Wednesday, June 7, 2023
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Head of Pediatrics
Hospital Clínico Universitario de Santiago
Professor of Pediatrics
University of Santiago de Compostela
Santiago de Compostela, Spain
This activity has been peer reviewed and the reviewer has no relevant financial relationships.
Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™
This educational activity is intended for an international audience of non-US primary care practitioners, infectious disease/HIV specialists, pediatricians, nurses/nurse practitioners, and pharmacists.
The goal of this activity is for the learner to better be able to use COVID-19 vaccination strategies in babies.
Upon completion of this activity, participants will:
Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated. Others involved in the planning of this activity have no relevant financial relationships.
Disclosures for additional planners can be found here.
Head of Pediatrics
Hospital Clínico Universitario de Santiago
Professor of Pediatrics
University of Santiago de Compostela
Santiago de Compostela, Spain
This activity has been peer reviewed and the reviewer has no relevant financial relationships.
Medscape, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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CME Released: 2/22/2023
Valid for credit through: 2/22/2024
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Posted: 22/02/2023
Lilliana is a 7-month old infant presenting to her general practitioner’s office for an 8 week follow-up after a serious RSV infection. Her mother would like to discuss vaccine possibilities with the doctor.
Clinician: She is such a little sweetheart. Absolutely precious.
Liliana’s mother: Thank you. Well, she's everything.
Clinician: Yeah. So your motherly instincts are correct. There is persistent wheezing from her RSV infection.
Liliana’s mother: I thought so. I mostly hear it at night when it's quiet. It's been almost 2 months now. Is that normal?
Clinician: Well, most children will improve within a few weeks, but sometimes it may last longer or recur in connection with other infections. This can be expected and it's difficult to predict when Liliana will completely return to her normal self.
Liliana’s mother: Does this mean she's still infected?
Clinician: No. The infection itself lasts about 3 to 7 days, but her infection was severe. Her lungs are still healing and they can remain especially sensitive to other unrelated infections.
Liliana’s mother: I can tell she's feeling better. She's eating and drinking, but I'm still traumatized. It was awful watching her struggle to breathe, just so helpless. You want to do everything in your power to protect them, but so much is out of your control.
Clinician: Motherhood. Impossible to know how hard it is until you become one.
Liliana’s mother: Probably best that way. Can she get RSV again?
Clinician: It's possible, but subsequent RSV infections are usually less severe.
Liliana’s mother: Is there a vaccine against RSV?
Clinician: No, not yet. And unfortunately, it's possible for infections other than RSV to take advantage of her damaged lungs and trigger a boost in her wheezing.
Liliana’s mother: I wish there were vaccines for all this stuff. RSV, the flu, COVID. I know there's a vaccine for COVID but not for her age.
Federico Martinón-Torres, MD, PhD: Hello, I'm Professor Federico Martinón-Torres, Pediatrician, Vaccinologist and Clinical Researcher, based at Santiago de Compostela University Hospital, in Spain.
Currently, the Pfizer vaccine has full approval from the FDA and EMA for those 16 and older and is authorized for emergency use in ages 6 months and older. The Moderna vaccine also has full FDA and EMA approval for people 18 and up and is authorized for emergency use in ages 6 months and older. These authorizations are based on clinical trial regulatory requirements of safety and immunogenicity and include infants with or without comorbidities or predisposing conditions, including any infant from 6 months of age.
The 2 available vaccines have slight differences in their dosing schedules for children. For the Moderna monovalent vaccine, children between 6 months through 5 years should get a second dose at least 4 weeks after the first. A booster dose with a Moderna bivalent vaccine should be administered at least 4 weeks later. In moderately to severely immunocompromised children age 6 months to 4 years, a 3-dose primary series and 1 bivalent Moderna booster dose is recommended. The first and second doses are separated by 4 weeks, and the second and third doses are separated by at least 4 weeks. The bivalent booster dose is administered at least 2 months after completion of the primary series. Currently, only the bivalent Moderna booster is authorized for children in this age group who complete a Moderna primary series.
For the Pfizer monovalent vaccine, young children 6 months through 4 years should get a second dose at least 3 weeks after the first. And a third dose with a Pfizer bivalent vaccine, should be administered at least 8 weeks after the second. In moderately to severely immunocompromised children ages 6 months to 4 years, a 3-dose primary series is recommended. A monovalent vaccine is administered for the first and second doses, which are separated by 3 weeks. A bivalent vaccine is administered for the third primary series dose at least 8 weeks after the second monovalent dose. Children who previously received a 3-dose monovalent primary series are not authorized to repeat the third primary series dose, using the bivalent Pfizer vaccine. Currently, a booster dose using any COVID-19 vaccine is not authorized for children in this age group who complete a 3-dose Pfizer primary series, regardless of whether a monovalent or bivalent Pfizer vaccine was administered for the third primary series dose.
Most children with COVID-19 have milder clinical symptoms and better prognosis than adults. However, as the number of SARS-CoV-2 infected children and adolescents continues to rise globally, the number of children with severe forms of the disease also increases. So risks of COVID-19 are indeed lower in healthy pediatric patients, but they are never zero. Recognizing prognostic factors for unfavorable outcomes is crucial to identifying children who are at the highest risk early, to allow prevention of serious disease.
Although the risk factors and comorbidities in children predisposing to a higher risk of severe COVID-19 are less well defined than in adults, any child irrespective of age, belonging to any of those high-risk groups and particularly those with moderate to severe immunocompromising conditions, should be vaccinated.
In Liliana's case, we are seeing an infant less than 1 year old that just by age might have a higher risk than older children, to suffer more severe consequences from SARS-CoV-2 infection, as the hospitalization rate due to COVID-19 is the highest among children in those below 1 year. In addition, Liliana has lung damage secondary to a previous severe RSV infection, which further increases her odds of having complications and decreases the threshold for hospitalization, derived from a COVID-19 infection. Let's head back to the clinic where the physician is beginning to explain the risk and benefits of COVID vaccination to Liliana's mother.
Clinician: Actually, there are COVID vaccines that can safely be given to infants.
Liliana’s mother: And that will keep her from getting COVID?
Clinician: The COVID vaccines don't prevent transmission, but they can prevent hospitalization and severe infections. So even if Liliana did get COVID, her illness would not be as severe had she not gotten the vaccine.
Liliana’s mother: Do you think it's worth it then?
Clinician: Well, in general, children are less likely to have severe disease. Most are asymptomatic or will have minor symptoms, but the risk for severe disease is never zero. And it's higher for children who are under the age of one, children with comorbidities or who've had prior severe infections. You've seen that a common viral disease can have long-term comorbidities and Liliana has already shown herself to be vulnerable. This could make the eventual benefit of COVID vaccination greater for Liliana than for other children.
Liliana’s mother: Sorry, I'm just processing.
Clinician: Of course. There are 2 vaccines available to children as young as 6 months. One is given in 2 doses, 4 weeks apart. The other is given in 3 doses. The first 2 doses are given 3 weeks apart, followed by a third dose around 8 weeks later. Both vaccines are given as injections in the upper arm or thigh.
Liliana’s mother: Do they offer the same level of protection?
Dr Martinón-Torres: The physician honestly explained to Liliana's mother that the risk of COVID-19 in children is indeed lower than in adults, but not zero and that there are currently approved COVID-19 vaccines available for infants as young as 6 months old. Also in Liliana's case, being less than 1 year old and having persistent wheezing after the previous viral infection, may pose additional risk for her in the case of suffering COVID-19.
Right now, everyone ages 6 months and older can get at least one of the available booster shots after receiving the primary COVID vaccine series. A booster helps enhance or restore the protection against COVID-19 that the vaccine offers. As of December 2022, children as young as 6 months old are eligible for both the Pfizer and Moderna updated booster, which are also available for kids 5 and older and adults.
The new bivalent vaccine contains 2 mRNA components of COVID-19, one based on the original strain of the virus and the other one targeting BA.4 and BA.5. It's perfectly fine for a child to get the COVID-19 vaccine at the same time as another routine vaccine or shortly before or after, including the flu shot which may facilitate vaccine acceptance and diminish the need of extra visits to the doctor. There are no increased risks of side effects from getting the COVID vaccine along with another vaccine. Having already been infected with COVID-19 should not prevent those who are eligible from receiving the vaccine.
Let's head back to the clinic and see what's happening now.
Liliana’s mother: When I got vaccinated, the second dose made me quite ill, and I had to take the day off work. Are the side effects the same for children as they are for adults?
Clinician: Side effects in younger children are usually mild and go away in about a day. They may have a sore arm or fever, and it's okay to give them a children's pain reliever. You might also notice some irritability, sleepiness, some loss of appetite. Again, these are usually mild side effects and short term, and in the same breath, most patients have no side effects, but when they do, it's a normal sign of the body's immune system working.
Liliana’s mother: I know this is going to sound silly, but is the COVID virus inside the vaccine?
Clinician: You're not the only one to ask. It's a very common question. The vaccines do not contain the virus, so you won't get COVID from getting the vaccine. How it works is the vaccine instructs your cells to make a protein that is part of the coronavirus, the spiky bit. Your immune system then recognizes that protein as foreign and makes antibodies against it, essentially building a shield of immunity. The protein doesn't cause infection of any sort, but if you're later exposed to the coronavirus, your immune system quickly recognizes it and is ready to defend the body against it.
Liliana’s mother: The human body is fascinating.
Clinician: It is, isn't it?
Liliana’s mother: I have a nephew who is of school age, and my sister was hesitant to vaccinate him because she heard it could cause heart trouble. Is there any truth to that?
Dr Martinón-Torres: Safety is indeed one of the most frequent, if not the most frequent cause of the fear to vaccinate. This goes for any vaccine, not only COVID-19 vaccines. In this case, the physician addresses the questions raised about the safety of COVID-19 vaccines in infants in a natural way and anticipates the most probable scenario. No serious adverse events, and if any, generally benign and self-limited. No myocarditis or any other severe adverse event like anaphylaxis has been reported so far in the infant population with either of the available vaccines.
Myocarditis cases have been previously described associated with the use of mRNA based COVID-19 vaccines, but these events are rare, usually self-resolve and have been reported in adolescents and young adult males, mainly. This adverse event usually presents within the first week after the second dose or a boosted dose of mRNA COVID-19 vaccine. An interval of 8 weeks between vaccine doses, may further lower myocarditis risk.
Most patients with vaccine-related myocarditis have fully recovered at follow up. Getting vaccinated is safer for the heart than getting COVID-19. Risk of adverse cardiac outcomes were 2 to 6 times higher after COVID infection than after COVID vaccination. There's been no evidence of increased risk for myocarditis following mRNA vaccines in children that are 6 months to 5 years old. Most of the adverse events described with the use of COVID-19 vaccines are benign and self-limited. In a randomized, observer blind trial, the most common adverse effects of the monovalent Pfizer vaccine in children's 6 to 23 months old were irritability, decreased appetite, fever and injection site tenderness, redness, and swelling. Lymphadenopathy occurred rarely, less than 0.5% of the cases. Most adverse effects were mild to moderate in severity.
In randomized, observer blind trials, the most common adverse events of the monovalent Moderna vaccine in children 6 to 36 months old were irritability, sleeplessness, loss of appetite, fever, axiliary or ground swelling or tenderness, injection site pain, erythema and swelling. Most adverse effects were mild to moderate in severity and occurred at a higher frequency after the second dose.
For both vaccines, post-marketing surveillance of safety and registration of any adverse event is ongoing. The management of side effects in babies following COVID-19 vaccination is not different from that of any other vaccine. In general, observation and usual antipyretics or painkillers at the regular dose is enough. Information before vaccination may decrease the family's anxiety related to the eventual onset of side effects following vaccination and reassure them in case they appear.
We currently have immunogenic and efficacious COVID-19 vaccines with favorable safety profiles for use in infants from 6 months of age. The expected benefit of COVID-19 vaccines in this age group may be more limited than in adults, as COVID-19 tends to be milder in children. However, the risk is not zero. In addition, any child with an existing condition or risk factor for severe COVID-19 should be prioritized for vaccination. No major safety signals have been seen so far related to COVID-19 vaccination in infants with either of the mRNA vaccines available. Specifically, no cases of myocarditis have been described for this age group. The most frequent side effects are benign and transient.
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