The SmPC (Summary of Product Characteristics) for #Covaxin (see the link to Bharat Biotech's website here: bharatbiotech.com/images/covaxin…
has not been updated since the #EUA was granted for use in the 12-18 year age group. It still says (page 1):
has not been updated since the #EUA was granted for use in the 12-18 year age group. It still says (page 1):
"COVAXIN® is indicated for active immunization against SARS-CoV-2 Virus infection for age ≥18years."
The SmPC is a legal document that is part of the approval process. On the question of expiry date, it says:(page 10),
The SmPC is a legal document that is part of the approval process. On the question of expiry date, it says:(page 10),
"6.3 Shelf life
The expiry date of COVAXIN® is indicated on the label and carton of the vaccine. Do not use the
vaccine after the expiration date shown on the label and carton of the vaccine."
The expiry date of COVAXIN® is indicated on the label and carton of the vaccine. Do not use the
vaccine after the expiration date shown on the label and carton of the vaccine."
So, technically speaking, a letter from the drug regulator that extends the shelf life should be seen as a modification of the original EUA and should be reflected in a revised #SmPC that has been approved by the Regulator.
The shelf life extension should ideally have led to recall of batches with the old expiry date and re-issued after testing of samples and re-labeling.
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