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Regulatory Focus™ > News Articles > 2021 > 12 > Asia-Pacific Roundup: New Zealand probes role of Pfizer’s COVID-19 vaccine, myocarditis in three dea

Asia-Pacific Roundup: New Zealand probes role of Pfizer’s COVID-19 vaccine, myocarditis in three deaths

Posted 21 December 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: New Zealand probes role of Pfizer’s COVID-19 vaccine, myocarditis in three deaths

Authorities in New Zealand are reviewing whether the Pfizer-BioNTech COVID-19 vaccine played a role in the deaths of three people who died with potential myocarditis in the period following vaccination.
Myocarditis, inflammation of the heart muscle, is a rare reaction to vaccination with Pfizer’s Comirnaty and Moderna’s Spikevax. However, myocarditis can occur in response to viral infection, too, and the New Zealand COVID-19 Vaccine Independent Safety Monitoring Board said the risk of inflammation is higher in people with COVID-19 than in individuals who receive Pfizer’s vaccine against the pathogen.
Even so, the board is reviewing the three deaths. At a recent meeting, the board determined that one of the deaths, of a man in his 60s, is unlikely to be related to Comirnaty because time from vaccination to the onset of symptoms and clinical factors point to other causes. The board is awaiting more information before ruling whether the vaccine is likely to be implicated in the death of a 13-year-old child.
The third case involves a 26-year-old man who died within 2 weeks of his first dose of the Pfizer vaccine. Myocarditis is the probable cause of death, based on preliminary information from the post-mortem examination. As the man developed symptoms of myocarditis in the days after vaccination, the board ruled the inflammation was probably caused by Comirnaty but maintained its position on the vaccine.
“The Board considers that the circumstances of these cases do not impact or change the known information on myocarditis, and the benefits of vaccination with the Pfizer vaccine for COVID-19 continue to greatly outweigh the risk of such rare side effects,” the board stated.
Press Release, Medsafe Notice
TGA warns about imports of counterfeit ivermectin, urges use of legitimate sources
Australia’s Therapeutic Goods Administration has issued a warning about the importation of counterfeit ivermectin, the antiparasitic human and veterinary medication that some consumers have flocked to without evidence as a way to prevent and treat COVID-19.
TGA issued the warning after testing a number of imported products labeled as ivermectin. The laboratory tests found that three 12mg ivermectin products — Iversun-12, Covimectin-12 and Ivilife-12 — contained less of the active ingredient than was declared on their labels. The difference between the claimed and actual quantities of ivermectin led TGA to declare the products to be counterfeit under the Therapeutic Goods Act 1989.
The discovery of counterfeit ivermectin imports led TGA to warn consumers against buying the drug from unverified online sellers. While TGA’s notice only addresses the shortfall of active ingredient, the agency is concerned that counterfeit products may contain undeclared and hazardous ingredients that cause serious adverse reactions. TGA also warned that counterfeit products can be contaminated because of a lack of manufacturing and testing standards.
TGA also reiterated its warning against the importation of ivermectin for the treatment of COVID-19. Regardless of whether ivermectin is authentic or counterfeit, TGA strongly discourages self-medication and self-dosing for the treatment or prevention of COVID-19 because it is dangerous to take large doses of ivermectin and there is insufficient evidence of its safety and efficacy in the indication. Those concerns led TGA to impose new restrictions on the prescribing of ivermectin earlier in the year.
With some consumers bypassing the restrictions by purchasing potentially counterfeit ivermectin online, TGA is stepping up its monitoring of imports into Australia. TGA is working with the Australian Border Force (ABF) to target counterfeit and unlawful ivermectin. ABF will refer suspected counterfeit products to TGA.
TGA Notice
TGA grants provisional determination to COVID-19 vaccine from crowdfunded local biotech
Australian biotech Vaxine has received provisional determination from TGA for a COVID-19 vaccine that it is trying to bring to its home market using money from a crowdfunding campaign.
The vaccine, Advax-CpG55.2, is a recombinant protein product that Vaxine tested in a Phase 3 clinical trial of almost 17,000 people in Iran. Like Novavax’s recombinant protein vaccine, Advax-CpG55.2 uses a genetically engineered version of a part of the coronavirus, in this case made in insect cells, to induce immunity against the pathogen.
While the vaccine is approved for emergency use in Iran, TGA is yet to authorize it for use in Australia. The provisional determination is an early step to entering the Australian market. Vaxine is now eligible to apply for provisional registration of the vaccine in the Australian Register of Therapeutic Goods.
Vaxine began the TGA process after raising money in a crowdfunding campaign. At the time of writing, the biotech has raised AU$868,619 ($618,608) in a campaign that is pitching Advax-CpG55.2 as “a safe and effective protein-based vaccine alternative” for “thousands of concerned Australians who are being threatened with loss of their jobs if they don’t comply with onerous government vaccine mandates.”
TGA Notice, Crowdfunding Page
TGA finalizes changes to Permissible Ingredients Determination after consultation
TGA has finalized low-negligible risk changes to the Permissible Ingredients Determination. All four changes were accepted, with some revisions, after a consultation that attracted 20 comments.
The agency received the most feedback on its plan to address peripheral neuropathy associated with lower-dose vitamin B6. TGA received a wide range of responses, with some calling for it to impose more restrictions while others pushed for a relaxation of the rules. In light of the feedback, TGA has changed the maximum recommended daily dose of pyridoxine for adults from 50 mg to 100 mg.
TGA also tweaked two of the other proposals in response to the feedback. The agency has imposed additional restrictions on benzalkonium chloride concentration in nasal sprays and exempted products that use three Artemisia species as excipients in steam-distilled essential oil from the requirement to carry a pregnancy warning statement.
Finally, TGA adopted an allergen warning statement for mollusk-derived ingredients without making any changes to its original proposal. All the changes will commence 1 March 2022, but sponsors have until 1 March 2023 to ensure their products comply with the new rules.
Consultation Results
Pakistan limits initial validity of local GMP medical device certificates to 1 year
The Drug Regulatory Authority of Pakistan (DRAP) has limited the initial validity of good manufacturing practice (GMP) certificates for medical devices to one year to “ensure conformance to standards.”
At a recent meeting of its policy board, DRAP decided to restrict the validity of GMP certificates for local manufacturing of medical devices to one year for the first three years from the date of the grant of the establishment license. Once three years have passed, DRAP will extend the validity of GMP certificates to three years, in effect creating a risk-based system that focuses oversight on new manufacturers.
The medical device rules in Pakistan require holders of establishment licenses to comply with GMPs and good distribution and storage practices. Authorities can cancel or suspend licenses for non-compliance.
DRAP Notice
Other News:
TGA has fined Commcare, trading as St Francis Pharmacy, AU$39,960 ($28,442) for alleged unlawful advertising of medicinal cannabis. The agency issued three infringement notices in relation to an alleged reference to medicinal cannabis in advertising on Commcare’s website, thereby breaching the ban on promoting prescription medicines to the public, and on a poster displayed in its shop. TGA Notice


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