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The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.
Novavax announced on Jan. 28, 2021 that its COVID-19 vaccine candidate, NVX-CoV2373, met the primary endpoint with a vaccine efficacy of 89.3% in a Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a Phase IIb trial in South Africa.
The UK study, which enrolled more than 15,000 participants between 18–84 years of age, was based on the first occurrence of polymerase chain reaction (PCR)-confirmed symptomatic mild, moderate, or severe COVID-19 with onset at least seven days after the second study vaccination, Novavax said in a company press release. The analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group and six cases observed in the vaccine group, resulting in a vaccine efficacy of 89.3%.
Additionally, the vaccine showed to be effective against the UK variant strain of COVID-19. According to the press release, the strain was detected in over 50% of the PCR-confirmed symptomatic cases and, based on PCR performed on strains from 56 of the 62 cases, the vaccine showed 85.6% efficacy against the UK variant strain.
“These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine,” said Clive Dix, Chair, UK Vaccine Taskforce, in the press release. “The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus.”
The Phase IIb study in South Africa enrolled 4400 participants and showed a 60% efficacy for the prevention of mild, moderate, and severe COVID-19 in the population of the study that was HIV-negative, Novavax said in the press release. For the HIV-positive population, the vaccine was 49% effective in preventing the disease.
“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” said Professor Shabir Maddi, executive director of the Vaccines and Infectious Diseases Analytics Research Unit at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa, in the press release. “I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19.”