Covaxin has been in question since it was approved for restricted emergency use by the CDSCO expert panel as issues remain with its approval without clear evidence from Phase III clinical trials evaluating the effectiveness of the vaccine.
Covaxin was developed by Bharat Biotech in collaboration with the Indian Medical Research Council (ICMR) and the National Institute of Virology (NIV) Pune.
- Data that Bharat Biotech produced data on safety and immunogenicity for the Covaxin approval
DCGI said that Bharat Biotech produced data on safety and immunogenicity in various animal species, such as mice, rats, rabbits, Syrian hamsters, and also conducted challenge studies on non-human primates (Rhesus macaques).
The regulator added that Phase I and Phase II clinical trials have been performed in approximately 800 subjects and the findings have shown that the vaccine is safe and offers a strong immune response.
- Why is it approved before the third phase trial?
The DCGI stated that Covaxin was approved as an extensive precaution in the “clinical trial mode” in the public interest to provide more options for vaccination, particularly in cases of mutant strain infection. The clinical trial of the firm will proceed in the world.
Dr Harsh Vardhan, Minister of Health and Family Welfare, said Covaxin’s approval is a “monitored approval” with strict follow-up and ongoing review.
- Central Government Disapproved the authorisation of Covaxin for children below 18 years of age-
The central government reportedly disapproved of the authorisation of Bharat Biotech’s Covid vaccine – Covaxin – for children under 18 years of age in the latest development a day before the massive national vaccination campaign against the Covid-19 virus.
The Drug Controller General of India (DCGI) had previously approved the use of the vaccine for children over 12 years of age.
According to a letter from the Office of the Deputy Secretary to the Ministry of Health of the Union, the comparative fact sheet for the two indigenous vaccines – the other being the ‘Covishield’ of the Serum Institute of India – indicated that the Center did not prescribe the emergency authorisation of these drugs for those under 18 years of age.
Since granting permission for emergency use of medicines, DCGI has granted authorisation for children over 12 years of age.
“Active immunization against Corona Virus Disease (Covid-19) over 12 years of age when administered at two dose intervals of day 0 and day 28,” read the document of permission to the Hyderabad-based Bharat Biotech signed by the DCGI.
“We were told about the provision and soon it was revised on the condition that the vaccines would only be administered to recipients over 18 years of age,” a senior official at CDSCO reportedly said.
- No Consent And No Follow-Up
In the meantime, a number of complaints involving infringements of various protocols of human clinical trials have been submitted by Covaxin volunteers in Bhopal’s People’s Medical College and Hospital, one of the 26 Phase III clinical trial sites of Bharat Biotech.
Trial participants in Bhopal, who were also victims of the 1984 gas disaster, claimed “severe violations” of the model code of conduct for the trials, including lack of consent and no follow-up to their health following the occurrence of adverse reactions after the first dose at a specific clinical trial site.
Notably, a 45-year-old trial participant in Bhopal also died nine days after taking his first Jab at People’s Hospital on December 21. However, Bharat Biotech claimed in a statement that the death was “thoroughly investigated” and that it was found to be “not related to vaccine or placebo” The Madhya Pradesh government panel also ruled out any “lapses” from the hospital in the case of death.
