The Maryland based company, Novavax’s covid-19 vaccine candiate, named Covavax in India is all set to be launched in August-September this year in association with the Pune based Serum Institute of India. The vaccine has shown 90% efficacy in the clinical trials conducted in the U.S.

With U.S. easing the availability of the key raw materials of the vaccine, SII has accomplished all the preparatory work and is now at an advanced stage of the completion of its trials. The production will be ramped up to produce at least 5 crore doses a month to provide at least 20 crore doses by the end of 2021.

SII is also planning to begin clinical trials of the vaccine for children from July 2021.

What do we know about the vaccine?

Novavax’s vaccine candidate NVX-CoV2373, is a protein-based vaccine based on their recombinant nanoparticle vaccine technology that combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic particles that target a variety of viral pathogens. 

The vaccine is engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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What does the trial results say?

A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study was conducted in U.S. and Mexico to evaluate the efficacy, safety, and immunogenicity of the vaccine in Adult Participants ≥ 18 Years with a paediatric expansion in adolescents (12 to 17 Years)

• Out of the 77 individuals out of 29,960 in the trial who contracted COVID-19, 14 received the actual vaccine, doses of which were spaced three weeks apart, while 63 had received placebos.

• The results showed that NVX-CoV2373 was well-tolerated and reactogenicity events were generally mild.

• There were no severe unsolicited adverse events; the ones found were mostly mild or unrelated to vaccination.

• All of the participants developed wild-type virus neutralizing antibody responses after Dose 2.

• It is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure.

• Vaccine efficacy was found to be 91% even in patients above 65 years of age, or under 65 years with comorbidities.

“The data showed consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid on-going genetic evolution of the virus. NVX-CoV2373 offers a reassuring tolerability and safety profile,” said Gregory M. Glenn, President of Research and Development, Novavax.

The vaccine also detected strains of the virus found first in the U.K., U.S., Brazil, South Africa and India, according to data released by the company.

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