New Delhi: It took Bharat Biotech just a day and new data to convince the government’s expert panel to change its mind on approving the Covid-19 vaccine candidate Covaxin for use, albeit conditional.
The company had also cited the UK variant of the Covid-19 infection, a fast-spreading mutation of the SARS-CoV-2 virus, when it submitted the vaccine for consideration again on 2 January.
Covaxin, India’s indigenous Covid-19 vaccine, is a collaborative effort between the Hyderabad-based Bharat Biotech, known for its low-cost vaccines, and the Indian Council of Medical Research (ICMR).
The vaccine was drawn into a controversy after the country’s apex drug regulator, Drug Controller General of India (DCGI), gave the “conditional nod” despite incomplete Phase 3 trial results data.
The subject expert committee (SEC) — the panel of experts which recommend the approval or rejection of new drugs to the DCGI — wasn’t convinced about approving the vaccine initially, according to the minutes of the meeting uploaded Tuesday.
In a meeting on 1 January, the expert panel had decided that “efficacy (of Covaxin) is yet to be demonstrated”. After detailed deliberation, it also recommended that the firm “should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval”.
However, on 2 January, the panel gave its approval after Bharat Biotech “requested” it to consider their vaccine for the new mutated strain and submitted fresh data.
“In light of the recommendations of the committee dated 01.01.2021, the firm further presented the updated data, justification and requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection.”
The minutes of the meeting do not explain on what points the vaccine maker provided the “justification”.
U-turn on Covaxin
In the first meeting of the panel, experts analysed the company’s “safety and immunogenicity data”, including data on serious adverse effects from the Phase 1 and Phase 2 clinical trial along with data from the ongoing Phase 3 clinical trials in the country.
The committee noted that the vaccine has the “potential to target mutated coronavirus strains” and “the data generated so far demonstrates a strong immune response…,” it said while concluding that “the efficacy is yet to be demonstrated”.
However, just a day later, on 2 January, the panel said “the firm further presented the updated data, justification and requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection”, according to the minutes.
“The firm presented the safety and efficacy data from a non-human primate challenge study where the vaccine has been found to be safe and effective.”
Considering this data, the SEC changed its mind and gave the approval for using the vaccine as a backup in India’s immunisation program.
“…After detailed deliberation, the committee recommended for grant of permission for restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” the minutes stated.
Further, the panel advised: “The firm shall continue the on-going Phase III clinical trial and submit data emerging from the trial as and when available.”
Malini Aisola, co-convenor, of a public health NGO, All India Drug Action Network (AIDAN), said the panel’s reversal was perplexing.
“We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended while apparently discounting the need for efficacy data as the condition of the approval,” she said.
Conditions for Oxford-AstraZeneca approval
According to the minutes also uploaded Tuesday, Pune-based Serum Institute of India (SII) had submitted a revised factsheet and prescribing information of the Oxford-AstraZeneca vaccine in the Indian context as required by the committee for further consideration. The vaccine has been granted emergency use authorisation in the United Kingdom.
The panel considered the data which was used by the UK’s health regulator, Medicines and Healthcare products Regulatory Agency (MHRA), for their approval. The panel also reviewed the conditions and restrictions imposed by the agency.
The committee noted that the safety and immunogenicity data presented by the firm from the “Indian study is comparable with that of the overseas clinical trial data”.
“Considering the serious nature of the COVID-19 pandemic emergency situation, there is an urgent need for a vaccine in the country. After detailed deliberation, the committee recommended for grant of permission for restricted emergency use of the vaccine.”
Some of the top conditions for the approval included providing a factsheet and separate leaflet along with the vaccine for the guidance of the healthcare provider. Also, SII has been asked to ensure that the factsheet for the vaccine recipient or his attendant should be provided prior to administration of the vaccine.
Further, SII should disseminate the instructions and educational material including factsheet, storage instructions etc., on their website. It has also been asked to submit latest data from time to time and report the side-effects, if any, registered by the company.