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 The Phase 2b trial study of NVX-CoV2373 will be conducted on about
2,665 healthy adults and will evaluate the safety and immunogenicity
in about 240 medically stable, HIV-positive adults, the company said
in a statement https://reut.rs/3g0sRzb.
"Because South Africa is experiencing a winter surge of COVID-19
disease, this important Phase 2b clinical trial has the potential to
provide an early indication of efficacy, along with additional
safety and immunogenicity data for NVX-CoV2373," said Novavax
research chief Gregory Glenn.
South Africa is fifth worst affected country with 583,653
coronavirus cases and 11,677 deaths, according to a Reuters tally.
The Bill & Melinda Gates Foundation is providing a $15 million grant
towards the clinical trial, the company said.
Novavax said it intends to initiate the Phase 2 portion of this
trial in the United States and Australia in the near future and that
it would include about 1,500 candidates.
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Earlier this month, Glenn told Reuters the company would start much larger
late-stage clinical trials soon and could potentially glean enough data to
obtain regulatory approvals as early as December.
The U.S. government in July had awarded Novavax $1.6 billion to cover testing
and manufacturing of a potential vaccine for the novel coronavirus in the United
States with the aim of delivering a 100 million doses by January.
Last month, AstraZeneca said late-stage trials of its experimental drug AZD1222,
which is developed by AstraZeneca and Oxford University, are under way in Brazil
and South Africa and due to start in the United States, where prevalence is
higher.
(Reporting by Sabahatjahan Contractor in Bengaluru; Editing by Amy Caren Daniel)
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