Faktisk.

Too soon to say whether 23 Norwegians died because of the covid-19 vaccine

The Norwegian Medicines Agency is investigating 23 deaths among elderly who have received the coronavirus vaccine. The reports made people think they all died from the vaccine, but that is not clear.

Foto: Lise Åserud, NTB.

Reports of 23 deaths among old people who had received a vaccine against covid-19 in Norway, have spread worldwide.

Several international media outlets covered the reports from the Norwegian Medicines Agency, and several featured the story prominently.

Data from CrowdTangle, an analysis tool, shows that posts sharing stories about the Norwegian deaths have generated more than 400 000 Facebook interactions in the past week.

An article in the New York Post was one of the news stories creating the most engagement on Facebook around the deaths in Norway. Skjermbilde fra Facebook.

A news article from the New York Post is one of the stories being shared and discussed the most. The article has been shared more than 100 000 times. Facebook users wrote more than 100 000 comments, and left more than 180 000 likes and other reactions on posts connected to the article.

The media stories did not necessarily report the deaths as directly caused by the vaccine, but were read that way by many readers worldwide.

– Taken out of context

The figures from Norway are also shared by vaccine sceptics and people opposed to the coronavirus vaccines.

Some of them allege that «mainstream media is silent about the deaths», and that sharing information about the deaths will be censored as misinformation on social media.

In a statement from the Norwegian Medicines Agency to Faktisk.no, they state that reports about the deaths in Norway have been spread online in ways introducing errors or losing context.

– We will not give any general advice against taking the vaccines due to these reports of deaths in Norway, Pernille Harg with the Norwegian Medicines Agency writes to Faktisk.no in an email.

This is what we know so far about the 23 deaths in Norway:

1. Did 23 Norwegians die after receiving the coronavirus vaccine?

Yes. But that does not mean that they died of the vaccine.

According to the Norwegian Medicines Agency, 23 deaths have been reported in connection to the covid-19 vaccine rollout in Norway. At present, 13 of those deaths have been assessed by the agency, and they have not been able to conclude the deaths were caused by the vaccine.

The numbers were last updated on the 14th of January. The agency publishes updated figures each Thursday. In Norway two different vaccines are approved for use (Pfizer/BioNTech and Moderna). Since the first dose of the Moderna vaccine in Norway was administered on the 15th of January – these numbers only include the Comirnaty vaccine from Pfizer/Biontech.

Update: The Norwegian Institute of Public Health (NIPH) updated the number of reported deaths to 33 in a press conference Monday. Still 13 deaths have been assessed by NIPH and Norwegian Medicines Agency.

All suspected side effects are reported, and the reports describe events that have occurred in the time following vaccination.

That an event has been reported, does not necessarily mean that there is a causal connection between the suspected side effect and the vaccine, the Norwegian Medicines Authority writes.

2. Is it correct to say that they died of the vaccine?

No, it is not concluded that the deaths were caused by the vaccine. But it can not be excluded in some of the cases.

Sigurd Hortemo, chief physician at the Norwegian Medicines Agency. Foto: Legemiddelverket.

Sigurd Hortemo at the Norwegian Medicines Agency, tells Faktisk.no, they have not concluded with a causal connection between the vaccine and the 13 deaths.

In their report, the agency writes that not all reported deaths are considered as possibly linked to the vaccine, but that deaths are reported in the interest of safety:

In several of these deaths, the person who reported it, states that they do not suspect any link to the vaccine, and that the cause of the event was an underlying condition, but that they reported the death just in case.

Still, The Norwegian Medicines Agency can not exclude that common adverse reactions may have contributed to serious consequences for some frail patients, their report states.

– The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, in a press release.

3. Who are the deceased?

The Norwegian Medicines Agency writes that the 13 deaths that have been assessed occurred in nursing homes. They were all above 80 years of age, and some of them were above 90. They had serious underlying conditions and «severe frailty».

The Norwegian Institute of Public Health and the government have decided that the oldest citizens and those who reside in nursing homes, will receive the coronavirus vaccine first in Norway. A large share of those who receive the first doses of the vaccines are either very frail or terminally ill patients.

«Frail» denotes patients with serious heart failure, dementia, chronic obstructive pulmonary disease and other serious illnesses, according to state broadcaster NRK, who cites medical director Steinar Madsen from the Norwegian Medicines Agency.

4. Were deaths among the vaccinated expected?

Yes. Each week, an average of 300-400 people die in Norwegian nursing homes.

When such a group is vaccinated, deaths closely connected to the time of vaccination will occur, according to the Norwegian Medicines Agency.

Steinar Madsen, medical director with the Norwegian Medicines Agency. Foto: Berit Roald / NTB.

Madsen has previously said to Faktisk.no that it is important to distinguish between causal connections and events that simply occur in close proximity in time. At that time, Madsen emphasized that many care home residents are not expected to live much longer, and that the Medicines Agency expects many of them to die shortly after they receive the vaccine.

Are S. Berg at the Norwegian Institute of Public Health agreed with Madsen, pointing to the fact that deaths among nursing home residents who have received the coronavirus vaccine, has been observed in other countries.

5. Is the vaccine still considered safe?

Norwegian Minister of Health, Bent Høie, has previously said to Faktisk.no there is always risk involved when taking medicines, but a vaccine will only be approved if the benefits outweigh the risks.

The Norwegian Institute of Public Health writes that «for most of those who are old and who are living with frailty, potential side effects of the vaccine are more than outweighed by the reduced risk of becoming seriously ill from covid-19».

Mr. Hortemo with the Norwegian Medicines Agency tells Faktisk.no one cannot say the vaccine is «safe» in the meaning of excluding all unknown adverse effects, or that patients can expect no adverse effects at all when taking it.

– But it is «safe» in the meaning that serious adverse effects are very rare, and the benefits outweigh the risks of adverse effects, Hortemo says.

The Norwegian Institute of Public Health has adjusted their recommendations with a statement that for the most frail, side effects from a vaccine may have serious consequences. They also write that the benefits provided by a vaccine for those nearing the end of their lifespan may be marginal or irrelevant.

Steinar Madsen agrees with the Institute of Public Health, and says to VG that there are two reasons supporting the assessment.

– One reason is the number of life years the patient has left, and many nursing home residents are not expected to live much longer. Another reason is that some of the oldest patients may experience the same side effects as younger patients – fever, vomiting, a sense of discomfort and suppressed appetite, which may result in them not drinking a sufficient amount of water, for example, Madsen said to the newspaper.

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