European Commission approves ‘next-generation’ Covid-19 booster vaccine

THE European Commission has announced that it has approved a ‘next-generation’ Covid-19 booster vaccine.

Sanofi and GSK’s new jab, which is VidPrevtyn Beta, is the only next-generation protein-based adjuvanted Covid booster approved in Europe.

Experts say it has shown a “strong immune response against all tested variants of concern” across several studies and will be ready to supply for winter vaccination campaigns in Europe for those aged 18 and over.

The same recombinant-protein technology is used in Sanofi’s approved seasonal flu vaccines.

One study’s results showed a 64.7 per cent efficacy against symptomatic SARS-CoV-2 infection in adults, regardless of their infection status prior to vaccination, and 75.1 per cent efficacy in participants previously infected with the virus.

This study, named VAT08 Stage 2 Efficacy & Safety, was the first ever to report efficacy data in an Omicron environment.

Studies show that #COVID19vaccines protect against severe disease and hospitalisation caused by #Omicron variant, especially in people who have had a booster dose.

Read more in our latest press release: https://t.co/SOKVhWwMQo pic.twitter.com/zVTDnrNBPA

— EU Medicines Agency (@EMA_News) January 11, 2022

In another study, VAT02 cohort 2 study, reactions were “mostly mild to moderate, transient and self resolutive”.

The European Medicines Agency says that vaccines “protect against severe disease and hospitalisation caused by Omicron variant, especially in people who have had a booster dose”.

The European Commission will now fast-track the decision-making process to grant a decision on the standard marketing authorisation for VidPrevtyn Beta, allowing this vaccine to be included in vaccination programmes rolled out across the EU.

The European Commission signed off on Sanofi and GSK's booster shot to augment protection against COVID-19 in adults ages 18 and up, making VidPrevtyn Beta the first next-gen, protein-based adjuvanted coronavirus vaccine approved in Europe.https://t.co/F8uhjA3XOc

— FiercePharma (@FiercePharma) November 10, 2022

Thomas Triomphe, executive vice president of vaccines at Sanofi, said: “Today’s approval validates our research in developing a novel solution for the COVID-19 pandemic.

“As we’re ready to start first shipments, VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19.”

Philip Dormitzer, global head of research and development vaccines, at GSK “This EC approval is an important step in providing further vaccine solutions to Europe for the coming winter.

“Our protein-based, adjuvanted vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further.”

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