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Secretary finds that the risks of the new coronavirus vaccine were not clearly communicated to the man who died of myocarditis

Secretary finds that the risks of the new coronavirus vaccine were not clearly communicated to the man who died of myocarditis


The Commissioner intends for public authorities to communicate the risk of myocarditis to consumers as part of the consent process, and consumers will be provided with safety net advice regarding symptoms of myocarditis following vaccination. He said he was satisfied with what was expected.

However, she concluded that finding a pharmacy in breach of the Code was disproportionately harsh given the important mitigating factors and that an educational approach was more appropriate.

McDowell said that at the time the man was vaccinated, the vaccine was “relatively new and no new information had yet emerged about its use, risks and side effects.”

He said a broader public context was also relevant to the incident, which took place amid “an unprecedented international and national response to the pandemic with a steady and simultaneous influx of information from official sources.” pointed out that it happened.

However, she found that none of the official sources explicitly required vaccine recipients to disclose the risk of myocarditis as part of the pre-vaccination informed consent process.

He also pointed to evidence that the importance of the new information compared to other information was not made clear to vaccination providers.

“Given the seriousness and amount of information available about myocarditis risks, it is reasonable to expect that the risks will be emphasized or highlighted in some way in communications with health care providers,” she said.

Mr McDowell did not find that the pharmacy was in breach of the code, but the standard to ensure consumers were given appropriate safety net advice about the risk of symptoms of myocarditis to look out for. He criticized the company for not updating its business procedures.

She also made negative comments about the pharmacist who administered the vaccine to the man, but similarly, the mitigating factors outlined did not find her in violation.

Mr McDowell said the Ministry of Health Manatu Hauora needs to provide clear and unambiguous guidance to vaccination providers on what and when they need to tell consumers about myocarditis when it comes to the Komilnati vaccine. , made educational comments.

This was particularly relevant after New Zealand's first death from myocarditis following COVID-19 vaccination in Cominati, which occurred before the man's death.

Mr McDowell made several recommendations for both pharmacies and Te Whatu Ora, including:

The pharmacy has updated its standard operating procedures to include a separate section on the COVID-19 vaccine, informed consent process, and advice on necessary safety nets.

Pharmacies will submit a copy of their updated procedures to the Health and Disability Commission within three months of the date of this report. 94.

Noting that NIP is now part of Te Whatu Ora rather than Manatu Hauora, 24 McDowell asked Te Whatu Ora at what point in the process should health care providers be asked about the risks and symptoms of myocarditis. They recommended that they consider updating their operational guidelines to clarify what should be discussed. The same goes for other side effects when a consumer takes her Comirnaty vaccine.

Te Whatu Ora shall report its findings, including details of any updates to the operational guidelines, to HDC within three months of the date of this report.




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