
Photographer: Nathan Laine / Bloomberg
Photographer: Nathan Laine / Bloomberg
Like all new drugs, the vaccines approved to protect against Covid-19 pose some safety concerns and side effects. Many people who received the first two Western shots have been deployed, one of them Pfizer Inc. and BioNTech SE, and one more of them Moderna Inc. has experienced fever, headache, and pain at the injection site. These side effects usually disappear quickly. Even more worrying is Norway reported deaths in elderly people with serious underlying health problems following the administration of the Pfizer-BioNTech vaccine – possibly related to those side effects. A few other recipients of the various shots have had a serious, but treatable, allergic reaction called anaphylaxis.
1. What is known about the dead?
Twenty-nine were reported in mid-January among about 40,000 people receiving the Pfizer-BioNTech vaccine in Norway, where authorities prioritized immunization of nursing home residents. Those who died all fell into the “75 years +” category (exact ages were not given for privacy reasons) and included terminally ill patients expected to have only weeks or months to live. All deaths that occur within a few days of vaccination are carefully assessed. Those who are close to the time of vaccination not necessarily because of the intake: average According to the Norwegian Medicines Agency, 400 people die every week in nursing homes and long-term care facilities. Sigurd Hortemo, the agency’s chief physician, said he cannot rule out that common side effects of the vaccine, such as fever and nausea, could be potentially life-threatening in patients with serious underlying health conditions.
2. Were there any deaths elsewhere?
In Germany, where more than 800,000 people received their first of two doses of the Pfizer-BioNTech vaccine, the Paul Ehrlich Institute has investigated at least seven cases of elderly people who die shortly after vaccination. In its report, it said the deaths were likely due to the patients’ underlying diseases, including carcinomas, kidney deficiencies and Alzheimer’s disease, not the vaccination.
3. What reactions developed in these fatal cases?
The deaths in Norway were associated with fever, nausea and diarrhea – relatively common, short-term effects that some people may experience after almost any vaccination, according to information provided by the Australian Therapeutics Administration. (It is working with the European Medicines Agency, which also includes Norway, before deciding whether to approve the drug in Australia.) Responses are not expected to be significant in the vast majority of people. Millions of doses of the Pfizer BioNTech vaccine have been administered the US, UK and some other countries with no deaths were reported from the vaccine, Abrar Chughtai, a lecturer in the School of Public Health and Community Medicine at the University of New South Wales, told the Australian Science Media Center.
4. What is known about the risks of the vaccine in elderly, vulnerable people?
Not much. It is possible that common side effects of vaccines that are not dangerous in fitter, younger patients may be worsen the underlying disease in the elderly, Steinar Madsen, the Norwegian agency’s medical director, told The BMJ Medical Journal. Only a limited number of people over age 85 participated in large clinical trials with the Pfizer-BioNTech vaccine, the agency said. The average subject for the two approved Western vaccines was in their early 50s.
5. What is done about the dead?
The Norwegian Institute of Public Health has updated its Covid-19 vaccination guide with more detailed advice on vaccinating frail older people. “We are now asking doctors to continue with the vaccination, but to perform additional evaluation on very sick people whose underlying condition may be exacerbated,” Madsen said. The evaluation includes discussing the risks and benefits of vaccination with patients and their families to decide whether or not immunization is sensible. Separately, the Nordic neighbor Finland has made a recommendation against systematic vaccinations of terminally ill patients whose active treatment (in other words, those who are being alleviated) has been discontinued. The reason is that common side effects, such as temporary fever, can weaken their condition.
6. What other serious reactions have there been?
The body fights off foreign invaders through a variety of mechanisms, including making protective proteins called antibodies, releasing toxins that kill microbes, and arranging protective cells to fight infection. As with any conflict, trying to fend off an infection can sometimes itself be harmful. In rare cases, it can cause runaway inflammation and swelling of tissues called a severe allergic reaction anaphylaxis. As much as 5% of the US population has had such a reaction to various substances. It can be fatal if, for example, the person’s airways swell even though there have been deaths special. Allergies to insect stings and food can cause it, although drug reactions are most common cause of deaths from anaphylaxis in the US and UK
7. Where have Covid-19 vaccines caused cases?
According to a January 6 report from the US Centers for Disease Control and Prevention, 21 cases of anaphylaxis related to the Pfizer-BioNTech vaccine were confirmed in the country on Dec. 23. Of those people, 17 had a documented history of allergies and seven had a history of anaphylaxis. A December 19 CDC presentation refers to two cases in the UK related to the same vaccine, and later in the month, in Israel, a man developed anaphylactic shock an hour after receiving it, according to the Jerusalem Post. He said he had had previous reactions to penicillin, the paper reported. CDC officials say they have also seen the responses from recipients of the Moderna recording and are collecting data on them.
8. Has anaphylaxis been previously associated with vaccines?
Yes. Such reactions occur about 1.3 times per million doses of influenza vaccine administered. With other vaccines they have been seen at rates of 12 to 25 per million doses, although the studies have been small. For the Pfizer-BioNTech Covid vaccine, according to the CDC, the rate on Dec. 23 is 11.1 per million doses, which is very low. The agency said the risk around the vaccine is less than the risk of a serious case of Covid-19.
9. How long is the risk of an allergic reaction?
Usually not long. Anaphylactic reactions normally occur within minutes to hours of exposure to a specific substance, said Michael Kinch, a drug development expert and associate vice chancellor at Washington University in St. Louis. In the US, the delay so far has ranged from two to 150 minutes, with a median of 13 minutes, according to the CDC.
10. What is being done about it?
The UK and the US has advised people allergic to any component of a Covid vaccine not to get it. Anaphylaxis can be quickly controlled with antihistamines in combination with adrenaline injectors such as Mylan NV’s Epi-Pen that slows down or stops immune responses, and health professionals who administer the vaccine, keep such products on hand. These treatments do not cancel out the beneficial effects of vaccines. In the US, health professionals observe anyone who receives the vaccine for at least 15 minutes after the injection to look for signs of a reaction; people with a worrying history of allergic reactions are monitored for twice as long. People who have had reactions to a first dose of vaccine should, according to the CDC.
11. Do we know what causes the reactions in the shots?
That is not clear. The two main candidates are polyethylene glycol – a chemical found in many foods, cosmetics and medicines – and lipid nanoparticles that encapsulate messenger RNA, a genetic component in the vaccines, according to Eric Topol, a clinical trial expert and director of the Scripps Research Translational Institute. Polyethylene glycol has been previously linked to a handful of cases of anaphylaxis. Once a cause has been narrowed down, it may be possible to make Covid vaccines even safer than they are today, Topol said.
The Reference Shelf
– With the assistance of Lars Erik Taraldsen and Kati Pohjanpalo