Unapproved COVAXIN in a race against time

The Government is not shy in admitting that the global shortage of COVID-19 vaccines is weighing on the mind of the Holness administration, but it is holding firm that it will only use products approved by the World Health Organization (WHO).

That could put pause to overtures by Indian manufacturer Bharat Biotech, which is seeking to enter the Jamaican market.

Bharat Biotech’s COVAXIN is yet to be shortlisted by the WHO for emergency use, much less final approval.

In early March, the company announced interim clinical results based on the efficacy data in its Phase 3 clinical trial indicating that COVAXIN was 81 per cent effective against COVID-19.

The Sunday Gleaner reported that Montego Bay-based Bioprist Pharmaceuticals, a company led by medical doctor and entrepreneur Dr Guna Muppuri, has signed a deal for the exclusive importation and distribution in Jamaica of the India-made COVID-19 vaccine COVAXIN.

But with COVAXIN not even on the pre-approval timeline published by the WHO, it is unclear whether it will be ready soon enough to pique the interest of Kingston.

Tufton told The Gleaner on Sunday that based on the negotiations so far, Jamaica has a gap of just over 1 million vaccines, with contemplation that just under three million persons will receive two doses each.

And he is in a rush to find approved vaccines to fill those gaps.

“There is a risk that if we don’t get vaccines during April and maybe May, we could run out. What the Government is doing is looking at all avenues to secure vaccines which are available, but also vaccines that have gone through the trials, not yet approved but anticipate approval in a relatively short space of time,” he said.

Those vaccines would be the Russia-made Sputnik and the China-manufactured Sinovac and Sinopharm. Data are still outstanding for Sputnik, and the Chinese vaccines will not be eligible for approval before April.

“So the Government is looking and discussing pre-ordering in anticipation of approval, and Cabinet will have to sign off,” Tufton told The Gleaner on Sunday.

The health and wellness minister said, however, that the Government would still maintain dialogue with the producers of COVAXIN, cautioning that the door was not shut.

“A lot of the vaccine manufacturers that we are negotiating with are requiring minimum volumes and in some cases prices that are beyond high prices, and I suspect they are taking advantage of the demand in anticipation that in months to come, the market is going to be freed up with more entries and the prices will come down, so they are forcing countries to lock into prices and volumes, which can be a challenge,” Tufton told The Gleaner.

Jamaica is scheduled to receive, initially, 500,000 vaccines from the African Medical Supply Platform by April.

That is from the 1.95 million that are being procured.

Within two weeks, some 26,000 additional doses from the COVAX facility are scheduled to arrive on the island.

Tufton disclosed that as at Saturday, 24,502 doses of the AstraZeneca vaccine had been administered.

That figure represents 52 per cent of the 47,650 first-month target.

The health and wellness minister revealed that 0.03 per cent of the 2,200 vials, containing 10 doses each, have been wasted.