A health worker administers a COVID-19 vaccine to a teenager in Kanyakumari, January 3, 2022. Photo: PTI
- The health ministry has said 42 lakh people aged 15-18 years received their first COVID-19 shot dose on January 3 – the first day of the expanded vaccination drive.
- However, the ministry waded into a controversy early in the day when some parents expressed concerns about expiry dates on vials used to vaccinate their children.
- The ministry also hadn’t followed WHO guidelines about which vaccine vials could be deemed to be expired nor the process of declaration.
New Delhi: As many as 42 lakh people aged 15-17 years received COVID-19 vaccine doses on January 3, 2022 – the first day of the expanded vaccination drive to include minors. According to the government’s CoWIN dashboard, more than 50 lakh people of this age group had registered to receive their doses on January 3.
Although a Union health ministry statement issued at 7 pm said 40 lakh doses were administered, the figure on CoWIN increased later.
On his Christmas day announcement, at 10 pm, Prime Minister Narendra Modi had said the COVID-19 vaccination drive would include young adults aged 15-18 years from January 3. On the CoWIN dashboard, the vaccination figures for 18-year-olds (i.e. birth year 2004) were included in the 18-44 age group, and not that of minors.
The highest number of doses were administered in Madhya Pradesh, Gujarat, Andhra Pradesh, Karnataka and Rajasthan, in that order.
Currently, paediatric vaccine recipients receive Covaxin, an inactivated whole-virion vaccine manufactured by Bharat Biotech. As The Wire Science reported earlier, there are around 100 million people in India aged 15-18 years and could be eligible to receive COVID-19 vaccines. And since they will receive Covaxin, the immediate additional demand for this shot is 200 million doses.
Extension in shelf life
A controversy of sorts erupted earlier on January 3 when a mother named Navanita Varadpande tweeted that her son found the vial containing his dose of Covaxin had already expired in November. After he raised his concern, authorities at the centre showed him a letter saying the government had extended the shelf life of Covaxin doses. Varadpande asked if the health ministry was “experimenting” on children.
A couple of hours later, around noon, the Union health ministry issued a statement saying that the Central Drug Standards Control Organisation had approved the extension: “The CDSCO on October 25, 2021, in response to M/s Bharat Biotech International Limited’s letter, has approved the shelf life of Covaxin from 9 months to 12 months.”
According to the letter, the extension was granted on the basis of “comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers.”
It’s not uncommon for manufacturers to extend the shelf-lives of their vaccines. This said, the WHO has recommended that the lifespan shouldn’t be enhanced for doses that are about to expire and have already been distributed for use.
“Any extension in the shelf-life will only apply to vaccines not yet labelled and distributed,” the WHO recommendation, issued in May 2020, said. “Therefore, the expired or near to expire doses in distribution for use will not be affected by the future decision of shelf-life extension.”
M.J. Hegde, a principal scientist at pharmaceutical company GlaxoSmithKline, had tweeted early on January 4 that the decision for drug regulators to extend the shelf life of vaccines and therapeutics is always difficult, especially during a pandemic in which such resources are scarce.
So my son went to get his first vaccine, the drive for kids begin today and realized 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? pic.twitter.com/259ZHDBMSN
— Navanita Varadpande (@VpNavanita) January 3, 2022
But if such a decision is made, Hegde added, the regulator must have communicated it in advance and must issue a detailed accompanying statement – like the US Food and Drug Administration did when extending the lifespan of the Pfizer-BioNTech COVID-19 vaccine.
In fact, the Union health ministry’s January 3 statement, clarifying Covaxin’s extended lifespan, was the first official communication from any quarter of the government in this matter. Before this, the only entity that had formally confirmed Covaxin’s shelf-life extension was its maker Bharat Biotech, in November 2021, that too via a tweet.
In its May 2020 statement, the WHO was also unequivocal that the expiry date wouldn’t affect the vaccine’s safety but would affect its potency.
Addressing this issue, the chief of the National Technical Advisory Group on Immunisation, N.K. Arora, claimed emphatically in an interview to NDTV yesterday that Covaxin’s potency doesn’t dwindle past the nine-month mark, and invoked studies on animals as reference. He didn’t get into the details of these studies, however.
In November, virologist Gangandeep Kang told Hindustan Times that extending the expiry date of vaccines is not unusual because manufacturers would learn more about the shots’ stability as more time passes, and that a regulator would have to be satisfied with the stability data before making any decisions on the shelf-life.
The other part of India’s newly expanded vaccination drive, to administer booster doses to frontline and healthcare workers and to elderly citizens, is expected to commence from January 10. The government is yet to say which vaccines will be administered as boosters.
Currently, four vaccines – Covishield, Covaxin, Sputnik V and ZyCov D – are part of India’s primary vaccination drive. But as Neeta Sanghi explained for The Wire Science, only Covishield is available in sufficient quantities but the regulator hasn’t approved its use as a booster dose.
But the regulator had approved two more vaccines last week, Covovax and Corbevax, and Covovax – experts have said – could be a suitable booster dose.