In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited.
Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and European Medicines Agency (EMA).
In a Phase 3 efficacy trial, two doses of the vaccine in seronegative individuals were 100% effective against severe COVID-19 disease and hospitalization. Protection against moderate or severe COVID-19 was 75%, while protection against symptomatic COVID-19 was 57.9%.
A booster dose of the vaccine increased neutralizing antibodies 18- to 30-fold in recipients of mRNA and adenovirus vaccines.
The companies note that the research was carried out while challenging variants of concern were circulating. “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,” said Thomas Triomphe, executive vice president, Sanofi Vaccines, in a press release.
In individuals who solely received the Sanofi-GSK vaccine, neutralizing antibodies increased 84- to 153-fold after administering the third dose.
GSK and Sanofi noted that the vaccine had a favorable safety profile.
The companies plan on releaseing full data from the primary series trial and booster study later this year.
The vaccine candidate from GSK and Sanofi is based on an adjuvanted recombinant protein-based platform. It thus has more in common with Novavax’s adjuvanted recombinant NVX-CoV2373 vaccine than the mRNA vaccines from Pfizer and Moderna or the adenovirus-vectored vaccines from AstraZeneca or Johnson & Johnson.
GSK and Sanofi are touting the fact that their vaccine candidate is stable at refrigerator temperature.
First-generation mRNA vaccines, conversely, have more stringent storage requirements.
GSK and Sanofi also note that a two-dose primary vaccine series yielded a higher neutralizing response, with a geometric mean titer of 3711 units. Comparable sera from individuals who received two doses of an mRNA vaccine had a GMT of 1653 units.
Sanofi had an mRNA-based COVID-19 vaccine in development but halted development of it last year.
The company projected in 2021 that the recombinant protein-based vaccine developed jointly with GSK would cost roughly $10 per dose.