The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had a week ago recommended granting a nod for the mix-and-match trial.
The Drugs Controller General of India (DCGI) has granted approval for trials that will mix two different Covid vaccines — Covishield by Serum Institute of India and Covaxin by Bharat Biotech. The study will be conducted by Christian Medical College, Vellore.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had a week ago recommended granting a nod for the mix-and-match trial. Combination of the two different vaccines had not been allowed in the country so far as no such trials were conducted and no data was available regarding the safety and efficacy of such combinations. This will be the first-of-its-kind study in the country and will involve 300 participants.
The approval for the study follows an ICMR study in Uttar Pradesh, where 18 people were given two different doses of the Covid-19 vaccine by mistake in May. They had received Covishield as their first dose and were administered Covaxin as the second dose after six weeks. According to the ICMR study, the vaccine combination was safe and there were no adverse reactions. Also, those who got a mixed dosage of the vaccines demonstrated better immunogenicity that those who had got the same vaccine doses.
The country has administered 52.15 crore vaccines till August 11, of which 45.22 crore were Covishield and 6.41 crore were Covaxin, while the remaining were Sputnik vaccines. There is a shortage of Covaxin with Bharat Biotech’s capacity ramp-up delayed due to technical glitches. Sputnik, too, has faced supply chain challenges. A mix-and-match approval is expected to help in dealing with shortages.
According to the health ministry, the monthly production of Covaxin was projected to go up to 58 million doses per month, while Covishield production was expected to reach 120 million doses a month from September. SII also has plans to make 300 million doses of the Sputnik vaccine.
There are similar studies being conducted globally to assess the safety and efficacy of combining two different vaccines and to see if combination of vaccines worked better that two doses of the same vaccine. Russia Direct Investment Fund has initiated partnerships with other vaccine producers to conduct joint studies of a combination of the first component of Sputnik V with foreign vaccines. They have completed a study of combining the first shot of Sputnik V vaccine with the AstraZeneca-Oxford University vaccine and the interim analysis on immunogenicity demonstrated high safety. There are studies of single dose of the AstraZeneca vaccine combined with the mRNA vaccines from Pfizer or Moderna as second doses and this was found to be effective.