Three days after Bharat Biotech issued a public statement in response to DH's queries on its 28-day open vial policy, the state government in a press release issued on Thursday clarified that opened Covaxin vials cannot be used for 28 days for the lack of vaccine vial monitors (VVM) on them.
The VVM is a circular sticker with a small square inside it. It can be printed on a product label, attached to the cap of a vaccine vial or tube, or attached to the neck of an ampoule. The inner square of the VVM is made of heat-sensitive material that is light at the starting point and becomes darker with exposure to heat.
DH on December 20 had reached out to Covaxin manufacturer Bharat Biotech seeking clarification on their 28-day open vial policy as no government or private vaccination centre had any knowledge of it. Bharat Biotech in response issued a public statement saying Covaxin vials once opened can be used for up to 28 days if stored between 2 and 8 degrees Celsius.
In its public statement, it has also said that its vials can be used for up to one year as its shelf life has been extended. Bharat Biotech had not responded to DH's queries on taking back Covaxin vials, even for relabelling purposes.
The state government said, "Ministry of Health and Family Welfare has clarified regarding open vial policy and shelf life of the Covaxin."
In a press note issued on Thursday, the state government said, "Ministry of Health and Family Welfare (Immunisation division), Government of India, in its letter dated December 23 has clarified regarding open vial policy and shelf life of the Covaxin vaccine manufactured by Bharat Biotech under Covid-19 vaccination programme."
"The open vial policy for Covaxin vaccine has not been allowed as it is not possible to ensure quality implementation of open vial in the absence of Vaccine Vial Monitor (VVM). Secondly, all vaccines including Covid-19 vaccine should not be utilised beyond the expiry date mentioned on the label of each vaccine vial," the press note added.
Attached in the press note was also a copy of the letter conveying the same to the Mission Director, National Health Mission, Karnataka, written by Dr Pradeep Haldar, Advisor, Reproductive and Child Health, Immunisation Division, Ministry of Health and Family Welfare.
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