expresspharmaApril 23, 2021
Tag: Renu Swarup , Biological E , Bharat Biotech , Gennova , Zydus Cadila
Efforts are being ramped up for massive production of COVID-19 vaccines and make them available in the shortest possible time, said Renu Swarup, Secretary, Department of Biotechnology, stressing that India currently has a promising pipeline of four-five vaccine candidates, while three have already been approved for emergency use.
She said financial support of Rs 400 crore is being provided to vaccine candidates from Zydus Cadila, Biological E, Gennova and Bharat Biotech (single-dose intranasal vaccine).
The regulators have also permitted manufacturing at risk and stockpiling doses even before approval so that they can be rolled out into the immunisation programme without any time lag, she said.
Her statement comes days after the Centre widened the vaccination drive to cover everybody above 18 years of age.
According to the latest government data, more than 21,000 people have tested positive for the novel coronavirus infection after the first dose of either of the two vaccines (Covishield or Covaxin), while nearly 5,700 have tested positive after the second dose of the vaccines, accounting for 0.03-0.4 per cent approximately.
“There are three vaccines in India, which have been approved for Emergency Use Authorisation – ‘Covishield’ by Serum Institute of India (SII), ‘Covaxin’ by Bharat Biotech International Ltd (BBIL) and the Russian vaccine, ‘Sputnik-V’. Besides these, there is a promising pipeline of four-five candidates in advanced clinical stages of development,” Swarup told PTI.
DNA vaccine candidate by Zydus Cadila, protein subunit vaccine candidate by BioE, mRNA vaccine candidate by Gennova, and single-dose intranasal vaccine candidate by Bharat Biotech are in advanced stages of clinical trials, she said.
Zydus Cadila’s vaccine candidate is in the Phase-III trial stage, while the vaccine candidate of Biological E has nearly completed phase-II clinical development and is awaiting approval for the phase-III trial. The vaccine candidate by Gennova has initiated the phase-I trial.
“The Department of Biotechnology (DBT) has provided technical, advisory and financial support for these vaccine candidates during their early development. Now, under the ‘Mission COVID Suraksha’, financial support of nearly Rs 400 crore for late-stage clinical development of these vaccine candidates is being provided.
“The manufacturers already have existing capacities and can contribute to about 15-20 million doses per month, which can be made available for immunisation, once approved,” Swarup said.
Mission COVID Surkasha was launched by the DBT last year to provide support for vaccine development and therapeutics in its fight to combat COVID-19.
In the case of Sputnik-V, Dr Reddy’s and five local manufacturing partners have been identified, including Hetero Biopharma, Virchow Biotech, Stelis Biopharma, Gland Biopharma and Panacea Biotech, which collectively could produce about 70 crore doses per annum, she said.
In case of ICMR-Bharat Biotech’s Covaxin, the official said the support by the DBT is to make the facilities ready to support augmented vaccine production over the next six to eight months.
With support of approximately Rs 200 crore, it is expected that the current manufacturing of Covaxin of one crore doses per month will be enhanced to nearly 10 crore doses/ month in the next few months.
Besides, the Centre has provided Rs 1,500 crore to Bharat Biotech for commercial production of Covaxin.
Last week, the DBT also expedited efforts to ramp up the production of indigenously developed COVID-19 vaccine Covaxin.
Covaxin’s production will be doubled by May-June and the department has roped in three public sector companies, it said.
They are Haffkine Biopharmaceutical Corporation, Mumbai, a public sector undertaking (PSU) under the Maharashtra government; Indian Immunologicals Limited (IIL), Hyderabad, a facility under the National Dairy Development Board; and Bharat Immunologicals and Biologicals Limited, Bulandshahr, a PSU of the Department of Biotechnology.
The Centre is pro-actively engaging with vaccine manufacturers to facilitate and provide the necessary support to meet the manufacturing requirements as per the demand, Swarup said.
Prime Minister Narendra Modi had interacted with vaccine manufacturers of the country via video conference and urged them to continuously scale up their production capacity to inoculate all Indians in the shortest possible time.
He also assured all possible support and smooth approval process for the vaccine candidates which are currently under trial phase.
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