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Like all new drugs, vaccines that have been cleared to protect against Covid-19 have safety concerns and side effects. Many people who received the first two western shots deployed, one of Pfizer Inc. and BioNTech SE, and another from Moderna Inc., had a fever, headache, and pain at the injection site. These side effects usually go away quickly. More worryingly, Norway has reported deaths in elderly people with serious underlying health problems following administration of Pfizer-BioNTech vaccine – possibly related to these side effects. A few other recipients of the various injections have had a serious but treatable allergic reaction called anaphylaxis.
1. What do we know about deaths?
Twenty-nine were reported in mid-January among some 40,000 people who received the Pfizer-BioNTech vaccine in Norway, where authorities have prioritized vaccination of nursing home residents. Those who died were all in the “75 and over” bracket (exact age not given for confidentiality reasons) and included terminally ill patients who were expected to be born. ‘only have weeks or months to live. All deaths occurring within a few days of vaccination are carefully assessed. Those close to the time of vaccination are not necessarily because of the cliché: an average of 400 people die every week in retirement homes and long-term care facilities, according to the Norwegian Medicines Agency. Sigurd Hortemo, the agency’s chief medical officer, said he could not rule out that common side effects of the vaccine, such as fever and nausea, could be life-threatening in patients with severe underlying health problems.
2. Have there been deaths elsewhere?
In Germany, where more than 800,000 people received the first of two doses of the Pfizer-BioNTech vaccine, the Paul Ehrlich Institute investigated at least seven cases of elderly people dying shortly after vaccination. In his report, he said the deaths were likely due to patients underlying diseases, including carcinomas, kidney failure and Alzheimer’s disease, not inoculation.
3. What reactions did these fatal cases develop?
Deaths in Norway were associated with fever, nausea and diarrhea – relatively common and short-lived effects that some people can experience after almost any vaccination, according to information relayed by the Australian Therapeutics Administration. (He works with the European Medicines Agency, which includes Norway, before deciding whether or not to approve the drug in Australia.) The reactions should not be important to the vast majority of people. Millions of doses of Pfizer-BioNTech vaccine have been administered the United States, United Kingdom and some other countries with no deaths from the vaccine have been reported, Abrar Chughtai, professor in the University of New South Wales School of Public Health and Community Medicine, told the Australian Science Media Center.
4. What do we know about the risks of the vaccine in the elderly and frail?
Not much. Common side effects of vaccines that are not dangerous in younger patients may be worsen the underlying disease in older people, Steinar Madsen, the Norwegian agency’s medical director, told the BMJ medical journal. Only a limited number of people over the age of 85 have participated in large clinical trials of the Pfizer-BioNTech vaccine, the agency said. The average trial participant for the two approved Western vaccines was in their early 50s.
5. What do we do in response to deaths?
The Norwegian Institute of Public Health has updated its Covid-19 vaccination guide with more detailed advice on vaccinating frail elderly people. “We are now asking doctors to continue with the vaccination, but to conduct further evaluation of very ill people whose underlying condition could be made worse by it,” Madsen said. The assessment includes discussing the risks and benefits of vaccination with patients and their families to decide whether vaccination is safe or not. In addition, Finland, a Nordic neighbor, has recommended not to systematically vaccinate terminally ill patients whose active treatment (in other words, those who are palliated) have been stopped. 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 foreign invaders through a variety of mechanisms that include making protective proteins called antibodies, releasing toxins that kill microbes, and mobilizing guardian cells to fight infection. As in any conflict, efforts to fend off infection can sometimes be damaging. In rare cases, it can produce uncontrollable inflammation and tissue swelling during a severe allergic reaction called anaphylaxis. As much as 5% of the American population has had such a reaction to various substances. It can be fatal if, for example, a person’s airways swell, while deaths are rare. Allergies to insect bites and food can cause it, although most common cause of death from anaphylaxis in the US and UK
7. Where have Covid-19 vaccines triggered cases?
According to a January 6 US Centers for Disease Control and Prevention report, 21 cases of anaphylaxis associated with the Pfizer-BioNTech vaccine had been confirmed in the country as of December 23. Of these people, 17 had a documented history of allergies and 7 had a history of anaphylaxis. December 19 CDC’s presentation referred to two UK cases associated with the same vaccine, and later that month in Israel, a man suffered anaphylactic shock an hour after receiving it, according to the Jerusalem Post. He said he had had previous reactions to penicillin, the newspaper reported. CDC officials say they have also seen reactions from recipients of Moderna’s shot and are compiling data about them.
8. Has anaphylaxis ever been linked to vaccines?
Yes. Such reactions occur about 1.3 times per million doses of influenza vaccine given. With other vaccines, they have been seen at rates of 12 to 25 per million doses, although the studies are small. For the Pfizer-BioNTech Covid vaccine, according to the CDC, the rate as of December 23 is 11.1 per million doses, which is very low. The agency said the risk surrounding the vaccine was lower than the risk of contracting a severe case of Covid-19.
9. How long does the risk of an allergic reaction last?
Usually not long. Anaphylactic reactions normally occur minutes to hours after exposure to a specific substance, said Michael Kinch, drug development expert and associate vice-chancellor at Washington University at St. Louis. In the United States so far, the time lag has ranged from two to 150 minutes, with the median being 13 minutes, according to the CDC.
10. What do we do about it?
Great Britain and the United States has advised people who are allergic to any component of a Covid vaccine not to receive it. Anaphylaxis can be quickly countered with antihistamines in tandem with epinephrine injectors like Mylan NV Epi-Pen that slows or stops immune reactions, and health workers who administer the vaccine keep these items handy. These treatments do not negate the beneficial effects of vaccines. In the United States, health workers observe all people who receive the vaccine for at least 15 minutes after the injection to watch for signs of a reaction; those with a worrying history of allergic reaction are followed for twice as long. People who have had reactions to a first dose of vaccine should not receive a second, according to the CDC.
11. Do we know what in the plans is causing the reactions?
It’s not clear. The two main candidates are polyethylene glycol – a chemical found in many foods, cosmetics and drugs – and lipid nanoparticles that encapsulate messenger RNA, a genetic component of vaccines, according to Eric Topol, clinical trials expert and director of Scripps Translational Research Institute. Polyethylene glycol has been previously linked to a handful of anaphylaxis cases. Once a cause has been reduced, it may be possible to make Covid vaccines even safer than they currently are, Topol said.
The reference shelf
– With the help of Lars Erik Taraldsen and Kati Pohjanpalo
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