Source : bloomberg.com
By Lars Erik Taraldsen and Naomi Kresge
15 janvier 2021 à 09:12 UTC+1 Updated on
Norway said Covid-19 vaccines may be too risky for the very old and terminally ill, the most cautious statement yet from a European health authority as countries assess the real-world side effects of the first shots to gain approval.
Norwegian officials said 23 people had died in the country a short time after receiving their first dose of the vaccine. Of those deaths, 13 have been autopsied, with the results suggesting that common side effects may have contributed to severe reactions in frail, elderly people, according to the Norwegian Medicines Agency.
“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences,” the Norwegian Institute of Public Health said. “For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”
The recommendation does not mean younger, healthier people should avoid being vaccinated. But it’s an early indication of what to watch as countries begin to issue safety monitoring reports on the vaccines. Emer Cooke, the new head of the European Medicines Agency, has said tracking the safety of Covid vaccines, especially those relying on novel technologies such as messenger RNA, would be one of the biggest challenges once shots are rolled out widely.
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 in line with expectations,” Pfizer said.
Allergic reactions have been uncommon so far. In the U.S., authorities reported 21 cases of severe allergic reactions from Dec. 14-23 after administration of about 1.9 million initial doses of the vaccine developed by Pfizer Inc. and BioNTech SE. That’s an incidence of 11.1 cases per million doses, according to the Centers for Disease Control and Prevention.
Though both Covid-19 vaccines approved so far in Europe were tested in tens of thousands of people — including volunteers in their late 80s and 90s — the average trial participant was in his or her early 50s. The first people to be immunized in many places have been older than that as countries rush to inoculate nursing-home residents at high risk from the virus.
Norway has given at least one dose to about 33,000 people, focusing on those considered to be most at risk if they contract the virus, including the elderly. The Pfizer-BioNTech vaccine approved late last year has been used most broadly, with a similar shot from Moderna Inc. approved earlier this month also now being administered.
Of 29 cases of potential side effects investigated by Norwegian authorities, almost three-quarters were in people age 80 or older, the regulator said in a Jan. 14 report.
In France, one frail patient died in a care home two hours after being vaccinated, but authorities said given the patient’s previous medical history there is no indication the death was linked to the vaccine. The French pharmaceutical safety agency on Thursday reported four cases of severe allergic reactions and two incidents of irregular heartbeat after vaccination.
The first Europe-wide safety report on the Pfizer-BioNTech vaccine will probably be published at the end of January, the regulator’s key medicines committee said Friday. Vaccine makers are required to submit data monthly.
In the U.K., which has carried out more immunizations per capita than anywhere else in Europe, authorities will assess safety data and plan to publish details of suspected reactions “on a regular basis,” the Medicines and Healthcare Products Regulatory Agency said, without giving a date.
— With assistance by Rudy Ruitenberg, Stephen Treloar, and Suzi Ring(Updates with comment from company in fifth paragraph, regulator in final paragraphs)