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With the U.S. Foods and Drug Administration authorizing the Moderna and Pfizer-BioNTech vaccines for children as younger as 6 months of age, UF Wellness pediatrics pro Sonja A. Rasmussen, M.D., discusses what dad and mom ought to know about the pictures. Rasmussen is a professor in the departments of pediatrics and epidemiology at the UF School of Drugs and the UF College or university of Public Wellness and Well being Professions.
Issue: What had been the main criteria and info the Food and Drug Administration made use of in producing its determination to approve the Pfizer-BioNTech and Moderna vaccines for children underneath age 5?
Reply: The Fda and their impartial advisors critique facts from the vaccine companies to be guaranteed the vaccines are harmless and powerful. The fantastic news is that the Food and drug administration evaluation of these reports confirmed that that the Pfizer and Moderna vaccines are safe and successful for young youngsters 6 months to 5 decades of age. These vaccines shield young children towards serious condition from COVID-19.
Q: How arduous was the vaccine-testing system in children beneath age 5? What aspect results ended up witnessed most typically?
A: The experiments had been meticulously carried out — security details ended up out there on a lot more than 3,000 young children who been given the Pfizer vaccine and just about 4,800 children who received the Moderna vaccine. Regional side results (discomfort or redness at the injection site) were widespread. Facet effects these types of as fever had been a lot more widespread right after the Moderna vaccine than after the Pfizer vaccine. Fever is a frequent aspect effect soon after other vaccines that are provided to kids.
Q: Study has shown the vaccine is about 91{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} successful in blocking COVID-19 in kids ages 5-11. What does the efficacy information present amongst children beneath age 5?
A: The 91{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} vaccine success estimate suggests the vaccine’s capability to shield versus some of the earlier COVID-19 virus variants. The virus has modified given that it 1st was discovered so vaccine usefulness versus having COVID-19 is decrease for the Omicron variant that is circulating now than it was before in the pandemic. Even so, the key benefit of these vaccines is their skill to protect against critical illness, this kind of as needing to be hospitalized, or dying. The vaccine performance is better for that.
For kids beneath 5 yrs outdated, vaccine efficiency versus obtaining COVID-19 for the two-dose Moderna vaccine is 41.5{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d}. For the 3-dose Pfizer vaccine, the vaccine effectiveness was 80.3{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d}, but that selection was centered on a compact selection of small children so it could be lessen or higher than this. As with more mature kids, we assume that these vaccines will do a far better position of stopping severe disorder than they do protecting against gentle illness.
Q: If moms and dads are made available a option, which vaccine should really their baby get?
A: Equally the Pfizer and Moderna vaccines are protected and powerful so the essential matter is for small children to get vaccinated. Even so, there are some discrepancies that mother and father will need to contemplate. The Moderna vaccine is a two-dose sequence, with the two doses separated by at least 28 days. The Pfizer vaccine is a 3-dose collection, with the first two doses finished at the very least 21 days aside and the 3rd dose presented at the very least 8 weeks afterwards. Both of those the Pfizer and Moderna vaccines may have to have added booster doses later on.
Although the studies confirmed increased vaccine efficiency for the Pfizer vaccine than the Moderna vaccine, moms and dads need to have to look at several crucial troubles: The Pfizer vaccine necessitates 3 doses so little ones will not get that increased amount of defense until right after the 3rd vaccine dose, whilst the Moderna vaccine needs two doses to get the stage of safety located in the reports. The scientific tests were conducted at different occasions and diverse areas. That suggests the variants circulating ended up unique so the vaccine efficacy estimates can’t be directly in comparison. At last, the selection of kids who received COVID-19 in the Pfizer review was smaller. For that rationale, the vaccine usefulness could possibly be bigger or lower than the quantity quoted.
Based on what we know, we anticipate that each vaccines will be remarkably protecting against significant COVID-19. Talk with your doctor if you need help selecting which vaccine your baby should get.
Q: If young children never experience serious COVID-19 indications as normally as adults, why do they want the vaccine?
A: Even though small children are at lower danger of significant disorder, hospitalization and loss of life than grownups, that doesn’t signify they are not at risk. In excess of 400 young children considerably less than 5 decades of age have died of COVID-19. We also have viewed quite a few youngsters who have wanted to be hospitalized throughout the the latest Omicron wave. Little ones underneath age 5 had the highest fee of hospitalizations when compared with other children. Fewer than half of the young little ones who desired to be hospitalized had an fundamental healthcare problem. The other youngsters were being earlier nutritious. Amongst small children who were hospitalized, about one particular in 4 required intense treatment unit care.
On top of that, conditions of prolonged COVID in which signs or symptoms past for months immediately after getting contaminated with the virus, can manifest in children. Vaccines decrease the prospects of receiving long COVID.
Also, it’s vital to observe the disruption in little one treatment and college of youngsters because of to COVID-19. We anticipate that these COVID-19 vaccines will reduce infections, bringing us closer to returning our lives to normal.
Q: What is the variation in vaccine dosing and facet consequences in youngsters younger than 5 years aged in comparison with grownups?
A: The dose of the Pfizer vaccine is 3 micrograms, one-tenth of what grown ups obtain. The dose of the Moderna vaccine is 25 micrograms, a single-fourth of what grown ups acquire. All through the clinical trials, the aspect effects ended up nominal. For the more youthful age group (6-23 months), irritability and drowsiness had been the most widespread side consequences. In the older age team (2-5 year olds), ache at the injection web site and fatigue were the most prevalent side outcomes. For those obtaining Moderna vaccine, 1 in 4 experienced a fever. For those receiving Pfizer, 1 in 20 had a fever. This helps make perception because the dose of Moderna vaccine is greater. In the Moderna review, just one child experienced a fever, seizure, and a rash immediately after the vaccine. That was the only significant adverse function that was considered to be attributable to the vaccine.
Q: Are there any children below age 5 who should not get the COVID-19 vaccine?
A: Little ones who have experienced a intense allergic response to a component of the COVID-19 vaccine need to not get the vaccine. Request your physician if you believe your little one could possibly be allergic to a component of the COVID-19 vaccine.
Q: How shortly and exactly where regionally may I be in a position to get my youngster below age 5 vaccinated?
A: We are hopeful that the vaccines will start off to be available someday this week at doctors’ offices, pharmacies and other spots the place vaccines are typically specified.Media get in touch with:
Doug Bennett at dougbennett@ufl.edu or 352-265-9400.
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Nearly a quarter of Monroe County’s 5-11 aged children have received their first dose of the COVID-19 vaccine, but many parents are still wrestling with the question: Should I get my child vaccinated?
Last week, Monroe County Board of Health member and retired pediatrician Dr. Carol Litten Touloukian hosted a town hall with local pediatricians Dr. Scot Moore, Dr. Jim Laughlin and Dr. Jason Simmonds to answer that question and many others, Art Of Landscaping.
Dr. Moore currently serves as chairman of the IU Health Bloomington Infection Control Committee. Dr. Laughlin is the chief practice officer of IU Health Southern Indiana Physicians and a volunteer pediatric consultant for Monroe County Community School Corporation district. Dr. Simmonds is the medical director for Riley Physicians in the South Central Region of Indiana.
Here are some of the common questions that were asked during Wednesday’s town hall.
Indiana residents can find and schedule an appointment nearby at ourshot.in.gov. Due to high demand, vaccine appointments in Monroe County are mostly booked through the year, but residents are encouraged to frequently check back, in case there have been cancellations.
If appointments are not available locally, health officials urge residents to look in nearby counties, such as Brown, Lawrence or Greene, that do not have the same level of demand as Monroe.
The child vaccine is also available at various pediatric offices and local pharmacies.
Yes, it is different. The approved Pfizer vaccine for people aged 5-11 is only a third of the amount of an adult dosage.
Because of that, pediatricians are seeing fewer short-term side effects in that age group, Simmonds said.
More:County outpaces state in 5-11 child vaccination rate as youth COVID cases surge nationwide
People can experience pain, redness, or swelling where the injection was given. They can also have mild symptoms such as headache, muscle pain, fever, chills or fatigue. These side effects usually go away after one to two days.
“Not that there can’t be some side effects, but I think overall we’ve definitely seen less. I’ve not had, from personal reports, any of my patients report significant side effects from the vaccine,” Simmonds said.
Yes, children who have already had COVID-19 should still be vaccinated.
“For COVID itself, the immunity varies for that. So you may not get as long-lasting immunity (from the virus) as you might get from the vaccine, so there’s no need to wait,” Simmonds said.
According to the U.S. Centers of Disease Control and Prevention, research has not yet shown how long one is protected from getting COVID-19 again after they recover.
Residents should wait until they have recovered from COVID-19 before they get the vaccine.
“It is definitely fine to go ahead and get (the COVID-19 vaccine) at the same time as the flu vaccine. There’s no need to spread that apart,” Simmonds said.
Right now, Monroe County, like most areas of the country, is experiencing the height of flu season.
More:COVID cases on the rise again in Monroe County; fewer people taking protective measures
“We are seeing flu in our community right now, so it’s important to get your child the flu vaccine as soon as possible,” Simmonds said.
Several pediatric offices and clinics offer both the flu and COVID-19 vaccine in tandem.
Yes, someone with an egg allergy can receive the vaccine. The COVID-19 vaccines that currently are authorized by the FDA, including the Pfizer vaccine, are not manufactured using egg products or egg culture.
Children tend to have mild cases of COVID-19, but many have been hospitalized or died as a result of COVID-19.
Currently, 25{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} of all COVID-19 cases nationwide are in children under the age of 18. In the United States, there were more than 20,400 hospitalizations of children as of early September and 731 child deaths due to the virus as of Nov. 24.
For the past several months, COVID-19 has been in the top 10 leading causes of death in children in the United States.
While these cases are mostly mild, children with COVID-19 can also contribute to spreading the virus around the community to infect others who are more vulnerable.
“We’ve already identified that (COVID-19) has a significant mortality in certain age groups and in people who have comorbid conditions and immune-compromised conditions, so vaccinating the healthy kids that are likely to still spread it to these people is our priority,” Laughlin said.
Even children who have mild cases of COVID-19 or are asymptomatic can run the risk of suffering long-term effects.
According to Moore, between 10{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} and 20{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} of children who have had COVID-19 also have developed “long COVID,” which can occur within three months after infection and lasts for at least two months. Some symptoms of this condition include fatigue, shortness of breath and cognitive dysfunction (commonly referred to as “brain fog”).
While younger people are more likely to be asymptomatic or have mild symptoms, the COVID-19 virus can have long-term effects such as multisystem inflammatory syndrome in children or long COVID.
While extremely rare, MIS-C is a serious and life-threatening condition that can occur two to six weeks after the COVID-19 infection. It prompts an autoimmune response that causes inflammation in several parts of the body, including lungs, heart, skin, kidneys, brain or stomach. According to the town hall panelists, 75{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} to 90{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} of cases have occurred in children who were considered healthy prior to COVID-19. The Centers for Disease Control and Prevention is still studying MIS-C and how it affects children; the CDC is still unsure why some children have gotten sick with MIS-C while most others have not.
Only 142 cases of MIS-C have been identified in Indiana so far.
In contrast to the virus’ long-term impact, the COVID-19 vaccine has not demonstrated any lasting negative impacts.
According to several panelists, within all the vaccines that have ever been developed, any significant long-term complications have been recognized within the first six months of it being used on the population. It is unlikely that the public will have any new long-term consequences.
In all U.S. age groups, a very low number of deaths (0.0022{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d}) have occurred following a COVID-19 vaccination, according to the CDC, and in many of those cases something other than the vaccine may have been the cause of death.
Myocarditis occurs when the body’s immune system causes inflammation of the heart muscle in response to an infection or some other trigger, as defined by the CDC.
According to the CDC, since April 2021, there has been an increase in U.S. cases of myocarditis following COVID-19 vaccination, predominantly in male teenagers and young adults. The symptoms typically present within a few days after the vaccine, especially the second dose. The CDC and its partners are currently investigating these cases.
Most of these cases, as rare as they are, are mild and do not lead to hospitalization. Patients who seek medical care and rest have recovered very quickly.
“It’s not a reason (to) not get the vaccine,” Simmonds said.
The panelists confirmed they had not seen any report of children aged 5-11 with myocarditis after being vaccinated.
There have been some case reports of myocarditis following COVID-19 infection.
“I’ve been in multiple meetings with infectious disease experts where they’ll tell you that the virus itself is much more likely to cause myocarditis than the vaccine,” Simmonds said.
“I would not recommend waiting. I would get it as soon as you’re able to just because you’re delaying that time. You could catch it during that time that you’re waiting,” Simmonds answered.
It has also been fine to mix doses for children on that age cusp, according to Simmonds. While they are still 11, the child can receive the 5-11 vaccine dose. If they have since turned 12 when it’s time for that second shot, they can receive the adult dosage.
“I don’t typically recommend it. I don’t think there’s really a problem with it,” Simmonds said. “My advice to my patients is if they have side effects after the vaccine, it’s fine to give Tylenol or ibuprofen if they’re achy or feverish, which does happen. At that point, give Tylenol or ibuprofen.”
Laughlin said he could not say for certain whether a vaccine for COVID-19 could be required at schools.
“We don’t require flu vaccines, but we encourage them,” Laughlin added.
Laughlin, and many other health officials, hope that COVID-19 will become like other mild viruses that cause some symptoms but do not lead to serious illness.
“We also hope that more and more people will get vaccinated so that it becomes a milder virus and doesn’t continue to mutate,” Laughlin said.
“I see it as the way to eventually not have to wear masks at school and to get back to normal life,” Laughlin answered.
Being fully vaccinated gives children reassurance that they are less likely to contract the virus, less likely to have symptoms if contracted and less likely to spread it to others.
“We’re hoping that if we get enough people vaccinated, we’ll have what you would refer to as ‘herd immunity’ so that it’s very unlikely to acquire the virus when you’re around other people,” Laughlin said.
Health officials still don’t know much about the newest variant, Omicron.
According to Laughlin, it appears that the Omicron variant is likely more contagious than the Delta variant, but the severity is still unknown. Over time, as it continues to spread, health officials will have more information.
“Should you wait to get the vaccine now until we know more about the Omicron variant? I would say definitely not because that’s going to take a while for any change in vaccine to come out if they do decide to change the vaccine,” Laughlin said. “We don’t even know that we’re going to need to change the vaccine to provide protection.”
So far, the FDA-approved vaccines have been highly effective in all other previous variants.
“Based on current knowledge, there’s no reason to wait,” Laughlin concluded.
Pfizer is currently conducting clinical trials of its vaccine in children ages 6 months to 4 years. Laughlin estimated that the vaccine for that age group could be approved in late winter or early spring of 2022.
In the meantime, families are encouraged to get their children aged 5 and older vaccinated to protect their younger siblings.
Residents are also encouraged to be masked where unvaccinated people might be, such as community gatherings. Monroe County currently has a health order that requires masking, regardless of vaccination status, in indoor public spaces.
“I think that boosters likely will be necessary. We don’t know that yet,” More said. “We started giving vaccine to 12- to 15-year-olds in May, so we will have six months of information on that pretty soon.”
A COVID booster shot is an additional dose of the vaccine some time following the original dosages, which have demonstrated decreased protection over time.
“With a lot of the world yet to be vaccinated, including many people in the United States, it’s likely that there will be more variants over time, and if they are more transmissible and whatever the severity is, we may need boosters. To this point, the vaccine that we have right now is really very protective for most all of us,” Moore said.
The current recommendation by the CDC is anyone over 18 should receive a booster shot six months after their second shot.
Residents interested in watching the full town hall can find a recording on https://catstv.net/.
Contact Rachel Smith at rksmith@heraldt.com or @RachelSmithNews on Twitter.
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