Sanofi/GlaxoSmithKline's potential COVID-19 vaccine triggered strong immune responses in all adult age groups in preliminary trials, writes <strongMedicalBrief. New trials will test the vaccine against the South African variant.
After two doses of the vaccine candidate, participants showed neutralising antibodies in line with those found in people who had recovered from the disease, according to results of the Phase 2 trial. Sanofi announced the findings in a statement this and said it plans to soon publish the results in a medical journal.
They plan to begin late-stage trials and production in the coming weeks and hope to win regulatory approval for the vaccine before the end of 2021. It will test two formulations of the vaccine, one aimed at preventing the original strain of the virus and the other aimed at the B.1.351 variant first seen in South Africa that some vaccines appear to be less effective against.
The trial involved 722 volunteers aged 18 to 95 who were recruited in the US and Honduras. The vaccine showed even stronger antibody results in people who had already recovered from the virus. Sanofi said that makes it a potentially strong candidate as a booster shot in the future for those who have already been vaccinated with rival products.
The companies said they will begin producing the vaccine “at risk” — before they are certain it will work. While there is financial uncertainty in that approach, if the vaccine does prove to be efficacious, they will have product ready to distribute as soon as the vaccine is authorised for use.
The New York Times writes that Sanofi and GSK are much more experienced in vaccine development than a number of their rivals that have already won authorisation. The two companies used a more established approach than those deployed in other, more swiftly developed Covid vaccines. Their shot is based on viral proteins produced with engineered viruses that grow inside insect cells. GSK is supplying the Sanofi vaccine with an adjuvant, an ingredient used in many vaccines meant to boost the immune response.
Sanofi and GSK’s vaccine was one of six selected for funding from Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development. Last summer, the federal government agreed to give the companies $2.1 billion to develop and manufacture the vaccine, in exchange for 100 million doses once the shot was ready.
Sanofi also has supply deals with the European Union and Canada. It has also agreed to supply 200 million doses to Covax, the program to deliver vaccines to middle- and lower-income countries that has been struggling with a shortfall in expected doses. Sanofi has also announced plans to help manufacture the authorised vaccines made by Pfizer-BioNTech, Moderna and Johnson & Johnson.
Sanofi statement (Open access)