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DCGI Approved a Drug and Two Vaccines. Officials Have Now Sidelined Them.

DCGI Approved a Drug and Two Vaccines. Officials Have Now Sidelined Them.

An employee at Serum Institute of India removes vials of Covishield from a visual inspection machine inside a lab, March 2021. Photo: Reuters/Francis Mascarenhas

  • The DCGI recently approved the vaccines Covovax and Corbevax and the antiviral drug molnupiravir for emergency-use in the country.
  • But top government officials have indicated that the vaccines won’t be able to participate in the country’s COVID-19 vaccination drive anytime soon.
  • ICMR chief Balram Bhargava also enumerated multiple problems, in his telling, with the drug molnupiravir.
  • These statements raise questions about the DCGI’s basis of approving molnupiravir and purpose of approving Covovax and Corbevax.

New Delhi: At 4 pm on January 5, top members of India’s COVID-19 response programme and vaccination drive organised a press conference to answer questions about issues on these fronts.

As the event progressed, two points of contention emerged that underscored uncertainties about the vaccines and drugs India plans to include as part of its national epidemic response.

It seems that the Drug Controller General of India’s (DCGI’s) three most recent approvals, which Union health minister Mansukh Mandaviya celebrated as well, have now been put on the backburner.

If statements by Indian Council of Medical Research (ICMR) director-general Balram Bhargava and NITI Aayog member (health) Vinod K. Paul at the presser are any indication, the antiviral drug molnupiravir and two protein subunit vaccines – Covovoax and Corbevax – are not going to be included in the Centre’s treatment protocol and the country’s COVID-19 vaccination drive any time soon.

The vaccines

At the press conference, and in reply to a question about Corbevax, Paul said it is “technically” an option still available for India’s adult population, since the DCGI has approved it, but that 90% of the country’s population has already received its first dose, in the form of Covishield or Covaxin.

“It is in trial for paediatric use,” Paul added, referring to Corbevax. Its maker “has” or “will file an application to get a nod for starting trial as a [booster dose].”

He didn’t formally exclude it from the country’s vaccination drive but also said there is no clarity as yet about how it will be used in India.

“We can also export it for the benefit of larger humanity,” Paul said.

In addition, there is no data in the public domain on Corbevax’s efficacy. At the presser, Paul said he didn’t have the data either but claimed that the DCGI had found its efficacy to be “impressive and clinically relevant”.

Corbevax was originally developed at the Texas Children’s Hospital’s Centre for Vaccine Development in Houston, and is being manufactured under licence by Hyderabad-based Biologicals E.

But Paul didn’t say anything vis-à-vis Covovax.

However, he did make another announcement that, for the time being, effectively rules out the use of Covovax in India. He said those eligible for booster doses – currently frontline workers and the elderly – will receive a “homologous” booster. That is, those who got Covishield for their primary doses will receive Covishield as the booster, and so also among Covaxin recipients.

Given the extant coverage of Covishield and Covaxin, Covovax is effectively out, at least for now.

“The data on use of mixed vaccines is yet to pour in,” Paul added.

However, virologists Gangandeep Kang, Shahid Jameel and others have said that Covovax could be a good booster shot should the government go with a heterologous (i.e. mix and match) boosting regimen.

Covovax has been developed by Novavax, a US-based biotechnology company, and the Coalition for Epidemic Preparedness Innovations (CEPI). Novavax licensed Serum Institute of India to produce its vaccine, called Covovax in India. The WHO placed Covovax on its list of vaccines available for emergency-use worldwide in December 2021.

(Notably, CEPI, WHO and Gavi are the agencies managing COVAX – the global initiative created to ensure countries with lower purchasing power aren’t beset by vaccine shortages.)

Corbevax is still to get WHO approval.

The antiviral drug

At the time it was made, the DCGI’s decision to approve Merck’s antiviral drug molnupiravir last month was a big-ticket announcement.

However, at the presser, ICMR chief Bhargava ruled out a place for the drug in India’s official COVID-19 treatment protocol, citing a long list of safety concerns.

“It can cause teratogenicity – the ability to cause deformities in foetuses; it may create new variants (of COVID-19) too, known as mutagenicity. It can cause cartilage damage and can lead to damaging muscles,” Bhargava said.

According to him, the drug was trialled in the US with ‘only’ 1,433 individuals who hadn’t been vaccinated. “So there are concerns about past infections, vaccination history, pregnancy, lactation, soft-tissue injury, reproductive age group,” etc. He also said no major country other than the US has included molnupiravir in their respective clinical protocols.

Not including a drug in the government’s official treatment protocol means doctors working in government facilities won’t be able to prescribe it. However, since the DCGI has approved it, at least seven pharmaceutical firms in India have readied themselves to roll it out in the market, and will now have to hope that doctors in the private sector will prescribe it.

Dr Reddy’s, for example, has been manufacturing molnupiravir under the brand name ‘Molflu’ and has priced a five-day course at Rs 1,400.

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