After Serum Institute, Bharat Biotech seeks emergency use nod for Covaxin in India
NEW DELHI: The Serum Institute of India (SII) has sought emergency use authorization for the Covid-19 vaccine by AstraZeneca-Oxford University from the Central Drugs Standards Control Organisation, after US-based drug maker Pfizer applied for the approval of its coronavirus vaccine in the country.
“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD,” tweeted SII CEO Adar Poonawala on Monday.
“This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support,” he wrote.
Government officials said that the vaccine, developed from adenovirus which is a common cold virus, will be the first preventive option against Covid-19 available in India and it could be administered to the first priority group comprising healthcare workers beginning the next month.
Though the company has not revealed the details of the application sent to the regulator, sources said that it will submit the full analysis released by AstraZeneca-Oxford last month which showed that their vaccine candidate was 70% effective on average in a late-stage trial in the UK and Brazil.
As per the details shared, one dosing regimen given to 2,741 volunteers had shown the efficacy of 90% when the vaccine was given as a half dose, followed by a full dose at least one month apart and another dosing regimen, given to 8,895 individuals showed 62% efficacy when given as two full doses, one month apart.
In India, a phase 2/3 trial being conducted on 1600 individuals however is aimed at looking for the only immunogenicity and not for actual protection against Covid-19 as per the vaccine's trial design.
Also, as the trial in India involves the dosing regimen with two full doses, the regulator can accept just the 62 % efficacy and the bridging immunogenicity from SII and grant the approval for restricted use, officials told The New Indian Express.
As per the rules, any changes in a vaccine dosing and s
Schedule are treated as a new drug application in India and it essentially means needing to repeat the studies with the new dose. However, the new clinical trials rules, 2019 also say that the regulator can skip any or all stages of clinical trials, said a source in the CDSCO.
Meanwhile, experts stressed that even with the lowered efficacy, the vaccine can be counted as “safe and effective”.
“Even the lowest efficacy results of the vaccine are at 60-70%. This makes it a viable vaccine against the virus,” said a vaccine scientist with a government institution.
“However, it is likely that varied age groups with different dosage forms will result in slight variations and efficacy,” he said.
The scientist also pointed out that there are differences in the primary endpoints of the 3 clinical trials in India for Covid-19 vaccine by SII -- Russia’s Sputnik V for which Dr Reddy’s Laboratories is the Indian partner and indigenously developed vaccines candidates such as the ones by Bharat Biotech and Zydus Cadila.
“While the SII gets away with antibody data from only 450 of 1600 individuals being tested, Dr. Reddy’s Laboratories will only assess volunteers for safety while Covaxin by Bharat biotech is being evaluated for protective efficacy from coronavirus in 26,000 individuals,” he added.
After SII, Bharat Biotech seeks approval for emergency use of Covaxin
Following applications by SII and Pfizer, Bharat Biotech, whose Covaxin is in the most advanced stage of clinical trials among the indigenously developed Covid-19 vaccines, has also applied for emergency use authorisation, official sources said on Monday.
The applications by all three pharmaceutical majors will be considered for approval through an acceleration evaluation process and the decisions are likely within two weeks, sources also said.
Covaxin, based on inactivated SARS CoV2, as of now is in the third stage of trial in India and is being tested on 26,000 individuals but the emergency use authorisation has been sought based on safety and immunogenicity data generated in phase 1 and 2 trials.