The World Health Organization has raised unspecified concerns about the manufacturing of Covaxin, one of India’s home-grown COVID19 vaccines.
According to a WHO spokesperson, ANVISA later told the agency that Bharat Biotech had addressed the deficiencies, and in November 2021, WHO awarded the vaccine an emergency use listing. The listing is a prerequisite for a vaccine to be supplied through the COVID-19 Vaccines Global Access Facility, an effort by WHO and two other organizations to provide doses to low- and middle-income countries, and a stamp of approval that helps member countries decide which vaccines to deploy.
But when WHO inspectors visited the plant between 14 and 21 March, they found several GMP deficiencies, some of which overlapped with those identified by ANVISA, according to the spokesperson. The company had changed its manufacturing process after its listing but hadn’t communicated these changes to CDSCO and WHO for evaluation and validation.
Hans Meerburg, a Netherlands-based vaccine-quality consultant, says manufacturers are required to inform drug regulators of any major postapproval changes, because they can impact the safety, efficacy, or quality of the vaccine. “If not, the product may not comply with specifications, such as potency, or the absence of active material,” Meerburg says.
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