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Sanofi/GSK’s next-generation COVID-19 booster granted EC approval

Two trials compared the immune response induced by VidPrevtyn Beta with approved vaccines

Sanofi

Sanofi and GSK’s next-generation COVID-19 booster vaccine, VidPrevtyn Beta, has been approved by the European Commission (EC) in adults aged 18 years and older.

Shipments of the Beta-targeting booster are ready to be distributed to European countries as per advance purchase agreements, the companies said in a statement, in time for autumn/winter COVID-19 vaccination campaigns.

“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,” said Thomas Triomphe, executive vice president, vaccines, Sanofi.

The approval follows the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion of the booster.

This was based on positive results from two ‘immunobridging' trials comparing the immune response induced by Sanofi/GSK’s new booster with currently approved vaccines.

In the independent COVIBOOST study, VidPrevtyn Beta generated a higher immune response than Pfizer/BioNTech’s booster as well as Sanofi/GSK's first-generation booster, both of which target the original D614 parent strain.

In the study, which included 247 adults, all three vaccines also elicited neutralising antibodies against the Omicron BA.1 variant, with highest responses generated by the Sanofi/GSK next-generation candidate, one month after injection.

The companies reported that VidPrevtyn Beta elicited around 2.5 times more neutralising antibodies against Omicron BA.1 and, in an exploratory analysis, against BA.4/BA.5 strains than mRNA COVID-19 booster comparator.

Sanofi/GSK’s booster also demonstrated a significant boost in pseudo-neutralising levels above baseline against multiple variants of concern in individuals ages 18 to 55 years previously vaccinated with mRNA COVID-19 vaccines in the phase 3 VAT02 cohort 2 trial.

In terms of safety, the most common side effects observed with VidPrevtyn Beta in studies were pain at the injection site, headache, muscle or joint pain, feeling generally unwell and chills. These were usually mild and cleared within a couple of days after vaccination.

Philip Dormitzer, global head of research and development vaccines, GSK, said: “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.”

Article by
Emily Kimber

14th November 2022

From: Regulatory, Healthcare

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