Business Standard

RACE FOR VACCINE GETS TIGHTER AS FIELD WIDENS

More competitor­s get DCGI nod to advance to clinical trial stage

- VINAY UMARJI & SOHINI DAS report

The race to develop a vaccine for novel coronaviru­s just got hotter as more competitor­s received the regulatory nod to conduct phase-ii clinical human trials. Recently, Bharat Biotech’s Covaxin was approved for human trials. On Thursday, the Central Drugs Standard Control Organisati­on approved Zydus Cadila’s plasmid DNA vaccine candidate ZYCOV-D. Meanwhile, the University of Oxford and Astrazenec­a’s experiment­al vaccine has entered the final stage of clinical trials. Scientists have initiated clinical trials in South Africa, while Serum Institute of India is hopeful it will be made available by year-end.

The race to develop a vaccine for SARS-COV-2 (novel coronaviru­s) just got hotter as more competitor­s received regulatory approval from the Drugs Controller General of India’s (DCGI’S) Central Drugs Standard Control Organisati­on (CDSCO) to conduct phaseII clinical human trials.

Recently, Bharat Biotech’s Covaxin, a vaccine candidate that it developed in collaborat­ion with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), was approved for human trials, making it the first indigenous­ly developed vaccine to get the nod. To develop Covaxin, NIV Pune isolated the virus strain and transferre­d it to Bharat Biotech. And the vaccine has shown positive results in pre-clinical animal trials.

On Thursday, CDSCO also approved Zydus Cadila’s plasmid DNA vaccine candidate ZYCOV-D, developed at its Vaccine Technology Centre in Ahmedabad. With the ICMR setting August 15 as the deadline to launch a Covid-19 vaccine, Zydus Cadila intends to ramp up production capacities of ZYCOVD to cater to Indian and global demand.

The firm said the vaccine elicited a strong immune response in mice, rats, guinea pigs, and rabbits. “The antibodies produced by the vaccine were able to completely neutralise the wild type virus… indicating the protective potential of the vaccine candidate,” Cadila

Healthcare said on Friday.

Meanwhile, the University of Oxford and Astrazenec­a’s experiment­al vaccine has entered the final stage of clinical trials. Scientists have initiated clinical trials in South Africa, while the Indian partner, Serum Institute of India (SII), is hopeful it will be made available by year-end.

Scientists at the University of Witwatersr­and have started clinical trials in South Africa with the team set to test the ‘Ox1cov-19’ or ‘Oxford Vaccine’. Adar Poonawalla, CEO of SII, has said the firm will need to conduct phase-iii clinical trials before launching the vaccine.

Apart from partnering with Astrazenec­a to supply a billion doses of Oxford’s potential vaccine to low and middle-income countries, SII is working on a recombinan­t BCG vaccine as an immunity booster against respirator­y viruses. Trials for this are on in India, and the first batch might go into production by August-september.

Indian Immunologi­cals (IIL) is also conducting preclinica­l trials on small animals and non-human primates. However, according to the company’s Managing Director Anand Kumar, these trials could go on till December. The company is working on a liveattenu­ated weakened placid vaccine candidate that almost resembles the Covid-19 virus, but does not have the capacity to multiply.

However, if other developers taste success before IIL, the firm is open to collaborat­ing with them to make the vaccine. “Anyone who comes up with the vaccine but is short of capacity, we are ready to collaborat­e for manufactur­ing. Given the population, there is no single vaccine manufactur­er that has all the capacity. We are talking to other vaccine makers, but the technology has to be compatible with our manufactur­ing,” Kumar told Business Standard.

 ??  ?? The University of Oxford and Astrazenec­a’s experiment­al vaccine has entered the final stage of clinical trials. Scientists have initiated clinical trials in S Africa, while the Indian partner, Serum Institute of India, is hopeful it will be made available by year-end
The University of Oxford and Astrazenec­a’s experiment­al vaccine has entered the final stage of clinical trials. Scientists have initiated clinical trials in S Africa, while the Indian partner, Serum Institute of India, is hopeful it will be made available by year-end

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