Published 09:15 IST, December 17th 2020

Health officials track safety as COVID-19 vaccines roll out

On Tuesday, a health worker in Alaska suffered a severe allergic reaction after receiving the Pfizer COVID-19 vaccine. Doctors already knew to be on the lookout after Britain reported two similar cases last week

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As COVID-19 vaccinations roll out to more and more people, health authorities are keeping close watch for any unexpected side effects.

On Tuesday, a health worker in Alaska suffered a severe allergic reaction after receiving Pfizer COVID-19 vaccine. Doctors already knew to be on lookout after Britain reported two similar cases last week.

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In U.S., vaccine recipients are supposed to hang around after injection in case signs of an allergy appear and y need immediate treatment — exactly what happened when health worker in Juneau became flushed and short of breath 10 minutes after shot.

Allergies are always a question with a new medical product, but monitoring COVID-19 vaccines for any or, unexpected side effects is a bigger challenge than usual. It's t just because so many people need to be vaccinated over next year. Never before have so many vaccines made in different ways converged at same time — and it’s possible that one shot option will come with different side effects than ar.

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first vaccine beginning widespread use in U.S . and many Western countries, made by Pfizer Inc. and Germany’s BioNTech, and a second option expected soon from competitor Moderna Inc. both are made same way. Food and Drug Administration says huge studies of each have uncovered major safety risks.

But allergy concern “points out again importance of real-time safety monitoring,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.

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And authorities have multiple ways of tracking how people fare as se COVID-19 vaccines, and hopefully additional ones in coming months, get into more arms.

HOW WILL I FEEL AFTER VACCINATION?

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Getting eir Pfizer-BioNTech shot or Moderna version can cause some temporary discomfort, just like many vaccines do.

In addition to a sore arm, people can experience a fever and some flu-like symptoms — fatigue, aches, chills, headache. y last about a day, sometimes bad eugh that recipients miss work, and are more common after second dose and in younger people.

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se reactions are a sign that immune system is revving up. COVID-19 vaccines tend to cause more of those reactions than a flu shot, about what people experience with shingles vaccinations. But some are similar to early coronavirus symptoms, one reason hospitals are staggering when ir employees get vaccinated.

WHAT ABOUT SERIOUS RISKS?

FDA found serious side effects in tens of thousands enrolled in studies of two vaccines.

Still, problems so rare y don’t occur in even very large studies sometimes crop up when a vaccine is used more widely and without stringent rules of a clinical trial.

first allergy reports from England were in people with a history of serious allergies, and British authorities warned those with severe prior experiences to hold off vaccination as y determine what ingredient might be a problem.

U.S. health authorities are giving more nuanced advice. People always are asked about allergies before vaccinations, and instructions for Pfizer-BioNTech shot say avoid it if you’re severely allergic to one of its ingredients or had a severe reaction to a prior dose. Health workers can go over ingredient list.

Centers for Disease Control and Prevention advises people to stick around for 15 minutes after vaccination, and those with a history of or allergies for 30 minutes, so y can be treated immediately if y have a reaction.

Alaska health worker, who doctors said had history of allergies, was following that advice and got prompt care for a particularly severe reaction called anaphylaxis. She has recovered after a night of observation in hospital — but won't be allowed a second vaccine dose.

Alaska doctors alerted U.S. authorities, who will continue monitoring required to tell just how common this kind of reaction really is. That will be especially important as eugh vaccine arrives for injections to be given outside of health care settings that have lots of experience handling this type of reaction.

“Balancing any potential risks with benefits vaccine provides in pandemic is an ongoing process,” CDC's Dr. Jay Butler cautioned Wednesday.

WHAT IF OR RISKS CROP UP?

challenge is telling wher vaccine caused a health problem or if it’s coincidence. Don’t jump to conclusions that re’s a connection, health authorities stress.

way to tell: Comparing any reports of possible side effects with data showing how often that same condition occurs routinely in population.

government has multiple ways to do that. Doctors are required to report any patient problems. But FDA is scrutinizing massive databases of insurance claims for early red flags that any health problems are occurring more often in newly vaccinated than everyone else.

On its list to check is Bell’s palsy, a temporary facial paralysis that occurred in a handful of people in both vaccine studies. FDA said it’s probably coincidence, but will track to be sure.

Vaccine recipients can help with extra safety tracking. Called “ v-safe ,” program run by CDC automatically sends a daily text first week after each vaccine dose asking how people feel, and n a weekly text for next five weeks. Any responses that suggest concern prompt a phone call for furr information.

 

09:15 IST, December 17th 2020