Bharat Biotech will address WHO concerns about Covaxin as soon as possible

*Paromita Das

According to sources, Bharat Biotech will soon address WHO concerns about Covaxin.

Bharat Biotech, a Hyderabad-based pharmaceutical company, will address the World Health Organization’s concerns about its COVID-19 vaccine, Covaxin, in the coming days, according to sources. The company has also informed the Drugs Controller General of India (DCGI) and the Union Health Ministry about this development.

“Bharat Biotech has informed the Union Health Ministry that it will resolve the issues raised by WHO within 15 to 20 days,” ANI reported, citing sources.
“The suspension of the World Health Organization (WHO) is not related to safety or efficacy issues, but rather to supply for United Nations agencies,” sources said.

“I’ve received some feedback… I’ll make the necessary changes. WHO has made no statements about safety or efficacy “According to Bharat Biotech sources.

“It’s a routine inspection for Covaxin (WHO post-‘Emergency Use Authorization’ inspection),” sources added.

According to sources, the WHO has suspended the supply of Covaxin only to UN agencies. “We are now only doing direct supplies to other countries and nine others under ‘Vaccine Maitri,'” according to sources. They also stated that the suspension of supply will have no effect on the supply of Covaxin vaccine.

“We intend to apply to the WHO for full licensure of Covaxin,” a Bharat Biotech source said.
According to sources, they have yet to receive a final copy of the WHO’s official report, and “once we receive the report, we will respond to it.”

Bharat Biotech recently stated in response to WHO’s suspension of Covaxin, “For the millions who have received Covaxin, the vaccine certificates issued remain valid as there is no impact on the efficacy and safety of the vaccine.”

Bharat Biotech has also stated that the company is slowing Covaxin production in order to optimize the facility, and that the company will focus on pending facility maintenance, process, and facility optimization activities.
“These upgrades were overdue because all existing facilities had been repurposed for the manufacture of Covaxin, with continuous production over the previous year to meet the public health emergency of COVID-19. During the COVID-19 pandemic, certain highly sophisticated equipment that was required to improve process stringency was unavailable. It should be noted that the quality of Covaxin was never jeopardised at any point in time “According to company sources.

The company has also stated that it is working on additional improvements and upgrades to ensure that Covaxin production continues to meet increasing global regulatory requirements.
“Despite this excellent safety and efficacy record, Bharat Biotech is working hard to make additional improvements and upgrades to ensure that Covaxin production meets the ever-increasing global regulatory requirements. Because patient safety is the most important consideration for any new vaccine, there can be no compromises when it comes to meeting operational excellence goals “Further, the company added.

The vaccine Covaxin, manufactured by Hyderabad-based Bharat Biotech, has been suspended by WHO under the Covax facility, the UN health body announced on Saturday, citing deficiencies in manufacturing practices.
“The WHO is today confirming the suspension of supply of Covaxin produced by Bharat Biotech through UN procurement agencies and recommending to countries that received the vaccine to take appropriate actions,” the WHO stated in a recent statement, adding that there will be no issues with the vaccine’s safety and efficacy.

“To date, the risk assessment does not indicate a change in the risk-benefit ratio.” The data available to the WHO indicate that the vaccine is effective and that there are no safety concerns. “Countries should refer to the respective Strategic Advisory Group of Experts on Immunization (SAGE) recommendation for continuation of vaccination with alternative sources of COVID-19 vaccines,” the WHO said.
Bharat Biotech responded to a WHO inspection by saying, “During the recent WHO post-EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practicable.”

This suspension came as a result of the WHO post-emergency use listing inspection, which took place between March 14 and March 22.