US biotech firm Novavax’s request to India’s Comptroller General of Drugs for approval of its COVID-19 vaccine “Covovax” has hit a roadblock, sources revealed on Sunday. While the submission took place in August, DCGI’s expert group requested additional data from the company before seeking approval for this vaccine. In addition, he also pointed out that the United States Food and Drug Administration has yet to clear Covovax for emergency use.
In June, the Serum Institute of India, an Indian partner of Novavax, began production of the first batch of this vaccine at its plant in Pune. In accordance with the agreement, the SII is responsible for the manufacturing and marketing of Covovax in India. In particular, Novavax and SII have undertaken to supply more than 1.1 billion doses of this vaccine to the COVAX facility.
While Indonesia became the first country to grant an emergency use authorization for Covovax, it has yet to be approved by the World Health Organization, the European Union, the United Kingdom, Australia, Canada and New Zealand. Emergency use approval may be a game-changer amid the COVID-19 crisis as it has the potential to encourage countries to import the vaccine, facilitate its manufacture abroad, and facilitate travel within the world for people vaccinated with. So far, DCGI has granted emergency use authorization to Covishield, Covaxin, Sputnik V and Moderna.
A panel of experts from India’s Central Drug Authority, which recently reviewed the Serum Institute’s request for emergency clearance of the COVID-19 Covovax vaccine, requested additional data from the company, while noting that the vaccine has not yet been approved in country of origin: sources
– Press Trust of India (@PTI_News) November 28, 2021
What is Covovax?
Considered the first protein-based COVID-19 vaccine, Covavax is designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19. It was created using recombinant nanoparticle technology and formulated with Matrix-M adjuvant from Novavax to enhance the immune response and stimulate high levels of neutralizing antibodies. According to the phase 3 trial conducted in the UK, it demonstrated an overall efficacy of 89.7% and 86.3% efficacy against the Alpha variant (B.1.1.7).
On the other hand, the results of phase 3 trials in the United States and Mexico showed an overall efficacy of 90.4% and an efficacy of 100% against moderate and severe COVID-19 disease. The two doses of Covovax, packaged as a ready-to-use liquid formulation, should be administered 21 days apart. Most importantly, this vaccine can be stored between 2 ° and 8 ° Celsius, allowing the use of existing vaccine supply and cold chain channels.
Vaccination against COVID-19 in India
At present, there are 1,05,691 new cases of active coronavirus in India, while 3,398,278 patients have recovered and 4,68,554 deaths have been reported. The improvement in the COVID-19 situation in India has been attributed to rapid advances in immunization. In addition to Covishield and Covaxin, DCGI has approved Sputnik V, Moderna, Janssen vaccine from Johnson & Johnson and ZyCoV-D from Zydus Cadila. A total of 22.214.171.1243 people were vaccinated while 126.96.36.199 of them also received the second dose of the vaccine.