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.
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