Sanofi-GSK COVID-19 vaccine effective against omicron

GSK plc (LSE/NYSE:GSK) and Sanofi (NYSE:GSK) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study.

For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron.

The vaccine is based on the original D614 virus and the beta (B.1.351) strain.

Across variants, the vaccine was 64.7% efficacious against symptomatic infection in adults. For those previously infected with COVID-19, the vaccine was 75.1% efficacious overall.

GSK and Sanofi noted that the vaccine candidate appeared to be well-tolerated.

Moderna (Nasdaq:MRNA) is developing a bivalent omicron booster vaccine candidate known as mRNA-1273.214.

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) have released minimal data to date on their next-generation COVID-19 vaccine.

Sanofi’s and GSK’s Phase 3 COVID-19 clinical trial, dubbed VAT08, enrolled more …

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HHS halts distribution of Lilly’s bamlanivimab/etesevimab antibody cocktail

U.S. government authorities have decided to immediately pause the distribution of Eli Lilly’s bamlanivimab and etesevimab over concerns that the monoclonal antibody cocktail is ineffective against some SARS-CoV-2 variants.

CDC recently concluded that the Gamma variant (P.1) and the Beta variant (B.1.351) make up 11% of COVID-19 infections. They are also continuing to become more dominant, as is the Delta variant (B.1.617.2). CDC has determined that the Delta variant is possibly less responsive to some monoclonal antibody treatments.

The Beta and Gamma variants are significantly less responsive to bamlanivimab and etesevimab than other viral lineages.

Bamlanivimab and etesevimab image courtesy of Lilly.

FDA is recommending Regeneron’s REGEN-COV and GSK’s sotrovimab as more robust antibody therapies.

In related news, FDA recently granted emergency use authorization to tocilizumab, a monoc…

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EU and US take steps to battle coronavirus mutations

Electron microscopic image from the first confirmed case of SARS-CoV-2 in the U.S. Image from CDC.

The EU recently added clauses to COVID-19 vaccine contracts to prioritize vaccines that are effective against emerging SARS-CoV-2 variants.

Meanwhile, a U.S. House bill that would provide $1.75 billion for genomic sequencing of coronavirus samples is scheduled for floor debate and the Senate is considering similar legislation.

The UK variant (B.1.1.7) that is spreading across Europe and the U.S. is more infectious and possibly more dangerous than earlier strains and could become dominant in the U.S. by March, according to CDC projections. Even more potentially threatening are the South Africa (B.1.351) and Brazil (P.1) variants, which are also spreading in both regions.

The U.K. helped the world understand the threat of B.1.1.7 with its sizable genomic sequencing apparatus. The country has sequenc…

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South Africa pauses rollout of AstraZeneca COVID-19 vaccine

South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there.

In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE).

Researchers at Oxford University and the University of the Witwatersrand in South Africa found the AstraZeneca vaccine to offer little to no protection against mild-to-moderate disease. The research has not been peer-reviewed.

Get the full story from our sister site, Drug Discovery & Development.

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