The Health Secretary has hailed the huge “boost”. Matt Hancock said: “Really encouraging results from Novavax tonight on its efficacy against variants. We’ve ordered 60 million doses and if approved by the medicines regulator it will be another boost to the UK’s vaccination rollout as we work to overcome this virus.”
Importantly, the vaccine was also found to be roughtly 86 percent effective in protecting against the more contagious virus variant first discovered and now prevalent in the UK.
It was only about 55 percent effective in a separate, smaller trial in South Africa, where volunteers were primarily exposed to another newer, more contagious variant that is widely circulating there and spreading around the world.
In both trials, the vaccine was 100 percent effective in preventing serious illness and death.
Results from the final analysis of the UK trial were largely in line with interim data released in January, which also showed the Novavax shot to be 96 percent effective against the original version of the coronavirus and around 86 percent effective against the UK variant.
The company expects to use the data to submit for regulatory authorization in various countries. It is not clear when it will seek U.S. authorization or if regulators will require it to complete an ongoing trial in the United States.
Stanley C Erck, President and Chief Executive Officer, Novavax, said: “We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials.
“Importantly, both studies confirmed efficacy against the variant strains.
“Today marks one year since the WHO officially declared the COVID-19 pandemic, and with this data in hand, we are even more motivated to advance our vaccine as a potential weapon in the fight to end the suffering caused by COVID-19.”
The study enrolled more than 15,000 participants between 18-84 years of age, including 27 percent over the age of 65.
The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
(More to follow)