On Monday, India celebrated a milestone when it administered the first dose of the COVID-19 vaccine to over 41 lakh children in the age group of 15 to 18 years on the first day of the inoculation drive for this group of beneficiaries.
However, the celebrations were a bit marred when reports surfaced about 'expired' COVID-19 vaccines being administered, which the government refuted, calling them 'false and misleading'.
So, what’s the deal about COVID-19 vaccines? Do they have an expiry date? Here’s all we know.
What’s the row about?
As India began its coronavirus vaccination for children on 3 January, reports emerged that COVID-19 shots that expired in November were being administered to the teenagers.
A concerned parent in Gurugram posted on the same, asking why her son was being given an 'expired' vaccine. Navanita Varadpande on Twitter wrote that she had taken her son to a vaccine centre in Gurugram, Haryana on Monday where the officials were administering 'expired' vaccines. When she raised the issue, a letter was displayed wherein the shelf life of the jabs was shown to be extended.
I need the secret recipe to expand shelf life. So that the shelf life of idli and dosay batter can be extended to keep them forever in the fridge. https://t.co/J7Tjn8PN93
— Shree D N🇮🇳 (@Chilipili) January 3, 2022
Her post quickly went viral, prompting the Centre to step in and issue a clarification.
The Centre dismissed the report of the 'expired' vaccines, saying the national regulator had approved the shelf life extension of Covishield and Covaxin in February and October, 2021 respectively.
"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 health ministry said in a statement.
The Central Drugs Standard Control Organisation (CDSCO) had on 25 October 2021, in response to Bharat Biotech International Limited's letter approved the extension of shelf life of Covaxin (Whole Virion, Inactivated Coronavirus Vaccine) from nine months to 12 months, the ministry said.
Similarly, the shelf life of Covishield has been extended by the national regulator from six months to nine months on 22 February 2021.
The expiry extended
The shelf life of Bharat Biotech's Covaxin was extended by the CDSCO late last year based on the availability of additional stability data, which was submitted to CDSCO.
The Hyderabad-based company was given permission for the sale and distribution of Covaxin with a shelf-life of six months when stored at two to eight degrees Celsius. “Now, we are herewith applying for the extension of shelf-life from six months to 24 months when stored at two to eight degrees Celsius," the firm had said in its application to the Drugs Controller General of India.
What does the 'shelf life' of vaccines mean?
Vaccines are usually complex and expensive, tend to be less stable than chemicals and more vulnerable to temperature changes. Like other medicines, vaccines too, come with an 'end date', meaning till when can it be stored and used on patients.
In India, the drug agency performs numerous stability assessments to determine how long a particular drug product can remain safe and effective, which is known as its shelf life.
“Shelf life is determined by checking potency and concentration of substances within any given pharmaceutical product,” Naor Bar-Zeev, PhD, deputy director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health was quoted as saying. “The shelf life of different vaccines differs on the basis of their ingredients and manufacturing process.”
Can the shelf life of a vaccine be extended?
When vaccines are developed, manufacturers continue to perform stability assessment studies to ensure ongoing monitoring of how long the vaccines will remain safe and effective for use.
With each passing month, scientists are given a longer period in which to evaluate vaccines in real-time, allowing them to observe if a vaccine's shelf life can be extended.
Crystal Tubbs, PharmD, the associate director in the department of pharmacy at The Ohio State University Wexner Medical Center, explained to VeryWellHealth.com, "Since we have the opportunity to study the vaccines over longer periods of time, it is not a surprise that expiration dates have been extended.”
Has the shelf life of other vaccines been extended?
Besides Covaxin and Covishield, America’s Food and Drug Administration (FDA) had extended the shelf life of the Johnson & Johnson single-dose COVID-19 vaccine from four-and-a-half months to six months in July 2021.
With inputs from agencies