Long wait: Vaccine makers queue up for WHO approval, shows data
Industry insiders say typically a WHO EUL takes between two months and a year
 "Coronavirus vaccine, Covid-19 vaccines")
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As public interest piques around when a final nod from the World Health Organisation (WHO) would come for Bharat Biotech’s Covaxin, data shows that several other Covid-19 vaccines from around the globe are also waiting for WHO Emergency Use Listing (EUL).
Industry insiders say typically a WHO EUL takes between two months and a year. “During the pandemic, however, this audit process has been expedited. Even then, the Chinese vaccines took five months before they got a final nod from the WHO,” said a senior official at a vaccine firm.
France’s Sanofi, US major Novavax (along with its Indian partner Serum Institute of India), and China’s CanSinoBio, etc., are also awaiting WHO EUL (see chart). These makers have also submitted data around the same time as India’s Bharat Biotech.
Another industry source pointed out that for G-20 nations, the process of review is usually stringent. For countries that have stringent regulators such as the US, UK, Japan, EU, the process is usually faster.
On Monday, the WHO clarified that the timeframe for EUL procedure is dependent on how quickly the company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries. It added that it cannot “cut corners” before recommending a product for emergency use. Bharat Biotech has submitted “one last piece of information” on Monday.
“If the information provided addresses all questions raised, WHO and the Technical Advisory Group (TAG) will complete the assessment and come to a final recommendation on the EUL,” WHO said.
Industry insiders say typically a WHO EUL takes between two months and a year. “During the pandemic, however, this audit process has been expedited. Even then, the Chinese vaccines took five months before they got a final nod from the WHO,” said a senior official at a vaccine firm.
France’s Sanofi, US major Novavax (along with its Indian partner Serum Institute of India), and China’s CanSinoBio, etc., are also awaiting WHO EUL (see chart). These makers have also submitted data around the same time as India’s Bharat Biotech.
Another industry source pointed out that for G-20 nations, the process of review is usually stringent. For countries that have stringent regulators such as the US, UK, Japan, EU, the process is usually faster.
On Monday, the WHO clarified that the timeframe for EUL procedure is dependent on how quickly the company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries. It added that it cannot “cut corners” before recommending a product for emergency use. Bharat Biotech has submitted “one last piece of information” on Monday.
“If the information provided addresses all questions raised, WHO and the Technical Advisory Group (TAG) will complete the assessment and come to a final recommendation on the EUL,” WHO said.
Topics : Coronavirus Vaccine WHO Bharat Biotech