NIE plans study on booster for those with comorbidities

The Indian Council of Medical Research's NIE has proposed to conduct phase-2 safety and immunogenicity study specifically on people with comorbidities such as HIV, cancer and those on dialysis.

Chennai-based National Institute of Epidemiology (NIE) has approached India's drug regulator for granting approval to conduct a study to evaluate the impact of third dose of Covid-19 vaccines on people with comorbidities.

The Indian Council of Medical Research's NIE has proposed to conduct phase-2 safety and immunogenicity study specifically on people with comorbidities such as HIV, cancer and those on dialysis.

According to the proposal, the study will evaluate the safety profile of both homologous and heterologous boosters.


"The institute proposes to evaluate both the regimens," said a senior government official, who did not wish to be identified.

The study will evaluate the effectiveness of vaccines in comorbid people. "In the study one set of participants will get a booster dose of the same vaccine as that of the primary dose and another set would get a different vaccine as booster than the primary vaccine," said the official.

The study will be conducted on both Covishield and Covaxin as boosters. The subject expert committee under the drug regulator will review the proposal in its next meeting.
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India has started giving the same vaccine as the third dose of booster or precaution dose of vaccine and no mix-and-match has been allowed, as of now.

This means, those who have received Covishield as their first and second dose have been receiving Covishield as their third dose. Similarly, those who have received Covaxin in their first two doses have been receiving Covaxin as the third dose.

The mix-and-match approach was not given a go-ahead by the government due to lack of data on the effectiveness of a different vaccine.

The Centre had earlier said that as more data is received about a heterologous approach in the administration of vaccines, decisions will be taken accordingly.
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