Gengulphus wrote:idpickering wrote:Sanofi/GSK COVID-19 Vaccine Positive Ph2 ResultsSanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial
· Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups
· High immune response after a single dose in patients with prior infection shows strong booster potential
· Global Phase 3 study expected to start in the coming weeks
The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks.
The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and with no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
https://www.investegate.co.uk/glaxosmit ... 00098031Y/
This is obviously good news for the company, and also for the world (the total number of vaccine doses given so far is only about 9% of the number required to give everyone in the world two doses, so there's a lot of vaccinations still to be done). But even assuming that everything goes well from here on, there are still months of phase 3 clinical trials to go, plus the time required for national authorities to approve it, so GSK is probably the best part of a year late to the COVID-19 market. That severely limits how good the news will be for GSK even if all goes well from here on - by the time their vaccine is available for actual use, most of the better-off countries will be approaching full vaccination (*), so I think they'll mainly be supplying vaccines to countries that can only afford lower prices.
So I think it's likely to prove better news for the world than for GSK itself...
Gengulphus
The interesting bit for me is that they are already testing two variants (Wuhan original and South African) and they are planning to test multiple variants with the aim of giving booster jags for variants to people who have had the full course of other companies vaccines - so they could have large market in the developed countries that are already well into their vaccination program.
The Phase 3 trial is expected to enrol more than 35,000 adult participants from a broad range of countries and will assess the efficacy of two vaccine formulations including the D614 (Wuhan) and B.1.351 (South African) variants.
In parallel, the Companies intend to conduct booster studies with various variant formulations in order to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine platform received.