A blog post being shared on social media claims the New Zealand government ignored warnings by the country’s independent medicines regulator, Medsafe, relating to 58 serious issues with the Pfizer COVID-19 vaccine.
The claim is false. Medsafe did not issue any warning or cite serious issues with the vaccine. Its original provisional approval of the vaccine was subject to 58 conditions that Pfizer’s New Zealand operation needed to satisfy. Medsafe told AAP FactCheck none of the obligations attached to the conditions were considered serious or the approval would not have been granted.
The claim was made in a blog post that stated the New Zealand government “lied about the safety of the COVID19 vaccines”. The blog article has been shared on Facebook at least 600 times (here and here).
The post claims the New Zealand government and Prime Minister Jacinda Ardern “ignored MedSafe’s warnings that the Pfizer vaccine had 58 serious issues with it, but pushed it on NZers anyways (sic) and lied about its safety.”
The false claim appears to refer to the 58 conditions in Medsafe’s original provisional consent in February, 2021. These conditions, which are publicly available, placed obligations on Pfizer relating to provision of information about ongoing developments.
Medsafe’s website states Medsafe has been granting provisional consent for COVID-19 vaccines, as opposed to full consent, in order to be able to impose conditions on the use of the vaccine according to the data available at the time of approval. Provisional consent is a longstanding feature of New Zealand’s Medicines Act.
Medsafe group manager Chris James told AAP FactCheck that the regulatory body did not consider any of the conditions on the Pfizer approval to be serious, “otherwise the provisional approval would not have been granted”.
“Medsafe evaluates applications for all new medicines, including vaccines, to ensure that they comply with international standards and local requirements for quality, and that expected benefits outweigh the risks of side effects,” Mr James said in an email.
“Only then will Medsafe recommend approval for use in New Zealand. Medsafe has assessed and approved a large number of variations (updates on the use, stability, manufacturing and safety) from Pfizer since Comirnaty was first approved, all of which have gone through the same stringent approval process.”
Helen Petousis-Harris, associate professor at the University of Auckland and co-director of the Global Vaccine Data Network, told AAP FactCheck the imposition of obligations is a normal part of Medsafe’s regulatory process, particularly for products with provisional approval.
“Regulatory agencies such as Medsafe can ask the product sponsor to keep them appraised of developments,” Dr Petousis-Harris said in an email response.
“This has no bearing on whether or not there is a problem with the product.”
Dr Petousis-Harris said that “at no time has the New Zealand regulator said it found 58 ‘serious issues’ with the Pfizer vaccine.”
The majority of the 58 obligations in Medsafe’s original provisional consent involved requirements to provide additional data as it became available — and none of them related to issues with the vaccine.
The provisional consent for the Pfizer COVID-19 vaccine (for people aged 12 years and older) was renewed on October 28, 2021, with eight of the original 58 obligations remaining. Mr James told AAP FactCheck that eight of the original obligations remained because they relate to ongoing requirements, such as providing Periodic Safety Update Reports, or because they are not yet required according to the dates specified in the conditions.
The Verdict
The claim that the New Zealand government ignored warnings from Medsafe about 58 serious issues with the Pfizer COVID-19 vaccine is false. Regulator Medsafe has confirmed it did not raise 58 serious issues. Instead, the publicly available approval document shows there were 58 conditions applied to the approval, none of which comprise “serious issues” with the vaccine.
The majority of the conditions obligated Pfizer to provide vaccine-related data to Medsafe as that information became available.
False – The claim is inaccurate.
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