Hyderabad-based pharmaceutical company Bharat Biotech will rectify issues raised by the World Health Organization regarding its COVID-19 vaccine – Covaxin – in a few days and added that the company has informed the Comptroller General of Medicines of this development. of India (DCGI) and the Union Ministry of Health, sources said on Monday.
According to sources close to ANI, “Bharat Biotech has informed the Union Health Ministry that it will rectify the issues reported by WHO in 15-20 days.” “The suspension of the World Health Organization (WHO) is not related to safety or efficacy concerns, but is limited solely to supply to United Nations agencies,” sources told Reuters. ‘ANI.
“Received comments…will make these changes. WHO has not said anything regarding safety or efficacy,” Bharat Biotech sources told ANI.
“This is (a WHO post-’emergency use authorization’ inspection) a routine inspection for Covaxin,” the sources added.
According to the sources, the WHO suspension of the supply of Covaxin only affects United Nations agencies. “We are now only providing drop-shipments to other countries and nine others under ‘Vaccine Maitri’,” sources said. They further added that the supply suspension will not impact Covaxin’s vaccine supply.
“We intend to apply for a full license for Covaxin from the WHO,” the Bharat Biotech source said.
Sources further said they have yet to receive a final copy of the official WHO report, and “once we receive the report, we will respond to it.”
Recently, in a statement on the suspension of Covaxin by the WHO, Bharat Biotech said: “For the millions of people who received Covaxin, the vaccine certificates issued are still valid as there is no impact on the efficacy and safety of the vaccine”. Bharat Biotech further stated that the company is slowing Covaxin production for plant optimization and the company will focus on pending maintenance, process and plant optimization activities.
“As all existing facilities were repurposed to manufacture Covaxin, with continued production over the past year, to respond to the public health emergency of COVID-19, these upgrades were due. Some equipment sophisticated equipment, which was needed to improve the rigor of the process, was not available during the COVID-19 pandemic. It should be emphasized that the quality of Covaxin has never been compromised at any time,” the sources said. of the company.
The company also mentioned that it was working on further improvements and upgrades to ensure Covaxin production continues to meet increasing global regulatory requirements.
“Notwithstanding this excellent safety and efficacy record, Bharat Biotech is working diligently for further improvements and upgrades to ensure that Covaxin production continues to meet ever-increasing global regulatory requirements. is the primary consideration for any new vaccine, it may not compromise to achieve operational excellence goals,” the company added.
Hyderabad-based Bharat Biotech’s vaccine Covaxin has been suspended by the WHO as part of the Covax facility, the United Nations health body announced on Saturday, blaming it on shortcomings in vaccine practices. manufacturing.
The WHO today confirms the suspension of the supply of Covaxin produced by Bharat Biotech through the United Nations supply agencies and recommends that countries that have received the vaccine take appropriate measures,” the statement said. WHO in its recent statement. However, the UN body clarified that there will be no issues related to the safety and efficacy of the vaccine.
“The risk assessment to date does not indicate a change in the risk-benefit ratio. The data available to WHO indicate that the vaccine is effective and that there are no safety concerns. For the continuation immunization with alternative sources of COVID-19 vaccines, countries should refer to the respective recommendation of the Strategic Advisory Group of Experts on Immunization (SAGE),” the WHO said.
During the WHO inspection, Bharat Biotech said, “During the recent WHO post-EUL inspection, Bharat Biotech agreed with the WHO team on the scope of planned improvement activities and indicated that they will be executed as soon as possible.” This suspension was made after the inspection of the WHO post-emergency use list which was conducted between March 14 and 22.
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Posted: Monday, April 4, 2023, 11:35 p.m. IST