WHO suspended Bharat Biotech’s Covaxin cause of technical GMP deficiencies. Following Red tape and procedural traps, the UN’s Covid vaccine supply to poorer countries will be affected.
The World Health Organisation (WHO) on Saturday, 2nd April suspended the supply of Bharat Biotech’s Covaxin to UN Procurement agencies. The WHO cited GMP deficiencies as the cause for the suspension and clarified that the vaccine efficiency is not questionable and no safety concerns exist. According to World Health Organisation “The data, available to WHO, indicate the vaccine is effective and no safety concerns exist”.
Bharat Biotech had said the day earlier, to temporarily slow down its production of Covaxin for facility optimization. The World Health Organisation said that there will be interruptions to the Covaxin supply because of the suspension of production for exports.
As per the TOI report WHO statement said, “ Bharat (Bharat Biotech) has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DGCI) (Indian Regulatory Authority) and WHO. In the interim, as a precautionary measure, Bharat (Biotech) has indicated its commitment to suspend its production of Covaxin for export.”
Good Manufacturing Practices (GMP) are the practices required to conform to the guidelines recommended by authorizing agencies. The normal route for vaccine clearance pre-covid took around 4-5 years minimum but the Covid pandemic forced the procedure to be fast-tracked and certain regulatory procedures were eased or side-lined and vaccines were given Emergency Use Listing (EUL). To avoid any discrepancies or side effects of vaccines the World Health Organisation regularly conducts EUL inspections and in the recent EUL inception on March 14-22,2022, it had found certain GMP deficiencies in Covaxin, but the WHO didn’t give details of GMP deficiencies.
Countries preferred India over WHO
In a time of crisis what people don’t need is flip-flop policies and politicians giving unscientific advice just to please their masters. Well, the exact opposite happened during the Corona Pandemic. WHO to court China made a tweet saying that no clear evidence of human-to-human transmission was found. This tweet didn’t age well and the world paid the price for Chinese-WHO callousness and criminal bond.
Preliminary investigations conducted by the Chinese authorities have found no clear evidence of human-to-human transmission of the novel #coronavirus (2019-nCoV) identified in #Wuhan, #China🇨🇳. pic.twitter.com/Fnl5P877VG
— World Health Organization (WHO) (@WHO) January 14, 2020
Later also World Health Organisation had many times changed its stance on travel advisories, curative treatments, bearing masks, the aerial transmission of the virus, etc. More than hundreds of nations bypassing the WHO advisories requested India to send medical supplies.
The WHO failed to prevent the pandemic and was clueless about medication, curative treatment etc and worse of all patted the Chinese back when it should have asked for more clinical data about the virus and patient zero. The WHO also failed to analyse the actual cause of Covid origin and the World Health Organisation team visited China to probe the Covid-Origin after months had passed since the pandemic began.
The cases may be low right now in many countries and vaccination coverage is high in Western, rich nations and in our country as well but the low coverage in Africa and other poorer nations is still a cause of worry as the virus mutations are rapid and may even render the vaccination success ineffective. This suspension by WHO is more of a technical reason or a bureaucratic hurdle and is like a mental blockade to follow the procedure as it is instead of pushing on the success, the WHO’s move seems to be laid back, comical and tragic at the same time.