India has started vaccinating teenagers, continuing its largest inoculation drive to further protect individuals from the COVID-19 virus. As the decision to inoculate teens was seen as a welcoming move, some factions were spreading misinformation and creating panic to hinder the vaccination drive.
Last week, Prime Minister Narendra Modi had announced that Covid-19 vaccination for children between 15-18 years of age will be rolled out from January 3. According to official estimates, there are approximately 10 crore children in this age group. On day one of the vaccination drive, over 40 lakh individuals between 15-18 ages received their first dose of COVID-19 vaccine, which is a remarkable feat for India. Many more lakhs continue to get inoculated.
In the face of this drive, the news of Covaxin's shelf life extension was received with much doubt and criticism. Many feared that teens were getting vaccine shots from an expired Covaxin vial. But the truth is far from it.
Note: Covaxin is the only vaccine available for vaccination of teens now.
Covaxin shelf life debate
The Central Drugs Standard Control Organisation (CDSCO) on December 24 granted emergency use authorisation to the indigenously-developed Covaxin for children above 12 years of age. In November, the India's drug regulator had approved the extension of shelf life of indigenously-developed Covid-19 vaccine Covaxin from nine to 12 months, from the date of manufacture.
"This approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO. The shelf life extension has been communicated to our stakeholders," Bharat Biotech had explained at the time.
It was initially given permission for sale and distribution of Covaxin with a shelf life of six months when stored at two to eight degrees Celsius. The CDSCO later gave its approval for extending the shelf life to nine months after Bharat Biotech submitted updated accelerated and real-time stability data of Covaxin.
Even though some vials would carry the old print of 9-month shelf life, it is to be noted that Covaxin is safe to administer for up to 12 months from the date of manufacture under advised storage conditions. To further allay the fears of people, Bharat Biotech has started picking up unused stock from hospitals to re-label the shelf life from 9 to 12 months.
Furthermore, CDSCO had also noted that an opened vial of Covaxin can be stored at 2-8 degree Celsius for up to 28 days and need not be discarded immediately after one use or one day.
It is also worth pointing out that the shelf life of Covishield has also been extended by the national regulator from 6 months to 9 months on February, 2021.
Allaying people's fears
Due to this, some people, especially parents were concerned that their children were getting expired vaccine. In light of the above facts, it is completely false. In fact, Union Health Ministry even issued a clarification on the matter.
"There have been some media reports alleging that expired vaccines are being administered in India under its national COVID-19 vaccination programme. This is false and misleading and based on incomplete information," the official statement said.
Ashok Malik, Policy Advisor, Ministry of External Affairs, further explained that extension of vaccine shelf life is "routine and scientific." Drug regulators in other countries have also extended shelf life since the COVID-19 vaccines are constantly being researched upon to determine how long they remain stable.
Covaxin vaccines had expiry dates extended in November 2021. This was routine and scientific, similar to extensions for many other Covid-19 vaccines in many other countries. As a parent who got his child vaccinated this morning, I would urge caution against social media alarmism https://t.co/K2CxwYJW97— Ashok Malik (@MalikAshok) January 3, 2022
For anyone questioning the reason behind such decisions, the FDA had said that COVID-19 vaccines authorised for emergency use do not have fixed expiry dates as the products are not approved under biologics license application and are still being studied. Even the FDA had approved the extension of J&K's COVID vaccine shelf life by six weeks in June and then again for a total of six months in July.
Based on the data produced by vaccine makers, the respective drug regulators of any country will take a decision to either approve or reject extension of shelf life. But for the ones approved by CDSCO in India, COVID-19 vaccines past their initial expiration date are not unsafe and shouldn't fuel vaccine hesitancy.