Novavax Inc’s COVID-19 vaccine Covovax, which is produced by India’s Serum Institute, is effective in generating an immune response against the Omicron variant, and an additional booster dose produces further immune resistance to the new variant, the US biotechnology company said, citing early data from a study. Novavax said the data was taken from its ongoing studies of its vaccine’s effectiveness in adolescents and as a booster.
Novavax and its partner, Serum Institute of India, have agreed to send COVAX more than 1.1 billion doses of Novavax’s vaccine, NVX-CoV2373.
“In the midst of an evolving pandemic, Covovax COVID vaccine showed strong immune responses against Omicron and other circulating variants. We are encouraged that boosted responses against all variants were comparable to those associated with high vaccine efficacy in our Phase 3 clinical trials, suggesting that NVX-CoV2373 can play an important role in the ongoing fight against new variants,” said Gregory M. Glenn, President of Research and Development, Novavax.
Novavax is working on developing an Omicron-specific vaccine and said Wednesday it expects to begin manufacturing doses of the variant-specific shot in January.
“Given the continued evolution of the coronavirus, the development of an Omicron vaccine could be necessary. Novavax has cloned, expressed and characterized the Omicron spike protein vaccine and will soon enter the GMP-phase of production. We expect to begin clinical studies in the first quarter of 2022,” Glenn said.
Novavax’s two-dose, protein-based vaccine Covovax was authorized recently for use by European Union regulators and the World Health Organization. It has previously been approved by countries including Indonesia and the Philippines but not the United States.
“CovovaxM was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally, ” WHO had said while issuing an emergency use listing.
Commenting on the WHO approval, Adar Poonawalla, CEO of Serum Institute, in a recent tweet, said, “This is yet another milestone in our fight against COVID-19, Covovax is now W.H.O. approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration.”
Serum also manufactures the Covishield covid vaccine which is authorised for use in India.