The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has recommended granting emergency use authorization (EUA) to Bharat Biotech’s Covaxin for vaccination of 2 to 18-year-olds against covid-19. Mint explains:
What has the panel recommended?
The SEC has recommended emergency use of Covaxin for children under the covid-19 national immunization programme. Bharat Biotech has submitted data from clinical trials in the 2-18 years age group to the CDSCO. The data has been reviewed by the CDSCO and the SEC, who have given positive recommendations. The trials showed that the safety and immunogenicity of Covaxin are almost the same in children and adults. As the recommendations are subject to certain conditions, the SEC said, the firm should continue the study as per the approved clinical trial protocol.
Why is vaccinating children important?
In India, a third wave of coronavirus infections are anticipated. This wave may impact children as they are the only population group left unvaccinated. India has more than 50% of its population below the age of 25; the 0-14-year age group constitutes 28.6% of the total population. The Drugs Controller General of India (DCGI) has already given the EUA to the world’s first DNA vaccine by Zydus Cadila which will also be used to vaccinate 12 to 18-year-olds. Vaccination of children may lead to the reopening of more schools and colleges and thereby cut learning losses.
What are the next steps in terms of regulation?
The next step is for DCGI-CDSCO to go ahead with a regulatory approval. In the private markets, the vaccination would depend on paediatricians and parents, according to Bharat Biotech. Meanwhile, the Union health ministry has said that India may start inoculating children against covid-19 from October. However, an official announcement is awaited.
Why should one trust Covaxin for kids?
Bharat Biotech has completed phase-2 and -3 trials of Covaxin on children below 18 years of age. Covaxin is already approved for adults and in clinical trials, has demonstrated 77.8% efficacy against symptomatic coronavirus disease and 93.4% against severe symptomatic covid-19. Clinical trials were carried out among three age groups—12 -18 years, 6- 12 years, and 2-6 years. The final results of these trials are awaited and the interim results have been submitted to the drug controller.
What sort of Covaxin stocks are needed?
The 2-18 years age group in the country is estimated at about 400-500 million, so the company would need to produce twice as many doses. In September, Bharat Biotech said it would scale up production from 35 million to 55 million doses in October. The firm has partnered with Indian Immunologicals and Hester Biosciences to ramp up production. The capacity could increase to 100 million doses if all safety parameters are in place and the manufacturing partners are prepared.
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