India has started stockpiling its first mRNA vaccine against Covid-19 manufactured by Pune-based Gennova Biopharmaceuticals, News18.com has learned.
Though the company had submitted in March the interim data for the approval of India’s first indigenously developed mRNA Covid vaccine to the Central Drug Standard Control Organization (CDSCO), the review process is still going on and the regulatory agency has sought some more information.
Meanwhile, 1.35 lakh doses of the vaccine have already been cleared by the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, for stocking. The CDL, Kasauli, under the health ministry, is responsible for checking the safety and efficacy claims of the vaccines administered in India, and no vaccine can be rolled out in market until cleared by the apex lab.
“The flow of mRNA vaccine is now expected to be regular at the laboratory. Once it gets permission from CDSCO, it can be immediately rolled out in the market from the stockpile checked and approved by CDL,” a senior government official, privy to the development, told News18.com.
“If India decides to go for a different booster dose, the stock can be diverted for the same. mRNA is a plug and play technology, which can be tweaked faster against the strains and in the current situation, we need something of this kind,” the senior official added.
Meanwhile, Gennova Biopharmaceuticals, a subsidiary of drugmaker Emcure Pharmaceuticals, has already tweaked its mRNA platform, which will target Omicron — the strain that led to the third wave, and is reportedly the variant behind the fresh surge in Covid cases in several countries.
The trials of the redesigned vaccine are likely to begin soon.
The company plans to use its vaccine as a booster shot for those who have received two jabs of a primary Covid-19 vaccine.
The novel mRNA-based vaccine, which uses Spike (S)-protein of the virus as antigen, will be administered in two doses with a gap of 28 days.
While the majority of the Indian population, eligible to receive vaccination against Covid-19, has been given the primary dose, however, top health experts, including Niti Aayog’s member VK Paul had said the “vaccine is stable at normal temperature. It is a remarkable possibility, and technology on the horizon.”
Paul said the mRNA platform continues to be “important in the medium term, near future and beyond”.
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