Mumbai Whether India should combine COVID-19 vaccines and give a booster dose may be answered by the end of January, as a study examining their effectiveness is nearing its final stages.
Professor Gagandeep Kang, lead virologist and head of the Institute of Medical Research, said that CMC Vellore is nearing the end of its study on mixed doses including Covaxin and Covishield.
Research has shown that combining two different vaccine platforms, such as an mRNA platform and an adenovirus platform (eg; Pfizer and AstraZeneca Vaccine), results in a better immune response to the SARS CoV-2 virus. The India study, the first of its kind, will explore whether the inactivated and adenovirus platforms also provide a similar response.
The study of 1,100 participants that began in August took time because of the mandatory 12-week gap between vaccine doses, an official said on condition of anonymity, adding that initial vaccine shortages prolonged the wait.
The study’s clinical protocol says it aims to explore the benefits of a flexible vaccination program where the second dose is not necessarily the same as the first dose and the vaccine intervals are also similar.
“This study will determine the safety as well as immune responses to mixed administration of Covaxin and vice versa Covishield given at 56+/- 7-day intervals and will compare these two vaccines with the same two-dose administration,” according to the description Mint have seen.
Safety and immune response will also be determined following mixed booster dose administration of available vaccines after an interval of 3-6 months after the second dose.
The second phase of the study on the combination of booster doses is now recruiting participants.
The US Food and Drug Administration has recommended combining Johnson & Johnson vaccine (an adenovirus vaccine) with Moderna’s mRNA vaccine as part of its boosting strategy. In October, an FDA advisory stated that “a single booster dose of any of the available COVID-19 vaccines should be administered as a heterogeneous booster dose after completion of primary immunization with a different available COVID-19 vaccine.” … the eligible population(s) and the dosing interval for a heterogeneous booster dose is the same as that authorized for the booster dose of the vaccine used for primary immunization”.
Despite demand by healthcare workers citing their high risk, India is yet to decide to give a booster dose.
But unlike other countries, which have based their booster strategy on available data, India has not released any data on the effectiveness of a population-level vaccine.
“There is no incentive for vaccine manufacturers to conduct studies such as vaccine effectiveness; That’s why we need the government to conduct a study like this so that we can make an informed decision on boosters and population level immunity,” Kang said.
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