Novavax, a biotechnology company dedicated to developing and commercialising new vaccines for serious infectious diseases, said that studies in adults and adolescents have shown that the booster dose of its Covid vaccine produced robust antibodies against several Omicron variants, including BA.1, BA.2 and BA.5.
The data, presented at the World Vaccine Congress Europe 2022, came from two studies – Phase 3 PREVENT-19 trial and Study 307 (Lot Consistency).
Gregory M Glenn, MD, President of Research and Development, Novavax, said: “These data further demonstrate the consistent immunogenicity and safety profile of the Novavax Covid-19 vaccine as a booster, regardless of previous vaccine history.
“These data are an early indication that our vaccine may be effective against variants such as Omicron. We have ongoing trials further exploring the Novavax Covid-19 vaccine’s potential as an effective booster against these variants, including BA.4/5, and look forward to sharing these data.”
PREVENT-19 data in both adults aged 18 and older and adolescents aged 12 through 17 showed the prototype vaccine, called NVX-CoV2373, achieved its pre-specified immunologic endpoint.
In the trial, a single booster dose was given to adults approximately 8-11 months after their primary series. Following a booster dose, SARS-CoV-2 anti-spike (anti-S) Immunoglobulin G (IgG; a type of antibody) levels increased significantly relative to pre-boost levels, rising above the level correlated with 95 percent vaccine efficacy in a recent USG study.
Neutralising antibodies against the prototype strain also increased by 34- to 27-fold compared to pre-boost levels when boosted at eight or 11 months. Boosting also increased IgG and human angiotensin-converting enzyme 2 (hACE2) receptor inhibition antibody levels against Omicron BA.1, BA.2, and BA.5 variants, with levels that are comparable to those observed in Phase 3 efficacy studies.
In both adults and adolescents, a third dose of the Novavax Covid-19 vaccine decreased the antigenic distance between SARS-CoV-2 variant and prototype virus strains, suggesting benefits against contemporary variants such as Omicron. The booster doses were well tolerated in adults and adolescents, with mostly mild to moderate reactogenicity of short duration.
Study 307 (Lot Consistency) met its primary endpoint, showing that three lots of the Novavax Covid-19 vaccine tested as a heterologous booster, induced consistent immune responses in previously vaccinated adults aged 18 to 49.
In the late-stage study, a single homologous booster dose significantly increased antibody levels against these variants relative to pre-boost levels, the company said.
Study 307 (Lot Consistency) showed that heterologous boosting responses were consistent across participants who received primary vaccines from Moderna, Pfizer, or Johnson & Johnson.
Novavax has established partnerships for the manufacture, commercialisation, and distribution of the vaccine worldwide. Existing authorisations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume.
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