Pune-based Gennova Biopharmaceuticals, whose mRNA Covid-19 vaccine GEMCOVAC-19 got the nod from the Drug Controller General of India, said on June 29 that the company was working on a booster dose that would be effective against the omicron variant as well.
Gennova Chief Operating Officer Samit Mehta said the clinical trial protocol for the booster shot has been submitted". “As far as the booster goes, we already have a candidate ready that will also address the omicron variant in addition to delta. We have made minor tweaks in the current formulation, and we have already submitted that protocol for clinical trials for boosters,” Mehta told mediaperson on June 29.
Gennova’s GEMCOVAC-19, India’s first home-made mRNA jab, is a thermostable vaccine and can be stored between temperatures of 2 to 8 C, which makes it favourable for deployment in India and other developing nations, as it can be transported to the most remote parts easily.
In contrast, mRNA vaccines made by Pfizer-BioNTech and Moderna need to be stored at sub-zero temperatures, which remains a challenge in lower and middle-income countries.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
When asked about the procedure Gennova would follow to reach out to lower and middle-income countries waiting for an mRNA vaccine, Mehta said they would undertake a three-pronged approach.
"Indian government procuring and supplying vaccines under Maitri programme to several countries; from the WHO, where we get our WHO pre-qualification done and then they procure and supply and through our parent company Emcure’s Network, where we have reached out to a lot of these countries… in case they want to procure from us," he added.
Mehta said the prequalification of the vaccine by the World Health Organisation was the next step for the company.
“The EUA (emergency use authorisation) was the last step, given the fact that the facility that we are making it at has regulatory approvals. The pathway with WHO should be quick,” he added.
Mehta said the government would decide the vaccine price.
Gennova plans to introduce the vaccine soon and aims to produce four to five million doses a month and productions can be doubled or tripled, the company said.
The company has 7 million doses approved and released by the Central Drug Laboratory in Kasauli.The approval comes at a time when the country is seeing an uptick in Covid infections, though the cases are nowhere close to what the country saw in the first, second and third waves. The rise in cases has also seen more people going for booster shots.