Therapy Areas: AIDS & HIV
Novavax announces two booster studies to evaluate its COVID-19 Vaccine, NVX-CoV2373
28 March 2022 -

Biotechnology company Novavax Inc (Nasdaq:NVAX) reported on Friday that its protein-based COVID-19 vaccine NVX-CoV2373 is part of two trials, to evaluate the vaccine's safety, immunogenicity and reactogenicity as a booster amidst the ongoing COVID-19 pandemic.

Both the studies, which was launched in partnership with NIAID and United Arab Emirates, have initiated participant enrollment to extend knowledge of how a range of vaccines, including the company's COVID-19 vaccine, can be used as boosters following primary immunization.

Under the National Institute of Allergy and Infectious Diseases (NIAID) ongoing Phase 1/2 trial, Novavax will assess the homologous and heterologous boosting regimens in participants who received a primary series of a COVID-19 vaccine, which has received full approval or Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

The NIAID study is enrolling 1,130 healthy individuals aged 18 years or older, about 180 of whom will receive Novavax's NVX-CoV2373 as a heterologous booster. Participants will be followed for 12 months, with topline results expected later this year and full results in 2023.

In the UAE, Novavax' COVID-19 vaccine is being evaluated in an observer-blinded Phase 3 study to assess homologous versus heterologous boosting of participants who have already been immunized with Sinopharm's COVID-19 vaccine. The safety and immunogenicity of a single booster dose of Novavax' COVID-19 vaccine in adults previously vaccinated with Sinopharm's COVID-19 vaccine will be evaluated.

As part of the UAE study, the company is enrolling approximately 1,000 participants aged 18 years or older at two centres in Abu Dhabi, with the goal of providing data to support boosting with NVX-CoV2373 in the large number of individuals who have been vaccinated with inactivated vaccines globally. Participants will be followed for six months, with full results expected during the Q4 2022.

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