The Made-In-India vaccine manufacturer, Bharat Biotech, may have to face a delay in getting approval from the Indian drug regulator for Covaxin.
According to Economic Times, the vaccine manufacturer might get the requisite approval till next year since the phase three trial has not been completed. A senior government official while speaking to the publication stated that until the company carries out follow-up studies and furnishes data on the amount of protection the vaccine can provide, full licensure cannot be granted.
Phase Three Trials
Bharat Biotech on Tuesday, June 22, submitted data from Covaxin's phase three trials to the Central Drugs Standard Control Organisation (CDSCO). Covaxin has shown a 77.8 per cent efficacy against coronavirus.
The trial was carried out on 25,800 volunteers, and the results were submitted to the Subject Expert Committee (SEC) of the CDSCO.
"The required data was submitted by the company, and the subject expert committee went though it today. The experts were satisfied with the results presented, and the vaccine efficacy is confirmed at 77.8%," a government official told Hindustan Times.
However, the SEC did not accept the company's proposal seeking full licensure for the vaccine and recommended the continuation of its emergency authorisation.
Covaxin For Emergency Use
Bharat Biotech had a pre-submission meeting with WHO (World Health Organization) on June 23. The manufacturer submited phase two and three trial data and receive guidance from WHO authorities before the final submission. The listing will help Covaxin get recognition in more countries and agencies.
On June 17, Bharat Biotech had dismissed the news report that said that the company had already shared phase three trial data with WHO.