NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). The DCGI also approved Covaxin, which was developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research, and is still in phase III trials.
Covishield is the Indian name for Astrazeneca’s AZD-1222 recombinant chimpanzee adenovirus vector vaccine, renamed COVID-19 Vaccine Astrazeneca. It has shown 72% efficacy in global trials and was approved in the U.K. at the end of the December. SII has 50 million doses of Covishield already available and could roll out as many as 80 million doses by mid-February.
Covaxin is an inactivated virus vaccine currently undergoing phase III trials in India that started in November. The vaccine “has been evaluated in approximately 1,000 subjects in phase I and phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals,” Bharat said.
“We'll never approve anything if there is slightest of safety concern. The vaccines are 110% safe,” said DCGI’s Venugopal Somani.
Both vaccines require two doses and can be stored at 2-8 degrees Celsius, which makes them easier to distribute in hot countries like India with limited cold chain storage than the mRNA vaccines such as Pfizer Inc. and Biontech SE’s BNT-162b2 or Moderna Inc.’s mRNA-1273 that have been among the first approved in the U.S. and Europe and have to be stored at extremely cold temperatures.
Pfizer has applied for emergency use authorization of its coronavirus vaccine in India, while the government is looking for Indian partner companies to make and test the Moderna vaccine.
The DGCI also gave the green light for the launch of phase III trials to a DNA-based vaccine ZyCov-D developed by Cadila Healthcare Ltd. (Zydus Cadila), of Ahmedabad, in collaboration with India’s Department of Biotechnology. This would be India’s first DNA plasmid vaccine, according to Zydus Cadila Chairman Pankaj Patel, who added the vaccine can remain stable at high temperatures of 30 degrees Celsius for about three months.
On Dec. 22, Bharat and Pennsylvania-based Ocugen Inc. said they would work together to develop Covaxin for the U.S. market. Covaxin “offers a vaccine candidate that is different from other options currently available in the U.S. market with potentially broader coverage against multiple protein antigens of the virus,” said Harvey Rubin, professor at the University of Pennsylvania and a member of Ocugen’s vaccine scientific advisory board.
The Indian government has already announced its vaccination program and an ambitious target of vaccinating at least 300 million priority people by August.
On Jan. 2, India Minister of Health Harsh Vardhan announced that 10 million health care workers and 20 million front-line workers will be the first to be vaccinated and will receive the shots for free. That leaves another 270 million priority beneficiaries, including people over the age of 50 and people with co-morbidities, but details about when they will be vaccinated are sparse.
Even ahead of the approvals Jan. 3, several Indian states started conducting dry runs to identify gaps in implementation of the rollout of vaccines.
More vaccines in development
India also is considering at least seven other vaccine candidates. An mRNA-based vaccine HGCO 19 developed by Gennova Biopharmaceuticals Ltd., of Pune, India, and HDT Bio Corp., of Seattle, was cleared in December to initiate phase I/II trials.
Hyderabad-based Biological E. Ltd. is working with the U.S.-based biopharmaceutical firm Dynavax Technologies Corp. and Baylor College of Medicine in Houston on a vaccine candidate that includes an antigen in-licensed from BCM Ventures, Baylor’s integrated commercialization team, and Dynavax’s advanced adjuvant, CpG 1018.
SII has two more COVID-19 vaccine deals, one with Novavax Inc. for NVX-CoV2373, based on a virus protein subunit engineered from the genetic sequence of SARS-CoV-2, and another with New York’s Codagenix Inc. to develop Covi-vac, a single-dose intranasal, live attenuated vaccine.
Bharat Biotech has also signed an exclusive deal with Thomas Jefferson University, from Philadelphia, to develop a vaccine based on an inactivated rabies vaccine platform used as a vehicle for coronavirus proteins.
Russia has also announced that some 300 million doses of the human adenovirus vaccine Sputnik V, developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology, will be produced in India through tie-ups with four local partners, including Dr. Reddy’s Laboratories Ltd. and Hetero Biopharma Ltd. and two undisclosed companies.