Corbevax gets approval as heterogenous vax, but isn't listed on CoWin

Company had issued a press release on June 4 where it said DCGI has approved Corbevax as a heterologous Covid booster dose to individuals aged 18 and above after 6 months of primary vaccination

The National Technical Advisory Group of Immunisation (NTAGI) is yet to review any data on using Corbevax as a heterologous booster shot after two doses of Covishield or Covaxin, sources revealed. The vaccine, which was approved as a heterologous booster by the Drugs Controller General of India (DCGI), is thus not yet available on Co-WIN as an option for precaution shots. 

A senior member of the NTAGI said the Union Ministry of Health decides the agenda for meetings, and the matters that need NTAGI review. “The health ministry has not yet asked us to look into the matter of Biological E vaccine Corbevax as a heterologous booster. There is a meeting scheduled for the end of this month, but the agenda for it is not firmed up yet,” said the source.

The person further added that in some cases the Union Health Ministry can also take a call on whether this vaccine will be used in the private market as a heterologous booster shot. NTAGI does not usually call companies to present data before them suo-moto, unless it is part of the review agenda set by the Ministry of Health. 

While the Hyderabad-based company had issued a press release on June 4 where it said the DCGI has approved Corbevax as a heterologous Covid-19 booster dose to individuals aged 18 and above after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishield, the Union Health Ministry has not issued any communication in this regard.

“Recently, BE has furnished its clinical trials data to the DCGI, which, after detailed evaluation and deliberations with Subject Experts Committee, granted their approval for administering Corbevax as a heterologous booster dose to those who have already taken two doses of either Covishield or Covaxin. BE’s clinical trial data showed that Corbevax booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster,” the company said. 

The Corbevax vaccination slot can be booked through the Co-WIN app or Co-WIN portal, Biological E had said.

When asked about why the Co-WIN is not yet showing Corbevax as an option, a company source said the approval has its own process and that they were waiting to hear from the government on the matter. 

Private hospitals, however, are in a wait-and-watch mode. No large corporate hospital has placed large orders of Corbevax. “We are using Covaxin and Covishield. Co-WIN does not show this as an option yet, and so we want to wait for clarity,” said the COO of a corporate hospital, who did not wish to be quoted. 

Vaccine industry insiders feel that since adult precaution doses are to be administered only in private vaccination centres, the Union Health Ministry may not involve NTAGI in the process, if it so wishes. “The NTAGI takes a call on how public money will be spent on vaccination, and thus decides the national immunisation policy. There are several vaccines that are approved by the DCGI and available in the private market, which are not part of the National Immunisation Mission. These are non-Covid vaccines of course,” said the MD of a vaccine company. He further added that during Covid19 pandemic, vaccination policies have been centrally decided, and thus before taking a major step of mixing vaccines, the health ministry is likely to consult experts in the NTAGI. 

The NTAGI is also reviewing data from several institutions including CMC, Vellore, on mixing vaccines. No decision on the matter has been taken yet. 

BE has conducted a multicentre Phase-III placebo-controlled heterologous booster clinical trial in 416 subjects from 18-80 years, who were previously vaccinated with two doses of either Covishield or Covaxin at least six months prior to the administration of Corbevax as a booster dose.

The company claimed that the booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly when compared to placebo. There were no severe or adverse events of interest for 3 months of follow-up after the booster dose was administered, it added.

“After the booster dose of Corbevax, Omicron nAbs were observed in 91 per cent and 75 per cent of subjects who had received primary vaccination by Covishield and Covaxin, respectively,” Biological E said, adding that the Corbevax booster also resulted in enhanced cellular immune response.

So far, 51.7 million doses of Corbevax have been administered to children across the country, including 17.4 million who have completed the two-dose regimen. BE has supplied 100 million doses of Corbevax to the Government of India.