Sanofi and GSK Seek FDA Approval for COVID-19 Vaccine

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COVID-19 vaccine
Source: Freepik

Sanofi and GSK seek regulatory authorization of their COVID-19 vaccine for use as a booster and a two-dose regimen.

Despite being the world’s biggest vaccine maker, GlaxoSmithKline (GSK) has failed to develop a COVID-19 vaccine of its own. Instead, the vaccine manufacturer has stuck to providing developers with its adjuvant technology. In one such collaboration, GSK joined forces with Sanofi to develop a COVID-19 vaccine. Now, based on the results of its phase 3 trials, the vaccine manufacturers are seeking a regulatory authorization for its joint candidate.

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.

Thomas Triomphe, Executive Vice President, Sanofi Vaccines

According to a recent press release, the companies will submit data from both their booster and Phase 2 clinical trials. Unlike mRNA vaccines, the GSK-Sanofi candidate is a protein-based vaccine. The vaccine combines a viral particle with a recombinant antigen to induce an immune response. Previously, the vaccine technology had proven successful against influenza.

During the phase 3 trials, two doses of the vaccine provided 100% protection against severe disease and hospitalizations and 75% efficacy against moderate or severe COVID-19. Moreover, the trial did not find any safety concerns among younger or older adults.

When used as a booster among participants previously given other COVID-19 vaccines, the Sanofi-GSK vaccine increased neutralizing antibody levels by 18- to 30-fold. However, participants who had previously received a regimen of Sanofi-GSK demonstrated an increase of 84- to 153-fold after a booster.

The companies are planning to submit their data to various regulatory authorities, including the US FDA and European Medicines Agency (EMA). According to the President of GSK vaccines, Roger Connor, their vaccine candidate can play a major role in controlling the pandemic. Full trial results are expected to be published later this year.

Source: Sanofi

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