Virginia Dept. of Health answers parent questions about kids and vaccines
RICHMOND, Va. (WWBT) - Parents across Richmond voiced concerns about COVID-19 vaccinations and their children. NBC12′s Sarah Bloom raised those questions to the Virginia Department of Health.
Parent questions listed in bold, response from VDH follows.
“I’m deeply concerned about the long-term effects of this vaccine, because of how quickly it was approved. I know there’s no way to know for sure. What can you tell me about the safety and testing of the vaccine in children?”
ANSWER: One of the reasons that these COVID-19 coronavirus vaccines could be produced and tested so quickly is that vaccine research for two previous coronavirus diseases, SARS that emerged in China in 2002 and MERS that emerged in the Middle East in 2012, taught us a lot about developing safe and effective coronavirus vaccines. In addition, we also learned a lot about developing new mRNA vaccines from the recent research into new rabies and influenza vaccines. mRNA vaccines are an idea that is decades in the making. Information about the use of mRNA in the development of vaccines can be found here.
This article from the Children’s Hospital of Philadelphia also includes useful information about vaccine safety.
In addition, although the COVID-19 vaccines were developed faster than any other U.S. vaccines, that increased speed of development was also made possible by making new funding and other resources available, by creating new partnerships between government and private-sector organizations, and by reducing non-scientific bureaucratic obstacles. In fact, development of these new vaccines has followed the same effectiveness and safety review processes as other vaccines, including studying tens of thousands of participants of different ages, races and ethnicities for each vaccine.
For every vaccine used in the United States (including COVID-19 vaccine), trials start with Phases 1 and 2, when small groups of people are vaccinated and then monitored for immune response and for safety. Then, in Phase 3, tens of thousands of people are vaccinated to be sure the vaccine is both safe and effective for all types of people.
Development of vaccines for use in the United States is strictly controlled by the U.S. Food and Drug Administration (FDA). After the FDA authorizes or approves a vaccine, an independent immunization committee at the Centers for Disease Control and Prevention (CDC) decides whether to recommend it and for whom. In all stages of the process, the most important factor is safety. Vaccines must meet the highest standards of safety and have minimal side effects, because they are given to healthy people to prevent disease. And in fact, the United States currently has the safest, most effective vaccines in its history.
The CDC and FDA monitor the safety of vaccines even after authorization and approval to be sure they are safe and effective in the long-term. These long-term studies to monitor the safety and effectiveness of vaccines as they are being widely used for the public are considered to be Phase 4 of vaccine research. These long-term studies, which include people at high risk for COVID-19, will help identify any common side effects or other safety concerns and will help clarify how long protection lasts after vaccination.
VDH shares the goal of ensuring safe vaccines and has the safety of the Commonwealth and its citizens as its number one priority. VDH works closely with the CDC to review all vaccines to be sure its recommendations are based on sound science.
Finally, the U.S. COVID-19 vaccine program has been the most carefully monitored vaccine program in this country’s history. More than 380 million doses of COVID-19 vaccine have now been given in the United States and have been successfully preventing SARS-CoV-2 infections and COVID-19 disease in this country for almost a year. During that period, serious adverse effects have been identified only rarely in the five different surveillance systems studying COVID-19 vaccine side effects.
Pfizer-BioNTech and Moderna, the developers of the first two COVID-19 vaccines to be used in this country, have now collected enough safety and effectiveness data to allow them to apply to FDA for full approval for their vaccines. The Pfizer vaccine has now been fully approved and licensed for individuals 16 and up, and the FDA is still considering the Moderna application.
“I’d love to know why it’s taken so long. For many months it was “the vaccine will be available before kids start school. Then it was September….now it’s MAYBE Halloween. Why the setbacks?”
ANSWER: The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are taking all steps necessary to ensure the safety of vaccine dosing in children, and this takes time. One thing that must be determined is the proper dosing for younger children -- do they get two full adult doses, should it be two smaller doses in the same time frame as adults and adolescents, should it be one smaller dose? These ongoing trials need to be completed and data provided to the FDA and CDC before the medical and scientific communities approve their use for children ages 5 years through 11 years of age. Once these children are able to receive the vaccine, data from children younger than 5 years of age will be reviewed.
“What’s the reaction been like for kids who have had it? Have they gotten sick afterwards like many adults? Should parents plan for kids to be out of school a day or two the way some adults were out of work after the shot?”
ANSWER: Thus far, only the Pfizer-BioNTech vaccine has been approved for use under the Emergency Use Authorization in adolescents ages 12 years through 15 years of age -- the original EUA included persons ages 16 years of age and older. For the most part, the side effects in the adolescent population have been similar to those experienced in the population at large.
Your child may have some short term local or systemic side effects from the vaccination, which are normal (and expected) signs that their body is building protection against COVID-19.
Some vaccinated people have had local reactions such as pain or redness or tenderness at the injection site. In terms of systemic side effects, a small number of vaccine recipients have had transient symptoms such as fatigue, nausea, chills, fever, headache or other body aches for a few days. These expected side effects mean that the vaccine is causing your child’s immune system to react and create antibodies to fight off the virus that causes COVID-19 if they are exposed in the future.
A small number of vaccine recipients have experienced swollen lymph nodes. For the two mRNA vaccines, these expected side effects are more common in younger people than older people and with the two-dose vaccine series, they are more common after the 2nd dose than after the first dose.
Less commonly, some people have reported redness, swelling, and itching around the injection site beginning a few days or in the second week after their first vaccine dose. Although these reactions will get better within a few days, some of them have been quite large. However, these local reactions, which are now called “COVID arm” are not considered to be allergic reactions and are not felt to represent a risk for anaphylaxis upon receipt of the second dose. A few of those people who experienced this reaction have had a similar reaction after their second dose. Thus, individuals with such delayed injection site reactions after the first mRNA COVID-19 vaccine dose should receive the second dose using the same vaccine product as the first dose and at the recommended interval, and preferably in the opposite arm. More information about these uncommon “COVID arm” reactions can be found here.
As happens occasionally with other vaccines such as influenza vaccine, fainting soon after injection has also been noted among a small number of COVID-19 vaccine recipients, especially among adolescents and other young adults. This kind of short term reaction after the first injection of a two-dose COVID-19 vaccine series is also not a reason to avoid the second dose.
Even if your child experiences discomfort after the first dose of mRNA COVID-19 vaccine, it is very important that you still receive the second dose a few weeks later for the vaccine to be effective.
“I’m curious about the distribution plan. Will we be fighting for slots at CVS? Going to the pediatrician? Will it be readily available or a struggle at first? Will there be a tiered “phase” plan like the adults had?”
ANSWER: VDH is working with its delivery channels to identify gaps in need throughout the Commonwealth in the instance that children younger than 12 years become recommended for COVID-19 vaccination. Our goal is to ensure vaccines are available to children in a fair and equitable manner as quickly as possible once authorized by the FDA and recommended by the CDC.
“Kids don’t seem to be getting that sick- do we really need to vaccinate them?”
ANSWER: While it is true that children are not experiencing severe illness at the same rates as adults, the numbers of pediatric hospitalizations are increasing in the wake of the Delta variant surge, and the number of pediatric deaths is increasing. Children are also at risk of developing multisystem inflammatory syndrome (MIS-C) or long COVID. MIS-C is a condition in which organs, such as the heart, lungs, or brain, become inflamed. Most children with MIS-C require hospitalization and may require the intensive care unit. Long COVID is when individuals develop symptoms such as fatigue, chest pain, headaches, or shortness of breath that last for weeks or months, and may not appear until several weeks after infection. Also, infected children, even those who are asymptomatic, can still spread the virus to vulnerable persons such as the immunocompromised who are receiving certain medical treatments. Vaccination of children will contribute to cutting off that many more avenues of transmission of the virus, thereby bringing the end of the pandemic that much closer.
“Where’s a good place to find out what is fact and what is not?”
ANSWER: The VDH Facts and Myths website is a good place to find reliable information about the COVID-19 vaccines being used in the United States.
“I’d like to know the distribution plan and the interval time frame between a child receiving the COVID-19 vaccine and flu shot”
ANSWER: The CDC has determined that the COVID-19 and flu vaccines may be given at the same time in children and adolescents.
“When will kids under 5 be eligible?”
ANSWER: This is dependent on the clinical trials currently underway. Once the data from clinical trials is available, it will be submitted to the FDA for authorization under emergency use and then reviewed by the CDC Advisory Committee on Immunization Practices (ACIP) for recommendation.
“Should children who have had COVID-19 defer the vaccine?”
ANSWER: No. Full COVID-19 vaccination is recommended for all those who previously had a COVID-19 infection. Studies have shown that compared to the “natural immunity” in people who had COVID-19 illness before but have not been vaccinated yet, the immunity provided by COVID-19 vaccination in people who also had COVID-19 illness before is both stronger (that is, provides higher antibody levels) and broader (that is, it can better protect against some of the new variant strains).
“Do parents have to commit to boosters? Will kids need shots every six months?”
ANSWER: Parents should consult with their pediatrician or other healthcare provider on the question of boosters for children and adolescents. FDA and CDC will continue to monitor the data, and provider recommendations on boosters if and when they are needed.
“Will religious exemptions still stand?”
ANSWER: The only vaccine religious exemption related to children is associated with school required vaccines. Requiring COVID-19 vaccine to attend school would require an update to the Code of Virginia during Virginia’s legislative session by the General Assembly. VDH cannot comment on private entity COVID-19 vaccine requirements and whether religious exemptions would be accepted.
“Have kids had serious reactions?”
ANSWER: From the Vaccine FAQs: As happens occasionally with other vaccines such as influenza vaccine, fainting soon after injection has been noted among a small number of COVID-19 vaccine recipients, especially among adolescents and other young adults. This kind of short term reaction after the first injection of a two-dose COVID-19 vaccine series is not a reason to avoid the second dose.
For those older children recently authorized to receive COVID-19 vaccines, the side effects seen after vaccination in the recent research studies were similar to those seen in older adolescents and young adults.
Finally, even if you or your child experience discomfort after the first dose of mRNA COVID-19 vaccine, it is very important that you still receive the second dose a few weeks later for the vaccine to be effective.
Some of these side effects could interfere with your - or your child’s - ability to do daily activities, but they should go away in a few days.
Remember to sign yourself and your vaccinated child up for v-safe, where you can use your smartphone to tell CDC about any side effects after getting the COVID-19 vaccine. You’ll also get reminders from v-Safe about your second vaccine dose.
Medicines such as acetaminophen, ibuprofen, or naproxen or other medicines called “non-steroidal anti-inflammatory drugs” (NSAIDS) can help with the common side effects (for example, arm pain or fever) after those side effects start to occur. However, these drugs should not be taken before your COVID-19 vaccine doses since information on their possible impact on the body’s ability to create immunity to COVID-19 infection is not yet available. If you or your child have persistent injection site pain, short term fever, or other discomfort, talk to your healthcare provider about taking one of these over-the-counter medicines.
To reduce pain and discomfort where you or your child got the shot:
- Apply a clean, cool, wet washcloth over the area
- Use or exercise your arm.
To reduce discomfort from fever:
- Drink plenty of fluids.
- Dress lightly.
When to call the doctor:
In most cases, discomfort from arm pain or swelling where you or your child got the shot or from fever, headache, fatigue, etc., will not last more than a few days after a COVID-19 vaccine dose. Contact your doctor or healthcare provider:
- If the redness or tenderness where you got the shot increases
- after 24 hours
- If your side effects are worrying you or do not seem to be going
- away after a few days
Side effects or adverse events can be reported either in v-safe or VAERS.
Some adolescent and young adult recipients of either Pfizer or Moderna vaccines have experienced rare but serious side effects: Myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the outer lining of the heart.
The cases reported to VAERS have been rare, and respond well to conservative management (e.g., medicine and rest). The cases have been mostly observed in male adolescents and young adults (aged 12-29 years) and more often after getting the second dose of an mRNA vaccine. Cases typically occur within 1 week after COVID-19 vaccination. Follow-up of people with these conditions is ongoing, including looking at a longer-term assessment. Anyone who has a concern should consult with their healthcare provider.
More Questions added from Sarah Bloom:
What is the official updated timeline for child vaccinations?
ANSWER: This can’t be answered until there is final guidance from the FDA and CDC.
Do we know the guidance on how the shots will be given? Same time frame as adults?
ANSWER: This can’t be answered until there is final guidance from the FDA and CDC.
How will priority be sorted?
ANSWER: This can’t be answered until there is final guidance from the FDA and CDC.
How will prior COVID-19 cases be factored in to getting a shot?
ANSWER: This can’t be answered until there is final guidance from the FDA and CDC.
Where will they be available to kids?
ANSWER: VDH is working to provide a variety of channels to parents for the vaccination of children such as pediatricians’ offices and in-school clinics.
What’s the timeline for younger kids?
ANSWER: This can’t be answered until there is final guidance from the FDA and CDC.
Copyright 2021 WWBT. All rights reserved.
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