WHO approved Biological E Limited as additional production location for Johnson & Johnson’s COVID-19 vaccine

The US Embassy in India congratulated Biological E. Limited, a pharmaceutical and vaccines firm located in Hyderabad, on receiving WHO permission as an extra production site for the Janssen/Johnson and Johnson COVID-19 vaccine.

“Congratulations to @biological e on being approved by the World Health Organization as an extra production site for the Janssen/Johnson & Johnson COVID-19 vaccine! Through US technical assistance and @DFCgov funding, the Quad Vaccine and #USIndiaHealth collaborations have made significant progress “The US Embassy in India sent a tweet. Previously, on June 4, Biological E.

Limited announced that the Drug Controller General of India (DCGI) has approved its Corbevax COVID-19 vaccine 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.

“The BE’s Corbevax is the first such vaccine in India to be licenced as a heterologous COVID-19 booster,” according to a statement made by the pharmaceutical and vaccine business. Biological E recently provided clinical trial data to the DCGI, which granted approval for administering the Corbevax vaccine as a heterologous booster dose to people who have already received two doses of either Covishield or Covaxin after a thorough evaluation and deliberation with the Subject Experts Committee.”

According to the release, clinical trial data from Biological E indicated that the Corbevax booster dosage delivered considerable improvement in immune response as well as the good safety profile necessary for a successful booster.

Biological E. Limited’s Managing Director, Mahima Datla, stated, “We are delighted with this clearance, which will fulfil India’s requirement for COVID-19 booster dosages.

We’ve reached a new milestone in our COVID-19 immunisation journey. This clearance supports Corbevax’s continued world-class safety standards and high immunogenicity.”

“Biological E has conducted a multicenter Phase III placebo-controlled heterologous booster clinical trial in 416 subjects aged 18 to 80 years 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 statement continued.

According to the pharmaceutical business, the Corbevax booster dosage significantly boosted neutralising antibody titers in the Covishield and Covaxin groups when compared to the placebo.

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“The Corbevax booster injection resulted in a substantial rise in nAb titers against the Omicron variant in a subgroup of participants assessed for nAb against the Omicron variant.”

“Omicron nAbs were found in 91 percent and 75 percent of participants who had received primary immunisation with Covishield and Covaxin, respectively, after the booster dose of Corbevax,” according to the release.

According to the company’s statement, the Corbevax booster dosage also resulted in a strong Th1 biassed cellular immune response as demonstrated by cytokine expression analyses post-stimulation of the T-cells.

“The Corbevax heterologous booster vaccination was well accepted and proven to be safe. For the three months following the booster dosage, there were no serious or adverse events of interest “said the statement

The Corbevax vaccination session may be reserved through the Co-WIN app or web. Corbevax has been provided to 51.7 million children across the country, with 17.4 million completing the two-dose schedule. BE has provided the Government of India with 100 million doses of Corbevax.

“Corbevax is a recombinant protein subunit vaccine against COVID-19 developed and manufactured solely by Biological E. Limited in collaboration with Texas Children’s Hospital and Baylor College of Medicine,” the statement ended.

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