Covaxin may see higher uptake post authorization
2 min read 10 Mar 2021, 05:31 AM ISTConfidence among states in using the jab may go up after phase 3 trial results are out
PremiumUptake of the domestically developed covid-19 vaccine Covaxin may significantly increase as states that have been cautious about administering it become more confident after a full regulatory emergency licensure is given to it.
Bharat Biotech International Ltd, the manufacturer of Covaxin, has submitted its interim data on the vaccine, which showed 81% efficacy, to the Drugs Controller General of India (DCGI) V.G. Somani and a subject expert committee (SEC) may scrutinize it soon, a person aware of the matter said.
“It (Bharat Biotech) has submitted interim efficacy data to the DCGI and the SEC will soon meet to decide whether to recommend a full emergency use authorization to Covaxin," the person quoted above said.
On Monday, Bharat Biotech’s indigenously developed vaccine got another boost when its phase 2 trial results were published in The Lancet, a prestigious peer-reviewed journal, in which immune response against covid-19 was seen in 96% of the people who got the higher dose of the vaccine. The study also showed that after two doses, local and systemic adverse reactions observed in both vaccine groups were minimal.
“The probability of experiencing a side effect was 10-12%, which is six-times lower than other emergency use authorized vaccines," a spokesperson for Bharat Biotech said on Tuesday.
Experts have said that they are already seeing an increase in registrations for vaccinations at hospitals such as Delhi’s All India Institute of Medical Sciences (AIIMS) where Covaxin is being administered after Bharat Biotech last week announced its interim phase 3 trial data that showed the vaccine has an efficacy of 80.6%.
“Possibly, confidence among doubters is going up after the 81% interim efficacy data was reported by Bharat Biotech and some senior political leaders of the country have taken it. So, it also makes people believe that it is efficacious. To that extent, I think uptake will increase. Once the trial is completed and phase 3 trial results are out, the confidence will go up further," said K. Srinath Reddy, president of Public Health Foundation of India.
Reddy said his peers at hospitals such as AIIMS have also said that uptake has increased since last week.
The increased interest in Covaxin also comes amid questions over the efficacy of Serum Institute of India’s (SII’s) Covishield for the four-week dosage interval. Covishield has an efficacy of 53% if two full doses are given four weeks apart, according to SII’s package insert for the vaccine. A four-week gap is followed by the Indian government. However, a study published in the Lancet on Saturday showed Covishield could have an 81.3% efficacy if there was a 12-week gap between two doses.
The Union health ministry does not provide a breakup of how many Covaxin and Covishield doses are being administered on a daily basis. So far, more than 1.5 million people have received Covaxin, while more than 15 million people have received Covishield, according to government data on the CoWin website.
The low uptake of Covaxin is primarily on account of some states such as Chhattisgarh being hesitant to use Bharat Biotech’s jabs because of lack of efficacy data earlier.
This may change if the vaccine gets an emergency authorization on par with Covishield. A day after Bharat Biotech announced the efficacy results for Covaxin, Chhattisgarh health minister T.S. Singh Deo tweeted his satisfaction at the result.
“We hope that the DCGI will notify and publish the Phase 3 results in a few days and place Covaxin out of the clinical trial mode so that we can start its use in Chhattisgarh," Deo tweeted on 4 March.
