As COVID-19 vaccines are given to more and more people, health authorities are closely monitoring for unexpected side effects.
On Tuesday, an Alaska health worker suffered a severe allergic reaction after receiving the Pfizer COVID-19 vaccine. She is in the hospital one more night under observation while another worker, vaccinated on Wednesday, has recovered. Doctors already knew they were on the lookout after Britain reported two similar cases last week.
In the United States, vaccine recipients are supposed to stay after the injection in case signs of allergy appear and need immediate treatment, exactly what happened when the Juneau health worker washed himself. and ran out of breath 10 minutes after taking it. The second worker experienced swelling of the eyes, mild dizziness and scratches in the throat.
Allergies are always an issue with a new medical product, but controlling COVID-19 vaccines to detect any other unexpected side effects is a bigger challenge than usual. It’s not just because so many people have to be vaccinated over the next year. Never before have so many vaccines crafted in different ways at the same time come together, and one shot option may have different side effects than another.
The first vaccine to be used in the United States. and many western countries, manufactured by Pfizer Inc. and German company BioNTech, and a second option is expected soon of competitor Moderna Inc. both are made in the same way. The Food and Drug Administration says huge studies of each have found no major safety risks.
But allergic concern “re-points to the importance of real-time safety monitoring,” said Dr. Jesse Goodman of Georgetown University, a former FDA chief vaccine manager.
And authorities have multiple ways to track how people behave as these COVID-19 vaccines, and hopefully additional ones in the coming months, take on more weapons.
HOW WILL I FEEL AFTER VACCINATION?
Getting the Pfizer-BioNTech shot or the Modern version can cause temporary discomfort, as many vaccines do.
In addition to a sore arm, people may experience fever and some flu-like symptoms: fatigue, aches, chills, headache. They last about a day, sometimes bad enough for recipients to miss work and are more common after the second dose and in younger people.
These reactions are a sign that the immune system is increasing. COVID-19 vaccines usually cause more of these reactions than a flu vaccine, about what people experience with shingles vaccines. But some are similar to the early symptoms of coronavirus, one of the reasons hospitals are hesitant when their employees are vaccinated.
WHAT IS SERIOUS RISK?
The FDA found no serious side effects in tens of thousands of participants in studies of the two vaccines.
However, problems so rare that they do not occur in very large studies sometimes arise when a vaccine is used more widely and without the strict rules of a clinical trial.
The first reports of allergies in England they were found in people with a history of severe allergies, and British authorities warned those with previous serious experiences of stopping vaccination to determine which ingredient might be a problem.
U.S. health authorities are giving more nuanced advice. People are always asked about allergies before getting vaccinated and the instructions for shooting Pfizer-BioNTech say avoid it if you are severely allergic to any of its ingredients or if you have a severe reaction. at an earlier dose. Healthcare workers can review the list of ingredients.
The Centers for Disease Control and Prevention advises people to stay for 15 minutes after vaccination and those with a history of other allergies for 30 minutes, so they can be treated immediately if they have any reaction. .
The Alaska health worker, who doctors said had no history of allergies, followed this advice and received prompt attention for a particularly severe reaction called anaphylaxis. He has recovered after a night of observation at the hospital, but will not be allowed to take a second dose of vaccine.
Alaskan doctors have alerted U.S. authorities, who will continue to follow up to find out how real this type of reaction is. This will be especially important, as a sufficient vaccine arrives so that the injections can be made outside the healthcare settings who have a lot of experience in handling this type of reaction.
“Balancing the potential risks with the benefits that the pandemic vaccine provides is an ongoing process,” CDC Dr. Jay Butler warned Wednesday.
WHAT IF OTHER RISKS APPLY?
The challenge is whether the vaccine caused a health problem or whether it is a coincidence. Don’t jump to the conclusions that there is a connection, health authorities stress.
The way to explain it: compare reports of possible side effects with data showing how often the same condition routinely occurs in the population.
The government has several ways to do this. Doctors should report any problems to the patient. But the FDA is studying massive databases of insurance claims for the first red indicators that indicate that all health problems occur more often in newly vaccinated than not all.
On his checklist is Bell’s palsy, a temporary facial paralysis that occurred in a handful of people in both vaccine studies. The FDA said it’s probably a coincidence, but will follow up to be safe.
Vaccine recipients can help you do extra security monitoring. Called “v-safe”“The program run by CDC automatically sends a daily text the first week after each dose of vaccine asking how people feel, and then a weekly text for the next five weeks. Any response that suggests concern calls for a phone call for more information.
___
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.