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Supply Concerns As India Fast Tracks COVID-19 Vaccines Approved By Certain Regulators

Private Sales Likely But Will Pricing Be Sticking Point?

 
• By Vibha Ravi

In an unusual move prompted by an enormous second wave of infections, India is accelerating approvals for COVID-19 vaccines granted emergency use authorizations by other selected regulators or on the WHO’s emergency use list without a local bridging study. While this seems a prelude to permitting private sales, where will the supplies come from?

Welcome Mat
India Lays Out Welcome Mat For Vaccine Producers As It Looks To Contain The Pandemic • Source: Alamy

With a second wave of COVID-19 hitting India like a tsunami, the government has taken an unprecedented decision of accelerating approvals for vaccines minus a prior bridging study, though a post-approval parallel bridging trial is still required.

The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) recommended the move, which makes vaccines which have received emergency use authorizations from regulators in the US, UK, Europe or Japan, or those on the World Health Organization (WHO)’s emergency use list, eligible for such approvals. This takes the country one step closer to getting Pfizer Inc

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