April 8th 2021
Fiji’s Ministry of Health and Medical Services shares the position of the United Kingdom Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency that, for most people, the benefits of the AstraZeneca vaccine’s effective protection against COVID-19 far outweigh the risks.
This follows investigations by British and European regulators into an association between the AstraZeneca vaccine and thrombosis with thrombocytopenia, a rare blood clotting disorder. After the review of data of millions of people who have received the vaccine, this unusual blood clotting event has been plausibly identified as an extremely rare but serious side effect, affecting an estimated 4 to 10 people out of every million people, with death in estimated 25% of cases.
The Ministry is developing new clinician guidance and standard operating procedures to manage the rare but serious risk associated with the AstraZeneca vaccine to accompany its ongoing administration to frontline workers and vulnerable members of the general public. In line with the most recent evidence, the Ministry is recommending that individuals who have received their first dose of the AstraZeneca vaccine take the second dose.
The symptoms of the rare side effect can occur from 4 days to 28 days after receiving the first dose of the vaccine and are more severe than the mild symptoms of fever, chills, and headache that are expected within two days of the first dosage. The new clinician guidance will aid healthcare professionals in identifying the symptoms of the rare side effect and allow members of the public to access a dedicated line to report severe symptoms.
“With tens of millions of doses administered around the world, we have a clear picture of the low risks of this vaccine against the proven benefits. The highest reported likelihood of this rare but serious side effect from the AstraZeneca vaccine is 1 in 100,000. The likelihood of dying from the coronavirus, on the other hand, is nearly 2 in 100. To put those numbers into perspective, receiving this vaccine is safer than riding in a car or a bus, or even walking down a set of stairs. Meanwhile, COVID is one of the deadliest pathogens on the planet,” said the PS for Health and Medical Services, Dr James Fong. “I’ve been vaccinated and so has my family. I encourage all eligible Fijians to do the same. Register now, and come forward to be vaccinated when it is your turn. We may not have community transmission of the coronavirus, but that’s no excuse to be complacent about protecting ourselves. Morally and medically, it’s the right thing to do.”
Given the low incidence rate of the potential side effects, the new guidance and SOPs will also accompany the rollout of the vaccines to members of the public in the next phase of Fiji’s vaccine deployment. Globally, most of the rare side effect events have been reported in younger women. However, more data is needed to determine if age and gender are contributing factors. Out of an abundance of caution, this guidance will apply to women and men of all age groups.