India Pharma Outlook Team | Wednesday, 09 March 2022
Christian Medical College (CMC) Vellore will soon share preliminary results of a study to test the feasibility of mixing Covishield and Covaxin - the two main Covid-19 vaccines available in the country - with the country's drug regulator, a senior official said.
"We have permission from Data and Safety Monitoring Board (DSMB) to unblind our analysis. On Monday, we approached the drug regulator to give us time so that we can present our data before the experts," Winsley Rose, principal investigator of the study, told.
CMC Vellore carried out mixed vaccine study that aims to discover how a fully vaccinated person responds to booster dose of another vaccine, and how such a person responds to a third dose of the same vaccine. Both the studies have been carried out on 200 participants each, Rose said. "These are preliminary results." He did not disclose the findings of the studies. The government has been waiting for their results to take a decision on whether to allow booster shots or not. The Drug Controller General of India had approved the trial in July last year.
In heterologous doses (change in the vaccine) trials, participants vaccinated with two doses of Covaxin receive a booster dose of Covishield while those fully vaccinated with Covishield gets Covaxin.
Earlier CMC Vellore professor Gagandeep Kang had told that the institute was finding it difficult to find enough people to recruit into the study and had reached out to other institutes. India has started giving the same vaccine as the third dose, or precaution dose, to senior citizens, healthcare workers and frontline workers.
Mix and match of vaccines were not given a go-ahead by the government due to lack of data on the effectiveness of a different vaccine. "The government will expand the booster doses to other age groups depending on the data," a person familiar with the matter told.
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. Studies are being undertaken to understand whether mixing two Covid-19 vaccines can result in developing stronger and long-lasting immunity against the infection.
Evidence from studies done in some other countries on heterologous vaccination suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the Covid-19 virus and a higher T-cell response than using the same vaccine (homologous vaccination).
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