Official reports of allergic reactions have been rare as governments launch vaccines. (Archive photo)
Norway expressed growing concern about the safety of the Pfizer Inc. vaccine. in elderly people with severe underlying health conditions after raising to 29 an estimate of the number of deaths after receiving inoculations.
The latest figure adds six to the number of known fatalities in Norway and reduces the age group believed to be affected from 75 to 80. Although it is unclear exactly when the deaths occurred, Norway has given at least a dose to about 42,000 people and has focused on those who are 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 therefore “all deaths are 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. It was reported that all deaths related to “elderly people with severe underlying disorders.” “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site and the worsening of their underlying condition.”
Official reports of allergic reactions have been rare as governments rush to deploy vaccines to try to contain the global pandemic. U.S. authorities reported 21 cases of severe allergic reactions from December 14 to 23 after the administration of about 1.9 million initial doses of the Pfizer vaccine. The first European-level safety report on the Pfizer-BioNTech vaccine is due in late January.
The concern of Australia
Australia, which has an agreement for 10 million doses of the Pfizer vaccine, is seeking urgent information on the issue from the producer, health authorities and the Norwegian government, Health Minister Greg Hunt said in Melbourne on Sunday.
The Australian Therapeutic Products Administration will look for “additional information, both from the company and from the Norwegian medical regulator,” Hunt said. The Australian Foreign Ministry will also contact its Norwegian counterpart on the issue.
The Norwegian experience does not mean that younger and healthier people should avoid the vaccine. But it is an early indication of what to look for when countries start issuing safety control reports on vaccines. Emer Cooke, the new head of the European Medicines Agency, has said that monitoring the safety of Covid vaccines, especially those that depend on new technologies such as messenger RNA, would be one of the biggest challenges once they are implemented. widely the features.
Although the two Covid-19 vaccines approved so far in Europe were tested on tens of thousands of people (including volunteers in the late 1980s and 1990s), the average participant in the trial was about 50 years old. The first people to be vaccinated in many places have been older than countries rushing to inoculate residents of nursing homes at high risk for the virus.
Too risky
The findings have prompted Norway to suggest that vaccines against Covid-19 may be too risky for very old and terminally ill people, the most prudent statement a European health authority has ever made.
The Norwegian Institute of Public Health judges that “for those with more severe fragility, even the relatively mild side effects of the vaccine can have serious consequences. For those with a very short shelf life, the benefit of 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 email statement. 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 also been reported in other countries, but we do not yet have all the details,” the Norwegian drug agency said. “There are also differences between countries in which vaccination is prioritized, and this could also affect the notification of side effects, including death.”
“The Norwegian Medicines Agency has stated, before vaccination, that when the oldest and sickest are vaccinated, deaths are expected to occur in a time-related context with vaccination. This does not mean that there is also a causal link between Also, in relation to reported deaths, we have transmitted that it is possible that the common and known side effects of vaccines may have been a factor contributing to a serious course or a fatal outcome, “the agency said. .
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)