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Data delivery: Sanofi and GSK seek authorisation for COVID-19 vaccine

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Synopsis :

Pharma giants take major stride as vaccine shows significant increase in neutralising antibodies

Sanofi and GlaxoSmithKline (GSK) have announced that they will submit data from both their booster and phase 3 effectiveness trials, thereby forming the basis for their COVID-19 vaccine regulatory applications.

In participants who had received a primary series of an already authorised mRNA or adenovirus vaccine, the Sanofi/GSK booster vaccine prompted a significant increase in neutralising antibodies of 18 to 30-fold across vaccine platforms and age groups.


When it was delivered as a two-dose primary series, the vaccine delivered robust levels of neutralising antibodies. Data from the efficacy study revealed that two doses of the Sanofi/GSK vaccine generated an efficacy of 57.9% against symptomatic COVID-19 and provided 100% protection against severe disease and hospitalisations. It also provided 75% effectiveness against moderate-to-severe disease.

Thomas Triomphe, executive vice president, Sanofi Vaccines, said: “We’re very pleased with the data, which confirms our strong science and the benefits of our COVID-19 vaccine. 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. 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 authorised vaccines.”

On the growing need for a diverse range of vaccines, Roger Connor, president of GSK Vaccines, commented: The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines. Our adjuvanted protein-based vaccine candidate uses a well-established approach that has been applied widely to prevent infection with other viruses including pandemic flu.

“We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period,” he concluded.

Sanofi and GSK are currently in discussions with regulatory authorities – such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) – and plan to submit the data to support the effectiveness of their joint vaccine.

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