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The Most Common Side Effects Of The COVID Vaccine In Kids Under 5 (And How To Alleviate Them)

COVID vaccines for kids under 5 are finally looking like a reality, after the FDA met this week and recommended authorizing the Moderna and Pfizer-BioNTech vaccinations for COVID for kids age 6 months to 5 years.

"Our expectation is that within weeks, every parent who wants their child to get vaccinated will be able to get an appointment," Ashish Jha, the White House COVID-19 response coordinator, told reporters during a recent press briefing.

The Pfizer vaccine for kids age 6 months to 4 years old is given in three doses: Each one is three micrograms, which is one-tenth of the dose for adults. The first two doses are spaced out three weeks apart and the third one is given at least two months after the second.

The Moderna vaccine for kids 6 months to 5 years old consists of two doses given four weeks apart. Each one is 25 micrograms, or one-quarter of the adult version.

A Kaiser Family Foundation survey from May found that about a fifth (18%) of parents with kids under 5 said they intend to get their child vaccinated "right away" once the FDA authorizes the shots' use. Meanwhile, another 38% say they would want to "wait and see" how it works for others in the age group before getting their child vaccinated.

Earlier this week, we answered some of the most pressing questions parents of kids under 5 may have about the vaccine. Top of mind for many parents and researchers are the side effects that may accompany the vaccine. 

Side effects, including fever and fatigue, were generally minor in both vaccines and less common than seen in adults, according to FDA reviewers.

"The side effects were definitely a discussion point during the FDA meeting yesterday," said Krupa Playforth, a pediatrician in Alexandria, Virginia, who reviewed the FDA data. 

"Both vaccines are actually generally well-tolerated, and the side effect spectrum is fairly similar to other age groups," she said. "The Pfizer vaccine contains a smaller amount of antigen, and this plays out in the side effects that were reported: There were fewer overall side effects for that vaccine."

So what are the known side effects? Below, Playforth and other pediatricians who reviewed the FDA's data ― and one doctor who was involved in the Pfizer clinical studies for kids under 5 ― explain what to expect and how to alleviate any symptoms your child may experience after getting the vaccines. 

Irritability And Drowsiness

For 6-to-23-month-year olds, irritability and drowsiness were most common, according to Patricia DeLaMora, a pediatric infectious disease specialist for Boston Children's Health Physicians.

Side effects like irritability and drowsiness are common following most vaccines, though, said Jaime Friedman, a pediatrician at Children's Primary Care Medical Group.

"Parents may notice their child wanting to sleep more, acting more cranky and clingy, or eating less," she told HuffPost. "These symptoms will most likely only last a day."

Pain At Injection Site

For 2-5 year olds, pain at the injection site was commonly reported, followed by fatigue.

But the pain is generally mild and children often don't complain about it unless asked, according to Janet Englund, a professor of pediatrics at Seattle Children's Hospital and University of Washington who was involved in the Pfizer clinical studies in young children this past year.

"For reaction site pain or swelling, it's often best to cover it with a long-sleeve shirt so they don't have to see it," she said. "Give Tylenol if pain is interfering with daily activities but in general, distraction alone works well."

One thing to note: It's not recommended that you give your child any over-the-counter pain medicine before the shot. It's fine to give your child some after the vaccine to help with any mild reactions. 

"After the vaccine, acetaminophen is thought to be safe to control discomfort caused by fever, pain at injection site," said DeLaMora.

 If you have any questions, talk to the vaccine provider or your child's doctor.

Fever

Most fevers occurred within two days of vaccination and resolved within a day or two, Playforth said.

"Both fever and local reactions were more common for Moderna than for Pfizer, but these also resolved quickly," she said. "One child in the Moderna trial had a febrile seizure ― a convulsion in a child that's caused by a fever ― after the first dose, but received a second dose without any incident."

Again, many of the side effects that children may experience after COVID vaccines (such as fever and pain at the injection site) can be managed with ibuprofen (Motrin) or acetaminophen (Tylenol), which can reduce pain and fever,

"Be sure to check with your child's pediatrician if you do not know the appropriate doses for your child," said Elizabeth Lloyd, M.D., a pediatric infectious diseases specialist at University of Michigan Health C.S. Mott Children's Hospital. "Aspirin is not generally recommended for use in children. But once the fever has resolved, many children will feel less irritable."

Make sure your child stays hydrated, too, Playforth said.

Fatigue

Fatigue was another side effect for kids under 5, according to the FDA, though it was much less severe and lasted a shorter time than the fatigue reported by adults, Englund said.

"Nearly all cases it lasted less than 24 hours," the doctor said. "These side effects are similar or even less than those seen with other childhood vaccines. In children, having fatigue means they may take a longer nap or go to bed earlier."

Parents may want to plan accordingly when getting their kids vaccinated by making sure they have free time to rest on the day of and the day following their vaccine, Friedman said.

"The big picture here is that even if there are local or systemic side effects, they are largely self-limited and resolve within a few days," Playforth said. "In terms of helping your child through them, focus on comfort and hydration, as with all illnesses."

Experts are still learning about COVID-19. The information in this story is what was known or available as of publication, but guidance can change as scientists discover more about the virus. Please check the Centers for Disease Control and Prevention for the most updated recommendations.

This article originally appeared on HuffPost and has been updated.

How To Treat Your Baby's Fever: The Dos And Don'ts Parents Must Know

You know the signs, mums — hot, flushed little bodies, restlessness and over-bright eyes. Your little one's temperature has risen and now, you are worried about your baby's fever. But what does it mean for your baby to have a fever in the hot and humid climate of Singapore?

Find out how you can treat your baby's fever as well as the dos and don'ts to be mindful of. From what symptoms to look out for to when you should be worried about your baby's fever, we've broken down everything you need to know for your little one's health.

Different types of fever babies can have

Let us explore five different types of fever in babies, their potential causes, and when to seek medical attention.

Low-grade fever: Low-grade fevers are mild and typically range between 100F (37.8 degrees celsius) and 102°F (38.9 degrees celsius). They are commonly caused by viral infections, such as colds or mild respiratory infections. Generally, low-grade fevers do not require immediate medical attention but should be monitored closely.

High fever: High fevers in babies are defined as temperatures above 102F (38.9 degrees celsius). They can be indicative of more severe infections, such as urinary tract infections or pneumonia. It's important to consult a healthcare professional if your baby has a high fever, especially if accompanied by other symptoms like lethargy, difficulty breathing, or dehydration.

Intermittent fever: Intermittent fever refers to a fever that comes and goes. It can be caused by various factors, including viral or bacterial infections, teething, or immunisation reactions. While intermittent fevers are usually not a cause for major concern, it's advisable to consult a doctor if they persist or if your baby displays other concerning symptoms.

Fever with rash: Some infections can cause a fever accompanied by a rash in babies. Common examples include viral infections like roseola or certain bacterial infections. If your baby develops a fever along with a rash, it's important to seek medical advice promptly to identify the underlying cause and ensure appropriate treatment.

Febrile seizures: Febrile seizures occur in a small percentage of babies and toddlers with high fevers. These seizures can be scary to witness but are generally harmless. However, it is crucial to seek immediate medical attention if your baby experiences a febrile seizure to ensure a proper evaluation and rule out any serious underlying conditions.

Remember, it's always important to consult with a healthcare professional if you have any concerns about your baby's fever or overall well-being.

How to tell if baby has a fever

A human body's regular temperature is around 36 to 37 degrees celsius (98 to 100F). Normal body temperature varies from person to person. It may also be influenced by activities such as exercise, sleeping, eating and even the time of day. For example, your body temperature generally peaks at around 6pm and is at its lowest around 3am.

According to Dr Ratna Sridjaja of SBCC Baby and Child Clinic, Gleneagles Hospital Singapore, "Fever occurs when the body's internal 'thermostat' raises the body temperature above its normal level."

She explains that this thermostat is located in the part of the brain known as the hypothalamus, which is responsible for regulating the body's temperature and keeping it within the normal range.

When your little one is ill or has an infection, sometimes, the hypothalamus will increase the body's temperature in response. Dr Sridjaja says that "researchers believe that turning up the heat is the body's way of fighting the germs that cause infections and making the body less comfortable for them."

So, when your child's body temperature rises, it means his immune system is healthy and working hard to fight an infection or illness. And while your baby's fever certainly is a worry, do remember that a mild fever (around 37.5 to 37.7 degrees celsius) in a baby over the age of six months is usually no cause for concern and means that his immune system is working just fine.

Remember: fever itself is not an illness; it is a sign of illness or infection.

How to take your baby's temperature

Medical experts describe a few ways to take a baby's temperature: rectally (via the rectum); orally (mouth); axillary (armpit); and forehead. You should only use a digital thermometer to take a child's temperature as mercury thermometers carry the risk of mercury poisoning if they break.

The most accurate temperature reading for babies under the age of one year old can be obtained by using a rectal thermometer.

Here's how you can take your baby's rectal temperature using a digital thermometer, according to WebMD:

"First make sure the thermometer is clean. Wash it with soap and water or wipe it off with rubbing alcohol. Lay your baby on the belly or on the back with legs bent toward the chest.

"Apply a little bit of petroleum jelly around the thermometer bulb and gently insert it about one inch into the rectal opening. Hold the digital thermometer in place for about two minutes until you hear the 'beep'. Then gently remove the thermometer and read the temperature."

Be sure to clearly label the rectal thermometer so it's not subsequently used in your baby's mouth. 

For children over the age of one year of age, paediatricians recommend using either an ear thermometer or an oral digital thermometer.

According to Dr Sridjaja, these are the temperatures that indicate a baby's fever, depending on the type of thermometer you use:

38 degrees celsius ( 100.4 F ) measured rectally ( in the bottom )

37.5 degrees celsius ( 99.5 F ) measured orally ( in the mouth )

37 degrees celsius ( 99 F ) measured an axillary position ( under the arm )

Common causes of baby's fever

Almost always, a fever is caused by an infection, with viruses causing 10 times more infections than bacteria.

The following are some of the most common causes of your baby's fever:

Viral infections: Colds, the flu and other common viral infections are the most common causes of fever in babies. In fact, little ones — especially if they are in daycare — may have seven to 11 viral illnesses accompanied by fever per year. Often, fever might be the only symptom you notice in the first 24 hours, followed later by other symptoms such as a runny nose and/or cough.

Bacterial infections: These infections are the second most common cause of fever in babies. Look out for bladder infections in girls especially if she has no other symptoms other than fever. Unexplained fever is also a symptom of common bacterial infections like strep throat.

Sinus infection: A sinus infection is a complication of a cold, with a symptom being the return of fever a few days after your child's temperature returns to normal (along with sinus pain).

Vaccine fever: Many babies develop a fever after most vaccines, usually within the first 12 hours. It may last for two to three days. This is normal and harmless and means the vaccine is working. However, if your baby's vaccine-related fever worries you, do see a doctor without delay.

Overheating: Low-grade fever can occur if your child is overheated. This could be either via overdressing or high environmental temperature. His temperature will return to the normal range once he is moved to a cooler place or the unnecessary layers of clothing are removed. Rest and drinking extra fluids also help in re-establishing a normal temperature.

When to be worried about baby's fever Newborn fever

When it comes to infants under three months old, any sign of a fever should be taken seriously, and immediate medical attention should be sought.

Infants in this age group have developing immune systems and are more vulnerable to serious infections. Even a slight increase in body temperature can be a cause for concern.

It is crucial to contact a healthcare professional if your baby under three months old has a fever, as they may require a thorough evaluation to identify the cause of the fever and provide appropriate treatment. Prompt medical attention can help ensure the well-being and health of your young baby.

Baby fever (Three months up)

Dr Sridjaja advises that you should see a doctor if your baby over three months of age has a fever under 39 degrees celsius, but also:

Refuses, or seems too sick to drink enough liquids

Has persistent vomiting and/or diarrhoea

Shows signs of dehydration, such as being less alert/active than usual, crying without tears or urinating less than usual

Feels pain when urinating

Is suffering from a medical condition such as cancer, kidney or heart disease

Has a fever for more than 72 hours

Also has a rash

Seek immediate medical attention, advises Dr Sridjaja, if your baby over three months of age has a fever over 39 degrees celsius, along with any of the following symptoms:

Inconsolable crying and extreme irritability

Lethargy and difficulty walking

Rash or purple spots that look like bruises on the skin (that were not there before the child got sick)

Stiff neck

Headache

Blue lips, tongue or nails

Seizure

Infant's soft spot on the head that bulges out or sunken inwards

Difficulty breathing

Leaning forward and drooling

How to manage your baby's fever: The do's and don'ts

While fever is a sign of a healthy immune system, it's still important to know ways of managing your child's fever, because if it goes too high (over 40 to 41 degrees celsius) there may be a risk of your little one developing a febrile fit.

Here are some dos and don'ts of managing your baby's fever:

Do give paracetamol or ibuprofen based on the package recommendations according to your baby's weight and age. A syringe is the best way to ensure you are giving your little one the correct dosage. Avoid household teaspoons to measure out the medication, as you run the risk of overdosing or not giving enough of it.

Do keep your child well-hydrated as fever causes little ones to lose fluids faster. If he is under six months of age, breastfeed him more often. Your breast milk also contains powerful antibodies that will help him fight the infection more efficiently.

Do dress your child in light, cotton clothing and use a light blanket too. Overdressing and using too much bedding can raise his core temperature even more.

Do encourage your child to rest. Running around can raise his temperature.

Do use a lukewarm compress to help bring your child's fever down. Apply it under his armpits, on his forehead and on either side of his groin.

Do not give ibuprofen until you are sure your child's fever is not caused by the dengue virus. This is because dengue affects the platelets, which are responsible for blood clotting, increasing the likelihood of internal bleeding. Ibuprofen (and aspirin too) has a similar blood-thinning effect and can aggravate, instead of helping to control the condition.

Do not give aspirin (unless advised by a doctor) due to its association with the potentially fatal Reye's Syndrome.

Do not give fever medications (ie panadol, ibuprofen) to a baby under two months of age says Dr Sridjaja, unless advised to do so by a paediatrician.

Do not immerse your child in cold/icy water. Instead, fill your tub with just a few inches of tepid water and using a washcloth, dribble the water over your little one's body to help bring his temperature down. Never leave your child unattended in the tub.

ALSO READ: 3 things not to do when your baby has a fever

Do not use rubbing alcohol as a way of lowering your child's temperature.

Do not over-medicate on fever medication. Read the label carefully for the recommended interval between dosages and stick to it.

Do not "starve a fever". Let your child eat what he likes, especially if he is already eating solids. This will give him much-needed energy to help him fight the infection. Don't worry too much if he refuses solids, as long as he is drinking enough fluids and his urine output is normal.

Do not send your child to daycare or school while he has a fever. Once your little one has been fever-free for 24 hours, he can go back.

Parents, if you are in doubt about what to do when it comes to your baby's health — fever or otherwise — please consult your little one's paediatrician without delay.

This article was first published in theAsianparent.

Pfizer RSV Vaccine Seen As Effective Against Severe Disease, FDA Documents Say

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

The agency's analysis said the vaccine was also shown to be effective at preventing non-severe lower respiratory tract RSV disease that required medical attention at 180 days after birth, though at 90 days the vaccine's efficacy against this endpoint was not statistically significant.

The FDA's assessment was released in advance of a meeting Thursday of an expert advisory committee, which will study the safety and efficacy data generated in trials of the vaccine and give the FDA guidance on whether it should be licensed.

The vaccine, which goes by the provisional name Abrysvo, would be given to pregnant people between 24 and 36 weeks of pregnancy with the goal of protecting their babies against RSV in the first six months of life by triggering production of maternal antibodies that would pass across the placenta to the fetus. The vaccine, which targets both subtypes of RSV — RSV A and RSV B — is given in a single intramuscular injection.

In a Phase 3 trial conducted in 18 countries, nearly 7,400 pregnant women were randomly assigned to receive either the vaccine or a placebo. The vaccine met one of two primary endpoints, showing a vaccine efficacy against severe RSV of nearly 82% at 90 days, and 69% at 180 days after birth.

A second endpoint, protection against any lower respiratory tract infection caused by RSV in the first 90 days of life, did not reach statistical significance, though at 180 days, there was a statistically significant vaccine efficacy of 51%.

William Gruber, Pfizer's senior vice president for vaccine clinical research and development, stressed the importance of showing that the vaccine can protect against severe RSV in infants, a group that is hard hit when infected with respiratory syncytial virus.

"One of the things that we wanted to be very clear about is the expectation going into this — like for other respiratory pathogens or pathogens like rotavirus —  that vaccine has its greatest efficacy against more severe disease," Gruber told STAT in an interview last week. "With on average 58,000 children hospitalized every year in the United States [for RSV] … that has a major impact."

On the issue of safety, the FDA analysis noted an imbalance between the number of preterm births in the vaccine arm of the trial as compared to the placebo arm. The imbalance was not statistically significant and the number of preterm births in both arms of the trial was below the background rate — the normal rate at which preterm births are seen to occur.

Still, the analysis sent a clear signal that the FDA would like to hear the thoughts of the experts on the advisory committee on this issue.

"The safety data appear generally favorable for vaccine administration, and we noted potential uncertainty based on the numerical imbalance in premature deliveries. FDA will be asking VRBPAC members to vote on whether the results of the vaccine efficacy trial demonstrate evidence of vaccine effectiveness and to vote on whether the safety data support a favorable risk analysis with VRBPAC discussion of the safety data, for example the numerical imbalance observed in premature deliveries," the analysis said.

The issue looms large over this vaccine because a competing vaccine that was being developed by GSK was dropped when a clinical trial showed a statistically significant imbalance in preterm births among pregnant people who received the vaccine.

Gruber noted that in the Pfizer trial, the imbalance was not seen in all countries, and wasn't seen in high-income countries. The study had 2.5 times more participants from high-income countries than the other countries; given the higher number, one would expect to see more precision in the data from that segment of the study, he said, but "we're not seeing this."

Further, another data point — the rate 0f low-birth-weight babies — actually points away from a safety concern, he said.

"When we looked at low birth weight and particularly low birth weight less than 1,500 grams, then it actually flips," Gruber said. "There are more low-birth-weight babies in the placebo group than there are in the vaccine group. To my mind, it provides additional reassurance."

Pfizer has said that if the vaccine is licensed, the company will conduct post-marketing surveillance for preterm births among vaccine recipients. Gruber said he expects it will become clear when the vaccine is administered to larger numbers of pregnant people that the imbalance was "a spurious finding."

The most common solicited adverse event was fatigue; headache, muscle pain, and injection site pain were also common, though all were graded in the mild and moderate range. Fever after vaccination was uncommon, and was reported by roughly the same percentage of people in the vaccine arm as in the placebo arm.

Seventeen babies born to the participants in the trial died, five born to people in the vaccine arm and 12 to people in the placebo arm. Four of the five deaths in the vaccine arm were ruled unrelated to the vaccine. But with the fifth — an extremely premature infant born at 27 weeks gestation — the FDA said it was "unable to draw definitive conclusions regarding potential relation of this case of extreme prematurity to the investigational product."

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