Federico Mercolini1 and Simone Cesaro2.
1 Pediatric Hematology and Oncology Unit, Department of Pediatrics, Bolzano Hospital, Italy.
2 Pediatric Hematology Oncology, Department of Mother and Child, Azienda Ospedaliera Universitaria Integrata Verona, Italy.
Federico Mercolini, M.D. Pediatric Hematology and Oncology Unit,
Department of Pediatrics, Bolzano Hospital, Italy. Tel: +39-0471909796.
Published: January 1, 2022
Received: October 10, 2021
Accepted: December 10, 2021
Mediterr J Hematol Infect Dis 2022, 14(1): e2022009 DOI 10.4084/MJHID.2022.009
| This is an Open Access article distributed
under the terms of the Creative Commons Attribution License
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medium, provided the original work is properly cited.
pandemic affected fewer children and adolescents with lower morbidity
and mortality rates than those reported for adults. This review focused
on the clinical course, risk factors for severe COVID 19, mortality,
treatment options, and prevention measures in the pediatric and
adolescent setting with special attention to pediatric
oncohematological patients. SARS-CoV-2 infection was often asymptomatic
in these subgroups of patients, but 47 to 68% of them required
hospitalization, and 9-10% of those hospitalized needed intensive care
with a COVID 19 attributable mortality of about 4%. The multisystem
inflammatory syndrome associated with COVID 19 was less frequent than
that reported in the non-oncohematological pediatric population.
Noteworthy, the course of COVID 19 was more severe in low-middle income
countries. The key measures to prevent SARS-CoV-2 infection are
reducing patient exposure to the SARS-CoV-2 and vaccination, now
available for parents and caregivers and patients and siblings above 12
years of age. The treatment of COVID 19 in pediatric patients is mainly
based on supportive care with dexamethasone and heparin prophylaxis for
severely ill patients. Other measures, such as convalescent plasma,
remdesivir, and monoclonal antibodies, have been used in limited cases
or within experimental protocols. Further studies are needed regarding
the risks factors and outcomes of SARS-CoV-2 infection in pediatric
(CoVs) are a family of enveloped positive-sense single-stranded RNA
viruses, which can infect humans, other mammals, or avian species.
Severe acute respiratory syndrome coronavirus (SARS- CoV) and the
Middle East respiratory syndrome coronavirus (MERS- CoV) have been
described in the human species respectively in 2002 and 2012, causing a
respiratory illness with high mortality rates. At the end of 2019, a
novel highly infective and pathogenic Coronavirus designated as severe
acute respiratory coronavirus 2 (SARS-CoV-2) was reported in the city
of Wuhan, China, causing an outbreak of unusual viral pneumonia and
rapidly spreading around the world.
This new coronavirus
targets both upper and lower respiratory tract tissues, and an
efficient human-to-human transmission even before the onset of symptoms
has been observed. It is mainly transmitted by droplets and aerosol
from symptomless and symptomatic infected subjects, with a median
incubation period of 5.7 days (range 2-14).
Covid-19 in Adults and Adults with Cancer
spectrum of infection severity in symptomatic patients ranges from mild
disease (81%), severe disease (14%), critical disease (5%), to death
(2.3%). On September 28, 2021, more than 200 million cases have been
reported worldwide, with more than 4 million 300 thousand deaths,
but the numbers are increasing day by day. Since the pandemic
onset, age was documented as the major risk factor for
mortality. In a recent systematic review and meta-analysis, age
was confirmed as the most important risk factor for both severe
clinical course (Odds Ratio> 75 years of 1.93 (1.32-2.52)) and
mortality (Odds Ratio> 75 years 5.82 (1.86-9.79)). Other risk
factors were obesity and the presence of comorbidities, in particular
cardiovascular diseases, chronic pulmonary and chronic kidney diseases.
In the same study, adult patients with active cancer showed an
increased risk, with Odds ratios for the severe course and mortality
1.48 (1.26-1.69) and 2.15 (2.15-2.16), respectively.
in the literature confirm increased risk of severe COVID-19 course in
adult cancer patients: a 3.61-fold higher risk of severe COVID-19 was
reported in cancer patients compared to patients without cancer;
and among cancer patients, a 2.45-fold increased risk of death was
reported in COVID-19 adult patients compared to non-infected
adults. In addition, 2-fold higher mortality due to COVID-19 has
been reported for patients with hematological malignancies compared to
the non-cancer population.[12,13] Moreover, the highest frequency of
severe COVID-19 events has been reported in patients with hematologic
cancer, lung cancer, or metastatic cancer (stage IV).
Table 1 shows the most important risk factors for a severe course and mortality of SARS-CoV-2 infection.
||Table 1. Main Risk factors for severe clinical course and mortality in adults and children/adolescents.
sequelae related to COVID-19 infection, better known as post-acute
COVID-19 syndrome, are commonly reported in adults. The post-acute
COVID-19, defined as the persistence of symptoms and/or delayed or
long-term complications beyond 4 weeks from the onset of symptoms, is
characterized by pulmonary (dyspnea, decreased exercise capacity and
hypoxia, reduced diffusion capacity, restrictive pulmonary physiology,
and ground-glass opacities and fibrotic changes on imaging),
cardiovascular (palpitations, chest pain, myocardial fibrosis or
scarring, arrhythmias, tachycardia), hematological (thromboembolism),
renal (reduced eGFR), endocrine (new or worsening control of existing
diabetes mellitus, subacute thyroiditis and bone demineralization) and
neuropsychiatric (fatigue, myalgia, cephalea, dysautonomia, and
cognitive impairment, anxiety, depression, sleep disturbances)
In the largest series[15,16] at least one of these symptoms was reported in 30-87% of patients.
most frequently reported symptoms were: fatigue (35-64%), dyspnoea
(11-44%), sleep disturbances (24-26%), anxiety / depression (20-25%)
and chest pain (5-21%).
SARS-CoV-2 Infection and Covid-19 in Children and Adolescents
to their developing immune system, children, compared to adults, are
more susceptible to infectious diseases. However, the susceptibility to
SARS-CoV-2 infection in children seems to be lower, with a low
incidence of severe COVID-19 and only rare fatality cases,
estimated between 2 and 5 cases per million for subjects below 18 years
About 80-90% of infected children and adolescents
(80%)[19,20] present with symptoms, usually mild or moderate. Since the
first months after the start of the pandemic, children presented
clinically milder cases and a better prognosis than adults. This
resulted in a lower hospitalization rate, ranging from 2.5 to 4.1%.
Among hospitalized patients, 15% were admitted to the ICU.
symptoms in children are similar to those in adults. The most frequent
are fever (46%), cough (37%), headache (15%), diarrhea (14%), sore
throat (13%), nausea/vomiting (10%), myalgia (10%), abdominal pain
(7%), rhinorrhea (7%) and shortness of breath (7%).[22,23]
organ-specific involvements have been reported: heart failure,
myocarditis, pericarditis, arrhythmias, pulmonary embolism in the
cardiovascular system;[24-26] encephalopathy, stroke, Guillain-Barrè
syndrome, cerebral edema, status epilepticus, transient ischemic attack
in the nervous system;[27,28] urticarial, maculopapular, vesicular skin
rash, livedo reticularis, chilblain-like lesions as skin
manifestations. The most fearful complication of COVID-19 infection
in pediatric age is the multisystem inflammatory syndrome in children
(MIS-C), described as early as April 2020. MIS-C is characterized by
fever, multisystem organ involvement, laboratory evidence of
inflammation, and severe course (Table 2).
Other features may include acute myocardial dysfunction, respiratory
failure, Kawasaki-like disease, and toxic shock syndrome.[30,31]
||Table 2. WHO Multisystem inflammatory syndrome in children and adolescent definition.
appears to be relatively rare, occurring in <1% of confirmed
COVID-19 cases in children, corresponding to about 5-7 cases per
million people per month.[32,33] Among the hospitalized patients, the
MIS-C rate varies between 10 to 25%. Currently, no long-term
follow-up studies that define with certainty the prognosis of patients
with MIS-C are reported. In a systematic review including 16 studies
and a total of 655 MIS-C patients, 10% of patients (68) required
critical care, and the mortality rate was 1.7% (11 deaths ).
Treatment of MIS-C is mainly based on organ support, immunoglobulins, and steroids.[36-38]
COVID-19 sequelae, these appear to be much less frequent than in
adults: in a cohort of 25 children, Denina et al. no
COVID-19-related sequelae up to 4 months after the infection were
In a larger collection of cases, out of 151 children
with COVID-19, whom 36% with asymptomatic course and 64% with mild,
moderate, or severe disease, 12 patients (8%) had post-acute COVID-19
symptoms. The most frequent documented symptoms were mild post-viral
cough (6 patients), fatigue (3 patients), or both post-viral cough and
fatigue (1 patient). Resolution of symptoms was seen in all cases in up
to 8 weeks.
Risk Factors for Severe Disease and Mortality.
Most pediatric patients affected by COVID-19 have a symptomless or
paucisymptomatic course that allows home management. In a review
including more than 7400 COVID-19 positive children, only 2% of cases
presented severe symptoms with dyspnea and hypoxemia, and critical
conditions in 0.7%. The reported fatality rate was 0.08% (6 patients
). Similarly low (0.28%) is the mortality rate reported by Wang et
al. in a meta-analysis that collects data from more than 11,000
COVID-19 positive children. However, some pediatric patients may
require hospitalization, particularly those with one or more
comorbidities. Kim et al. reported the different clinical
characteristics on a total of 576 hospitalized patients, with a median
age of 8 years and equal male/female distribution: 222 patients (38.5%)
had one or more comorbidities, such as obesity (38%), chronic lung
disease (18%), prematurity defined as gestational age <37 weeks
(15.4%), neurologic disorder (14%), immunocompromised condition (5.4%).
In a similar European study, out of 582 patients with a median age
of 5 years, 25% of hospitalized patients had one or more comorbidities.
The latter group of patients had a 3.7 greater relative risk of
admission to ICU. About one-third of hospitalized patients required
intensive care and about 5% mechanical ventilation.[42,44]
mortality, children and young people have a lower risk than adults.
However, several authors reported case series of deceased pediatric
patients. McCormick et al. reported 112 deaths, with a median age
of 17 years (range 0-21 years): 63% were male, and 86% of patients
presented with at least one of the following conditions: obesity (42%),
asthma (29%), and developmental disorders (22%). Similarly, Bixler et
al. reported 121 deaths in patients under 21 years old: only 30
(25%) were patients otherwise healthy, whereas 91 (75%) patients had at
least one comorbidity, and 54 (45%) had two or more comorbidities:
asthma (28%), obesity (27%), neurologic and developmental conditions
(22%), cardiovascular diseases (18%), cancer or immune system disorder
(14%) and diabetes mellitus (9.1%). In a systematic review that
analyzed 9335 children with COVID-19, 27% of patients had underlying
comorbidity, and among them, the most frequent was
immunosuppression. Conversely, other authors reported a similarly
favorable course, compared to healthy children, in patients undergoing
immunosuppressive treatment for inflammatory bowel diseases, rheumatic
diseases, and kidney diseases.[49-51] Table 1 summarizes the major risk factors for severe COVID-19 in pediatric patients.
Covid-19 in Children and Adolescents with Cancer
cancer is an established risk factor for severe COVID-19 in adults, it
has thus far not been considered so in children. In fact, the main risk
factors for severe COVID-19 course in children are medical complexity,
genetic, neurologic or metabolic conditions, congenital heart disease,
obesity, diabetes, asthma or other chronic lung diseases, sickle cell
disease, and immunosuppression.[52,53] Unlike the adult
oncohematological population, data regarding COVID-19 infection in
pediatric oncohematological patients are relatively scarce. The
incidence of COVID-19 is higher in patients with cancer than in the
general population, both in adults and children/adolescents.
This incidence could be explained by the increased susceptibility of
immunosuppressed patients towards viral respiratory community
infections and by the need for frequent hospital visits with higher
exposure to contagion. From the beginning of the
pandemic, recommendations for the prevention of infection have
been released by the scientific community of pediatric oncology
that are still valid today: physical and social distancing of children
on active treatment for cancer, patient screening before chemotherapy,
limitation of hospital access for parents/caregivers, creation of
dedicated COVID-19 free wards, implementation of telemedicine and the
use of adequate personal protective equipment for health personnel,
patients and parents or caregivers. However, the adherence to these
measures has been variable during the pandemic, depending on country or
region socio-economic level and readiness to implement the plans to
prevent the diffusion of SARS-CoV-2 infection.
of COVID-19 in children and adolescents with cancer have been reported
worldwide. In the systematic review by Meena et al., collecting
data from 33 studies (18 case reports and 15 case series),[55,58-89]
clinical and outcome of 226 children with cancer and COVID-19 were
described: 53% of the patients were affected by hematological
malignancies and 47% by solid tumors. The median age was seven years
with a male to female ratio of 1.7:1; 34 patients were in intensive
chemotherapy and 17 post-HSCT. Sixty-three patients were symptomless,
47 had mild-moderate and 20 severe infections. Interestingly, out of
169 patients with data regarding chemotherapy, 123 (72.8%) had a
treatment delay, and 10 had a regimen modification. In this review,
morbidity and mortality related to SARS-CoV2 infection and the risk of
severe COVID-19 was higher compared with the general pediatric
population. Indeed, 96 of 226 patients (47%) required hospitalization,
and 21 needed ICU admission. Fifteen patients (11.5% of hospitalized
patients) died due to COVID-19. A meta-analysis of 15 studies,
including pediatric patients with hematological malignancies and solid
tumors, showed that the overall survival rate was 99.4%, with no
statistically significant differences in the risk of hospitalization,
ICU admission, and need for ventilation between patients with
hematological conditions malignancies and solid tumors.
et al., in a review on COVID-19 in immunosuppressed children,
observed that pediatric cancer patients have overall good COVID-19
outcomes, though still slightly worse than the general population.
a European cohort of 582 hospitalized pediatric patients, 27% were
affected by malignancy and presented a relative risk of ICU admission
2.7 times higher than the entire group; on the contrary, 29 patients on
immunosuppressive treatment and 3 affected by immunodeficiency did not
show an increased risk of ICU admission.
The largest collection of
COVID-19 infection in the pediatric oncology field has been recently
published: this study included data of 1319 patients under
the age of 19 from 131 institutions of 45 countries who completed the
30-day follow-up. Deaths attributable to COVID 19 infection were 3.8%
(50 out of 1319), more than ten times higher than the general pediatric
An important risk factor associated with severe or
critical illness was low-income or lower-middle-income country status,
with a relative risk 5.8 times greater than high-income country status.
Other risk factors were an age between 15 and 18 years, lymphocytes
<300/mmc, neutrophils <500/mmc, comorbidities, and being on
intensive chemotherapy. Oncological treatment was modified globally in
55.8% of patients, and, among them, chemotherapy was suspended in 80%
and reduced in 13.1%. In addition, radiation therapy was delayed in
6.6%, whereas surgery was postponed in 6.7% of patients.
given the small number of fatal cases in pediatric oncology, the risk
factors for mortality are not known. On the contrary, in the adult
hematological oncology field, worse overall survival was associated
with advanced age, an uncontrolled or progressive disease status, the
diagnosis of acute myeloid leukemia, aggressive non-Hodgkin's lymphoma,
indolent non-Hodgkin lymphoma or plasma cell neoplasm, and the presence
of COVID-19 in severe or critical form.
According to the
European Society for Blood and Marrow Transplantation (EBMT) data, the
mortality in 382 patients with COVID-19 after stem cell
transplant was 25% with a 6-week overall survival rate of 77.9% 72.1%
for allogeneic and autologous recipients, respectively. In this
series, only 3 of 32 pediatric patients (29 allogeneic transplants and
3 autologous transplants) died, all after allogeneic stem cell
transplant, the 6-week overall survival being 93.4%. In multivariate
analysis, the risk factors for lower survival were older age, ICU
admission, and the moderate/high immunodeficiency index, whereas a
better performance status was protective.
The comparison between
the clinical course in the general pediatric/adolescent population and
the pediatric/adolescent cancer patients is shown in Table 3.
||Table 3. Differences in
clinical course of COVID 19 infection between the general
pediatric/adolescent population and pediatric/adolescent patients with
The treatment of pediatric cancer patients with COVID-19 is similar to
that of immunocompetent populations affected by COVID-19. Several
pediatric guidelines[48,90-92] stated that the cornerstone of treatment
is the supportive measures, such as the administration of fluids and
electrolytes, nutritional support, support of the respiratory function
with the administration of oxygen, or the use of non-invasive or
invasive ventilation systems, support of cardiac function with
inotropes, support of renal function, and antibiotic treatment in case
of bacterial superinfection.[96,97]
immunosuppression of pediatric cancer patients can prolong the viral
phase of COVID-19 and reduce, delay or even nullify the inflammatory
phase of the disease.
Since the onset of the pandemic, several
drugs have been used in the treatment of pediatric cancer patients with
COVID-19:[55,61,63,66-68,73,74,76,81-83,85,87,88] the most used drug
was hydroxychloroquine, followed by steroids and oseltamivir. In
addition, the use of lopinavir/ritonavir, azithromycin, remdesivir,
tocilizumab, convalescent plasma, chloroquine, and IVIG has also been
reported in the literature.
The use of these drugs was based on
the protocols adopted for adults, but no treatment specific for the
pediatric age has been developed. Currently, some drugs initially used,
such as hydroxychloroquine/chloroquine (both in outpatients and in
hospitalized patients),[99,100] lopinavir/ritonavir,[101-103] and
azithromycin)[104-107] are no longer recommended due to their
Instead, the following are the
currently used drugs for the treatment of COVID-19, concerning
the adult and pediatric literature.
Steroid therapy has shown conflicting results in adults hospitalized
due to SARS-CoV-2 infection. In a systematic review and
meta-analysis, the use of systemic glucocorticoids was evaluated on a
total of 15.754 patients: neither a reduction in mortality nor in
the duration of hospitalization and period of viral shedding was
demonstrated. Steroid therapy has not shown efficacy even in adult
oncology: Rivera et al. reported a numerical (but not
statistically significant) increase in 30-day all-cause mortality in
109 patients treated with high-dose steroids compared to negative
However, the efficacy of dexamethasone has been
demonstrated in hospitalized patients receiving oxygen, noninvasive or
invasive mechanical ventilation, determining lower 28-day
mortality. Unfortunately, the same benefit was not found in
patients not receiving respiratory support.
Guidance on the Use of Immunomodulatory Therapies for COVID-19 in
Pediatrics published in December 2020 concluded that steroid
therapy is not recommended for mild/moderate disease course, while it
may be beneficial for severe or critical illnesses. Therefore the risk
and benefits should be evaluated on a case-by-case basis.
there are no randomized trials that demonstrate the efficacy of steroid
therapy in patients with cancer or immunodeficiency, neither in the
adult nor in the pediatric population.
Remdesivir showed mixed results in the adult population: while in the
WHO solidarity trial on 11,330 patients, of which 2750 treated
with Remdesivir, no improvements of mortality, of the need for invasive
ventilation and duration of hospitalization was found in patients
treated with remdesivir, Beigel et al. reported a
significant reduction in mortality and days to recovery in a population
of 1062 patients (of which 80 with cancer) treated versus placebo; in
the analysis of subgroups based on respiratory support, efficacy was
demonstrated in patients not receiving oxygen or receiving oxygen, but
not in patients receiving high-flow oxygen, non-invasive ventilation,
or invasive ventilation. In a study conducted on 2186 adults with
cancer, including 470 with hematological malignancy, 124 were
treated with remdesivir alone: its use was associated with a reduction
in 30-day all-cause mortality in comparison with positive controls
(Odds Ratio 0.41), however without statistical significance.
the multicenter Interim Guidance on Use of Antivirals for Children With
Coronavirus, experts suggested as a first choice the use of
remdesivir for children with severe illness, defined as a supplemental
oxygen requirement without the need for non-invasive or invasive
mechanical ventilation or extracorporeal membrane oxygenation
(ECMO). The evidence of good tolerance[113,114] and the efficacy
data deriving from the adult population suggest using remdesivir
instead of other antivirals. and. However, no efficacy and safety data
are currently available in pediatric cancer patients.
The use of anti-Spike monoclonal antibodies to prevent severe COVID-19
has shown promising results in the adult population: several
studies[115-117] demonstrated a reduction of hospitalizations and
deaths among patients treated with banlanivimab + etesevimab and
casirivimab + imdevivab.
The best results were obtained with an
early administration of antibodies, and, therefore, their indication is
mainly in the early stages of the disease.[118,119] In 38 adult
patients with active cancer, the use of neutralizing monoclonal
antibodies led to a lower hospitalization and mortality rate than those
previously described among active cancer patients.
Based on the
evidence available in December 2020, a panel of experts expressed
an opinion against the routine use of monoclonal antibody therapy in
pediatric patients, including those at high risk of severe evolution.
Several randomized trials demonstrated that convalescent plasma has no
significant impact on the main outcome indicators of COVID-19 in adult
patients.[122,123] However, the efficacy could be linked to the
anti-SARS-CoV-2 antibody titer: Joyner et al. demonstrated a
reduction in the risk of death in hospitalized patients who were not
receiving mechanical ventilation by administration of convalescent
plasma with higher anti-SARS-CoV-2 IgG antibody levels, compared to
those treated with plasma with lower antibody levels.
factors that could influence the effectiveness of this treatment are
the timing of administration and the severity of the infection: Libster
et al. showed that early administration of high-titer convalescent
plasma against SARS-CoV-2 to mildly ill infected older adults reduced
Convalescent plasma with high neutralizing
antibody titers could find an indication in B-cell depleted
patients, although there are currently no randomized studies that
can confirm benefits in this cohort.
In the adult cancer
population, convalescent plasma has shown efficacy in treating
COVID-19. In a retrospective study conducted on 966 adult patients
with hematologic malignancy, hospitalized for COVID-19 infection, the
outcome of patients treated with plasma (n = 143) compared to those who
did not receive it (n = 823) was evaluated. In patients treated with
plasma, a favorable Hazard Ratio of 0.6 in 30-day all-cause mortality,
0.4 for ICU admission, and 0.32 for mechanical ventilation was found.
However, the efficacy of plasma in the adult cancer population remains unclear in the absence of randomized trials.
Convalescent plasma was generally well tolerated in the adult population, and no specific adverse reactions were reported.
a literature review, in pediatrics, 8 case report studies with a
total of 14 children treated with plasma (age range 9 weeks-18 years)
were described: no adverse events related to plasma administration were
documented. All patients had a positive outcome, and 7 of the 8 studies
concluded that convalescent plasma could be a useful therapeutic
option. However, given the small number and heterogeneity of the
sample, more studies are needed.
Although tocilizumab (anti-IL-6R monoclonal antibody) has been
emergently authorized in the USA in hospitalized patients over 2 years
of age on steroid therapy and in need of oxygen, mechanical
ventilation, or ECMO, there are currently no data on efficacy and
safety in the pediatric population.
Tocilizumab showed variable
efficacy in various retrospective and case-control studies in the adult
population.[131,132] Furthermore, being associated with an increase in
the rate of superinfection, the risk/benefit ratio of its use is
to assess carefully in oncology patients.
reports and case series[66,67,73,83] have shown that treatment with
Tocilizumab is feasible and well-tolerated in pediatric cancer
patients, but large studies are lacking.
The risk of thrombotic complications in children with COVID19 is not
yet well defined, and thromboprophylaxis in these patients is limited
to cases at higher risk of thrombosis.
There are two main
pediatric consensus-based recommendations[135,136] suggesting the
administration of low-dose low molecular heparin subcutaneously twice
daily, targeting a 4-hour post-dose anti-Xa activity level of 0.2 to
< 0.5 U/ml, as prophylaxis in children hospitalized for COVID 19.
The indication to prophylaxis with heparin is the presence of an
elevated D-dimer value (> 5 times above the upper limit) or of risk
factors for hospital-related deep vein thrombosis (i.e., presence of a
central venous catheter, mechanical ventilation, prolonged length of
stay, complete immobility, obesity, active malignancy, cystic fibrosis
exacerbation, sickle cell disease vaso-occlusive crisis, congenital or
acquired cardiac disease with venous stasis or impaired venous return,
previous history of venous thromboembolism (VTE), first-degree family
history of VTE before 40 years of age, known thrombophilia,
post-pubertal age, estrogen-containing oral contraceptive pill therapy,
status-post splenectomy for underlying hemoglobinopathy).
COVID-19 infection in the pediatric setting has other consequences than
health, such as social isolation and interruption of education.
Furthermore, the pediatric patient could act as a vector of the disease
within society and then pose risks for the adult population and certain
subsets of pediatric patients at risk of developing severe COVID
Therefore, vaccination against COVID 19 should be considered in the entire pediatric population.
date, safety, immunogenicity, and efficacy studies have only been
conducted in the population over 12 years of age. Frenck et al.
reported the experience of administering the BNT162b2 Covid-19 vaccine
in the population aged 12 to 15 years in a multinational,
placebo-controlled, observer-blinded trial: 2600 adolescents were
enrolled, of whom half received the vaccine and half received placebo.
The vaccine showed a favorable safety and side-effect profile,
presenting mostly mild to moderate reactogenicity in the absence of
serious vaccine-related adverse events. The vaccine efficacy was 100%.
the mRNA-1273 vaccine showed a good safety profile and a serological
response in the population between 12 and 17 years, comparable to that
of young adults, with efficacy in preventing COVID 19.
et al. reported recently the results of phase 2-3 study where 2268
children of 5-11 years of age were randomized (ratio 2:1) to receive 2
doses of 10 mg of BNT162b2 vaccine, 21 days apart, versus placebo.
After a median follow-up of 2.3 months from the second dose, the
vaccine efficacy against documented COVID-19 was 90.7%; moreover, no
vaccine-related serious adverse events were noted, and the serum
antibody level of neutralizing antibodies against SARS-CoV-2 was
comparable to that observed in a control group of subjects of 16-25
years vaccinated with the adult dose of 30 mg BNT162b2 vaccine.
mRNA vaccines' safety and tolerability profile is favorable,
myocarditis has been reported as a rare complication, especially in
adolescent or young adult males. A recent Israeli study showed
that the incidence of myocarditis, albeit low, was increased in
16-19-year-old males who received the BNT162b2 mRNA vaccine (8.62
events / 100,000). The relative risk of developing myocarditis was 5.34
for the entire population and up to 13.6 in males between 16 and 19
years. It should be noted that after SARS-CoV-2 infection, the
myocarditis complication is greater (11.54 events/100,000). The
clinical presentation of myocarditis after vaccination was generally
mild with response to conservative or symptomatic treatment.
on COVID 19 vaccines in patients with malignancy are limited since
these patients were largely excluded from the phase III vaccine trials.
However, the experience on 151 adult patients with cancer, of which 95
with solid tumors and 56 with hematological cancer, has recently been
reported. The vaccine was well-tolerated, and no vaccine-related
deaths were reported. The serological response (IgG positivity) was
found after the first dose in 38% of patients with solid tumors, 18% of
hematological malignancies, 94% of healthy controls, while after the
second dose in 95%, 60%, and 100%, respectively.
have been published in reference to specific cancers in the adult
population: after the second vaccine dose the antibody response was
45-65% for chronic lymphocytic leukemias,[143,144] 40-70% in
Non-Hodgkin lymphomas,[144,145] 94-100% in Hodgkin lymphomas,[144,146]
80-90% in acute lymphatic or myeloid leukemias,[144,146] 70-85% in
post-transplant patients.[147,148] Several observations showed
that, in the patients who have received anti-CD20 monoclonal
antibody therapy, B-cell directed immunotherapy or patients with
profound hypogammaglobulinemia or marked lymphopenia, the response to
vaccination is very poor.[149,150]
Revon-Liviere et al.
 reported the single-center vaccination experience of 10
patients between 16 and 21 years under treatment for solid tumors or
within 6 months after treatment conclusion. Vaccination was well
tolerated in all patients who presented exclusively mild local
reactivity symptoms; 7 out of 10 patients showed positive serology
after the first vaccine and 9 one month after the second. No patient
developed COVID 19 disease.
Vaccination has been shown to be safe
in adolescents and young adults (12-29 years) with a previous
PEG-asparaginase allergy, showing no vaccine reaction.
Europe, the indication issued by National Authorities is to recommend
the full vaccination with a vaccine approved by the European Medical
Agency (EMA) in all people above 12 years of age, including frail
patients due to the presence of comorbidities, immunosuppression,
cancer treatment, chronic disease, and organ or stem cell
Considering that vaccination is not yet available
for patients under the age of 12, full vaccination of all eligible
family members of cancer patients is of paramount importance because it
reduces the viral transmission to these patients at high risk of severe
COVID 19 course.
patients have a reduced incidence of severe COVID 19 compared to the
adult population. However, a subset of pediatric patients is at greater
risk for a severe course. This subset includes pediatric and adolescent
patients with active cancer and immunosuppression.
cancer patients, severity, morbidity, and mortality are higher than the
general pediatric population, particularly in low-middle income
The clinical course may be asymptomatic; however,
47-68% of patients require hospitalization and 9-10% admission to
intensive care. Mortality attributable to COVID 19 infection is about
A key measure for these patients is the prevention of COVID 19
infection by reducing the risk of exposure and vaccinating contacts.
regarding the efficacy and safety of vaccination in adolescent cancer
patients are still very limited; however, based on data collected on
studies in adults, the safety profile and tolerability are reassuring.
the case of COVID 19 infection, the cornerstone of treatment is
supportive care. However, transferring the evidence gained from adults,
some medical treatments, such as the use of dexamethasone for severely
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