DCGI nod to two Covid vaccines

Aditi Tandon

Tribune News Service

New Delhi, January 3

The national regulator on Sunday approved two made in India Covid-19 vaccines setting the stage for the world’s largest inoculation drive as the government aims to vaccinate 30 crore vulnerable people by July.

• Capacity to vaccinate 4L a day: Punjab Govt
• Click here for the latest developments on Covid-19 epidemic

In what Prime Minister Narendra Modi called a “decisive turning point to strengthen a spirited fight”, Drugs Controller General VG Somani announced permissions for restricted use in emergency situations to AstraZeneca/Oxford University/Serum Institute of India’s Covishield and Bharat Biotech-ICMR’s Covaxin. While Covaxin is a wholly indigenous shot, Covishield has been manufactured in India.

Covishield will only be available through the government to start with and not privately. Covaxin will only be used in extreme emergencies to handle mutation-related infections. Anyone receiving Covaxin will be treated like a participant in a clinical trial and monitored as such.

Amid criticism of the nod to Covaxin, which is yet to show efficacy through phase 3 human trials, the regulator said both approved shots were 110 per cent safe. “Covaxin phase 1 and 2 trial results show it is safe and provides a robust immune response,” said Somani.

The SII’s Covishield, with 70.42 per cent efficacy in phase 3 trials abroad and comparable safety data at home, will be the lead candidate of India’s vaccination plan, whereas Covaxin will work as a back-up plan, experts said. VK Paul, Chairman, Covid vaccine taskforce, said Covaxin worked against multiple viral proteins and could serve well in case of a sudden surge due to mutations. “While all other available vaccines target the virus spike protein, Covaxin targets multiple proteins and will be our special guarantee against mutations which can impact the efficacy of other vaccines in future,” Paul said.

The SII hailed the approval saying it was ready with 50 million doses. On conditions for Covishield use, SII CEO Adar Poonawala said, “We cannot export the vaccine or sell it in the private market until the government has procured enough stocks to vaccinate the vulnerable.”

BJP, Cong spar over safety of Covaxin

The BJP and Congress on Sunday clashed over the safety of Covaxin. After Congress leaders Anand Sharma, Jairam Ramesh and Shashi Tharoor said Covaxin had not completed the phase 3 human trials, BJP ministers hit back, calling the critics cynics.

A Milestone, says Bharat Biotech

Bharat Biotech on Sunday said the approval of Covaxin for emergency use was a giant leap for innovation and novel product development in India. Chief of ICMR, collaborators in Covaxin, Balram Bhargava said it was a red letter day for Indian science.

Govt aims to vaccinate 30 cr people by July

• The SII will supply vaccine to govt for Rs200 per dose
• While Covaxin is wholly indigenous shot, Covishield is manufactured in India
• Covishield will not be available in market for now
• Covaxin will only be used in extreme emergencies
• Zydus Cadila receives DCGI nod for phase 3 trials

About the vaccines

• Covishield (two dose) is a recombinant chimpanzee adenovirus vector vaccine with safety, immunogenicity and efficacy data available from 23,745 participants aged 18 and above from overseas clinical studies. Overall efficacy is 70.42 per cent
• Covaxin (twin dose): Bharat Biotech’s whole virion inactivated coronavirus vaccine (Covaxin) is based on vero cell platform, which has well established track record of safety and efficacy

Poonawala added that SII would roll out stocks soon as a purchase agreement with the GOI is signed.

“Only three Covid vaccines in the world have shown efficacy Pfizer, AstraZeneca and Moderna. The rest are safe as water,” Poonawala added.

The SII will supply Covishield to the government for Rs 200 per dose. Market cost — when private sales are permitted — would be Rs 1,000 per shot, Poonawala said. Covid national taskforce member Randeep Guleria said a third vaccine could also be available soon as Zydus Cadila received DCGI’s nod today for phase 3 trials of its DNA vaccine candidate.

The SII says it can ramp up production to 100 million doses a month.