GSK hopes for vaccine success as new shot enters late-stage trial

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A third Covid-19 shot using GlaxoSmithKline’s adjuvant technology has entered a late-stage clinical trial as the UK drugmaker seeks to make up lost ground in the development of a coronavirus vaccine.

The vaccine, produced by South Korea’s SK Bioscience, will be tested in 4,000 people, after earlier studies showed all participants developed strong neutralisating antibody responses.

The companies are hoping to distribute doses through the Covax facility, which supplies low and middle-income countries with vaccines, in the first half of next year if the results are positive.

Thomas Breuer, GSK Vaccines’ chief medical officer, said the company was pleased to contribute to the effort and to work with SK Bioscience to “deliver the vaccine at scale” if it is approved.

“While many countries have made good progress with vaccination, there remains a need for accessible and affordable Covid-19 vaccines to ensure equitable access and to protect people across the world,” he said.

The UK pharmaceutical company decided to supply the adjuvant rather than create its own vaccine from scratch in the hope of having more chances of success.

But despite being one of the world’s largest vaccine makers, it has lagged behind in the race for a Covid-19 jab. Rivals Pfizer, BioNTech and Moderna are set to generate tens of billions in revenue this year from their vaccines.

Its partnership with French drugmaker Sanofi suffered after a mistake in dosing meant that the pair had to repeat an earlier stage trial. The phase 3 trial for that vaccine — and another with Canadian biotech company Medicago — are due to report results in the fourth quarter.

GSK is also partnering with CureVac to create a second-generation Covid-19 vaccine using mRNA, the technology that proved to be successful for BioNTech/Pfizer and Moderna. The shot is aimed at targeting several variants of the Sars-Cov-2 virus at once.

Emma Walmsley, GSK’s chief executive, has been under pressure to fill the company’s drug pipeline, after activist investor Elliott Management took a multibillion pound stake to push for change. She will be investing further in its broader vaccine business, including potential shots for the widespread respiratory disease RSV that are in late stage trials.

Interim data from the SK Bioscience vaccine showed participants’ antibody levels were five to eight times higher than patients who had recovered from Covid-19. No safety issues were identified.

During phase 3 trials, the safety and effectiveness of the SK Bioscience GBP510 vaccine will be measured against the Oxford/AstraZeneca jab. Now that approved vaccines are available, trials are no longer using placebos as comparisons.

Jae-yong Ahn, SK Bioscience’s chief executive, said he was “grateful that we were able to advance to the phase 3 study with the unprecedented support of global initiatives, including GSK, Coalition for Epidemic Preparedness initiative and the Bill & Melinda Gates Foundation”.