The SEC asked SII to submit proposals for the above data for any evidence to support the administration of the booster dose in India along with justification for further consideration.
With many nations facing the Omicron variant threat of the coronavirus, the SEC in a recent meeting questioned the justification of the administration of boosters submitted by the Serum Institute of India. It directed the SII to first submit trial data pertaining to Indian demographics.
At a meeting held on 10 December, the Subject Expert Committee under the Central Drugs Standard Control Organisation denied giving permission to Serum Institute of India for administering booster doses.
India Today has exclusively accessed the SEC recommendations on the booster dose application submitted by SII.
What was the reason for denial?
SII had earlier presented the proposal for amendments to prescribing information (PI) of ChAdOx1 nCoV-19 coronavirus vaccine (Recombinant) Covishield. It also sought permission to administer booster (third) dose, six months after the second dose based on the results of phase I/II clinical trials of the Oxford/AstraZeneca vaccine conducted in the UK.
However, the SEC made the following observations and denied permission for the administration of booster doses in India.
1. The SEC committee noted that the firm had presented immunogenicity data of only 75 subjects from the UK study.
2. SII has not presented any data from the Indian population to show the requirement of booster dose based on demographical profile and waning immunogenicity, the interval between the first and second dose, etc.
3. Further, the firm also did not present the proposal for the generation of local clinical trial data for booster (third) dose.
The SEC has, hence, asked SII to submit proposals for the above data for any evidence to support the administration of the booster dose in India along with justification for further consideration.
Meanwhile, it wasn’t just SII. Another Pharma firm, Biological E presented its revised clinical trial protocol to conduct of phase-III clinical trial for the administration of booster dose of its vaccine containing RBD antigen of SARS-CoV-2. The vaccine has completed its phase-3 trial and is awaiting approvals to reach the country’s immunisation programme on Covid-19.
“After detailed deliberation, the committee recommended that the firm should submit complete safety and immunogenicity data of the vaccine and justification for the proposed age group, timing for booster, sample size and increase the frequency of safety monitoring after the second dose. Accordingly, the firm should submit the revised clinical trial protocol for further review by the committee.”
The national technical advisory group on immunisation says that they are yet to formulate a policy on administering a third or a booster dose in the country. Sources have said it will mostly be for those with low immunity or an immunocompromised population first.
There are also deliberations on which vaccine combinations can work as boosters. But nothing has been decided yet.
India has about 40 cases of omicron, the govt is more focused on full vaccination of those above 18 years, a target it needs to complete by this month.