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WHO for flexible labelling of Covid vaccine | India News – Times of India

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NEW DELHI: To ensure speedy availability of Covid-19 vaccine once it is approved for use, World Health Organisation (WHO) has recommended universal (standard) label for the shots with flexibilities such as having only ‘manufacturing date’ instead of an ‘expiry date’, QR codes if possible and vials to also carry a statement saying ‘for pandemic use only’.
In India, the National Expert Group on Vaccine Administration on Covid-19 (NEGVAC) is yet to take a call on the recommendations made by WHO’s Regulatory Advisory Group on Covid vaccine. “We are examining the suggestions and will take a call after evaluating them in detail,” said Dr V K Paul, NITI-Aayog member and head of NEGVAC.
“Due to urgent need of access to Covid-19 vaccine post-approval, the fact that doses intended for commercial use are manufactured at risk and the need for flexible allocation of doses, label items will be in a dynamic state at the time when the vial label needs to be finalised. It is critical that this topic is raised now in order for developers to have production ready labels when needed,” WHO said.
Officials said the idea behind providing such flexibility or waivers is because there may not be sufficient data generated to know the exact expiry of the vaccine, while there is a need to expedite the launch of the vaccine in a pandemic situation.
“For expiry date, companies are required to produce stability data for a minimum of six months. However, in a pandemic situation, it may not be in public interest to wait for six months to roll out the vaccine, once it is approved,” a senior regulatory official said, underlining that the efforts are being made to fast track supply of the anti-Covid vaccine once it clears safety and efficacy trials.
At present, there are four vaccines in advanced stage of clinical trials in India which includes Oxford-AstraZeneca candidate which is under Phase 3 trials, Bharat Biotech’s candidate, also in phase 3, Russia’s Sputnik V which has got permission for Phase II/III and Zydus Cadila’s candidate, which is also in advanced stages.



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