New Vaccine to Be Submitted for Regulatory Approval Based on Promising Study Results

On Wednesday two companies, Sanofi and GlaxoSmithKline, said they plan to submit a new COVID-19 vaccine for U.S. and European regulatory approval. This followed Phase 3 efficacy trials that showed promise of protection both as a primary series and a booster shot. 

“No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including omicron,” said Thomas Triomphe, executive vice president of Sanofi Vaccines, in a written statement.

When used as a booster after a primary series of already authorized mRNA or adenovirus vaccines, the data from the Phase 3 trial showed the extra shot increased neutralizing antibodies by 18- to 30-fold across vaccine platforms and age groups.

The results showed the vaccine provided 100% protection against severe COVID-19 disease and hospitalizations, 75% efficacy against moderate to severe COVID-19 disease and 57.9% efficacy against symptomatic COVID-19 infection. 

When the vaccine was used as a two-dose primary series followed by a booster, the results showed that neutralizing antibodies increased 84- to 153-fold, compared to pre-boost levels. 

The early data also indicates a 77% efficacy against any delta variant-associated symptomatic COVID-19 disease. The vaccine also showed a favorable safety profile with both the primary series and booster vaccinations, especially for older adults.

The company had previously worked to make the vaccine available in the spring of 2020, but the lack of promising data led the companies to reformulate the vaccine to its current version.

The data suggests that the vaccine may provide stronger protection than the currently available Moderna or Pfizer vaccines. 

In summer 2021, Sanofi also partnered with BioNTech to provide large-scale manufacturing to support over 125 million doses of the COVID-19 vaccine for the European Union, demonstrating a shared commitment to increasing vaccine accessibility.

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