Thread by @Banjotkaur

Though #BharatBiotech is now waiting to launch an all new intranasal vaccine against #Covid_19 pending regulator's nod, its problems with #Covaxin are still far from over ever since #WHO suspended its supply for UN agencies in April (1/n) science.thewire.in/health/exclusi…

It's 4 months into suspension already but WHO is still not satisfied with company's good manufacturing practises (GMPs), it told me last Friday, sharing its assessment of corrective and preventive action (CAPA) plan submitted by company in June. Here's what the WHO exactly said:

"In summary, based on the said CAPA response, the manufacturing site for Covaxin is still considered to be operating at an unacceptable level of compliance with WHO Good Manufacturing Practices for Pharmaceutical Products guidelines,"

On suspension, it said: “[Since the CAPA report has not been accepted] there is no ground to lift the suspension or to initiate any procurement for UN agencies."

WHO also said its assessment of CAPA response had been communicated to @CDSCO_INDIA_INF on July 14 and further details could be gathered from it only or from #BharatBiotech. Wrote to both of them; seeking details and their response to WHO's assessment. None replied, once again.

WHO said in the latest reply, as it said in April to me, CDSCO officials had JOINED WHO inspectors in March inspection.But when I asked govt to share the March inspection report,@MoHFW_INDIA replied my RTI on July 20 saying 'no info available'.

CDSCO works under @MoHFW_INDIA.

This was not surprising because @PriyankaPulla's RTI application filed with CDSCO in April seeking a copy of the report had met the same fate when the regulator plainly denied having any information about WHO's inspection.

https://twitter.com/PriyankaPulla/status/1527578567793868802

Can #Covaxin lose WHO's EUL status? It will depend on further responses of company and WHO's assessment of revised CAPA if at all it is submitted. But there is a possibility of revocation of EUL in case there are issues with QUALITY as per August update of EUL guidelines of WHO:

Even IND foreign ministry had apparently warned Vinod Paul in April itself to get the issue resolved, not doing which may lead to revocation of EUL status. It may affect international travel. science.thewire.in/health/bharat-…. Although it denied next day as being quoted 'out of context.

For those who had expressed doubts why #BharatBiotech, in first place, should have informed #WHO about changes in manufacturing process post-licensure, here's explanation. (It was not doing that 'precisely' that led to WHO's stricture and suspension against the company in April).

More in @TheWireScience's latest story: science.thewire.in/health/exclusi…

Here's @TheWireScience's April story going into details of WHO's suspension on Covaxin's supply to UN agencies: science.thewire.in/health/who-cov… (n/n)

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https://twitter.com/svaradarajan/status/1561331825665904640?t=8wkPLXhHsKUVl3ft78iaOg&s=19