The #WHO on April 2 issued a statement saying the supply of #Covaxin to UN agencies had been suspended due to "deficiencies in good manufacturing practices". There were not mny details. In an email, they have now told @TheWireScience the following : science.thewire.in/health/who-cov… (1/n)
"Problems were detected in some parts of the manufacturing process. SOME CHANGES WERE MADE after the emergency-use license was granted but were not submitted to the national drug regulator and WHO for evaluation and validation."
The WHO still didn't specify what were those changes. Whether those changes were related to increase the yield, or on the front of raw materials or due to some other reason--we don't know. A GMP expert said major changes, if done post approval, have to be informed.
WHO also said, "The inspections observation indicated that there are gaps in the quality assurance mechanisms and hence the need to take precautionary measures until the gaps have been addressed." (The measure being the suspension of supply; asking countries to take app action)
Again, the WHO didn't specify what those "gaps"were. When further prodded, the WHO advised that I should seek further information from #BharatBiotech because disclosing more details would mean breach of confidentiality on the part of WHO.
The WHO didn't say anything if the findings of Brazilian regulator and its own were similar at any point. However, it did say this was first onsite inspection of Covaxin manufacturing facility.
Sent a detailed questionnaire to Bharat Biotech on advise of WHO, asking it about the UN body's statement and few questions about the company's own press release issued a day prior to WHO's statement release. Went unanswered; as were the questions sent to #DCGI.
The role, or rather absence of any role of DCGI, whatsoever, has baffled experts. Covaxin is the first and only EUL Covid vaccine against which the WHO's has issued such a kind of statement; still the regulator has not said about its follow-up actions. It has remained silent.
When I asked WHO what facility upgrade is it expecting the Bharat Biotech to undertake, it said a CAPA plan will be prepared by the company concerned only and submitted to the regulator, DCGI. They will be coordinating with him. Any other action is mandate of DCGI, it said.
What some experts also wondered was why WHO had not given more details of its inspection, and, on the other hand, it suspended the supply to UN agencies. The experts felt that WHO ought to have more transparent in the interest of people. More science.thewire.in/health/who-cov… (n/n)
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