J&J, Pfizer To Gain As India Fast Tracks COVID-19 Vaccines Approved By Other Regulators
Supplies A Concern, Private Sales Likely
J&J and Pfizer should benefit from India’s unusual move to grant accelerated approvals minus a prior local bridging study for COVID-19 vaccines granted emergency use authorizations by certain regulators or on the WHO’s emergency use list. But while this seems like a prelude to permitting private sales, where will the supplies come from?
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The WHO has granted an emergency listing to Novavax's COVID-19 vaccine, paving the way for wider use along with a new approval in the EU this week. The protein-based product has also just been filed in Japan, where Moderna's mRNA shot has been newly cleared for booster use.
India has waived the need for local clinical trials for COVID-19 vaccines already approved in certain other countries, while the WHO has added a Chinese vaccine to its emergency use list. Meanwhile, South Korea issues new guidance for local vaccine trials and Japan gives more money to COVAX.
Prices for J&J and Pfizer’s COVID-19 vaccines will be watched closely as India permits private sales. While demand is set to spike with age criteria for those eligible to receive the shots expanded, local manufacturers Serum Institute and Bharat Biotech are ramping up capacities with the government’s help.