Vaccine maker Bharat Biotech on Tuesday stated it was in talks with at the very least 4 firms for switch of know-how to supply Covaxin, however solely state-owned Indian Immunologicals is able to begin manufacturing the vaccine quickly. was.
“Technology transfer to Indian Immunologicals is underway, and we expect that they will start manufacturing the vaccine very soon. The Indian government has presented three other companies to us for technology transfer, and we are in discussions with them as well. But these are slightly behind the curve, as none of them have manufacturing facilities yet,” a prime official of the Hyderabad-based firm instructed The Indian Express.
The official stated the corporate is producing round 25 million doses of Covaxin each month at its Hyderabad-based unit, and manufacturing at different facilities, together with the not too long ago acquired one at Ankleshwar in Gujarat, “is likely to start in a few months now.” Okay”.
In earlier statements, the corporate has stated that it plans to extend its manufacturing to 700 million doses yearly, or about 60 million doses a month.
The official stated the corporate was actively pursuing the trail of acquiring a Biologics License Application (BLA) for Covaxin to enter the United States market, as emergency use authorization (EUA) was granted by the US Food and Drug Administration. Its utility for a similar had beforehand been turned down. this month.
“This was not really a refutation of the EUA, and it was not specific to Bharat Biotech’s product. The US FDA has decided that they will not issue an EUA after June. So, no company is eligible. When we are ready with phase-3 efficacy data, we will proceed with biologics license application in the US. A clinical trial or a small bridging study may be needed, which we need to do among children. are planning,” he stated, including that the agency had additionally initiated discussions with potential US companions for the switch of know-how and manufacturing of Covaxin within the United States.
The official stated Covaxin had been obtained by the European Union in 14 nations, together with markets similar to Brazil, Argentina and Mexico, and a number of other others have been being pursued.
“We have applied to 50 other countries, and some have said that our clinical trial data were sufficient, some others have told us their slightly different requirements,” he stated.
An Emergency Use List (EUL) with the World Health Organization was additionally pending, he stated, including that “our phase-3 efficacy data will be available in July, and we expect to process our application for the EUL after that.”
The EUL is a prerequisite for Covaxin to be included within the world COVAX facility, which is buying vaccines on behalf of a whole lot of nations with the purpose of creating it accessible to all at an inexpensive price.
.
With inputs from TheIndianEXPRESS
