[ad_1]
Official reports of allergic reactions are rare as governments roll out vaccines. (File photo)
Norway has expressed growing concern about the safety of the Pfizer Inc. vaccine in older people with serious underlying health conditions after raising the estimated death toll from inoculations to 29.
The latter figure adds six to the number of known deaths in Norway and lowers the presumed affected age group from 80 to 75. While it is not known exactly when the deaths occurred, Norway has administered at least one dose to around 42,000 people and focused on those considered most at risk if they contract 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 therefore linked to this vaccine,” the Norwegian Medicines Agency said on Saturday in a written response to Bloomberg.
“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 the reported deaths concerned “elderly people suffering from serious basic 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 roll out vaccines to try to contain the global pandemic. U.S. officials reported 21 cases of severe allergic reactions from Dec. 14 to 23 after receiving approximately 1.9 million initial doses of Pfizer vaccine. The first European safety report on the Pfizer-BioNTech vaccine is expected to be published at the end of January.
Australia’s concern
Australia, which has reached a deal 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 on Sunday at Melbourne.
The Australian Therapeutics Administration will seek “additional information, both from the company, but also from the Norwegian medical regulator,” Hunt said. The Australian Foreign Office will also contact its Norwegian counterpart on this matter.
Norway’s experience does not mean that younger, healthier people should avoid being vaccinated. But it’s an early indication of what to watch out for as countries begin to publish vaccine safety surveillance reports. Emer Cooke, the new head of the European Medicines Agency, said 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 vaccines are widely deployed.
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 trial participant was in the early years of the fifties. The first people to be vaccinated in many places have been older than that as countries rush to vaccinate residents of nursing homes at high risk of the virus.
Too risky
The results 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 estimates that “for the most fragile people, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining lifespan anyway, the benefit of the vaccine may be marginal or unimportant. . “
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 to date is not alarming and in line with expectations,” Pfizer said.
“We know that deaths have been reported in other countries as well, but we do not yet have all the details,” the Norwegian Medicines Agency said. “There are also differences between countries as to who is a priority for vaccination, and this could also affect the reporting of side effects, including death.
“The Norwegian Medicines Agency has indicated, prior to vaccination, that when vaccinating the oldest and sickest people, deaths are expected to occur in a temporal context with vaccination. This does not mean not that there is a causal relationship between vaccination and We have also, in relation to the reported deaths, indicated that it is possible that the common and known side effects of the vaccines were a contributing factor in a serious course or a fatal outcome, ”the agency said.
(Except for the title, this story was not edited by NDTV staff and is posted from a syndicated feed.)
[ad_2]
Source link