Sanofi SA (NASDAQ:SNY) and GlaxoSmithKline Plc (NYSE:GSK) expect data from late-stage trials of its COVID-19 booster dose in Q1 2022, instead of this year.
- The news came as the companies shared preliminary data from trials that showed the single-dose booster provided strong immune responses.
- The companies said they need more time to test the booster on more people the virus has not infected before submitting data to regulators.
- The Phase 3 trial for the recombinant, adjuvanted COVID-19 vaccine recruited most participants in Q3, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said.
- "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022."
- No safety concerns were identified.
- Testing is underway to establish the vaccine candidate's ability to cross-neutralize against the omicron variant.
- The booster shot has been tested for all age groups and for people who have received shots either from AstraZeneca Plc (NASDAQ: AZN), Johnson & Johnson (NYSE: JNJ), Moderna Inc (NASDAQ: MRNA), and Pfizer Inc (NYSE: PFE) / BioNTech SE (NASDAQ: BNTX), as part of their primary vaccine.
- It was administered between four and ten months after a complete primary vaccination schedule. The omicron variant was not circulating during the trial.
- Preliminary results from the VAT0002 trial investigating the safety and immunogenicity of the booster showed neutralizing antibodies increased nine to 43-fold regardless of the primary vaccine received.
- Related Link: EMA Starts Rolling Review Of Glaxo - Sanofi COVID-19 Vaccine.
- Price Action: GSK shares are up 0.28% at $43.02, and SNY stock is up 1.31% at $48.68 during the market session on the last check Wednesday.
