Questions/Answers

Kids Health First is dedicated to providing healthcare information that is accurate, easily viewed, and printable for your patients/families. On this section of the member portal, you will find common questions and answers about pediatric healthcare topics that may impact, inform and/or influence the decision making process. Please click on each headline to view the full Q & A with noted sources. Please print and distribute to your patients/families.

All documents are reviewed prior to publication by the Kids Health First Medical Director, Dr. Lori DeSoutter, and/or other physicians, who specialize in these topics.

If you have any topics you would like us to address, please contact us at information@khfirst.com and we will try to provide you with the requested Q & A.

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March 12, 2023

On January 30, 2023, the White House announced its plans to end the coronavirus public health emergency (PHE) in May. The PHE is scheduled to end on May 11, which will result in changes that will affect the access and cost to vaccines, tests, and treatment for COVID-19. This will include changes to telehealth policies. During the pandemic, many of you received COVID tests, vaccines and treatments free of charge. When the emergency period ends on May 11, changes will occur on the availability and cost of the above. The White House did not want to end the PHE quickly and has given both patients and providers several months’ notice to learn more about the upcoming changes. Below is information to help guide you answer parent's questions during this transition. This will likely be the first of several announcements as information changes and/or is updated. We will notify you as soon as we know more.


Q: Does the end of the PHE mean that the pandemic is over? Do I still need to worry about COVID?  

A: No, it does not. How science defines a pandemic and how a government defines one are not necessarily the same According to the U.S. Department of Health and Human Services, daily cases have decreased. Hospitalizations and deaths have also decreased, but children and adults are still getting COVID, and it remains a public health issue. At this time, COVID is not interfering with our lives like it did at the start because many people have some protection from COVID, either through vaccination or from previously having COVID. Vaccines continue to be the most reliable way to protect you and your child from getting this virus. If your child has not been vaccinated, and you want your child vaccinated, please call your provider to schedule this appointment. If your child missed any other shots over the last three years, you could schedule those at the same time. Also, if your child has been around someone with COVID or is showing signs of COVID, please contact your provider for testing guidance.


Q: How does the Food and Drug Administration play into this change? Does this also mean the emergency use authorization for vaccines by the FDA goes away?

A: No. The emergency use authorization for both vaccines and boosters will remain in effect. The EUA is not connected to the public health emergency that ends in May.


Q: What will change for me and my family after May 11 when it comes to getting COVID vaccinations or boosters for my child?

A: As long as federally funded vaccines are available, the cost of the vaccines, including boosters, will remain free to everyone, regardless of healthcare coverage. Most physicians charge fan administration fee which covers the process of measuring and administering the vaccine, counseling the parent on potential side effects, answering questions, reviewing the vaccine information sheet, etc. This administrative fee has always been billed to the insurance company. At this time, we do not know if insurance will continue to cover the administrative fee after the end of the PHE. Also, no one knows how long the supply of federally funded vaccines will last.


Q: Can my pediatrician charge me for those vaccines after May 2023?

A: Again, as long as the federally purchased vaccines are available, there is no charge. This may not include an administration fee.

Please note: Providers of federally purchased vaccines are not allowed to charge patients or deny vaccines based on insurance coverage or network status:

  • Even after the federally purchased vaccine supply is gone, vaccines will continue to be free for most individuals with private or public insurance. You may need to confirm with your insurance plan that vaccines are covered after the supply is gone. However, even if covered, you may still need to make a co-pay or deductible for the vaccine. If you have private insurance please confirm that your provider is in network.
  • If you are uninsured or underinsured, there will be new costs for vaccines after the federally purchased supply is gone. You may still be able to get vaccines at a free clinic, community health center, or local health department at no cost or for a very small fee.

Q: I like to use at-home-tests for my children if I suspect COVID. What changes will occur with at-home COVID tests?

A: After May 11 the at-home tests for COVID will not be free. You may have to make a co-pay or apply the cost to your deductible:

  • For those on Medicaid, at-home tests will be covered at no-cost through September 2024. After that date, costs for at-home tests will vary by state.
  • If you want to have a supply on hand, you may want to visit your local pharmacy and pick up some tests before May 11. Be sure to look at the expiration dates on any tests you purchase.

Q: I don’t have any insurance coverage for my children, but they received temporary Medicaid coverage during the pandemic. How does the end of the PHE affect them?

A: There were 15 states in the U.S. that adopted a process of providing temporary Medicaid, and those who received temporary Medicaid coverage during the pandemic were able to receive testing services, including at- home testing, free of charge. Temporary Medicaid will end soon, depending on the state. If you are uninsured, or cannot afford at-home tests, you may still be able to find them at a free clinic, community health center, health department, library, or other local organization.


Q: What about a PCR or rapid COVID test ordered by the pediatrician or other health care provider?

A: Most individuals with insurance will still have coverage for tests ordered by the health care provider, but these tests may no longer be free. You may have to make a co-pay at time of testing or apply the cost to your deductible. Again, those with Medicaid will be able to have a COVID test at no charge through September 2024. However, some states may limit the number of tests allowed, or they may charge you a small fee for the test. If you were uninsured and issued temporary Medicaid coverage during the pandemic, you will not be able to obtain FREE COVID testing, including at-home testing, after the public health emergency ends, unless you re- apply and are approved for Medicaid. You will need to pay full price for testing or find a public clinic or community health center offering free testing if you are uninsured.


Q: Will I be required to pay for treatment once the public health emergency ends?

A: If your child is on Medicaid or CHIP, prescribed pharmaceutical treatments will continue to be covered through September 2024. After that, those treatments will continue to be covered, however, some states may place a limit on the number of treatments that can be given. You may be responsible for some of the cost. The limits or amount of the shared cost have not been decided at this point. For those with insurance, there has always been a cost-sharing for COVID treatments provided in a hospital or outpatient setting. This will not change. You will still be responsible for a shared cost which will be dependent on your insurance plan.


Q: When will the supply of federally purchased vaccines, tests, and treatments be gone?

A: No one knows when that will happen. When it does, there may be further changes announced related to availability and cost. The White House has said that it does not plan to fund more vaccines, tests or treatments at this time.


Q: Will telehealth visits still be allowed for COVID after the end of the public health emergency ends?

A: Many providers saw patients for telehealth visits during the pandemic, and most states have already made plans to make Medicaid telehealth flexibilities a permanent part of a practice’s service. According to the Kaiser Family Foundation, recent legislation will allow telehealth policies adopted during the pandemic to remain through December 31, 2024.

  • Most private insurances covered telehealth visits prior to the pandemic, and which most likely will remain the same with a few exceptions.

For Medicaid, states have a greater ability to authorize coverage for telehealth visits without federal approval.


Q: Will my child still be able to receive a prescription via a telehealth visit after the end of the PHE?

A: As of February 24, the federal government is proposing some restrictions on telehealth prescriptions for some drugs, if the provider has not seen the patient in-person. This may include prescriptions for attention deficit disorder, addictive painkillers, or prescriptions prescribed for mental/behavioral health problems. Currently, the proposed new rule would require a patient to see a provider at least once in-person to get a prescription for these types of medications. If your child was prescribed a medication via telehealth during the pandemic, your child must see a provider within 180 days after the end of the public health emergency to receive a refill. Patients will still be able to get medications such as refills, insulin, and skin creams through a telehealth visit. A decision has not been made about whether a patient can be seen via telehealth when out-of-state, which was allowed during the pandemic. This could affect a child who is on vacation and becomes ill, or a college student attending an out of state university. The American Academy of Pediatrics is working with the Drug Enforcement Agency (DEA) to make sure that children and teens are not left out of the discussion about these changes. By May 11 approaches, we should know more about the future of telehealth visits-its continued expansion, well as the limitations. Stay tuned for more information about this very important healthcare option.

If a child is on Medicaid or Peach care for Kids, please review the following information carefully


Q: I received temporary Medicaid enrollment for my child during the pandemic. Is that going to end?

A: Continuous enrollment in temporary Medicaid was tied to the end of the public health emergency but will end on March 31, 2023. Recent legislation has allowed states to begin disenrolling patients as early as April 1, 2023. Most states will take approximately one year to complete this process of disenrolling individuals. This is referred

to as Medicaid Unwinding or Medicaid Redetermination. The state of Georgia will begin the Medicaid Redetermination process on April 1, 2023. This includes all children currently on Medicaid and Peachcare for Kids. It is extremely important for you to make sure your information is up to date with the Georgia Department of Human Services (DHS) . If you have not created an account in Gateway, please visit gateway.ga.gov and create your account. Be sure to update all information including the following: 

  • Name
  • Phone number
  • Job or income
  • Number of people in the household

DHS encourages you to select “email” notifications which is the easiest way for them to reach you. DHS has also created a website that will post currents news and information about Medicaid. Go to staycovered.ga.gov to stay informed. You may also call 877-423-4746 for more information on Medicaid. Please pay attention to any communications you may receive from the Department of Human Services and CMS.

based on the child’s individual situation. Again, it should be noted that there is a specific set of individuals who have contracted mpox, and as of late July, only two pediatric cases of mpox had been identified. Remaining alert to potential exposure and the signs and symptoms is the best way to manage mpox at this time.


Resources

Stay Covered Georgia  staycovered.ga.gov

Gateway Georgia gateway.ga.gov


Sources

Kaiser Family Foundation—Unwinding the Continuous Enrollment Provision: Perspectives from Current Medicaid Enrollees read more

Kaiser Family Foundation—The End of the COVID-19 Public Health Emergency: Details on Health Coverage and Access read more

Government Executive—Here’s What the End of the COVID-19 Public Health Emergency Could Mean for Federal Agencies read more

U.S. Department of Health and Human Services—Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap read more

New York Times—U.S. Plans to End Public Health Emergency for COVID in May read more

Editor’s Note (Nov 2022)—Following a series of consultations with global experts, WHO will begin using a new preferred term “mpox” as a synonym for monkeypox. Both names will be used simultaneously for one year while “monkeypox” is phased out.

Monkeypox (mpox) and What to Know

August 14, 2022

In June of 2022, the CDC began to closely monitor cases of mpox in the U.S. as it does not naturally occur here, but due to the number of diagnosed cases since May, tracking those cases became more of a priority. Since that time, more than 10,000 cases of mpox have been documented by the CDC. “On Aug. 4, the Health and Human Services (HHS) Secretary Xavier Becerra declared mpox a public health emergency(PHE).” Much has been in the news about this disease, and we wanted to provide as much information as possible so that you have a better understanding of the disease, its signs, its symptoms, and its potential exposure to you and your family.


Q: What is mpox?  

A: Mpox is a disease caused by a virus. It has been in existence since the late 1950s and was discovered in lab monkeys at the time. It was not discovered in a person until 1970. Historically, mpox was most common in central and western Africa or in people who had traveled outside that area or who had been in close contact with imported animals. More recently, the disease has spread outside of Africa. It is important to note, that mpox is spreading mostly through close, intimate contact(sexual activity) with someone who has mpox. As of August 10, there were 10,392 cases of mpox diagnosed in the United States. The majority of those cases have been identified in California, Florida and New York. Many, but not all of those cases are among gay, bisexual, and other men who have sex with men. As of this date, only two children in the U.S. have been diagnosed with mpox. However, anyone can contract mpox from close contact with someone who has the disease or contact with diseased animals, so it is important to understand how its spread, and its signs and symptoms.


Q: What are the signs and symptoms of mpox?

A: The following are symptoms that may be seen in someone infected with mpox. These may occur in isolation or as a cluster of symptoms.

  • Rash which can be located on or near the genitalia or anus, hands, feet, chest, face, or mouth
    —  The rash will initially resemble pimples or blisters and may be painful or itchy
    —  The pimples/blisters will scab over before healing
    —  This rash can look a lot like chickenpox
  • Fever/chills
  • Swollen lymph nodes
  • Fatigue
  • Muscle aches/backache/headache
  • Sore throat, nasal congestion or cough

Q: How long will these symptoms last?

A: According to the CDC, mpox can show symptoms within 3 weeks of being exposed. A rash will usually surface within 1-4 days if the person infected has flu-like symptoms. The virus can be contagious from the first symptoms until the rash has healed, the scabs have fallen off, and fresh skin has formed. This usually lasts from 2-4 weeks.


Q: How does mpox spread?

A: This virus can spread through contact with blood, bodily fluids, or fluid from the blisters. It can also spread through contact with bedding or other items contaminated by the virus, or through breathing in the virus.


Q: What should I do now to keep my child safe? 

A: Avoid close contact with anyone who has been infected with the disease. Children can get rashes from many different causes, and if you or your child has a new or unexplained rash that looks like pimples or blisters and other symptoms, and you may possibly have been exposed, call your pediatrician or primary care doctor.


Q: Who is the most at risk for getting severely ill with mpox?

A: Young children under the age of 8, pregnant women, those who are immunocompromised, and individuals with severe eczema or other skin diseases, are more at risk of getting severely ill if they contract mpox. The CDC recommends that babies remain in a separate room and not have contact with a parent or caregiver who has mpox. If a new mother has been infected with mpox, breastfeeding should be delayed during the isolation period, and the breastmilk should not be used after pumping. If you have any questions about mpox, please reach out to your pediatrician or primary care doctor for more information. If the pediatrician suspects mpox, a history will be taken and a skin swab will be completed. Treatment may be recommended based on the child’s individual situation. Again, it should be noted that there is a specific set of individuals who have contracted mpox, and as of late July, only two pediatric cases of mpox had been identified. Remaining alert to potential exposure and the signs and symptoms is the best way to manage mpox at this time.


Sources

Past U.S. Cases and Outbreaks: view source

Signs and Symptoms: view source

What is monkeypox?: view source

COVID-19 Booster Vaccine for Ages 5-11 years and Others


May 22, 2022

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices’ met on May 19, 2022, to review the FDA recommendations on the expanded eligibility of the COVID-19 vaccine booster in anyone over the age of 5 years. The CDC now recommends that children 5 through 11 years of age should receive a booster at least 5 months after their initial Pfizer-BioNTech vaccination series. According to Rochelle P. Walensky, M.D., M.P.H., children in this age group have lagged behind other age groups leaving them more vulnerable to serious illness. For more information on their recommendations, click here


Q: My child has already received two vaccines, why should I choose to have my child receive a booster vaccine?

A: According to the CDC, since the beginning of the pandemic more than 4.8 million children between the ages of 5 and 11 have been diagnosed with COVID; 15,000 have been hospitalized and more than 180 of those children have died. As cases continue to increase throughout the country, a booster vaccine will help restore and improve protection against severe disease from COVID.


Q: When should I have my child get a booster vaccine?

A: According to the CDC, children ages 5 through 11 should get a booster at least 5 months after the initial Pfizer-BioNTech series has been completed. If your child completed the initial vaccine series in December 2021 and is eligible to receive a booster, now is the time to schedule one. Remember: The Pfizer-BioNTech vaccine is the only one currently approved to be used in children 5 to 11.


Q: Can my older child get a booster vaccine?

A: The CDC has also recommended that children 12 years of age and older, who are immunocompromised, and who have had an initial booster, receive a second booster at least 4 months after their first booster. Contact your child’s healthcare provider to schedule this appointment. This recommendation is also for people 50 and older. Encourage your family and friends in this age group to schedule their booster vaccines as well. According to Dr. Walensky, “it is important that all people have the protection they need.”


Q: Where can I get a vaccine booster for my child?

A: Contact your child’s healthcare provider first to determine if the practice is offering COVID-19 booster vaccines; not all physician offices will be offering the booster. Other resources may include a vaccination clinic, your local pharmacy, a community vaccination site, church, school, or other facilities. Some locations may have walk-in hours.


Q: What should I do now to keep my child safe?

A: The following checklist will help you:

  • Check to see if your child is up-to-date on all immunizations.
  • If not, call your pediatrician to schedule those at the same time as the booster vaccine. This is also the time to ask questions and share any concerns you may have.
  • Be certain your child is receiving the Pfizer- BioNTech vaccine booster. *This is the only vaccine approved for children 5-11.
  • Have the healthcare provider add a record of this booster vaccine to your vaccine card. Take a picture of it or make a copy and keep in a safe place.
  • Do not share the card on social media.
  • If you had the booster vaccine at a location outside of your child’s pediatrician’s office, make sure you make a copy for your pediatrician.
  • All vaccines and boosters should be reported to the Georgia Immunization Registry (GRITS). Any individual who is licensed to administer a vaccine licensed by the FDA is able to report this information in several different ways. For more information, click here

 

COVID-19 Bivalent Vaccine Boosters from Pfizer BioNTech and Moderna for children 5 years of age and older.


October 28, 2022

On Wednesday, October 12, 2022, Rochelle P. Walensky, M.D., M.P.H., Director of the CDC, signed a “decision memo” expanding the use of an updated bivalent COVID-19 vaccine booster for children from 5-11 years of age. These updated vaccines add Omicron BA.4/BA.5 spike protein components to the current vaccine. This helps to restore protection that has decreased since any previous vaccinations and targets the recent Omicron variants that are more easily transmitted and more likely to evade previous immunity.


Q: What does bivalent mean?

A: Mpox is a disease caused by a virus. It has been in existence since the late 1950s and was discovered in lab monkeys at the time. It was not discovered in a person until 1970. Historically, mpox was most common in central and western Africa or in people who had traveled outside that area or who had been in close contact with imported animals. More recently, the disease has spread outside of Africa. It is important to note, that mpox is spreading mostly through close, intimate contact(sexual activity) with someone who has mpox. As of August 10, there were 10,392 cases of mpox diagnosed in the United States. The majority of those cases have been identified in California, Florida and New York. Many, but not all of those cases are among gay, bisexual, and other men who have sex with men. As of this date, only two children in the U.S. have been diagnosed with mpox. However, anyone can contract mpox from close contact with someone who has the disease or contact with diseased animals, so it is important to understand how its spread, and its signs and symptoms.


 Q: What does bivalent mean?

A: In this instance it means that one single dose of the vaccine provides immunity for two diseases or variants. This particular vaccine contains a component for the original strain of SARS-CoV-2, and a


Q: What does monovalent mean?

A: In this instance it means the vaccine provides immunity for one disease or variant. The original COVID-19 vaccine contained a component for the original strain of SARS-CoV-2. This did not include the Omicron variant which is more prevalent today.


Q: My child has already been vaccinated. Why should my child get a booster?

A: Research has indicated that immunity from the COVID-19 vaccines can decrease over time. An additional booster provides increased protection against severe disease and death as immunity wanes.


Q: My child has never received a COVID-19 vaccine. Can my child get this bivalent vaccine booster?

A: The answer is “no.” The bivalent vaccine is not authorized as a primary series vaccination. It only includes one dose for children 5 years of age and older, and it can only be given at least two months after your child has received the primary vaccine series with any other approved monovalent COVID-19 vaccine, or as a booster dose at least two months after your child has received the most recent booster dose with any approved monovalent vaccine.

If you would like for your child to have the primary series vaccine for COVID-19, please contact your pediatrician or primary care provider to schedule an appointment. It is not too late to be protected from COVID-19.


Q: Everyone in my family, including my children have already had COVID-19, why should they get a booster now?

A: Research has shown that individuals can be infected with COVID-19 multiple times as the virus mutates and changes over time. An additional booster can again provide that additional amount of immunity protection against severe disease and death. The Centers for Disease Control and Prevention recommends that children receive vaccination even if they have had COVID-19.


Q: There are two different vaccines approved as a bivalent vaccine for children. What is the difference between these two boosters?

A: Previously Pfizer’s monovalent vaccine was given in two doses. Today, Pfizer’s bivalent booster vaccine can be given as a single dose for children 5-11 years of age. This booster can be given at least two months after completion of the primary vaccine series, or after any of the approved monovalent COVID-19 vaccine booster.

For more information about the Pfizer bivalent booster click here.

Moderna’s bivalent booster vaccine is also given in one dose and is available under emergency use authorization for children six years of age and older. The updated booster is a new vaccine (outside of the primary series vaccines) that is custom-designed to help protect against multiple COVID-19 variants—and can help provide greater protection against an ever-changing virus.

The updated booster is a new vaccine (outside of the primary series vaccines) that is custom-designed to help protect against multiple COVID-19 variants—and can help provide greater protection against an ever-changing virus.

For more information about the Moderna bivalent booster click here


Q: How do I know which one is best for my child?

A: Distribution of both vaccines has begun and will be available at pediatric practices, pharmacies, federally Qualified Health Centers, local health departments, clinics and other locations throughout Georgia. If you have questions about either of these vaccines, reach out to your pediatrician or primary care provider who can help guide you in your decision. It is possible that locations may not have both options available, so be certain to ask which vaccine is being provided if it is important in your decision making process.


Q: What kind of side effects have been seen in children?

A: The side effects in children have been similar to those seen in adults, as well as those seen in the primary series vaccines. The most common side effects were pain at the injection site, irritability and drowsiness. Reactions were mostly mild or moderate. If you have other questions about side effects, your pediatrician or primary care provider can help answer those questions.


Q: My child also needs other vaccines. Can I schedule the COVID-19 vaccine booster at the same time as other vaccines?

A: In addition, it is important for your child to be up to date on all vaccines which help prevent infectious diseases such as flu, mumps, measles, chicken pox, etc. Reach out to your pediatrician or primary care provider for more information about the timing of all vaccines. Your child’s healthcare provider is the best person to guide you in scheduling the vaccine booster with other vaccines.

COVID-19 Vaccine for Ages 5-11 years

November 3, 2021

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices met on November 2, 2021, to discuss the FDA recommendations on the emergency use authorization of the Pfizer COVID-19 vaccine in children 5-11 years of age. On November 3, 2021, the CDC posted this announcement:

Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine. CDC now expands vaccine recommendations to about 28 million children in the United States in this age group and allows providers to begin vaccinating them as soon as possible.” 

For more information on their recommendation, click here.


Q: Why should I choose to have my child vaccinated against COVID-19?

A: As of October 2021, more than 1.9 million children have been infected with COVID-19 in the 5-to-11-year old age group. In addition, there have been over 8,300 hospitalizations within this same age group, and approximately one third of those hospitalizations have required a stay in an intensive care unit. There have also been more than 2,500 cases of multisystem inflammatory disorder from COVID-19. These statistics were reported by Peter Marks, M.D., a top FDA vaccine official, during the independent FDA advisory panel which met on Monday, October 26, 2021.

While children do not appear to be as severely affected by COVID-19 as adults, they are susceptible to the disease. Additionally, all infants, and children with obesity, diabetes, chronic lung disease, sickle cell disease and immunosuppression are at a greater risk of severe disease.


Q: What data did the FDA and CDC need to know to determine the effectiveness of the vaccine in younger children.

A: On October 29, 2021, the FDA authorized the emergency use of the Pfizer BioNTech vaccine to include children from 5-to-11 years of age. This authorization followed a comprehensive evaluation of all data presented by Pfizer regarding their clinical trials in this age group.

This information noted that smaller doses of Pfizer vaccine were highly effective in triggering a robust response to the vaccine which proved to be more than 90% effective at preventing COVID-19 for children 5 to 11.

More than 3,000 children participated in the clinical trials with no serious side effects detected in this ongoing study.


Q: Now that the Pfizer vaccine has been approved for children 5-11 years of age, what do I need to know about the safety of that vaccine?

A: According to the FDA, initial data indicated that the Pfizer vaccine is 90.7% effective among children ages 5 to 11, including the highly contagious delta variant. Overall, the benefits of the vaccine outweigh any risks associated with the vaccine.


Q: What kind of side effects have been seen in children?

 A:  The side effects in children have been similar to those seen in adults. The most common side effects were pain at the injection site, fatigue, and headache. Reactions were mostly mild or moderate. There were no serious adverse events related to the vaccine, including myocarditis or anaphylaxis.


Q: Does the Pfizer vaccine require one or two doses?

A: The Pfizer-BioNTech vaccine requires two doses, which are 1/3 the amount given to anyone 12 years of age and older. The Pfizer-BioNTech vaccine is the only one currently approved to be used in children 5 to 11.


Q: How far apart do these two doses need to be administered?

A: Twenty-one days apart. During November and December there are many holidays so please keep this in mind when scheduling the vaccine for your child. Also, schedule the second dose at the completion of the first dose.


Q: How long does it take for the vaccine to be effective? 

A: According to the CDC you are considered “fully vaccinated” two weeks after the second dose of the Pfizer vaccine.  If it has not been two weeks since the second dose, continue to keep taking precautions such as wearing a mask, social distancing, avoiding large groups and hand washing.


Q: What kind of serious risks have been seen in the clinical trials for children 5-11 receiving the vaccine?

A: There have been rare cases of heart inflammation, known as myocarditis and pericarditis, primarily in younger males who have received either of the two mRNA-based vaccines made by Pfizer and Moderna. While those cases reported in adolescents and adults have often been mile, most have required hospitalization. Frequently these incidences resolved within a day, but early data from ongoing review indicated that some individuals continue to experience symptoms at least 3 months after first being diagnosed.

Other side effects and reactions noted in children ages 5 to 11 were similar and less common than those recorded in adolescents and young adults.

Rare events such as myocarditis or anaphylaxis (severe allergic reaction) have been seen in a small number of adults and in none of the children involved in the clinical trials.


Q: Are these vaccines going to be mandated by the schools?

A: At this time, there are no federal, state, or local COVID-19 vaccine mandates for any child. According to the CDC, “State laws establish vaccination requirements for school children. These laws often apply not only to children attending public schools but also to those attending private schools and day care facilities. All states provide medical exemptions, and some state laws also offer exemptions for religious and/or philosophical reasons. State laws also establish mechanisms for enforcement of school vaccination requirements and exemptions.”


Q: My child also needs a flu vaccine. Which one should I schedule first?

A: According to the CDC and its Advisory Committee on Immunizations Practices, these two vaccines can be administered at the same time.


Q:  Can my older child still get the vaccine?

A: Yes, the COVID-19 vaccine is available to children 12 years of age and older. Contact your child’s healthcare provider to schedule an appointment.


Q: Where can I get a vaccine for my child?

A: Contact your child’s healthcare provider first to determine if the practice is offering COVID-19 vaccines as not all physician offices will be offering the vaccine. Other resources may include a vaccination clinic, your local pharmacy, a community vaccination site, church, school, or other facilities. Some locations may have walk-in hours.


Q:  How do I prepare my child for the COVID vaccine?

A: The following checklist will help prepare you for your child’s vaccine:

  • Check to see if your child is up-to-date on all immunizations.
  • If not, call your pediatrician to schedule those as well.
  • Contact your pediatrician with any questions or concerns you may have.
  • Schedule a vaccine appointment.
  • Be certain your child is receiving the Pfizer vaccine. This is the only vaccine approved for children 5-11.
  • Schedule your child’s second dose as soon as the first dose is completed.
  • You will receive a vaccine card. Take a picture of it or make a copy and keep in a safe place.
  • Do not share the card on social media.
  • After the second dose, make sure that your child’s healthcare provider has a copy if you had the vaccine at a location outside of your child’s pediatrician’s office.

For more information on how to prepare your child for the COVID-19 vaccine, click here.


Sources

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age.view source

FDA panel: Benefits of COVID-19 vaccine for ages 5-11 outweigh risks.view source

CDC advisers endorse Pfizer’s Covid-19 vaccine for kids 5-11. view source

COVID Vaccine Checklist for Kids view source

State Vaccination Requirements. view source

Abbott Reaches Agreement with FDA to Reopen Baby Formula Plant to Ease Nationwide Shortage

May 19, 2022

On May 16, 2022, Abbott agreed to address insanitary conditions that led to contamination of its baby formula plant in Sturgis, Michigan. Under this consent decree, Abbott could restart plant operations in two weeks.

FDA Commissioner Robert Califf, said “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company will meet the FDA’s safety and quality standards.” For more information, click here.


Q: What does a consent decree mean?

A:  This is an agreement between Abbott and the FDA which was approved by the U.S. District of Court for Western Michigan. In order to open the plant, Abbott has agreed to bring in outside experts to help the facility in line with all food safety rules and regulations.  according to the Justice Department


Q: When did this situation happen and how will I know that the formula will be safe once the plant reopens.

 A: In February of this year, Abbott issued a voluntary recall of several formulas made at the Michigan plant. These included Similac PM 60/40, Similac, Alimentum and Elecare products.

The outside experts that Abbott has agreed to bring in will create a plan for Abbott to reduce the risk of bacterial contamination and will schedule periodic and ongoing evaluations to make certain that Abbott is following all the necessary rules and regulations. This process will be under the supervision of the FDA.

The CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.


Q: Now that the Michigan plant will be reopening, when can I expect to see these formulas on the shelves at the store?

A: Even though the Michigan may be allowed to open in two weeks, it can take between 6 to 8 weeks for these products to appear on retail shelves.


Q: What if this happens again?

A: Abbott is subject to this consent decree for at least 5 years. Under this decree, Abbott is required to shut down production again if any products test positive for any bacteria, dispose of the products, and find the source of the contamination and correct the problem. The FDA would have to approve any reopening once again. The company can also be fined for violations up to $5 million dollars a year.

According to Robert B. Ford, chairman and CEO at Abbott, "Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility." 

In a statement to the FDA, he continued, "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."

The Justice Department, the FDA and CDC are all committed to ensuring compliance with U.S. food safety laws.


Q: What if I choose not to continue using these products after the plant re-opens?

A: The FDA is also working with their other plants and other baby formula manufacturers to increase production in the U.S. These include Gerber and Reckitt manufacturers.

In addition, Abbott will continue to import formula from the FDA registered facility in Ireland to help alleviate the current shortage. They are also hoping to increase baby formula imports from other countries, such as the U.K., Australia and New Zealand. However, any foreign manufacturer must needs to apply to the FDA for approval. After receiving an application, the FDA determines whether the product is safe, provides enough nutrition, and all food and nutrition safety laws are followed. These countries have similar regulatory standards as the U.S.

Again, no foreign imports will be allowed without approval from the FDA and the U.S. Department of Agriculture.


Q: What if I still am not certain what to do?

A: Your primary care physician is always available to guide you. Please don’t hesitate to reach out to your pediatrician for advice.


Sources

Abbott Press Release. view source

CNBC: Abbott reaches agreement with FDA... view source

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