DCGI needs more safety data for Covaxin nod for under 12
NEW DELHI: Although India’s drugs regulator allowed Covaxin jabs for restricted emergency use in children aged 12-18 years, it did not do so for younger children despite a recommendation of an expert panel because it wanted to be absolutely sure of the safety aspects, according to people familiar with the matter.
“Safety data is of paramount importance, and the regulator has to be convinced about the data,” a person aware of the matter said on condition of anonymity.
“The safety and other related data that the regulator needed in children, also for a particular time period, he got it in the age group in which the approval was finally granted.”
“In this particular age group (children below 12 years) organs are developing and its impact on that has to be considered,” the person pointed out.
“The safety data was taken for longer period as compared to adults; at least for two-three months more.”
The approval on December 25 from the Drugs Controller
General of India (DCGI) came nearly 10 weeks after the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended Covaxin’s use in children on October 12.
The panel’s job is to make recommendations to CDSCO, but the final call is taken by DCGI.
“In children and pregnant women, the drugs regulator is taking extreme precaution, which does not mean that in other population groups precaution has not been taken,” the person said.
“It is just that when it comes to children, one has to tread even more cautiously. Also, the movement of children is more in this particular age group for which approval has been granted.”
Days after the government allowed the use of Covaxin among the 15 to 18 age cohort, Covaxin’s maker Bharat Biotech said that its vaccine was found to be “safe, well-tolerated, and immunogenic” in the age group of 2-18 years in phase II and III studies.
Neutralising antibodies in children on average were found to be 1.7 times higher than in adults, it said. No serious adverse events were reported during the clinical trials, it added.
“Covaxin clinical trial data from the paediatric population is very encouraging. Safety of the vaccine is critical for children, and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children,” Krishna Ella, chairman and managing director, Bharat Biotech, said on December 30.
As part of the firm’s phase II and III clinical trials and multicentre studies, 374 subjects in the relevant age group were inoculated with two 0.5 ml doses of Covaxin, the same formulation used in adults. The trials in the paediatric population were conducted between June and September last year.
Researchers involved in the trial have said that the report presented data obtained up to four weeks after the second of two vaccinations, but the study was ongoing to collect data up to six months after the last vaccination, which will be reported separately. The data was submitted to CDSCO in October, and received emergency use nod for children aged 12-18 from the drugs controller on December 25.
DEHRADUN: An earthquake measuring 2.5 on the Richter scale hit Bageshwar district on Tuesday, according to National Center for Seismology. The earthquake occurred at 12.05 am around 5 km beneath the surface of the earth.
This is the third earthquake in the state in the past three days. On Monday evening around 7.19 pm, Pithoragarh was hit by an earthquake, measuring 2.8 on Richter scale . On Sunday, earthquake tremors measuring 3.8 on the Richter scale were felt in Chamoli district. This is not the first earthquake in Bageshwar area in recent times. In January last year earthquake measuring 3.3 on the Richter scale hit Bageshwar. In February 2020, Bageshwar was hit by an earthquake of 4.7 on Richter Scale.
At least two persons including a woman and a girl were injured after earthquake hit the district at around 6.30 am, causing panic among the residents who soon came out of their houses, added officials.National Center for Seismology (NCS) is the nodal agency of Centre under earth sciences ministry for monitoring of earthquake activity in the country on 24X7 basis.
Dr Kalachand Sain, director Wadia Institute of Himalayan Studies, said that these small tremors were due to release of accumulated stress in Himalayan region in the area.