Bharat Biotech’s homegrown coronavirus vaccine, Covaxin, will no longer have to carry the “clinical trial mode” label, Dr VK Paul, the head of India’s vaccine administration committee, said on Thursday, according to NDTV. This came a day after the same recommendation was made by the Subject Expert Committee.
The approval from the Drugs Controller General of India means that beneficiaries will no longer have to fill up a consent form. Besides, those who take the vaccine will now not be needed to go through seven-day monitoring by medical teams.
Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology, is one of the two vaccines approved for emergency use in India. The other one is the Oxford vaccine, which is known as Covishield in the country, produced by the Serum Institute of India. Covishield already has this status.
“Covaxin is now in regular emergency use authorisation,” said Dr Paul. “This has taken the authorisation for Covaxin to another level. Both vaccines [Covaxin and Covishield] now have the same intensity of licensure. Therefore, it is a great day. Covaxin has now been given to more than 19 lakh people and there have been only 311 cases of side-effects. Covaxin has stood the test of time.”
The DCGI’s decision is based on the interim efficacy data released by the company. The regulator has asked Bharat Biotech to keep providing it data from its phase 3 trials. It has also directed the company to submit a revised summary of the characteristics of the drug.
“...after detailed deliberation the committee recommended for omission of the condition of the use of the vaccine in clinical trial mode,” the drug regulator said in a letter to the Hyderabad-based company, according to NDTV. “However, the vaccine should be continued to be used under restricted use in emergency situation condition. Further, the ongoing phase 3 clinical trial should be continued as per the approved protocol.”
The development follows Bharat Biotech’s announcement on March 3, that Covaxin had shown an efficacy of 81% in late-stage clinical trials. It was able to bring down symptomatic cases of Covid-19 by nearly 81% in those who were vaccinated as opposed to those who did not receive a shot.
Until now, Covaxin was being administered as an extension to its clinical trial, with the Hyderabad-based vaccine maker requiring to first take informed consent prior to administering Covaxin to healthcare and other frontline workers, senior citizens and those with underlying medical conditions. It also meant that the company needed to make follow-up calls to the beneficiaries to check for adverse effects for at least some period.
Additionally, Bharat Biotech had to submit updates on the safety, immunogenicity and efficacy of the vaccine from its phase 1, 2 and 3 clinical trials more regularly than Serum Institute, which has had to submit such data every 15 days, according to The Indian Express.
This was because the company had not completed the late-stage trial at the time it received emergency use approval on January 3. In fact, many state officials and doctors have refused to take Covaxin before its effectiveness could be proved.
“The company submitted the interim phase 3 trials data three-four days back,” an unidentified official of Central Drugs Standard Control Organisation told the Hindustan Times. “The SEC [Subject Expert Committee] looked into the phase 3 interim data before making its recommendation, which will now need to be cleared by the Drugs Controller General of India.”
Drugs Controller General of India VG Somani will be the one to review the panel’s recommendation, and decide whether the Central Drugs Standard Control Organisation can grant Covaxin this approval.
The change could give a further boost to the vaccination drive by dispelling vaccine hesitancy, President of Public Health Foundation of India K Srinath Reddy told The Indian Express.
The government has distributed to states a total of five crore doses of the vaccines but only 17,28,361 or 6.8% of the 2.52 crore people immunised so far have taken Covaxin, according to government data.
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