As India approved its first mRNA based Covid-19 vaccine manufactured by Pune-based Gennova Biopharmaceuticals, more than 70 lakh doses are ready for the roll-out soon, News18.com has learnt.
The company had been stockpiling the doses starting April, immediately after it submitted the interim data for the approval to the Central Drug Standard Control Organisation (CDSCO).
The vaccine, Gemcovac, is India’s first indigenously developed mRNA Covid vaccine and only third mRNA vaccine to be approved for Covid-19 in the world after Pfizer and Moderna.
Gemcovac’s 43 lakh doses have already been cleared by the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh. Moreover, 30 lakh doses are pending.
The doses, which were approved by laboratory for the stockpiling, are now eligible for the market roll-out.
The vaccine will be available for adults above 18 years of age. It is a two-dose vaccine to be administered intramuscularly 28 days apart.
The biopharmaceuticals company, on Wednesday announced that it aims to produce around 40-50 lakh doses per month and this capacity can be quickly doubled.
It also said that it aims to sell the vaccine beyond India as well.
“Gennova aims at providing sustainable access to low-and middle-income countries around the world to the vaccine to blunt the spread of pandemic,” it said.
PRICING COULD BE SLIGHTLY HIGHER, VACCINE AS BOOSTER?
The company, according to two government officials, was in talks with the government around the pricing of the vaccine since October 2021.
However, the talks were not aggressive as the government waited for the conclusion of the ongoing clinical trials.
“The company is expecting slightly different pricing criteria as it is an mRNA product which requires altogether a different research, development and launching,” a government official said, adding that the company had been in talks over the pricing with the ministry of health and family welfare since last several months.
“Gennova’s mRNA is a different vaccine and puts India on par with Pfizer and Moderna’s R&D. The investment on R&D (in this vaccine) has been much higher than all other vaccines available with India, so far.”
“The company had told us that vaccine uses different technology and hence, requires different pricing. Our discussions were not aggressive as we all waiting for successful completion of the trials,” he said, while adding that the final decision on pricing will be announced soon and the objective of reaching a “reasonable pricing” would be attained.
Also, the government has been considering the use of mRNA as a booster shot or precautionary dose. “That avenue can also be explored with Gennova’s product as some studies have pointed out that mRNA boosters provide quick antibody response,” the officer said, adding that Gennova is already conducting a clinical trial for testing the efficacy of the vaccine as booster shots.
“Once the trial concludes or throws the interim results, a decision can be made by subject expert committee.”