Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation

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Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation

Positive booster studies reveal a 9- to 43-fold rise in neutralising antibodies across all primary vaccines received (mRNA or adenovirus) and for all age groups examined, with a favourable safety and tolerability profile.

As populations around the world become more exposed to COVID-19 variations, the Phase 3 trial continues to accumulate the number of events needed for analysis; findings are expected in Q1, 2022.

Following the Phase 3 results, companies plan to register booster data with regulatory authorities.

Article Summary

Sanofi and GSK disclosed today that a single booster dose of their recombinant adjuvanted COVID-19 vaccine candidate delivered consistently high immune responses. Neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccination received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all age groups examined in the VAT0002 clinical trial, which investigated the booster’s safety and immunogenicity. The booster was well accepted, with a safety profile similar to that of COVID-19 vaccinations now on the market. This is the most thorough booster experiment to date, examining boosting across a variety of primary vaccination modalities.

An independent Data Safety Monitoring Board (DSMB) assesses the current worldwide Phase 3 trial, VAT0008, on a regular basis. The DSMB found no safety issues during its most recent evaluation and suggested that the experiment be extended until early 2022 in order to collect more data.

Regulatory agencies need that Phase 3 efficacy be proved in “naive” populations, or those who have never been infected with the COVID-19 virus (seronegative). In Q3 2021, the Phase 3 trial enrolled the majority of participants, coinciding with a considerable increase in the number of people infected with the COVID-19 virus worldwide due to the Delta variant. The trial will continue to accrue the number of events required for analysis in order to provide the requisite data to regulatory authorities for the booster vaccination submission, with findings expected in Q1 2022

Source: Sanofi  , 2021

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