since 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 the BA.2 variant is a sub-variant of Omicronwhich became a majority in France, between February 28 and March 6, according to information from Public Health France. “The Omicron variant was still circulating almost exclusively in the territory. Its BA.2 sublineage accounted for 92% of the sequences as of March 21.”points out Public Health France, in its epidemiological update of April 7.

authorizations to obtain

Pfizer further specifies that the strategy to be adopted “It does not depend solely on Pfizer and BioNTech”. “If these clinical trials are successful, additional discussions with health and regulatory authorities will need to take place 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) via son committee of 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 in West of France.

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

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

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

Given the increase in cases of COVID-19France now offers a new booster dose for people over 60. Until now, this fourth dose was only intended for people over 80 years of age. It could be given 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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