Official reports of allergic reactions have been rare as governments launch vaccines. (Photo file)
Norway has expressed growing concern about the safety of the Pfizer Inc. vaccine. in the elderly with serious underlying health conditions, after raising an estimate of the number of people who died after being vaccinated at 29.
The latest figure adds six to the number of known deaths in Norway and reduces the age group considered to be affected to 75 out of 80. Although it is not clear exactly when the deaths occurred, Norway gave at least one dose for about 42,000 people. people and focused on those considered most at risk if they contracted the virus, including the elderly.
Until Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway, and “all deaths are thus related to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.
“There are 13 deaths that have been assessed and we are aware of another 16 deaths that are currently being assessed,” the agency said. All reported deaths referred to “elderly people with severe underlying disorders,” he said. Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site and worsening of their underlying condition.
Official reports of allergic reactions have been rare as governments rush to launch vaccines to try to contain the global pandemic. US authorities reported 21 cases of severe allergic reactions between December 14-23 after the administration of approximately 1.9 million initial doses of Pfizer vaccine. The first European safety report on the Pfizer-BioNTech vaccine is due to be published at the end of January.
Australia’s concern
Australia, which has an agreement for 10 million doses of Pfizer vaccine, is seeking urgent information from the manufacturer, health authorities and the Norwegian government, Health Minister Greg Hunt told reporters in Melbourne on Sunday.
The Australian Therapeutic Products Administration will seek “additional information from both the company and the Norwegian medical authority,” Hunt said. Australia’s Foreign Ministry will also contact its Norwegian counterpart on the issue.
Norway’s experience does not mean that younger and healthier people should avoid vaccination. But it is an early indication of what to look for as countries begin issuing vaccine safety monitoring reports. Emer Cooke, the new head of the European Medicines Agency, said monitoring the safety of Covid vaccines, especially those based on new technologies such as messenger RNA, would be one of the biggest challenges once the launches will take place. be launched widely.
Although the two Covid-19 vaccines approved so far in Europe have been tested in tens of thousands of people – including volunteers in the late 1980s and 1990s, the average participant in the study was in the early 1950s. The first people to be immunized in many places were older than them, as countries rush to inoculate nursing homes at high risk for the virus.
Too risky
The findings have led Norway to suggest that Covid-19 vaccines may be too risky for the very elderly and terminally ill, the most cautious statement by a European health authority to date.
The Norwegian Institute of Public Health estimates that “for those with the most severe fragility, even the relatively mild side effects of the vaccine can have serious consequences. For those who have a very short life, however, the benefit of the vaccine may be marginal or irrelevant. . “
Pfizer and BioNTech are working with the Norwegian regulator to investigate deaths in Norway, Pfizer said in an email. The agency found that “the number of incidents so far is not alarming and is in line with expectations,” Pfizer said.
“We are aware that deaths have been reported in other countries, but we do not yet have full details about this,” the Norwegian Medicines Agency said. “There are also differences between countries in the priority for vaccination, and this could also affect the reporting of side effects, including death.”
“The Norwegian Medicines Agency said before vaccination that when the elderly and the sick are vaccinated, deaths are expected to occur in a time-related context with vaccination. This does not mean that there is a causal link between vaccination and Also, in connection with reported deaths, we have transmitted that it is possible that the common and known side effects of vaccines may have been a contributing factor to a serious course or outcome. fatal, “the agency said.
(Except for the title, this story was not edited by NDTV staff and is published in a syndicated stream.)