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India clears Corbevax as a booster dose for adults
Corbevax can be administered as a Covid-19 booster dose for individuals aged 18 years and above, six months after they have been administered the second doses of Covishield or Covaxin, the DCGi said.
New Delhi: India’s drugs regulator has approved Hyderabad-based Biological E’s anti-Covid vaccine Corbevax as the first mix-and-match booster dose for adults, the company said in a statement on Saturday.
It said that the Drug Controller General of India (DCGI) approved Corbevax as a Covid-19 booster dose for individuals aged 18 years and above, six months after they have been administered the second doses of Covishield or Covaxin. “BE’s Corbevax is the first such vaccine in India to be approved as a heterologous Covid-19 booster,” the statement said.
A heterologous booster dose is different from the primary vaccine administered. So far, the mixing of Covid-19 vaccines was not allowed in India — the booster dose had to be the same as the first two doses.
The Corbevax vaccination slot can be booked through the Co-WIN app or web portal. 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.
Biological E recently furnished its clinical trial data to the national drugs regulator, VG Somani, who after a detailed evaluation and deliberations with the Subject Experts Committee of central drugs standard control organisation granted approval.
“The clinical trial data was satisfactory on all counts, and after much deliberation, it was decided that the approval is going to be beneficial for those who take it as third dose,” a senior government official said, asking not to be named.
According to people familiar with the matter, clinical trial data showed that a booster dose of Corbevax provided significant enhancement in immune response and good safety profile required for an effective booster.
“We are very happy with this approval, which will address the need for Covid-19 booster doses in India. We have crossed yet another milestone in our Covid-19 vaccination journey. This approval reflects once again the sustained world class safety standards and high immunogenicity of Corbevax,” said Biological E Limited managing director Mahima Datla.
Corbevax is developed and manufactured by Biological E Limited in association with Texas Children’s Hospital and Baylor College of Medicine as a recombinant protein sub-unit vaccine against Covid-19.
In February, the DCGI gave emergency use authorisation (EUA) to Corbevax for children between the ages 12-14 years. In April, the drug regulator gave the vaccine EUA for the 5-12 years age group.
BE has supplied 100 million doses of the vaccine to the government so far.
In October last year, the company conducted a multicentre Phase 3 placebo-controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age who were previously vaccinated with two doses of either Covishield or Covaxin at least six months prior.
The Corbevax booster dose increased the neutralising antibody titers in the Covishield and Covaxin groups significantly when compared to placebo, according to the company.
In a subset of subjects evaluated for nAb (neutralising antibodies) against the Omicron variant, the Corbevax booster shot resulted in a significant increase in the nAb titers against the Omicron variant. After the booster dose of Corbevax, Omicron nAbs were observed in 91% and 75% of subjects who had received primary vaccination by Covishield and Covaxin, respectively.
The Corbevax booster dose also resulted in significant Th1 skewed cellular immune response as indicated by cytokine expression analysis post stimulation of the T-cells.
According to Biological E, the Corbevax heterologous booster was well tolerated and safe. There were no severe or adverse events of interest for three months of follow-up after the booster dose was administered.
