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The World Health Organization (WHO) has issued a second Emergency Use Listing (EUL) for Novavax NVX-CoV2373, the COVID-19 vaccine developed by American pharma giant Novavax Inc. NVX-CoV2373 is listed as Nuvaxovid and is the 10th COVID-19 vaccine to have been issued an EUL by The Technical Advisory Group for Emergency Use Listing .
Nuvaxovid was earlier given a conditional marketing authorisation in the European Union by The European Medicines Agency (EMA). NVX-CoV2373 is also being manufactured and marketed in India and licensed territories by Serum Institute of India Pvt. Ltd. (SII), as Covovax, which was granted EUL on December 17 .
"Covovax 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 said in a news release issuing an emergency use listing.
Novavax / Covovax COVID-19 Vaccine
A press release published by Novavax describes NVX-CoV2373 as a protein-based vaccine engineered from the genetic sequence of the first strain 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 is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19 .
The press release claims Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The recommended regimen of Novavax' COVID-19 vaccine is two 0.5 ml doses given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels .
Efficacy of Novavax COVID-19 Vaccine
The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic COVID-19 cases from 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared with people given placebo
According to data published in the New England Journal of Medicine, in a phase 3, randomised, observer-blinded, placebo-controlled trial, the vaccine projected an overall efficacy of 89.7 per cent against the disease .
Who Can Receive the Novavax Vaccine?
WHO recommends Novavax for individuals over the age of 18 years. However, the vaccine is not recommended for pregnant women since data regarding the safety and efficacy of the vaccine to the same group is not yet available. Novavax vaccine is recommended for people living with health conditions that could possibly increase the risk of COVID-19 including cardiovascular disease, respiratory disease, diabetes, liver disease, obesity and neurodevelopmental and neurodegenerative conditions
WHO does not recommend the vaccine to individuals with a history of anaphylaxis to any component of the vaccine. Individuals with acute PCR-confirmed COVID-19 should also avoid getting vaccinated until after they've recovered from the illness. Vaccination of persons under the age of 18 is also not recommended .
Does Novavax COVID-19 Vaccine Work Against Omicron Variant?
Nuvaxovid is effective in generating an immune response against the Omicron variant, according to Novovax.
"In the midst of an evolving pandemic, NVX-CoV2373 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. 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." Said Gregory M. Glenn, President of Research and Development, Novavax .
Nuvaxovid is manufactured and marketed in India by Serum Institute of India Pvt. Ltd. Under the brand name Covovax, which was granted EUL by WHO earlier this month. Covovax, a technology transfer of Novavax's US vaccine, has also been granted an emergency use authorisation (EUA) by the Central Drug Authority.
"The approval of Covovax in India marks a significant milestone in strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to deliver a protein-based COVID-19 vaccine, based on Phase 3 clinical data demonstrating more than 90% efficacy and a favorable safety profile, to our nation ."
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