May 6, 2021 -- Novavax announced results of a phase IIB trial of its COVID-19 candidate vaccine (NVX-CoV2373) published May 5 in the New England Journal of Medicine that suggest the vaccine is effective against the B.1.351 variant prevalent in South Africa.
Researchers randomly assigned adults who were negative for HIV infection between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years to receive two doses of either the NVX-CoV2373 vaccine or a placebo. The primary end points were safety and efficacy against laboratory-confirmed symptomatic COVID-19 at seven days or more after the second dose among participants without previous SARS-CoV-2 infection.
Out of 6,324 participants who underwent screening, 4,387 received at least one injection of vaccine or a placebo. Vaccine efficacy among HIV-negative participants was 60.1% and 38 out of 41 sequenced isolates were the B.1.351 variant, the researchers reported. Post hoc vaccine efficacy against B.1.351 was 51% among the HIV-negative participants, with serious adverse events rare in both groups.
In other news, Novavax announced it finalized an advance purchase agreement with Gavi, the Vaccine Alliance, to supply NVX-CoV2373 to the COVID-19 Vaccines Global Access (COVAX) Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.
Under the agreement, Novavax stated it is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVID-19 COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. The Serum Institute of India is expected to manufacture and deliver a balance of the 1.1 billion doses of Novavax's vaccine under a separate purchase agreement with Gavi, the company reported.