Official reports of allergic reactions have been rare as governments distribute vaccines. (File photo)
Norway expressed growing concern about the safety of the Pfizer Inc. vaccine in elderly people with serious underlying health conditions, after raising to 29 an estimate of the number of deaths after receiving the inoculations.
The latter figure adds six to the number of known deaths in Norway and reduces the age range considered affected to 75 out of 80. Although it is not clear exactly when the deaths occurred, Norway gave at least one dose to around 42,000 people and concentrated on those considered to be at greatest 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 “all deaths are therefore linked to this vaccine,” said the Norwegian Medicines Agency 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,” said the agency. All reported deaths are related to “elderly people with severe basic disorders,” the newspaper said. “Most people experienced the side effects expected from 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 are rushing to launch vaccines to try to contain the global pandemic. United States authorities reported 21 cases of severe allergic reactions from December 14 to 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 in late January.
Australia’s concern
Australia, which has an agreement for 10 million doses of the Pfizer vaccine, is seeking urgent information on the matter from the Norwegian producer, health authorities and government, Health Minister Greg Hunt told reporters in Melbourne on Sunday. .
Australia’s Therapeutic Goods Administration will seek “additional information, both from the company but also from the Norwegian medical regulator,” said Hunt. The Australian Ministry of Foreign Affairs will also contact its counterpart in Norway on the matter.
Norway’s experience does not mean that younger, healthier people should avoid being vaccinated. But it is an initial indication of what to watch for when countries start issuing safety monitoring reports on vaccines. Emer Cooke, the new head of the European Medicines Agency, said that tracking the safety of Covid’s vaccines, especially those that rely on new technologies like messenger RNA, would be one of the biggest challenges once vaccines were widely implemented.
Although the two Covid-19 vaccines approved so far in Europe have been tested on tens of thousands of people – including volunteers in their 80s and 90s – the average trial participant was in his 50s. The first people to be immunized in many places are older than that, as countries are in a hurry to inoculate nursing home residents at high risk of the virus.
Very dangerous
The findings led Norway to suggest that Covid-19 vaccines can be very risky for the very elderly and terminally ill, the most cautious statement by a European health authority.
The Norwegian Institute of Public Health assesses 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 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 e-mailed statement. The agency found that “the number of incidents so far is not alarming and is in line with expectations,” said Pfizer.
“We are aware that deaths have also been reported in other countries, but we do not have complete details about this yet,” said the Norwegian drug agency. “There are also differences between countries in whom vaccination is prioritized, and this can also affect reporting of side effects, including death.”
“The Norwegian Medicines Agency reported, prior to vaccination, that when vaccinating the oldest and the 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 death. We also communicate, in connection with reported deaths, that it is possible that the common and known side effects of vaccines may have contributed to a serious course or fatal outcome, “said the agency.
(Except for the title, this story was not edited by the NDTV team and is published from a syndicated feed.)