The National Technical Advisory Group on Immunization (NTAGI) is meeting on December 6 to take a call on India's booster programme.
In the meantime, Serum Institute of India has sought approval to roll out a third booster dose of their COVID-19 vaccine, Covishield. The request comes on the heels of the emergence of the new variant of concern, Omicron.
In their application to the Drugs Control General of India, SII argued that Covishield vaccine should be allowed as a third booster dose as its international counterpart AstraZeneca has already been approved by the UK Medicines and Healthcare products Regulatory Agency in September, reported PTI.
They also mention that they have enough supply of the vaccine to start rolling out a third booster shot, as well as a mounting demand in the country for the same.
On the other hand, experts have nearly unanimously held that India should focus on increasing its primary vaccine coverage before thinking of introducing boosters, and that there isn't enough evidence to suggest the need for them just yet.
What evidence has SII submitted with its application to the DCGI? Is it sufficient? Could India start rolling out booster shots soon?
Covishield Boosters: Limitations of the Data
While Serum Institute of India cited UK's MHRA giving the green light for AstraZeneca booster doses, they left out certain other key points.
For one, around the same time, higher ups at AstraZeneca had warned against rushing into giving booster doses for all before 2 dose data is adequately studied.
Expressing their reservations, Pascal Soriot, chief executive, and Sir Mene Pangalos, biopharmaceuticals research and development executive vice president at AstraZeneca were quoted by The Telegraph as saying, "Moving too quickly to boost across the entire adult population will deprive us of these insights, leaving this important decision to rest on limited data."
Two months on, data related to the efficacy and safety of AstraZeneca vaccines as booster shots is still limited.
A recent study published in the medical journal Lancet— the first of its kind— found the AstraZeneca vaccine (among others) to be safe and effective as booster doses.
But this study too has its limitations.
For one, the gap between the first two doses and the booster varied in some participants. Also, an age cut off of 30 and above adds to the limitation of the data.
Moreover, the number of people who received primary vaccine dosage of AstraZeneca and were boosted by AstraZeneca was only a small number.
The focus of the study was on whether mixing and matching of vaccines can be done when it comes to boosters, rather than testing the effectiveness and safety of the AstraZeneca vaccine as boosters in itself.
SII has also not, as far as official reports are concerned, submitted data from any published study conducted by them to supplement their application for boosters.
What Does the UK Authority Say About AstraZeneca as a Booster?
Infact, the September UK Medicines and Healthcare Products Regulatory Agency approval SII site for AstraZeneca boosters seems be misleading.
While MHRA approved AZ vaccine for boosters, according to a press release by Public Health England on Gov.UK on September 14, the Joint Committee on Vaccination and Immunisation (JCVI), the UK vaccine advisory body, had given a preference for the Pfizer-BioNTech vaccine for the booster programme, regardless of which vaccine was used for primary doses. The alternate was half a dose of Moderna vaccine as a booster.
Importantly, it said that where mRNA vaccines cannot be offered, perhaps due to allergies, the AstraZeneca vaccine may be considered for those who received it previously.
In its updated advise on November 15 on booster doses, JCVI once again advised that all adults aged 40 to 49 should also be offered a booster vaccination with an mRNA COVID-19 vaccine, 6 months after their second dose. This is irrespective of the vaccines used as primary doses.
Booster Shots in India: Where Do We Stand?
On 4 December, the Indian SARS-CoV-2 Genetics Consortium or the INSACOG said booster doses for people over the age of 40 in light of the spread of Omicron 'may be considered', but has since said that 'many more experiments are needed' before taking the call.
Last month, the Indian Medical Association also called for booster doses to be given to healthcare workers and other high risk patients.
Speaking to FIT for a different article, virologist Dr Shahid Jameel said, "if there’s one group of people who should get the boosters, that’s the healthcare workers."
However, he also added,
"Countries that are giving boosters have reached a point of saturation with their vaccines... for India I think the priority should be to get the two shots to the people who are eligible to get the two shots."Dr Shahid Jameel, Virologist
Speaking at a press conference on Thursday, 2 December, NITI Aayog member Dr V K Paul reiterated the Union Health Ministry's stand on the matter of boosters for now, saying, “complete the task of vaccinating all adults with both doses – this is the focus and strategy that will give us the best dividend at this moment of time.”
The rising concerns over the spread of Omicron could, however, mean a change in this stance.
(Written with inputs from PTI.)
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