Excerpts from an article and interview with Dr. Gregory Glenn, president of research and development at Novavax. There is also an audio interview in article linked below.
Gregory Glenn on next steps for Novavax’s COVID-19 vaccine
March 15, 2021
Novavax has proposed FDA accept final data from U.K., South African Trials
Novavax has proposed that FDA accept final data from a U.K. Phase III study of its COVID-19 vaccine candidate, supplemented by data from a Phase II study conducted in South Africa, as the basis for an emergency use authorization, the company’s president for R&D, Gregory Glenn, told BioCentury.
The lack of demographic diversity in the U.K. trial may lead FDA to wait for results from the Prevent-19 Phase III trial Novavax is conducting in the U.S. and Mexico, Glenn said. The endpoint is event-driven, so it isn’t possible to give a precise date to expect interim data. Results will be released after 72 participants are diagnosed with COVID-19, making them likely to be available by mid-April.
In the U.K. trial, “efficacy was 96.4% (95% CI: 73.8, 99.5) against the original virus strain and 86.3% (95% CI: 71.3, 93.5) against the B.1.1.7/501Y.V1 variant circulating in the U.K.,” the company said. “Five severe cases were observed in the study, and all occurred in the placebo group. Four of the five severe cases were attributed to the B.1.1.7/501Y.V1 variant.”
In a complete analysis of the Phase IIb South African study, the vaccine was 55.4% effective in HIV-negative participants in a region where the majority of strains are B.1.351 variants first identified in the country.
In both studies, the vaccine was 100% effective against severe COVID-19.
The U.K. and the South Africa data are signals “that the vaccine is working and working very well,” Glenn said. “We’ll just have to see how that goes with FDA and timing” of the EUA application.
Although three COVID-19 vaccines have been authorized in the U.S. and multiple vaccines are on the market in other regions, Novavax anticipates robust demand for its vaccine, both as a booster in countries where vaccination campaigns have reached much of the population and as an initial vaccination in parts of the world that haven’t had broad access to vaccines.
“We know immunity wanes on every vaccine, and it is likely that [COVID-19] will be no exception,” Glenn said. He added that Novavax expects that its vaccine, a protein-based product adjuvanted with the company’s proprietary saponin-based Matrix-M, could be used as a booster following immunization with vaccines manufactured using mRNA, viral vector or other technologies.
Novavax has launched animal studies of a vaccine targeted against the SARS-CoV-2 variant that is dominant in South Africa and expects FDA and EMA to accept applications based on immunological data.
Novavax could have a booster based on the new vaccine, or more likely a bivalent vaccine targeting both the original virus and a variant, in production in the fall, he said. The company expects that vaccine to be effective against a similar variant that has been identified in New York.
