Sanofi, GSK say COVID vaccine works as booster, but delay key study results
Sanofi and GlaxoSmithKline in December said their experimental COVID-19 vaccine spurs higher levels of virus-fighting antibodies when used as a booster after other shots, but delayed highly anticipated results from a large study meant to show whether their vaccine can prevent disease.
A booster dose administered between four and 10 months after a different vaccine regimen increased antibody levels by around nine to 43-fold, regardless of the initial shot received or age of the study volunteer. The safety profile of Sanofi and GSK's booster was similar to currently approved COVID-19 vaccines, the companies said, but without disclosing details.
Sanofi and GSK, however, won't be able to seek regulatory clearance of a booster unless their shot succeeds in an ongoing Phase 3 trial of roughly 10,000 volunteers. Results from that study had been expected by the end of 2021, but on Dec. 15 the companies said data won't be available until the first quarter of 2022.
Sanofi and GSK expected to have definitive results for their long-delayed coronavirus vaccine by now, having redesigned their shot after an initial formulation disappointed in late 2020.
A verdict on whether their revamped vaccine can match the effectiveness of other vaccines in preventing COVID-19 is likely coming soon, with the companies indicating the trial will continue into "early 2022." But results will have to be particularly strong for the shot to be used in countries with ready supplies of others from Pfizer, Moderna, Johnson & Johnson and AstraZeneca.
Complicating matters further is the omicron variant, which appears to at least partially escape the protection provided by available vaccines.
Should Sanofi and GSK's vaccine prove effective against COVID-19, the results released in December may help position the shot as a potential booster dose, particularly in areas with less supply of other vaccines.
The small study, which enrolled a little over 500 participants, tested one dose of the companies' protein-based vaccine four to 10 months after the volunteers had received an approved primary series of Pfizer, Moderna, J&J or AstraZeneca's shots.
Participants were enrolled across the U.S., U.K. and France and the trial is continuing to assess other vaccine formulations targeting the beta coronavirus variant. More data could come in the first half of 2022, although the companies noted that omicron was not circulating during the trial.
Instead, Sanofi and GSK are using blood samples from booster dose participants to measure how much their vaccine can help in neutralizing omicron.
But the companies' booster dose data will mean little until results are available from the larger Phase 3 trial, which began in May 2021 and has enrolled more than 10,000 participants across its first stage. A second phase is evaluating a tweak on the companies' formulation to incorporate targeting of the beta variant, which shares some of the mutations found on omicron.
An independent committee monitoring the trial recommended it continue so more data could be collected, particularly in people who have not been previously infected by the coronavirus. That became a harder task in the later summer and fall, when the delta variant spurred waves of infections in many countries.
The committee identified no safety concerns, Sanofi and GSK said.
Article top image credit: National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.