One and the same vaccine to protect against flu and Covid arrives in France

A new combined vaccine allowing to prevent both flu and Covid was developed by Pfizer and BioNTech. It is currently beingclinical test And may soon be available in France. “This mRNA-based vaccine has the potential to reduce the impact of two respiratory diseases with a single injection (to be redone each year) and can simplify immunization practices for providers, patients and health systems around the world” said Annaliesa Anderson, PhD, FAAM, Senior Vice President and Director, Vaccine Research and Development at Pfizer.

Effective in adults 18 to 64 years old

The combined flu/Covid vaccine has passed the phase 1 and 2 clinical trial. In this clinical trial, it was compared to a licensed influenza vaccine and the adapted bivalent COVID-19 vaccine Omicron BA.4/BA.5 from Pfizer-BioNTech, administered at the same visit. Main results demonstrated robust immune responses in antibodies and T lymphocytes It front of strains of influenza A, influenza B and SARS-CoV-2, showing its safety, tolerability and immunogenicity (antibody production) in healthy adults ages 18 to 64. Phase 3 will start In the coming months.

What’s her name ? How does it work ?

As it is not yet marketed, the name of this vaccine is not yet known. This vaccine is based on messenger RNA technology: “it contains strands of mRNA encoding the wild-type spike protein of the SARS-CoV-2 and sublineage spike protein Omicron BA.4/BA.5as well as strands of mRNA coding forhemagglutinin from four influenza strains different, recommended for the northern hemisphere 2022/23 by the World Health Organization“, specify the laboratories in a press release dated October 26.

This vaccine must be administered every year

This vaccine should be administered every year: “Studies of confirmed viral infections suggest that Covid-19 adopts a seasonal pattern with peaks in fall and wintersimilar to other respiratory diseases like influenza. Co-infections as well as subsequent respiratory infections during this period may further increase the risk of serious illness“, said Professor Ugur Sahin, MD, CEO and co-founder of BioNTech. Combination vaccines have the potential to become a pillar of routine vaccination against respiratory diseases, particularly for the vaccination of populations at higher risk of severe disease.

When available in France?

To be marketed and administered in France, this vaccine candidate must pass phase 3 clinical trials so that its vaccine effectiveness and tolerance are studied on thousands of people (see the diagram below of the different stages until the marketing of a vaccine). Pfizer-BioNTech plan to start pivotal phase 3 trial In the coming months, we can read in their press release. Once marketed, the National Medicines Safety Agency (ANSM) will have to monitor the effectiveness and tolerance of the vaccine and monitor rarer side effects. For information, Pfizer and BioNTech previously announced that their combined flu and COVID-19 vaccine candidate had received Fast Track designation from the Food and Drug Administration (FDA) the United States. This is intended to facilitate the development and accelerate the review of new drugs and vaccines intended to treat or prevent serious diseases and address unmet medical needs.

What side effects?

Allowing the patient to be protected against two respiratory diseases caused by evolving virusthis vaccine requires vaccination adaptation. Indeed, “the only difficulty is that it will be necessary, every year, or even more frequently, to adapt the vaccine against Covid and that against the flu, but with messenger RNA vaccines, this is not a problem“, because this technology makes it possible to quickly change the vaccine to adapt it to different variants. Furthermore, like all vaccinesthe combined flu/Covid vaccine can cause potential Side effects as a local reaction at the injection site (pain, redness, swelling), fatigueheadaches, myalgias, chills or fever. Generally, these effects are of intensity mild to moderate and disappear a few days after vaccination. “There is a small chance [que le vaccin] causes a serious allergic reaction“, would like to specify the laboratories.