(AP) – As more people get vaccinated with COVID-19 vaccinations, health officials are watching closely for unexpected side effects.
On Tuesday, a health worker in Alaska suffered a severe allergic reaction after receiving the Pfizer COVID-19 vaccine. She’s been under observation in the hospital for another night while another worker who was vaccinated on Wednesday recovered. Doctors already knew to be on guard after the UK reported two similar cases last week.
In the US, vaccine recipients are said to hang around after the injection if signs of allergy appear and they need immediate treatment – exactly what happened when health workers in Juneau were reddened and out of breath 10 minutes after the shot. The second worker had puffy eyes, lightheadedness and a sore throat.
Allergies are always an issue with a new medical device, but monitoring COVID-19 vaccines for other, unexpected side effects is more of a challenge than usual. This is not just because so many people will have to be vaccinated in the next year. Never before have so many vaccines made in different ways converged at the same time – and it is possible that one shot option has different side effects than another.
The first vaccine, widely used in the US and many western countries and manufactured by Pfizer Inc. and BioNTech in Germany, and a second option expected shortly from competitor Moderna Inc., are both manufactured in the same way . The Food and Drug Administration says large studies have not uncovered any significant safety risks from anyone.
However, the allergy problem “reiterates the importance of real-time security monitoring,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccines chief.
And authorities have several options to keep track of how people are doing as these COVID-19 vaccines and hopefully more embrace in the coming months.
How will I feel after the vaccination?
Receiving either the Pfizer BioNTech shot or the Moderna version can cause temporary discomfort, just like with many vaccines.
In addition to an aching arm, people may experience a fever and some flu-like symptoms – fatigue, pain, chills, headache. They last about a day, sometimes so bad that recipients miss work, and are more common after the second dose and in younger people.
These reactions are a sign that the immune system is speeding up. COVID-19 vaccines tend to cause more of these reactions than a flu shot, which is what people with shingles vaccinations experience. However, some resemble the early symptoms of the coronavirus. One reason for this is that hospitals fluctuate when their staff are vaccinated.
WHAT ABOUT SERIOUS RISKS?
The FDA found no serious side effects in the tens of thousands who participated in studies of the two vaccines.
Yet problems so rare that even in very large studies do not sometimes arise when a vaccine is used on a large scale and without the strict rules of a clinical study.
The first allergy reports from England were of people with a history of serious allergies and the UK authorities warned people with serious previous experience to stop vaccinating to determine which ingredient could be a problem.
The US health authorities give more nuanced advice. People are always asked about allergies before vaccinations, and instructions for the Pfizer BioNTech shot say you should avoid it if you are severely allergic to any of its ingredients or have reacted severely to a previous dose. Health workers can go through the ingredients list.
The Centers for Disease Control and Prevention advise people to stay 15 minutes after vaccination and people with a history of other allergies 30 minutes so they can be treated immediately if they have a reaction.
The Alaskan health worker, who doctors said had no history of allergies, followed that advice and was promptly prepared for a particularly severe reaction called anaphylaxis. She has recovered from a night of observation in the hospital – but has not received a second dose of vaccine.
Doctors in Alaska alerted US authorities, who will continue monitoring to see how common this type of reaction actually is. This is especially important as enough vaccine comes in for injections outside of the healthcare sector who have a lot of experience dealing with this type of reaction.
“Weighing potential risks against the benefits of the vaccine in the pandemic is an on-going process,” warned Dr. Jay Butler from CDC on Wednesday.
What if other risks arise?
The challenge is to tell if the vaccine caused a health problem or if it was a coincidence. Don’t conclude that there is a link, health officials point out.
The way to say: Compare reports of possible side effects with data showing how often the same condition routinely occurs in the population.
The government has several ways of doing this. Doctors must report all patient problems. However, the FDA is checking extensive databases of insurance claims for early red flags, which suggests that newly vaccinated people are more likely to have health problems than anyone else.
Bell’s palsy, a temporary facial paralysis that occurred in a handful of people in both vaccine studies, is on the list. The FDA said it was likely a coincidence, but it will certainly be followed up.
Vaccine recipients can help with additional safety monitoring. Called “v-safe” by CDC, the program automatically sends a daily text asking how people are feeling the first week after each vaccine dose, followed by a weekly text for the next five weeks for more information.
The Associated Press Department of Health and Science is supported by the Department of Science Education of the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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