The national drugs regulator’s subject expert committee is likely to meet on Friday to consider the application of Serum Institute of India , to use its Covishield vaccine as a booster dose, and an application from Dr Reddy’s Laboratories, for a Phase 3- trial to evaluate the Sputnik-V vaccine’s efficacy as a booster, people familiar with the matter said on condition of anonymity.
“When the subject expert committee meets, the applicants are provided an opportunity to present their case; there may not be a decision on it just as yet,” an official aware of the matter said on condition of anonymity.
The meeting comes even as preliminary data on the Omicron variant of the SARS-CoV-2 virus shows a reduction in the quantum of antibodies produced, suggesting the need for a booster – although the strength of an immune reaction depends not just on antibodies but also on T-cells.
Dr Reddy’s Laboratories, which has a partnership with RDIF, for Suptnik-V, has sought permission from the Central Drugs Standard Control Organisation (CDSCO) to conduct a phase-3 clinical trial to evaluate the efficacy and safety of Sputnik Light vaccine as a booster dose.
Earlier, Serum Institute of India sought approval for Covishield as a booster dose from India’s drugs regulator citing adequate stock of the vaccine in the country and a demand for a booster shot due to the emergence of new coronavirus variants.
In its application, the companythat the United Kingdom’s Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine. Covishield is the India-made version of this vaccine.
Serum Institute of India, as part of its partnership deal with RDIF, will also be manufacturing Sputnik Light in India.
The World Health Organisation’s Strategic Advisory Group of Experts (SAGE) that met on Tuesday to evaluate the need for a booster dose against Covid-19, also recommended that people who are immunocompromised or have received an inactivated vaccine should be prioritized to receive a booster dose.
The chairman, SAGE, Alejandro Cravioto, said in a briefing on Thursday that emerging data showed Covid-19 vaccine efficacy against Covid-19 wanes over time, especially among the older population group.
India’s expert panel on immunisation, National Technical Advisory Group on Immunisation (NTAGI), is currently deliberating the issue of allowing booster dose in the national immunization programme.
“The decision will take place based on the scientific evidence before the panel and what they recommend,” a senior government official said on condition of anonymity.