BANDAR SERI BEGAWAN – The Ministry of Health (MoH) said the decision to halt the rollout of the Oxford-AstraZeneca vaccine was done out of “an abundance of caution” after reports of rare blood clots were found in younger people who took the vaccine overseas.
The government “temporarily paused” the use of AstraZeneca in its COVID-19 vaccination programme on Tuesday evening pending a review from the Vaccine Technical Committee.
When asked why the ministry did not delay the rollout of AstraZeneca when the blood clot issues had been widely reported, the head of the Disease Control Division said while MoH is confident in the vaccine’s safety, the halt was a precautionary measure until international regulatory agencies released more detailed findings.
“As new evidence emerges, we’re following the science to decide how we move forward,” Dr Justin Wong said in an interview with media on Wednesday.
“We don’t just operate at a normal level of caution here, we are being hyper-cautious.”
MoH released an advisory on April 3, the first day of the vaccine rollout, reassuring the public of the safety of the Oxford vaccine, only to suspend its use on April 6.
“We put a temporary pause when we saw a number of different regions reporting the issue of blood clots associated with AstraZeneca,” said Dr Wong.
“While it’s very difficult to establish causal link, if trends are repeated elsewhere, then we think okay, let’s hold on a minute.”
Clotting events associated with the vaccine are extremely rare, occurring at rate of approximately four in a million, far less common then blood clots associated with the use of Heparin, a blood thinner, or hormonal contraceptives.
UK, EU find link to blood clots ‘plausible’, but data still unclear
The UK drugs regulator, MHRA, found that by the end of March, 79 people had suffered blood clots after taking the AstraZeneca shot – 19 of whom died.
Nearly two-thirds of the cases were seen in women, while the people who died were aged between 18 and 79, with 11 of them under 50.
MHRA said this was not proof the jab had caused the clots, but there was a possible link.
The European Medicines Agency said blood clots should be listed as a possible side effect of the AstraZeneca vaccine, while the WHO said it was “very rare” among nearly 200 million people who have received the jab worldwide.
After the findings were released late Wednesday, the UK said it would offer an alternative vaccine for people under 30, while Australia and several European nations also recommended a minimum age of 50-60 for recipients of the shot.
South Korea and the Philippines have restricted the use of AstraZeneca to those over 60.
Dr Wong said Brunei’s health ministry would review the findings of international drug authorities before coming to a decision, as well as analyse data from the 2,323 people who received the AstraZeneca vaccine in Brunei.
So far, no evidence of clotting has been reported locally.
Dr Wong echoed the opinions of experts worldwide that the benefits of taking the Oxford vaccine to prevent a COVID-19 infection still far outweigh any risks.
“If the committee felt that it is in any way or shape unsafe, we would discard it.”
Brunei received 24,000 doses of the AstraZeneca vaccine on April 2, with 108,000 doses expected to be delivered by the end of June.
The public health specialist was asked whether suspension of the AstraZeneca rollout would be damaging to public confidence in the COVID-19 vaccine, when a third of Bruneians are already unsure about taking the shot.
“I think our public is much more mature then to have knee jerk reactions and say ‘I’m not going to take that vaccine now because there was a pause for a couple of days.'”
Dr Shyh Poh Teo, chair of Brunei’s Pharmacovigilance Advisory Committee, added that the government’s recommendations may change as new data emerges.
“This is not the first time we have paused medication being rolled out as soon as there’s any concern with a medication’s safety or quality… But this is probably the most publicised one because the COVID-19 vaccine is in a mass immunisation programme,” he said.
“This is actually a normal process in terms of safety monitoring, the main thing is that the data is sufficiently and adequately reviewed and if we’re happy, then we will proceed.”
Dr Wong said they expect the vaccine committee to complete its review “within a few days” and come to a decision on the use of AstraZeneca.
“We don’t want to hold off and have a prolonged process… It could take a little bit longer while we satisfy ourselves and the data is robust enough for us to be able to restart and resume the vaccination program.”
“I don’t think that the the delays will impact our targets [for immunisation] in the coming couple of months. We do have other vaccines available and on the way, so if the finding of the review is that we don’t use [AstraZeneca] any longer, then we will try and source other options.”
Brunei’s vaccination drive will continue with Sinopharm, with approximately 52,000 doses gifted by China back in February.
The government is also expecting delivery of Moderna, Pfizer and Novavax vaccines to provide it with a number of different vaccine options.