British drug giant GlaxoSmithKline and South Korean colleague SK bioscience have entered the final phase of trials with a Covid-19 shot after positive early results, they announced Tuesday.
The vaccine is facing a phase 3 clinical trial to assess its “safety and immunogenicity” compared to AstraZeneca’s Covid vaccine, the two companies said in a joint statement.
GSK is still trailing in the wake of Anglo-Swedish rival AstraZeneca, who quickly developed a successful jab alongside Oxford University despite having little experience in vaccine development.
The new shot combines SK bioscience’s Covid vaccine candidate GBP510 with Glaxo’s pandemic adjuvant that boosts the immune response.
“Progress to Phase 3 study follows positive interim Phase 1/2 data showing that all participants who received the adjuvanted vaccine candidate developed strong neutralizing antibody responses,” the pair said Tuesday.
Those reactions showed a rate of seroconversion — or antibody production — of 100 percent, she added.
So far, no safety issues have been identified in the study.
The vaccine is then expected to be delivered through COVAX – the distributor backed by the World Health Organization and the Gavi Vaccine Alliance – subject to positive results and regulatory approvals.
“While many countries have made good progress with vaccination, there remains a need for accessible and affordable COVID-19 vaccines to ensure equal access and protect people around the world,” said Thomas Breuer, GSK’s chief global health officer.
“We are excited to contribute with GSK’s pandemic adjuvant and to work with SK to deliver the vaccine at scale via COVAX if approved.”
Results of the phase 3 study, which will involve 4,000 participants from different countries, are expected in the first half of next year.
This will be the first Phase 3 study to compare the results of two different Covid-19 vaccine candidates.
SK has received funding from the Coalition for Epidemic Preparedness Initiative and the Bill & Melinda Gates Foundation to help it develop a low-cost injection.
“By taking this important step towards overcoming the global pandemic, SK and GSK will bring together our technical expertise to develop an adjuvant vaccine candidate, GBP510,” said SK chief executive Jaeyong Ahn.
Glaxo is also working with French pharmaceutical giant Sanofi on final Phase 3 trials of another Covid vaccine, which they hope to launch by the end of this year.
Phase 2 trials of that shot have already shown a strong immune response after a single injection in participants who had previously contracted the coronavirus.
GSK is also working on two more separate vaccine projects, one with Canada’s Medicago and another with Germany’s CureVac.
(This story was not edited by NewsMadura staff and was generated automatically from a syndicated feed.)