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 Questions for Parents

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.

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