Biotechnology firm Novavax Inc and its Indian partner Serum Institute of India (SII) on Thursday said they have applied to the World Health Organization for emergency use listing (EUL) of Novavax’s COVID-19 vaccine.
The application to WHO is based on the companies’ previous regulatory submission to the Drugs Controller General of India (DCGI), Novavax Inc said.
“Today’s submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world,” Novavax President and Chief Executive Officer Stanley C Erck said.
The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, established to allocate and distribute vaccines equitably to participating countries.
It also said that in addition to the submission to WHO for EUL, SII and Novavax have completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data.
The Novovax vaccine is a two dose vaccine which will be given 21 days apart. The vaccine is stored at 2°- 8° Celsius, conveniently enabling the use of existing vaccine supply and cold chain channels.
The antibody quantitative test might have become popular, but antibodies are not the only immune response, experts say.
“There are different pathways of immunity post Covid-19 infection and vaccination the T cell immunity kicks up which unfortunately cannot be measured in clinical labs. After three weeks antibodies come into play which are easily measured in clinical lab. Both combined help the body fight infection,” Dr Poonam Das, Principal director, Max labs in Max healthcare.
