Sanofi, GSK claim their first COVID jab approval

For all their long history in vaccines, GSK and Sanofi have struggled to get a shot for COVID-19 authorised – but they have finally crossed the finish line in Europe.

The European Commission has backed the use of the companies’ adjuvanted VidPrevtyn Beta vaccine – which targets the Beta variant of SARS-CoV-2 – as a booster vaccine candidate on the back of two “immunobridging” trials comparing it with currently-approved jabs.

In those studies, VidPrevtyn Beta was found to trigger a higher production of antibodies against the Omicron BA.1 subvariant than Pfizer/BioNTech’s Comirnaty, and to restore immunity against multiple variants of the virus in people previously vaccinated with Comirnaty, Moderna’s Spikevax, and Janssen’s Jcovden.

The approval puts GSK and Sanofi’s shot into the mix of available candidates for the EU’s autumn and winter campaigns, although it will have to compete against Omicron BA.1-directed products from Moderna and Pfizer/BioNTech.

A joint statement from GSK and Sanofi points out that VidPrevtyn Beta stimulated around 2.5 times more neutralising antibodies against Omicron BA.1 than Comirnaty and, in an “exploratory analysis”, also elicited higher responses against the BA.4/BA.5 strains currently dominating in Europe.

“Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per advance purchase agreements,” according to Sanofi, whose head of vaccines – Thomas Triomphe – said: “VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19.”

So far, the volume of doses covered by those agreements has not been disclosed, but cover a majority of EU member states, as well as non-EU countries, including the UK.

The approval comes more than a year after GSK and Sanofi filed the vaccine for rolling regulatory review, and as the prospects for COVID-19 vaccine revenues are up in the air given that demand may be weakening.

Moderna trimmed its Spikevax forecasts this year to $18-$19 billion from an earlier prediction of $21 billion, although Pfizer has gone in the other direction, hiking its target by $2 billion to $34 billion for 2022 as a whole.

In the absence of new waves of infection, it’s not certain that governments will continue to fund widespread immunisation campaigns in 2023 and beyond, or what sort of market will remain when governments stop buying doses and sales shift to the private market.

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