Official reports of allergic reactions are rare when governments introduced vaccines. (File photo)
Norway raised growing concerns about the safety of the Pfizer Inc. vaccine for elderly people with serious underlying health conditions, after increasing the estimated number of deaths after receiving vaccinations to 29.
The latter figure adds six to the number of known fatalities in Norway, and lowers the age group believed to be affected from 80 to 75. While it is unclear exactly when the deaths occurred, Norway has given at least one dose to about 42,000 people and focused on those most at risk if they contract the virus, including the elderly.
Until Friday, the vaccine produced by Pfizer and BioNTech SE was the only vaccine available in Norway, and “thus all deaths are linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.
“There have been 13 deaths that have been identified, and we are aware of an additional 16 deaths currently being assessed,” the agency said. All reported deaths were in “elderly people with serious basic disorders,” the paper said. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local injection site reactions and worsening of their underlying condition.”
Official reports of allergic reactions are rare as governments rush to roll out vaccines to contain the global pandemic. US authorities reported 21 cases of severe allergic reactions from December 14-23 after administration of about 1.9 million initial doses of the Pfizer vaccine. The first European safety report on the Pfizer BioNTech vaccine will be published at the end of January.
Australia’s Concerns
Australia, which has an agreement for 10 million doses of the Pfizer vaccine, is seeking urgent information on the matter from the producer, health authorities and the Norwegian government, Health Minister Greg Hunt told reporters in Melbourne on Sunday.
The Australian Therapeutic Goods Administration will “obtain additional information, both from the company, but also from the Norwegian medical regulator,” said Hunt. The Australian Ministry of Foreign Affairs will also be contacting its counterpart in Norway on this matter.
Norway’s experience does not mean that younger, healthier people should not be vaccinated. But it’s an early indication of what to look for when countries start publishing safety reports on the vaccines. Emer Cooke, the new head of the European Medicines Agency, has said that monitoring the safety of Covid vaccines, especially those that rely on new technologies such as messenger RNA, would be one of the biggest challenges once the shots become widespread. be rolled out.
Although the two Covid-19 vaccines approved so far in Europe have been tested on tens of thousands of people – including volunteers in their late 80s and 90s – the average trial participant was in their early 50s. The first people vaccinated in many places are older than that, as countries rush to vaccinate nursing home residents at high risk for the virus.
Too risky
The findings have prompted Norway to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill, the most cautious statement to date from a European health authority.
The Norwegian Institute of Public Health finds that “for those with the most severe vulnerability, even relatively mild side effects from the vaccine can have serious consequences. For those who have a very short remaining life anyway, the benefit of the vaccine may be marginal or irrelevant. . “
Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, Pfizer said in an emailed statement. The agency found that “the number of incidents so far is not alarming, and in line with expectations,” Pfizer said.
“We are aware that deaths have also been reported in other countries, but we do not yet have full details on this,” said the Norwegian medicines agency. “There are also differences between countries in which vaccination is prioritized, and this may also affect reporting of adverse events, including death.”
“The Norwegian Medicines Agency has communicated prior to vaccination that when vaccinating the oldest and sickest, deaths are expected to occur in a time-related context with vaccination. This does not mean that there is a causal relationship between vaccination and we also have, in In connection with the reported deaths, it conveyed that common and known side effects of the vaccines may have been a factor contributing to a serious course or a fatal outcome, ”the agency said.
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