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JnJ single-shot COVID vaccine shelf life extended by USFDA to 6 months
New Delhi: The U.S. Food & Drug Administration extended the shelf life for Johnson & Johnson's single-shot COVID-19 vaccine to six months from four-and-a-half months, the company said late Wednesday.The FDA's decision is based on data from ongoing studies, which showed the vaccine is stable at six months when refrigerated at 2 to 8 degrees Celsius (36–46 degrees Fahrenheit),...
New Delhi: The U.S. Food & Drug Administration extended the shelf life for Johnson & Johnson's single-shot COVID-19 vaccine to six months from four-and-a-half months, the company said late Wednesday.
The FDA's decision is based on data from ongoing studies, which showed the vaccine is stable at six months when refrigerated at 2 to 8 degrees Celsius (36–46 degrees Fahrenheit), the drugmaker said.
Read also: Covid-19: JnJ, Pfizer yet to apply for license of vaccines in India
In a letter to the company, the FDA said it had completed the review of data provided by J&J, and based on the information submitted, it concurs with the extension.
The agency also said the extension was applicable to batches that might have expired prior to the issuance of the letter provided they were stored at the recommended temperature.
Read also: Despite neurological illness reports, JnJ Covid-19 vaccine benefits outweigh risks: US CDC advisers
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751