In its latest communication to the government, Pfizer has also thanked the Government of India to have agreed to its request for procurement through a central government pathway and to discuss the Indemnity and Liability protection . The timely alignment and execution of the draft Heads of Terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the Distribution and Supply Agreement, the company told the government while seeking fast-tracking the regulatory pathway to help it supply Pfizer s COVID-19 vaccine as expeditiously as possible to India .
Pfizer has said India should rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study. The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed.
Coronavirus News LIVE Updates: Our Vaccine Highly Effective on New Covid Variant, Suitable for 12 Yrs & Above, Pfizer Tells Govt
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Pfizer seeks fast-track approval for vaccine; says it s highly effective against India COVID-19 variant
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