Reuters reported late on June 15, 2021:
New Delhi: The Indian government doubled the gap between the two doses of the AstraZeneca COVID-19 vaccine without the agreement of the scientific group that it said recommended the increase, three members of the advisory body told Reuters.
The ministry of health announced the decision to change the gap from 6-8 weeks to 12-16 weeks on May 13, at a time when supplies of the shot were falling short of demand and infections were surging across the country.
It said the extended gap was recommended by the National Technical Advisory Group on Immunisation (NTAGI), based on real-life evidence mainly from Britain. Yet the NTAGI scientists, classified by the government as three of the 14 “core members”, said the body did not have enough data to make such a recommendation.
M.D. Gupte, a former director of the state-run National Institute of Epidemiology, said the NTAGI had backed increasing the dosing interval to 8-12 weeks – the gap advised by the World Health Organization. But he added that the group had no data concerning the effects of a gap beyond 12 weeks.
“Eight to 12 weeks is something we all accepted, 12 to 16 weeks is something the government has come out with,” he added. “This may be alright, may not be. We have no information on that.”
This was echoed by his NTAGI colleague Mathew Varghese, who said the group’s recommendation was only for 8-12 weeks.
The health ministry, citing the head of NTAGI’s working group on COVID-19, said that the dosing decision was based on scientific evidence. “There was no dissenting voices among the NTAGI members,” the ministry said on Twitter.
The ministry’s statement on May 13 said that it had accepted the 12-16 weeks recommendation from NTAGI’s COVID working group, as had a group of mainly government officials tasked with vaccine administration, known as NEGVAC.
Government health officials told a news conference on May 15 the gap was not increased to address a vaccine shortage but was a “scientific decision”.
J.P. Muliyil, a member of the seven-strong COVID working group, said there had been discussions within the NTAGI on increasing the vaccine dosage interval but that the body had not recommended 12-16 weeks.
“That specific number was not quoted,” he said, without elaborating.
N.K. Arora, the COVID working group head, declined to comment to Reuters on its recommendations but said all its decisions were taken collectively by the NTAGI at large.
A NEGVAC representative said it “respects the decisions of the NTAGI and use them for our work”, declining to elaborate.
Real-world data released early last month by South Korea showed that one dose of the vaccines from AstraZeneca and Pfizer was 86.6% effective in preventing infections among people aged 60 and older.
Muliyil said this increased confidence within the advisory body that delaying a second shot would not be harmful.
The AstraZeneca vaccine accounts for nearly 90% of the 257.5 million vaccine doses administered in India.
The dispute over doses comes amid criticism from some scientists that the government had been slow to respond to a new virus variant that led to a spike in infections in April and May.
The government has denied being slow to react, saying state-run laboratories had studied variants in real time and shared data with local authorities to allow them to take the necessary action.
Shahid Jameel, a top Indian virologist who recently quit a government panel on virus variants after criticising New Delhi over its response to the pandemic, said the authorities should clarify their position on the reasons for the decision to double the gap between doses.
“In a situation where we have a variant of concern spreading, we should really be vaccinating people at scale and making sure that they are protected,” he added.
(Reuters – reporting by Krishna N. Das and Devjyot Ghoshal; editing by Sanjeev Miglani and Pravin Char)
PTI reported early on June 16, 2021:
The decision regarding enhancing interval between two doses of Covishield was based on scientific evidence and taken in a transparent manner, NTAGI Chair N.K. Arora said on Tuesday.
There was no dissenting voice among the members of the National Technical Advisory Group on Immunisation (NTAGI ), he said, according to a tweet by the Union health ministry.
The government had on May 13 said it has accepted the COVID-19 Working Group’s recommendation and extended the gap between the two doses of the Covishield vaccine from 6-8 weeks to 12-16 weeks.
“Based on the available real-life evidence, particularly from the UK, the COVID-19 Working Group agreed for increasing the dosing interval to 12-16 weeks between two doses of Covishield vaccine. No change in the interval of Covaxin vaccine doses was recommended,” the ministry had said in a statement.
“The recommendation of the COVID-19 Working Group was accepted by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), headed by V.K. Paul, member (health), NITI Aayog, in its meeting on May 12, 2021,” the ministry said.
It has accepted this recommendation of the COVID-19 Working Group of extension of the gap between the first and second doses of Covishield to 12-16 weeks, the health ministry added.
Explaining the reason behind the extension, Paul had said at a press conference that it was a science-based decision taken on the recommendations of the NTAGI.
He said as per studies, initially, the interval between two doses of Covishield was four to six weeks but then as more data became available secondary analysis showed increasing the dosage interval to 4-8 weeks can have some advantage.
Paul said the UK by that time had already extended it to 12 weeks and WHO also had said the same, but many nations still did not change the dosage pattern.
“At that time, our science-based technical committee anchored by ICMR along with DBT by looking at the available data felt breakthrough infections may increase if the gap is increased (to 12 weeks).
“So in good faith, based on their capability, without any pressures, they increased the dosage interval to 4 to 8 weeks. The issue was reviewed periodically again and again
“Now based on the available real-life evidence, particularly from the UK, the decision to extend it from 6-8 weeks to 12-16 weeks has been taken with confidence that there will not be an extra risk. This is a dynamic decision and part of periodic review,” Paul had said.
Underlining that NTAGI is a standing committee which was constituted much before COVID-19 had emerged and works on immunization for children, Paul had said, ” It looks at scientific data and we must respect the decision of this institution.
“They make independent decisions. Have faith in our scientific processes. NTGAI is a group of individuals of high integrity.”