If things go according to plan, the vaccine would be available in the market by the end of this year.
Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
The Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
As of now, Gennova Biopharmaceuticals has launched a vaccine, Gemcovac-OM, which is based on the Omicron variant.
Efforts are being ramped up for massive production of vaccines and make them available in the shortest possible time, a top government official said on Wednesday, stressing that India currently has a promising pipeline of four-five Covid-19 vaccine candidates, while three have already been approved for emergency use.
The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology. The mRNA vaccines do not use the conventional model to produce immune response. Instead, they carry molecular instructions to make the protein in the body through a synthetic RNA of the virus.
On Tuesday, Rao said there was a possibility of the PM's visit to Pune, and if that happens, it would be aimed at reviewing the status of the vaccine candidate for coronavirus infection and to know about its launch, production and distribution mechanisms.
India's first mRNA platform-based vaccine will remain stable at 2-8 degrees Celsius while Pfizer-BioNTech's vaccine needs minus 70 degrees Celsius and Moderna vaccine can remain stable for six months at minus 20 degrees Celsius, reports Sohini Das.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said Zydus Cadila, Sputnik V, Biological E and Gennova are other vaccines also in the pipeline which are in advanced clinical trials in India.
The teams were from Gennova Biopharmaceuticals Ltd Pune, Biological E Ltd Hyderabad and Dr Reddys Laboratories Ltd Hyderabad.
Representatives from seven vaccine makers -- Serum Institute of India, Bharat Biotech, Dr Reddy's Laboratories, Zydus Cadila, Biological E, Gennova Biopharma and Panacea Biotech -- will be participating in the meeting.
To address the shortage of COVID-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
A longer shelf life is critical, given many makers have started manufacturing vaccines and stockpiling them, so as to make them available in the market immediately after approval, reports Sohini Das.
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
"Provide enough infrastructure and money to carry out surveillance and set up a robust routine surveillance machinery for the country to monitor any and every infectious disease'
As states grapple with a shortage of coronavirus vaccines, the Centre on Thursday said that over two billion doses will be made available in the country in five months between August and December, enough to vaccinate the entire population.
The prime minister was happy that the assurance given by the Serum Institute that it will make India self-sufficient in vaccines at the lowest possible price in the world was fulfilled.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
The primary objective was to get the adult vaccine as children rarely have a severe form of the disease. Once schools reopen, the demand for vaccines for children under 12 may soar.
Providence will sell up to 30 mn doses of its mRNA vaccine to Biological E. It would also provide the necessary technology transfer to make the vaccine in India, with a minimum production capacity of 600 mn doses in 2022 and targets capacity of 1 bn doses, reports Sohini Das.
According to the sources, there are limited prospects of J&J exporting its vaccine from the US to other countries in the near future and the "entire production" at the BE facilities in India, beginning July/August, will be handed over to the pharma giant under a contract between the companies.
India expects 2.16 billion doses of Covid-19 vaccines between August and December, including the jabs that are currently in clinical trials, reports Sohini Das
Apart from the 1.1 crore doses of Covishield being procured from the Serum Institute of India, 55 lakh doses of indigenously developed Covaxin were being obtained from Bharat Biotech, Union Health Secretary Rajesh Bhushan said at a press conference.
865 million Indian adults require vaccination.
The ministry further stated that it was advisable to receive a complete schedule of the anti-coronavirus vaccine irrespective of past history of infection with COVID-19 as this will help in developing a strong immune response against the disease.
Responding to another question, Choubey said that the phase-I of clinical trials have revealed excellent safety of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Cadila Healthcare Ltd, and now their immunogenicity testing is in progress. Their phase II clinical trials are ongoing.
Phase-I clinical trials have revealed "excellent safety" of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Cadila Healthcare Ltd and their immunogenicity testing is now in progress, minister of state for health Ashwini Choubey informed the Rajya Sabha on Tuesday.
The aim of the mission is to accelerate the development of at least six vaccine candidates and ensure that they are licenced and introduced in market for emergency use at the earliest.
At 8 million a month, times two doses, it will take us 17 years to administer the vaccine to our 800 million adults. The rollout must speed up twenty times, asserts Naushad Forbes.
A massive pan-India inoculation drive against COVID-19 was set in process on Tuesday with more than 56 lakh doses of the Covishield vaccine flown to 13 cities across India from Pune and taken to designated national and state-level stores amid tight security.
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