Published 20:47 IST, January 18th 2021
Australia seeks info from Pfizer, Norwegian regulator amid concerns about vaccine's safety
Australian govt has reportedly demanded detailed information from Pfizer-BioNTech and the Norwegian medical regulator after 30 vaccine recipients died in Norway
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The Australian government has reportedly demanded detailed information from Pfizer-BioNTech and the Norwegian medical regulator after 30 vaccine recipients died in Norway. As per reports, Australian Health Minister Greg Hunt called on both the Norwegian regulator and the vaccine manufacturers demanding detailed information regarding the incident. This comes after reports emerged on Norway's medicine regulator NOMA stating that the deaths of 29 people may have occurred due to Pfizer-BioNTech's COVID-19 vaccine.
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30 deaths among 40,000 elderly recipients
According to reports, Hunt is seeking additional information from the pharmaceutical companies and the Norwegian regulator through the Therapeutic Goods Administration (TGA). The additional information will help Australian authorities access the risk associated with the COVID-19 vaccine. This comes after reports of 30 deaths in over 40,000 elderly individuals in Norway in recent days. The deaths may be associated with the fact that all of them occurred in elderly people with underlying diseases, a factor not studied during trials.
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"The TGA was advised promptly of the Norwegian deaths and is working closely with the European Medicines Agency (of which Norway is a member) and Pfizer on further investigations. Because of Australia’s close working relationship with European regulators the TGA is one of the first non-European regulators to routinely receive early notification of any possible serious adverse events with COVID-19 vaccines," TGA said in a statement on Sunday.
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Australia is yet to approve a COVID-19 vaccine and is currently studying the information provided by Pfizer. TGA is also evaluating other available evidence, including from international experience with emergency use of the vaccine, before it could make a decision. "The TGA's processes for vaccine approvals are extremely rigorous and comprehensive. A vaccine will only be approved for use if it is demonstrated to be safe and effective in clinical trials and if the manufacturer can show it can be produced in a high quality, consistent and controlled manner," TGA said.
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Updated 20:47 IST, January 18th 2021