WHO approves Biological E as additional manufacturing site for J&J Covid Vaccine
New Delhi, June 22: US Embassy in India congratulated Biological E. Limited, a Hyderabad-based vaccine manufacturer company for getting approval from World Health Organisation as an additional manufacturing site for the Janssen/Johnson and Johnson Covid-19 vaccine.
"Congratulations to @biological_e on its @WHO approval as an additional manufacturing site for the Janssen/Johnson & Johnson COVID-19 vaccine! Great progress for the Quad Vaccine and #USIndiaHealth partnerships through U.S. technical support and @DFCgov financing," US Embassy in India said on Twitter.
Biological E. Limited had previously announced that its Corbevax Covid-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous Covid-19 booster dose for individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in an emergency situation.
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A statement issued by the company read, "The BE's Corbevax is the first such vaccine in India to be approved as a heterologous Covid-19 booster. Recently, BE has furnished its clinical trials data to the DCGI who after a detailed evaluation and deliberations with the Subject Experts Committee granted their approval for administering the Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin."
According to the release, Biological E's clinical trial data demonstrated that the Corbevax booster dose significantly improved immune response while maintaining the high level of safety required for an effective booster.
Biological E. Limited's managing director, Mahima Datla, said, "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."
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-PTC News
