SII plans Diphtheria, Tetanus, Pertussis vaccine

The company has submitted its phase 2-3 clinical trial data to the Drugs Control General of India (DCGI)’s expert panel seeking permission to manufacture the vaccines.

In the last two years, Serum Institute primarily focussed on developing and manufacturing Covishield following the outbreak of the pandemic.

“The firm presented its proposal for grant of permission to manufacture Diphtheria, Tetanus and Pertussis vaccines, along with phase II-III clinical trial report, recommendations by Data and Safety Monitoring Board, prescribing information, and summary of product characteristics. After detailed deliberation, the committee recommended to grant permission to manufacture Tdap vaccine for the 4-65 year age group,” according to the minutes of the meeting reviewed by Mint.

The panel however directed SII to submit a revised summary of product characteristics and product information summary of product characteristics, indicating that pregnant women must be excluded from it.

Tdap is a combination vaccine that protects against the three potentially life-threatening bacterial diseases—tetanus, diphtheria, and pertussis (whooping cough).

Queries emailed to Serum Institute of India and health ministry spokesperson did not elicit any response till press time.

According to the SEC panel, Serum Institute also presented a proposal seeking permission to manufacture Meningococcal vaccine, and has submitted phase II/III clinical trial report. “After detailed evaluation, the committee recommended grant of permission to manufacture Meningococcal vaccine for 18-85 year age group.”

The company is also developing a monkeypox vaccine and has filed an application before the Indian Council of Medical Research expressing interest to manufacture the vaccine.

“Covid is setting down. So, a lot of pharma companies who shifted their human resources in the production of covid-19 vaccines and its management are now gradually focussing in developing other important vaccines,” said an official seeking anonymity.

At the meeting, Serum also presented a proposal seeking permission for additional indication of pneumococcal vaccine for dose along with phase-III trial data, said the official.

Last week, SII launched India’s first quadrivalent human papillomavirus vaccine to prevent cervical cancer.

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The company has submitted its phase 2-3 clinical trial data to the Drugs Control General of India (DCGI)’s expert panel seeking permission to manufacture the vaccines.

In the last two years, Serum Institute primarily focussed on developing and manufacturing Covishield following the outbreak of the pandemic.

“The firm presented its proposal for grant of permission to manufacture Diphtheria, Tetanus and Pertussis vaccines, along with phase II-III clinical trial report, recommendations by Data and Safety Monitoring Board, prescribing information, and summary of product characteristics. After detailed deliberation, the committee recommended to grant permission to manufacture Tdap vaccine for the 4-65 year age group,” according to the minutes of the meeting reviewed by Mint.

The panel however directed SII to submit a revised summary of product characteristics and product information summary of product characteristics, indicating that pregnant women must be excluded from it.

Tdap is a combination vaccine that protects against the three potentially life-threatening bacterial diseases—tetanus, diphtheria, and pertussis (whooping cough).

Queries emailed to Serum Institute of India and health ministry spokesperson did not elicit any response till press time.

According to the SEC panel, Serum Institute also presented a proposal seeking permission to manufacture Meningococcal vaccine, and has submitted phase II/III clinical trial report. “After detailed evaluation, the committee recommended grant of permission to manufacture Meningococcal vaccine for 18-85 year age group.”

The company is also developing a monkeypox vaccine and has filed an application before the Indian Council of Medical Research expressing interest to manufacture the vaccine.

“Covid is setting down. So, a lot of pharma companies who shifted their human resources in the production of covid-19 vaccines and its management are now gradually focussing in developing other important vaccines,” said an official seeking anonymity.

At the meeting, Serum also presented a proposal seeking permission for additional indication of pneumococcal vaccine for dose along with phase-III trial data, said the official.

Last week, SII launched India’s first quadrivalent human papillomavirus vaccine to prevent cervical cancer.

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First article