Sanofi, GSK will seek authorization for COVID-19 vaccine
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Sanofi and GSK announced Wednesday that they will submit data from booster and phase 3 efficacy trials to support authorization of their two-dose protein-based COVID-19 vaccine.
The companies said they “are in discussions with regulatory authorities” — including the FDA and European Medicines Agency — “and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorizations.”
According to a press release, the phase 3 trial demonstrated that two doses of the vaccine provided 100% efficacy against severe disease and hospitalizations, 75% efficacy against moderate or severe disease and 57.9% (95% CI, 26.5%-76.7%) efficacy against any symptomatic COVID-19.
In a separate trial, a booster dose of the vaccine increased neutralizing antibodies 18- to 30-fold among recipients of other COVID-19 vaccines in all age groups, the companies said. People who received three doses of the Sanofi-GSK vaccine — including a booster dose — experienced an increased neutralizing effect of 84- to 153-fold compared with pre-boost levels.
“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” Sanofi Vice President Thomas Triomphe, MSc, MBA, said in the release. “The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages. We also observed robust efficacy of the vaccine as a primary series in today’s challenging epidemiological environment.
“No other global phase 3 efficacy study has been undertaken during this period with so many variants of concern, including omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines.”
Data from both the phase 3 study and the booster trial showed the vaccine was well tolerated in younger and older adults, with no safety concerns.
The phase 3 trial assessed a 10 µg antigen formulation of the protein-based vaccine compared with a placebo among 10,000 participants aged 18 years and older. Participants received either a vaccine dose or placebo at day 1 and day 22 at trial sites in the U.S., Asia, Africa and Latin America.
“The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines,” GSK President Roger Connor, said in the release. “Our adjuvanted protein-based vaccine candidate uses a well-established approach that has been applied widely to prevent infection with other viruses, including pandemic flu. We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period.”
Perspective
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The Sanofi COVID-19 vaccine, which uses a GSK adjuvant, will be a welcome addition to the vaccine portfolio. This vaccine harnesses the same innovative vaccine platform behind the influenza vaccine FluBlok. Having more options, including protein-based vaccines, may increase vaccine uptake and could form the basis for second-generation vaccines.
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