**Sanofi has announced that its two combination vaccine candidates for COVID-19 and influenza (flu) have been granted fast track designation by the US Food and Drug Administration (FDA) for use in individuals aged 50 years and older.**
The regulator’s decision comes seven months after Sanofi gained a sole licence to Novavax’s adjuvanted COVID-19 vaccine for use in combination with its own licensed flu vaccines.
It is hoped that the combined vaccine approach will alleviate the impact of both respiratory illnesses while simplifying immunisation practices for healthcare providers and patients, potentially leading to higher vaccine uptake.
Sanofi’s first vaccine candidate combines its protein-based trivalent flu vaccine Fluzone High-Dose with Novavax’s adjuvanted recombinant COVID-19 vaccine, while the second consists of Sanofi’s recombinant protein-based trivalent flu vaccine Flublok and the Novavax vaccine.
The combination vaccines will now benefit from the FDA’s fast-track process, which is designed to support the development and accelerate the review of products that address serious conditions.
Clinical trials have shown that Fluzone and Flublok can prevent more flu infections in older adults than standard-dose flu vaccines, Sanofi said, adding that both vaccines have demonstrated significant and consistent reductions in flu-related hospitalisations in real-world evidence studies.
Novavax’s COVID-19 vaccine has also been associated with a better tolerability profile than currently available mRNA COVID-19 vaccines when given as a booster dose, and has demonstrated high efficacy against COVID-19 as a primary vaccination in two late-stage studies, the company said.
Sanofi has already initiated two separate phase 1/2 studies to evaluate the safety and immune response generated by the combination vaccines.
Thomas Triomphe, executive vice president, vaccines at Sanofi, said: “Our goal is to develop a combined flu and COVID-19 vaccine that offers simpler scheduling and fewer injections without compromising on the… levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.”
Sanofi and Novavax’s licensing agreement announced in May, worth over $1.2bn, also gave Sanofi a co-exclusive licence to co-commercialise Novavax’s adjuvanted COVID-19 vaccine globally, except in countries that Novavax has existing partnership agreements with, as well as a non-exclusive licence to use the company’s Matrix-M adjuvant in vaccine products and a less than 5% stake in Novavax.