Serum, Bharat Biotech vaccines get restricted use approval from DCGI

By Administrator_India

Capital Sands

India’s drug regulator on Sunday gave its final approval to the Oxford-AstraZeneca and Bharat Biotech coronavirus vaccines for restricted use in an emergency situation, giving the country its first two shots for immunising its vast population in the coming weeks.

While the Oxford-AstraZeneca vaccine, manufactured by Serum Institute of India (SII), has 70.42 per cent efficacy, the indigenous vaccine from Bharat Biotech does not have efficacy details because the trials are underway. It is doing a study of 25,800 volunteers and around 22,500 participants have been given at least one jab.

Both vaccines can be stored at 2-8 degrees Celsius and the companies have been stockpiling them for dispatch once the approvals come.

SII has a stockpile of over 50 million doses at the moment and can make 100 million doses per month.

“After an adequate examination, the Central Drugs Standard Control Organisation (CDSCO) has decided to accept the recommendations of the subject expert committee,” said V G Somani, drug controller general of India (DCGI).

While in the short press briefing the DCGI did not take any questions, he said the data from Phase 3 trials in India had shown Bharat Biotech’s Covaxin to be “safe” (according to the data available to date).

Covaxin, however, may be used as a “back-up” vaccine, while the data from ongoing trials is being generated.

India’s drug regulator has allowed restricted use of Covaxin in an emergency situation.

Efficacy data is unblinded once a critical number of Covid-19 positive cases appears in the sample population where some people have received a placebo shot, while others have been given the vaccine. Once a certain number of Covid-19 positive cases happens, the investigators unblind the data to analyse the efficacy of the vaccine in preventing the disease. Therefore, it would take some more time for the data to be generated and the company will have to share it with the regulator on a rolling basis.

Sources in the expert panel indicated some interim data was shared with them for the review.

Meanwhile, SII, which is developing Covishield, the Oxford vaccine, had sought emergency approval for its vaccine on the basis of the interim safety and immunogenicity data from the Phase 2 and 3 trials, conducted on 1,600 participants in the country, along with the findings of overseas clinical studies done on 23,745 participants. The overall vaccine efficacy was found to be 70.42 per cent.

The DCGI has also allowed Zydus Cadila to conduct Phase 3 clinical trials on 26,000 Indian participants for its novel coronavirus vaccine, developed using the DNA platform technology.

Poonam Khetrapal Singh, regional director (Southeast Asia), World Health Organization, in a statement issued soon after the DCGI announcement, said: “This decision will help intensify and strengthen the fight against Covid-19 pandemic in the region. The use of vaccine in prioritised populations, along with continued implementation of other public health measures and community participation, will be important in reducing the impact of Covid-19.”

India is planning to inoculate 300 million people in the first tranche of vaccination. That includes health care workers, front line workers, and those above 50 and those with comorbidities.

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