As India began vaccinations for children aged 15-18 on Monday, 3 January, a number of parents have raised concerns over 'expired' doses of Covaxin being given to the eligible teens.
Parents and others have accused the government of "experimenting on kids" by administering vaccines beyond their original expiry date to the young population.
The central government has, however, challenged the reports of expired doses being administered to children, and has maintained that the expiry date for the vaccines had been previously revised after approval from authorities.
Covaxin, the only COVID-19 vaccine permitted for kids in India, has a shelf life of 12 months – recently revised from the previously stipulated period of 9 months.
What are the parents' concerns? What has the government said? Is the extension of the expiry date valid? Has the expiry date for other vaccines been changed in the past? What do experts say?
Here's what you need to know.
'Expired' Covaxin Doses for Kids?: Govt's Reply & Facts of 'Extended' Shelf Life
1. What Are the Concerns of the Parents?
Gurugram resident Navanita Varadpande tweeted that when her son went to receive his first dose on Monday, they were shown a letter indicating that the shelf life of Covaxin, which originally had an expiry date of 9 months, had been extended.
"My son went to get his first vaccine and realised that the vaccine had already expired in November. Then a letter was shown wherein it seems the shelf life has been extended!! How, why, on what basis? To clear stock you experiment on kids?"
Similar concerns have been raised by other Twitter users.
Further, reacting to the chatter, Nationalist Congress Party MP Supriya Sule said, "All drugs have a prescribed expiry period, hence how can the same be ‘extended’ and the vaccine re-labelled to administer the same? Above all, this is now being made available to provide vaccines to the young."
Expand2. What Has the Indian Government Said?
The Ministry of Health and Family Welfare, in an official statement issued on Monday, said that the reports of expired vaccines being administered in India are "false and misleading".
"The Central Drugs Standard Control Organization (CDSCO) on 25th October 2021, in response to M/s Bharat Biotech International Limited’s letter no: BBIL/RA/21/567 has approved the extension of shelf life of Covaxin (Whole Virion, Inactivated Coronavirus Vaccine) from 9 months to 12 months."
Ministry of Health and Family Welfare"The shelf life of vaccines is extended by the National Regulator based on comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers," the ministry stated.
Expand3. Why Was Covaxin's Shelf Life Extended?
The Central Drugs Standards Control Organisation (CDSCO) had approved the extension of shelf life of Covaxin from nine to twelve months, drugmaker Bharat Biotech had announced on 3 November 2021.
The drug authority had initially given permission for the 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 of Covaxin to nine months, after Bharat Biotech submitted additional real-time stability data of Covaxin.
"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 said in November.
Covaxin had received emergency use approval from the Drug Controller General of India (DCGI) for use in children on 25 December, nearly two months after the shelf life extension was approved.
It is the only vaccine being administered to the children whose birth year is 2007 or later, as per guidelines released by the government on 27 December.
Expand4. Has the Shelf Life for Other COVID-19 Vaccines Been Extended in the Past?
Yes.
The CDSCO had extended Serum Institute of India (SII)-manufactured Covishield's shelf life from six months to nine months in February 2021.
"As the drug or the vaccine becomes older, there is addition to the data and further extensions are given on the basis of stability and sterility data. The initial shelf life of six months was approved based on the earlier stability data,” Secretary to the Ministry of Health and Family Welfare Rajesh Bhushan had explained in March.
Further, elongation of shelf life has also been approved for a number of vaccines that are being administered elsewhere in the world.
For instance, the United States Food and Drug Authority (FDA) had in May 2021 increased the shelf life for Pfizer's coronavirus vaccine from 5 days to 1 month.
"Based on a review of recent data submitted by Pfizer Inc today, the US Food and Drug Administration is authorising undiluted, thawed Pfizer-BioNTech COVID-19 vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month. Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days," the US drug regulator had said.
The FDA had also extended the shelf span of Johnson & Johson's single-shot COVID vaccine from four-and-a-half months to six months in July 2021, based on stability assessment studies.
United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) had, as recently as December 2021, approved the lengthening of Moderna's coronavirus vaccine Spikevax from 7 months to 9 months.
Expand5. What Do Experts Say?
Speaking to FIT, Dr Swapneil Parikh, internal medicine specialist, and the author of the book, The Coronavirus: What You Need to Know about the Global Pandemic, explains: "Typically when a vaccine is first authorised, stability studies have been done for a certain period of time, let’s say six months. That’s part of the process."
"As more time passes the duration for which the stability studies have been done increases. So after another 3-4 months they may have a stability study that’s gone on for nine months. And that may show that the vaccine retains its immunogenicity and hasn’t degraded at nine months."
Dr Swapneil Parikh, Internal medicine specialist, MumbaiAt this point, he goes on to explain, the vaccine's shelf life may be extended to the timeframe till when it's stability has been studied.
After the initial Emergency Use Authorisation (EUA) is granted to a vaccine, stability studies may also be conducted in different temperatures or storage conditions that may result in changes in guidelines later on.
Dr Satyajit Rath told FIT that expiry dates are more to do with loss of efficacy than the possibility of harm for the receiver.
"Generally, vaccine expiry dates are more to do with loss of efficacy rather than about possibilities of any harm caused. So the issue is much more likely to be about 'do they still work', and not about 'are they dangerous'."
Dr Satyajit RathDr Parikh notes that the fears around the extended expiry date of Covaxin can be dispelled by sharing the studies that have been performed on its stability.
"What would be reassuring to allay these fears is if the process by which the extension was given and the studies that have been performed is shared. If stability studies have been done, then this should be shared so that you know the study has been done and the process by which this extension was given should be shared," he stated.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)
Expand
What Are the Concerns of the Parents?
Gurugram resident Navanita Varadpande tweeted that when her son went to receive his first dose on Monday, they were shown a letter indicating that the shelf life of Covaxin, which originally had an expiry date of 9 months, had been extended.
"My son went to get his first vaccine and realised that the vaccine had already expired in November. Then a letter was shown wherein it seems the shelf life has been extended!! How, why, on what basis? To clear stock you experiment on kids?"
Similar concerns have been raised by other Twitter users.
Further, reacting to the chatter, Nationalist Congress Party MP Supriya Sule said, "All drugs have a prescribed expiry period, hence how can the same be ‘extended’ and the vaccine re-labelled to administer the same? Above all, this is now being made available to provide vaccines to the young."
What Has the Indian Government Said?
The Ministry of Health and Family Welfare, in an official statement issued on Monday, said that the reports of expired vaccines being administered in India are "false and misleading".
"The Central Drugs Standard Control Organization (CDSCO) on 25th October 2021, in response to M/s Bharat Biotech International Limited’s letter no: BBIL/RA/21/567 has approved the extension of shelf life of Covaxin (Whole Virion, Inactivated Coronavirus Vaccine) from 9 months to 12 months."Ministry of Health and Family Welfare
"The shelf life of vaccines is extended by the National Regulator based on comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers," the ministry stated.
Why Was Covaxin's Shelf Life Extended?
The Central Drugs Standards Control Organisation (CDSCO) had approved the extension of shelf life of Covaxin from nine to twelve months, drugmaker Bharat Biotech had announced on 3 November 2021.
The drug authority had initially given permission for the 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 of Covaxin to nine months, after Bharat Biotech submitted additional real-time stability data of Covaxin.
"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 said in November.
Covaxin had received emergency use approval from the Drug Controller General of India (DCGI) for use in children on 25 December, nearly two months after the shelf life extension was approved.
It is the only vaccine being administered to the children whose birth year is 2007 or later, as per guidelines released by the government on 27 December.
Has the Shelf Life for Other COVID-19 Vaccines Been Extended in the Past?
Yes.
The CDSCO had extended Serum Institute of India (SII)-manufactured Covishield's shelf life from six months to nine months in February 2021.
"As the drug or the vaccine becomes older, there is addition to the data and further extensions are given on the basis of stability and sterility data. The initial shelf life of six months was approved based on the earlier stability data,” Secretary to the Ministry of Health and Family Welfare Rajesh Bhushan had explained in March.
Further, elongation of shelf life has also been approved for a number of vaccines that are being administered elsewhere in the world.
For instance, the United States Food and Drug Authority (FDA) had in May 2021 increased the shelf life for Pfizer's coronavirus vaccine from 5 days to 1 month.
"Based on a review of recent data submitted by Pfizer Inc today, the US Food and Drug Administration is authorising undiluted, thawed Pfizer-BioNTech COVID-19 vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month. Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days," the US drug regulator had said.
The FDA had also extended the shelf span of Johnson & Johson's single-shot COVID vaccine from four-and-a-half months to six months in July 2021, based on stability assessment studies.
United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) had, as recently as December 2021, approved the lengthening of Moderna's coronavirus vaccine Spikevax from 7 months to 9 months.
What Do Experts Say?
Speaking to FIT, Dr Swapneil Parikh, internal medicine specialist, and the author of the book, The Coronavirus: What You Need to Know about the Global Pandemic, explains: "Typically when a vaccine is first authorised, stability studies have been done for a certain period of time, let’s say six months. That’s part of the process."
"As more time passes the duration for which the stability studies have been done increases. So after another 3-4 months they may have a stability study that’s gone on for nine months. And that may show that the vaccine retains its immunogenicity and hasn’t degraded at nine months."Dr Swapneil Parikh, Internal medicine specialist, Mumbai
At this point, he goes on to explain, the vaccine's shelf life may be extended to the timeframe till when it's stability has been studied.
After the initial Emergency Use Authorisation (EUA) is granted to a vaccine, stability studies may also be conducted in different temperatures or storage conditions that may result in changes in guidelines later on.
Dr Satyajit Rath told FIT that expiry dates are more to do with loss of efficacy than the possibility of harm for the receiver.
"Generally, vaccine expiry dates are more to do with loss of efficacy rather than about possibilities of any harm caused. So the issue is much more likely to be about 'do they still work', and not about 'are they dangerous'."Dr Satyajit Rath
Dr Parikh notes that the fears around the extended expiry date of Covaxin can be dispelled by sharing the studies that have been performed on its stability.
"What would be reassuring to allay these fears is if the process by which the extension was given and the studies that have been performed is shared. If stability studies have been done, then this should be shared so that you know the study has been done and the process by which this extension was given should be shared," he stated.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)