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No evidence three older people's deaths linked to Covid-19 vaccine — Bloomfield

There is no evidence linking the deaths of three “older people” to the Covid-19 Pfizer vaccines they received, the Director-General of Health said today. 

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The Director-General of Health says the assessment was confirmed by medical assessors and the clinicians treating them. Source: 1 NEWS

Dr Ashley Bloomfield said that assessment was confirmed by regulatory medical assessors and the clinicians treating the three people. Two of the three are understood to be in their 80s. 

He said the deaths had been reported to the Centre for Adverse Reactions Monitoring, which monitors the safety of all medicines, including vaccines. The reports were made because the deaths had happened “within a period of a few days or slightly longer after that vaccination”. 

“This is good practice that any death that occurs within a period after a vaccination [is reported],” Bloomfield said.

For example, he said, if a person died within 28 days after leaving the hospital, it was reported so an investigation could take place. 

Bloomfield didn’t provide further details about the age or any underlying conditions of the three people. 

Anyone is able to report an adverse reaction to a medicine, including vaccines, to the Centre for Adverse Reactions Monitoring. It does not necessarily mean that the medicine or vaccine was the cause of the event. 

After questioning from 1 NEWS, the Ministry of Health on Saturday confirmed it was aware of the deaths of the two people, believed to be in their 80s, who received the Pfizer/BioNTech jab. 

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Deaths of two people who had Covid vaccine reported to NZ's medicines safety centre; no direct link established

No direct link between the vaccine and their deaths were established, and no detail was confirmed about who had made the report.

The deaths were not proactively reported at the time. Bloomfield said today that was because it “had just been reported” to the investigative agency. 

“It’s good the report has been made but we want to wait until the medical assessors have had a chance to look at those deaths and determine if there was any likely link to the vaccine.”

Bloomfield said serious reactions to the Pfizer Covid-19 vaccine are rare. Less serious reactions are more common, but are usually mild and don’t last long.

Medsafe’s latest report on adverse events after immunisation shows that of the more than 80,000 doses of the Covid-19 vaccine administered by April 3, only 19 reports were deemed “serious” and 644 were “non-serious”. 

As of today, more than 268,000 people have already received a first dose of the vaccine, and more than 120,000 people have received a second dose.

No safety issues with the Pfizer vaccines have been identified.

Serious reports included allergic reactions that were managed properly and chest discomfort and a fast heart rate. 

Common non-serious reports included headaches, nausea, dizziness, fever and pain at the injection site. 

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The Director-General of Health says serious reactions to the Pfizer Covid-19 vaccine are rare. Source: 1 NEWS

Bloomfield encouraged people to make reports to the Centre for Adverse Reactions Monitoring if they did experience a reaction after getting a Covid-19 vaccine. 

How should adverse reactions be communicated to the public? 

Melbourne University’s Dr Jessica Kaufman is a researcher in vaccine acceptance and communication at the Murdoch Children’s Research Institute. 

Kaufman told 1 NEWS hearing about adverse effects after immunisation, or even the fact there was a place to go to report events like it, showed the robustness of the safety monitoring system.

“So, picking up, if anything, that might be connected to the vaccine and doing something about it and investigating it, all of that really should reassure people that the system is working.

“So there shouldn't be a concern about letting people know that that's happening. It doesn't automatically mean that people are going to freak out and be panicked by it,” she said of health authorities’ reporting.

She said proactive and timely communication about Covid-19 vaccines, and transparency about any adverse reactions, are key to encouraging uptake as New Zealand continues its rollout.

“This is maybe an example of a situation where for a serious event, like a death, maybe they could look at a different timeframe on that. They may need to release a statement ahead of that so it doesn’t look like they’re hiding anything."

Medsafe publishes a Covid-19 Vaccine Safety Report every Wednesday. 

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Dr Helen Petousis-Harris told 1 NEWS was no reason for people to worry. Source: 1 NEWS

Kaufman said New Zealand could take some pointers from Australia’s experience. 

“We've had so many more of these sorts of events with AstraZeneca,” she said. For example, last month, Australia’s regulatory agency found no evidence linking the deaths of two Australians to the AstraZeneca vaccine they took. 

“The advice from the WHO and the way that Australia’s been going about it has been to be pretty transparent about things.”

The public were “more savvy than we give them credit for” and hold more nuanced views about vaccines, Kaufman added. 

“We’ve not seen dramatic drops in vaccine acceptance [in Australia] with the safety events that we've reported around the AstraZeneca vaccine. 

“Or, if we've seen people's attitudes towards that vaccine change because of the reports, they haven't necessarily had any impact on people's attitudes towards the Pfizer vaccine.”

She said this transparency could look like telling the public a report had been made to a regulator, then making a “really clear statement” about the fact investigations were underway and what it meant. 

“That's maybe where the media has a role to educate the public about what it means to have an event reported and the difference is between that and saying it has a ‘likely connection to the vaccine’, and making sure that that's included in the reporting.”

She said it should be acknowledged that it is normal for people to have questions about the vaccine, and that it is common. 

“They want to understand how they were developed or approved so quickly,” she said.

“It’s about understanding what people’s concerns are and trying to make sure that we're addressing those concerns, and they're different for different groups.

“I think that's a much more appropriate strategy than, you know, putting the vaccine as ‘once you get it, everything will be totally normal’.

“There's some uncertainty and people know there's uncertainty, and they know there's changing information. Preparing people for some of that uncertainty and changing evidence is a better way to maintain trust than being overly certain.”