Covaxin receives nod for trials on children
India’s drug regulator has given Bharat Biotech the permission to conduct clinical trials of its Covid-19 vaccine, Covaxin, on children between the age of 2 and 18, paving way for the first coronavirus inoculation to be tested in minors in the country.
According to officials who asked not to be named, the drugs regulator acted on the recommendations by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation’s (CDSCO) which was in favour of the trials, though with certain conditions.
The move comes as experts in India have underlined the need to vaccinate people below the age of 18 since there cannot be a proper opening up until the entire population is protected.
Bharat Biotech and Serum Institute of India, which produces Covishield, are the makers of the two Covid-19 vaccines approved in India in January.
US regulators this week gave emergency use authorisation to Pfizer-BioNTech’s Covid-19 vaccine for children aged between 12 and 15. The vaccine was already being administrated to those above 16. Canada became the first country in the world to approve Pfizer’s Covid-19 vaccine for ages as young as 12 on May 5.
“The panel [SEC] approval is for the phase II/III trials under certain conditions,” an official privy to the matter said, requesting anonymity.
The second interim phase-3 analysis of Covaxin has shown 78% efficacy, although the data is yet to be peer-reviewed and published.
As part of the SEC recommendation, the company was asked to submit the interim safety data of phase II clinical trials along with the data safety and management board recommendations to the CDSCO before it intended to proceed to seek permission for phase III of the trials.
The trials will evaluate Covaxin for safety, reactogenicity, or a subset of adverse events, and immunogenicity, which relates to how well a vaccine works. All these parameters are necessary for a vaccine to get approval for use.
The trials are expected to involve 525 participants at hospitals including Patna and Delhi’s All India Institute of Medical Sciences (AIIMS).
Covaxin, the first Covid-19 vaccine developed in India, was made following a partnership between Bharat Biotech and the Indian Council of Medical Research. It is a whole virion inactivated vaccine, which uses a weakened or deactivated virus (Sars-Cov-2) responsible for the disease to trigger immunity against it.
In February, Bharat Biotech approached the regulator with a proposal to conduct phase 3 Covaxin trials on people in the 5-18 age group. But the company was asked to return with the efficacy data of its vaccine in adults first before testing on people in this younger group. Bharat Biotech was also asked to submit a revised clinical trials protocol for children at an SEC meeting held on February 24.
“After detailed deliberation, the committee recommended that the firm should submit efficacy and safety data of the ongoing Phase III clinical trial in adults along with the age subgroup analysis. The design of trial should be revised to Phase II/III. Sample size and other consequential changes should be made to the protocol, accordingly. Accordingly firm shall submit revised clinical trial protocol for review of the committee,” the minutes of the February 24 meeting read.
In the subject expert committee meeting held on April 23, Bharat Biotech presented the second interim safety and efficacy data of the phase III clinical trials of Covaxin among adults in the country.
On Tuesday, May 11, SEC again heard the company’s proposal of conducting trials among children, and granted the requisite approval for conducting trials.
Bharat Biotech did not comment on the development at the time of going to press.
Experts said it’s high time to get data on how the vaccines behave in children. “We need quick data and some analysis of risk-benefit for children,” said Dr Randeep Guleria, director, AIIMS, Delhi.