New data released today shows Medsafe is investigating 15 reports of New Zealanders who died at some point after receiving a Covid-19 jab. About 2.94 million Kiwis have received at least one dose of the vaccine so far.
The 15 deaths under investigation are among 40 mortalities that have been flagged in reports about possible adverse reactions after a vaccine.
Of the 40 deaths, Medsafe says:
• 19 are "unlikely" linked to the vaccine.
• 5 "could not be assessed due to insufficient information".
• 15 cases are still under investigation.
• 1 death was likely due to vaccine-induced myocarditis
In July, a New Zealand woman died after suffering a potentially fatal side-effect of the vaccine that causes the heart muscle wall to become inflamed.
While the woman's death was still under investigation, the vaccine safety monitoring board said it considered it was due to myocarditis, a known rare side effect of the Pfizer vaccine. The Pfizer vaccine is the only jab being administered to New Zealanders.
When the woman's death was revealed, health officials said the "Covid-19 Vaccine Independent Safety Monitoring Board noted that there were other medical issues occurring at the same time which may have influenced the outcome following vaccination".
Of the 40 people in the reports, 19 of them were older than 80, 15 of the group were aged 60-79, and six were between the ages of 30 and 59. None were under the age of 30.
"By chance, some people will experience new illnesses or die from a pre-existing condition shortly after vaccination, especially if they are elderly," Medsafe says.
"Therefore, part of our review process includes comparing natural death rates to observed death rates following vaccination, to determine if there are any specific trends or patterns that might indicate a vaccine safety concern. To date, the observed number of deaths reported after vaccination is actually less than the expected number of natural deaths," Medsafe said in its latest report.
University of Otago clinical microbiologist and immunologist James Ussher said almost all deaths reported as being caused by the vaccine would be coincidental.
Acknowledging the recent death caused by myocarditis being linked to the virus, Ussher said there had been no signal in international data which suggested increased rates of mortality.
"Even the one very unfortunate death here is an extremely rare occurrence."
Based on the number of doses administered to date, Ussher said the risk of dying from Covid infection was 25,000 times higher than dying from the vaccine.
He did not believe Medsafe's 15 reports of alleged vaccine-related deaths under investigation was a high figure or of concern, but he emphasised the need to thoroughly investigate such claims to be confident in vaccine safety.
Adverse reaction events are filed with the University of Otago's Centre of Adverse Reactions Monitoring (CARM) and details are published each week on Medsafe's website.
Misinformation, however, has been circulating on social media that MedSafe had stopped publishing adverse reaction reports because of the number of people who had become ill from the jab.
Fuelling some of the recent concern was that data only covered reaction reports filed until August 21, two days after children 12 and over became eligible for the Covid vaccination. That has been dispelled by the release of more up-to-date information today.
MedSafe Group Manager Chris James said what was circulating on social media was false.
"Misinformation about time frames regarding the publication of MedSafe's adverse reaction reports is not only false and misleading, it's unhelpful and irresponsible."
James said Medsafe's website clearly states there is a time lag between when the Ministry of Health unit receives reports when the weekly data is published.
He said this allowed follow-up information to be incorporated into the reports.
Since the last update, the website states there have been 1838 new adverse reaction reports - 47 of which were deemed serious.
In total there have been 509 out of 12,900 reports classified as serious since the jab rollout began.
Serious reports are assessed by CARM according to World Health Organisation guidelines and also revised by the Covid Vaccine Independent Safety Monitoring Board.
CARM then directs Medsafe to investigate possible safety concerns.
The most common symptoms flagged in an adverse reaction reports include headaches (4115), dizziness (3828), and pain at the jab site (3122).
