Corbevax gets approval as booster after Covishield and Covaxin
The Corbevax vaccination slot can be booked through the Co-WIN app or Co-WIN 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. BE has supplied 100 million doses of the vaccine to the Government of India so far.
New Delhi: India’s drugs regulator on Saturday approved Hyderabad-based Biological E’s anti-Covid vaccine as a heterologous booster dose for adults having already taken two doses of Covishield or Covaxin vaccine, according to a company statement, making it the first vaccine to have been approved as booster.
“CORBEVAX® COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose to individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccines for restricted use in emergency situation. BE’s CORBEVAX® is the first such vaccine in India to be approved as a heterologous COVID-19 booster,” said the company in a statement.
Recently, BE furnished its clinical trials 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,” said a senior government official aware of the matter, requesting anonymity.
According to people familiar with the matter, clinical trial data showed that Corbevax booster dose provided significant enhancement in immune response and excellent 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 Mahima Datla, managing director, Biological E. Limited.
The company has 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 6 months prior to the administration of Corbevax as a booster dose.
The booster dose of Corbevax increased the neutralizing 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.
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 the company, Corbevax heterologous booster vaccine 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.
The Corbevax vaccination slot can be booked through the Co-WIN app or Co-WIN 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. BE has supplied 100 million doses of the vaccine to the Government of India so far.
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.