Following the successful conduct of its COVID vaccine, Serum Institute of India is focusing on developing a vaccine for Diphtheria, Pertussis and Tetanus (Tdap).
The company has sought permission to manufacture the vaccines by submitting its Phase 2-3 clinical trial data to an expert panel of the Drugs Control General of India (DCGI).
Over the past two years, Serum Institute mainly focused on the development and manufacturing of Covishield after the outbreak of the pandemic.
“The firm submitted its proposal to allow the manufacture of diphtheria, tetanus, and pertussis vaccines, as well as Phase II-III clinical trial reports, data and safety monitoring board recommendations, prescribing information, and product characteristics. summary of. After detailed deliberations, the committee recommended allowing the manufacture of the Tdap vaccine for the age group of 4-65 years,” 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 should be excluded from it.
Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases—tetanus, diphtheria, and pertussis (whooping cough).
Queries emailed to the spokesperson of the Serum Institute of India and the health ministry did not elicit any response till press time.
According to the SEC panel, the Serum Institute also submitted a proposal for permission to manufacture a meningococcal vaccine, and has submitted Phase II/III clinical trial reports. “After a detailed evaluation, the committee recommended allowing the manufacture of meningococcal vaccine for the age group of 18-85 years.”
The company is also developing the monkeypox vaccine and has filed an application with the Indian Council of Medical Research expressing interest in manufacturing the vaccine.
“Covid is setting in. Therefore, a lot of pharma companies that shifted their human resources to the production of COVID-19 vaccines and its management are now gradually focusing on developing other critical vaccines,” said an official seeking anonymity. Of.
In the meeting, Serum also presented a proposal to seek permission for additional indication of pneumococcal vaccine for doses along with Phase III trial data, the official said.
Last week, SII launched India’s first quadrivalent human papillomavirus vaccine to prevent cervical cancer.
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