“There have been discussions at the highest level to support ramping-up the production of Bharat Biotech’s capacities across Hyderabad as well as for upgrading other companies under consideration with required infrastructure and technology,” one of the officials told ET.
Apart from Bharat Biotech ‘s new Bangalore facility being repurposed to increase vaccine production and the recent approval for Haffkin Institute to produce the vaccine under transfer of technology basis, two additional public-sector enterprises – Indian Immunologicals Ltd in Hyderabad and Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL) at Bulandshahr – are being considered.
Maharashtra chief minister Uddhav Thackeray tweeted late Thursday that the Department of Science & Technology had approved Haffkine Institute to produce Bharat Biotech’s Covaxin vaccine on a transfer of technology basis.
“Financial support to the tune of approximately Rs 65 crore will be provided for this facility to be made ready for manufacturing,” the government said in a statement.
Haffkine Biopharmaceuticals Ltd has asked for 12 months to complete the task. However, the government has asked them to expedite and complete the task urgently within 6 months. “The facility will have a capacity of 20 million doses per month, once functional, the government added.
Bharat Biotech currently manufactures Covaxin only at its plant in Hyderabad and needs to scale up production from the current 0.5 crore doses a month rapidly to provide a critical boost to India’s Covid-19 inoculation programme amid a second wave of infections which has seen daily infections go well beyond 2 lakhs a day.
“While BIBCOL will take time to set up, Indian immunologicals can produce superfast as it has BSL 3 facility. Haffkine does not have a bio-safety level 3 (BSL3) production facility, it does have a laboratory of the category,” added second official.
BSL3 facilities are important to manufacture Covaxin, an inactivated virus vaccine, because it requires culturing large batches of the highly-infectious SARS-COV2 before killing them with an inactivating agent.
According to the government, the current production capacity of 1 crore monthly doses will be doubled by May-June 2021 and increased to nearly 6-7 by July-August 2021. “…It is expected to reach nearly 10 crore doses per month by September, 2021,” the statement further said.
Bharat Biotech is also set to start bulk production at its Bengaluru facility, having received approval from India’s drug regulatory authority recently.
As part of the augmentation plan, financial support is being provided as grant from the government to the tune of Rs 65 crore to Bharat Biotech’s Bengaluru facility which is being repurposed to increase the vaccine production.
“The company has got the test licence to start production of Covaxin in Bengaluru. The fill-finish lines of its existing Hyderabad facility will be used before the vaccine is sent to the Central Drug Laboratory (CDL) for final approval,” said another government official.
“The BIBCOL and Indian Immunologicals and Biologicals Ltd will also be supported to prepare their facility to provide 10-15 million doses per month by August-September 2021,” it further said.
The company is also in initial discussions with Panacea Biotec, the only other company apart from Bharat Biotech with BSL3 production, facility, for contract manufacturing the vaccine.
While the government maintains it has enough vaccine to meet its planned vaccination targets, the sudden surge in the cases and the resulting stress on the health infrastructure is prompting the government to revisit its vaccination strategy, depending upon the availability of doses.
Earlier this week, the government permitted emergency usage approval for vaccines, which were approved by the USFDA, the EU and Japanese authorities with some conditions, opening the possibility for the country to import vaccines such as Moderna, Pfizer, Sputnik and J&J.
In augmenting the capacities of the public-sector companies, the government plans to build long-term capacity to produce vaccines in the country. Once past the requirement to churn out Covid vaccines, these government enterprises will be well equipped to manufacture other vaccines in the future, the first official said.