There were 178 new cases of Covid-19 across New Zealand today and another virus-related death. Video / NZ Herald
There have been 17 reports of vaccinated women having miscarriages in New Zealand - but Medsafe is continuing to reassure women there is no increased risk for pregnant mums-to-be.
If anything, Medsafe says getting Covid poses a far greater risk to unborn babies and their mothers than if they were vaccinated in the first place.
It's a call backed by microbiologist Siouxsie Wiles who said there's a huge amount of vaccination misinformation around, especially regarding the safety of it in pregnancy.
"There are people who are weaponising information about what is happening to people after they have been vaccinated ... in order to frighten people into not getting vaccinated."
She said it was important people realised reactions, which are reported in weekly Adverse Events summaries, don't come with the context of how often those reactions happen naturally, even in unvaccinated people.
"Miscarriages is a really good example of that, there are people having miscarriages every day … (but) the research has been really clear that in the populations that have been studied that there is no increase in the risk of miscarriage."
There have been more than 35,000 adverse events reported to Medsafe since the Pfizer vaccination (Comirnaty) rollout began in February. Those reports are published in a weekly summary.
Up until the end of October, 17 of those reports were about miscarriage - something that has been treated as a potential safety issue and investigated further by Medsafe and the Covid-19 Independent Safety Monitoring Board.
After looking at those reports and medical literature the Board found there was no evidence to suggest an increased risk of miscarriage after vaccination.
"The (Board) emphasised the considerable risks to both mother and child of Covid-19 disease in pregnancy and considered that the available safety information supports routine vaccination of pregnant people with Comirnaty."
Microbiologist Dr Siouxsie Wiles says it is safer for pregnant women to be vaccinated than unvaccinated. Photo / NZ Herald
A Medsafe report said pregnant women who contract the virus are three times more likely to require treatment in an intensive care unit than women who weren't pregnant. Babies of mothers with Covid are also at increased risk of preterm birth and needing neonatal intensive care.
It also found that around 10 to 20 per cent of pregnancies resulted in miscarriage in New Zealand, more than 2,500 of which required hospital treatment.
"The number of (Adverse Event) reports received by CARM is lower than the expected rate."
Wiles said it was important to acknowledge there were real and genuine concerns about the impacts on fertility and pregnancy and breastfeeding but people should look at the research, not the misinformation being spread.
"These are legitimate things to be concerned about and that concern is being weaponised against us, used by people who are trying to push their agenda and their agenda is ending up with pregnant people in hospital with Covid."
This week's Adverse Events summary has also provided an update on concerns about the vaccine causing menstrual disorders and unexpected vaginal bleeding.
There have been just over 500 reports of post-menopausal bleeding and heaving, early, late, painful or unexpected periods - a similar number to what is being reported overseas.
"These case numbers are low when considering how commonly menstrual disorders normally occur, and the number of vaccines that have been administered."
The report said an in-depth analysis by Pfizer of post-marketing safety data found no safety signals for heavy menstrual bleeding or post-menopausal bleeding.
There have been just over 500 reports of women having changes in their periods after getting the vaccination. Photo / 123RF
Several international medicines regulatory bodies, including those in the United Kingdom, European Union and Australia also conducted investigations and found no link between menstrual disorders or unexpected vaginal bleeding and the vaccination.
"Similarly, in New Zealand, our review found no link."
"Menstrual disorders and unexpected vaginal bleeding occur commonly in the population, irrespective of vaccination, and there are many possible underlying causes, including anxiety caused by the ongoing pandemic.
Any changes occurring after Covid-19 vaccination are likely to be temporary, with no evidence that these temporary changes will impact future fertility."
Medsafe said it would however continue to monitor the rate and pattern occurrence of the issue.
Wiles said studies into the impact of the vaccine on menstruation haven't shown in real risk that would outweigh the risk of not being vaccinated.
One small study suggested that women with endometriosis might get their periods slightly earlier and women with polycystic ovaries might have a delayed period - however, things went back to normal pretty quickly.
She said menstrual cycles can also be impacted by the immune system - which is triggered by the vaccine - so it's understandable some women might notice a slight difference in their period short-term.
"That's just a side effect of getting that protection from covid. What we know from getting Covid is it's a serious disease which kills some people ... and there's now some evidence emerging that it may impact on fertility so you don't want any of those things and that's what you have to keep that in mind.
"All the evidence we have to date shows that the risks from the virus are far, far higher than the risks from the vaccine."
Meanwhile, there were 1,487 non-serious and 67 serious reports, including six deaths, in this week's report which is current up until November 6.
Of the 7,045,721 doses of Pfizer administered since February an average of 51 out of every 10,000 people - or someone who knows them - have gone on to make a report.
Medsafe points out it is "important to keep in mind that a report can be submitted for any cause and is not necessarily associated with the vaccine".
In total there have now been 103 deaths reported, three of which have been in people under the age of 30. Following medical assessments by both Medsafe and the Centre for Adverse Reactions Monitoring, only one is likely to be vaccine-induced, but a final decision on the exact cause of death is yet to be made by the Coroner.
A further eight deaths remain under investigation, 47 have been deemed unlikely to be linked to the vaccine and 47 couldn't be assessed due to insufficient information being provided.
The latest report also found that the number of people who died in the 21 days after having a vaccination was lower than the average number of deaths in previous years during the same time frame. That means there hasn't been a recorded spike in deaths in people who have been vaccinated.
Wiles said it was important that people report what happens to them so authorities can look for any patterns of reactions occurring at a higher rate than would normally be expected. But, she reminded people that a lot of reactions would be a coincidence and it was safer to be vaccinated than not.
"We are at the stage now where you will encounter this virus someway in the future - you either encounter it with your immune system ready and protected or you encounter it not protected and for some people there will be serious consequences for that."
