Vaccination is a medical decision, and the practice of medicine involves evaluating risk versus benefit, with the overarching ethos that physicians must first do no harm.
In the context of marketed COVID-19 vaccines still under clinical trials, the question of risk versus benefit is ramping up as countries evaluate whether to approve COVID vaccination in children.
The initial narrative regarding COVID-19 vaccines was that priority ought to be placed on those most vulnerable to death or serious illness from the virus.
None of the vaccines still in the experimental phase have been proven to stop the transmission of COVID-19, while manufacturers report high effectiveness in reducing the risk of severe illness and death.
When evaluating whether children ought to be vaccinated for COVID-19, physicians have pointed to four key factors to consider.
Those factors are whether the marketed vaccine has been proven safe; whether the risk of severe illness or death in children warrants exposure to potential risks of vaccination; whether children pose a significant risk in transmitting COVID-19; and whether it has been demonstrated that herd immunity can be achieved without vaccinating children.
RISK OF DEATH OR SEVERE ILLNESS IN CHILDREN
There have been no reported cases of pediatric death from COVID-19 in The Bahamas thus far.
Pediatricians Perspective previously interviewed advise that throughout the entire pandemic, there have been four children presenting with symptoms of multisystem inflammatory syndrome (MIS-C), all of whom have since fully recovered.
MIS-C is associated with COVID-19, and is a rare condition where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.
Consultant General Pediatrician at Princess Margaret Hospital (PMH) Accident and Emergency Dr. Charelle Lockhart recently told us that 16 COVID-positive children had been admitted to PMH throughout the course of the pandemic for symptoms including “unrelenting fever”, diarrhea and vomiting.
In a March 2021 correspondence published in The Lancet Child and Adolescent Health, authors indicated based on data that children and young people remain at low risk for COVID-19 mortality.
The report stated, “In the USA, UK, Italy, Germany, Spain, France, and South Korea, deaths from COVID-19 in children remained rare up to February 2021, at 0.17 per 100,000 population, comprising 0.48 percent of the estimated total mortality from all causes in a normal year.
“Overall, there was no clear evidence of a trend of increasing mortality throughout the period up to February, 2021.”
The American Academy of Pediatrics in its most recent State Level Data Report on children and COVID said, “At this time, it still appears that severe illness due to COVID-19 is rare among children. However, there is an urgent need to collect more data on longer-term impacts of the pandemic on children.”
As of May 20, with 24 states reporting, the Academy advised that “between 0.1 percent and 1.9 percent of all child COVID-19 cases resulted in hospitalization”, and with 43 states reporting, the Academy advised, “In states reporting, 0.00 percent to 0.03 percent of all child COVID-19 cases resulted in death.”
The United States Centers for Disease Control and Prevention (CDC) puts its best scenario estimate of the COVID infection fatality rate for children ages 0 to 17 at 20 in one million, or 0.002 percent.
Health Minister Renward Wells recently advised Parliament that more young people were testing positive in the third wave, including 106 children ages zero to nine, representing three percent of third-wave cases.
He said, “Recognizing the phenomena of increasing cases among young and adolescents, the government has moved with urgency to secure doses of the Pfizer vaccine, which is the only emergency use listing-approved vaccine for administration to the under 18 years age group.”
It has not been disclosed whether more children are being tested in the third wave than in previous waves, but do the numbers of children who are not dying and who mostly have mild to no symptoms, warrant administering to them a medical device whose long-term effects are still unknown?
The Ministry of Health has previously stated, “We assure the Bahamian people that COVID-19 vaccination among children will not be offered within this sub-population until evidence suggests it is safe to do so, and with the consent of parents and guardians.”
For a drug to receive approval from the US Food and Drug Administration (FDA), manufacturers must provide proof of safety and “substantial evidence” of effectiveness.
But for emergency use authorization — which is how COVID vaccines are currently being administered — the threshold is that the totality of scientific evidence “makes it reasonable to believe that the product may be effective”, and a determination of safety is weighted in judging the risks versus the benefits, given the threat posed by the existing emergency.
The FDA’s archives points to how legislation governing the safety of drugs came into effect back in 1938 – ironically coming on the heels of outrage over the effect of a drug administered to children.
The Food, Drug and Cosmetic Act mandates premarket approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug was safe before it could be sold, according to FDA archives.
Regarding the act, the archives noted, “A Tennessee drug company marketed a form of the new sulfa wonder drug that would appeal to pediatric patients, Elixir Sulfanilamide. However, the solvent in this untested product was a highly toxic chemical analogue of antifreeze; over 100 people died, many of whom were children.
“The public outcry not only reshaped the drug provisions of the new law to prevent such an event from happening again, it propelled the bill itself through Congress.”
Pfizer has been given an estimated study completion date of January 31, 2023.
While still under clinical trials, the safety of COVID-19 vaccines is still being determined, and what must be carefully examined for The Bahamas is the risk/benefit profile of administering the same to children.
CHILDREN AND COVID TRANSMISSION
In the earlier weeks and months of the pandemic, with widespread uncertainty about COVID-19, governments instituted lockdowns that included the closure of schools.
But that action was born out of fear of the unknown rather than science, which at the time was in its infancy regarding COVID-19.
Now that more studies have been conducted, the question is whether emerging data supports an argument that administering vaccines under clinical trials to children is necessary to prevent a disruption of in-person learning.
One of the world’s largest studies on COVID-19 in schools was conducted on 100 schools in the United Kingdom last year.
Professor Russell Viner, president of the Royal College of Pediatrics and Child Health and a member of the UK government advisory group Sage, was quoted in the August 9, 2020 Sunday Times as saying of the study, “A new study that has been done in UK schools confirms there is very little evidence that the virus is transmitted in schools.
“This is some of the largest data you will find on schools anywhere. Britain has done very well in terms of thinking of collecting data in schools.”
A study published August 2020 in the Lancet Child and Adolescent Health on the transmission of SARS-CoV-2 in educational settings in Australia concluded, “SARS-CoV-2 transmission rates were low in New South Wales educational settings during the first COVID-19 epidemic wave, consistent with mild infrequent disease in the 1.8 million child population.
“With effective case-contact testing and epidemic management strategies, and associated small numbers of attendances while infected, children and teachers did not contribute significantly to COVID-19 transmission via attendance in educational settings.”
A study in Norway published January in Eurosurveillance examining schools between August and November 2020, concluded, “With preventive measures implemented in schools, we found minimal child-to-child (0.9 percent, 2/234) and child-to-adult (1.7 percent, 1/58) transmission, supporting that under 14-year-olds are not the drivers of SARS-CoV-2 transmission.”
And a study published in April in the New England Journal of Medicine on the spread of SARS-CoV-2 in Iceland, tested high risk persons and concluded, “children under 10 years of age and females had a lower incidence of SARS-CoV-2 infection than adolescents or adults and males”.
As it relates to discussions on needing children to be vaccinated to reach herd immunity, Israel is touted as having one of the best vaccination campaigns in the world, and is thought to have already reached herd immunity.
Israel has accomplished this without children under the age of 16 being eligible for vaccination.
Though New Providence continues to experience a surge in COVID cases, deaths and hospitalizations, government has not deemed the situation serious enough to warrant a return to virtual learning.
It is an indication that government does not view the invariably close and sustained contact between students and teachers during a surge with growing risks from variants, as risky enough to close schools.
Given its risk assessment herein, government should explain the rationale for its plans to accept risks that could be posed by COVID vaccination with vaccines still undergoing clinical trials.
CARDIAC EVENTS AND mRNA VACCINES
AstraZeneca has paused its vaccine trial on children, pending investigations by UK’s medicines regulator about incidences of blood clots in vaccinated adults.
Pfizer received emergency use authorization from the FDA following its trial on 2,260 adolescents 12 to 15 years of age in the US.
Health care providers and vaccine recipients have recently reported cases of myocarditis and pericarditis following vaccination with the mRNA vaccines manufactured by Pfizer and Moderna.
Myocarditis is an inflammation of the heart muscle (myocardium), and pericarditis is swelling and irritation of the thin, sac-like tissue surrounding the heart (pericardium).
The CDC and the World Health Organization are currently investigating reports of myocarditis following administrations of both the Pfizer and Moderna vaccines.
The CDC’s COVID-19 Vaccine Safety Technical (VaST) Work Group in a May 17 technical report said most of the reported cases “appeared to be mild” and seem to occur, “predominantly in adolescents and young adults, more often in males than females, more often following dose two than dose one, and typically within four days after vaccination.”
The European Medicines Agency (EMA) announced that its Pharmacovigilance Risk Assessment Committee (PRAC) was assessing such reports, linked mainly to Comirnaty – the brand name for the Pfizer vaccine.
Advising that PRAC was assessing reports of myocarditis with both Comirnaty and Moderna, the EMA said it, “is aware of cases of myocarditis and pericarditis mainly reported following vaccination with Comirnaty.
“There is no indication at the moment that these cases are due to the vaccine. However, PRAC has requested the marketing authorization holder to provide further detailed data, including an analysis of the events according to age and gender, in the context of the next pandemic summary safety report and will consider if any other regulatory action is needed.”
Mayo Clinic states that myocarditis can affect your heart muscle and your heart’s electrical system, reducing your heart’s ability to pump, and causing rapid or abnormal heart rhythms (arrhythmias).
It points out that viral infection usually causes myocarditis, but it can result from a reaction to a drug, or be part of a more general inflammatory condition, adding that severe myocarditis can permanently damage the heart muscle, possibly causing heart failure, heart attack, abnormal heart rhythms or sudden cardiac death.
Last month, The Jerusalem Post revealed, from a report compiled by Israel’s team of experts monitoring the Pfizer vaccine’s side effects, “A total of 62 cases of myocarditis have occurred so far in Israel around the time of the vaccination, 56 of them after the second dose. Some 55 cases occurred among men.
“In most cases, the patients were discharged from the hospital in good conditions. However, two people – a 22-year-old woman and a 35-year-old man – died. According to the report, they did not have any pre-existing condition, but further investigation was needed to confirm the diagnosis.”
In a special update issued May 22, Seattle Children’s Hospital advised health care providers to “consider a diagnosis of myocarditis or pericarditis in any evaluation of chest pain following COVID-19 vaccination” and to, “Inquire about recent COVID-19 vaccination in any patient presenting with symptoms consistent with myocarditis or pericarditis.”
Seattle and King County Public Health in a May 21 health advisory said, “Public Health is investigating 12 reported cases of myocarditis and pericarditis since early May among King County residents, following the first or second dose of COVID-19 vaccine with either the Pfizer or Moderna vaccines.
“Cases range in age from 16-66 years (11 cases under 40 years), and the majority of cases are among males.”
The Oregon Health Authority asked health care professionals in the state to report cases of myocarditis, and six cases were documented in the city of Portland.
At least 18 adolescents and young adults in the state of Connecticut showed symptoms of heart problems after vaccination, according to Connecticut’s Acting Health Commissioner.
Meantime, the CDC is investigating the death of a 15-year-old Colorado boy who died from cardiac failure on April 20, two days after receiving the Pfizer vaccine.
Earlier this month, Utah media outlets reported the hospitalization of athlete Everest Romney, 17, who was diagnosed with blood clots in his head days after receiving the Pfizer vaccine.
His mother, who said her son was “100 percent healthy, playing and practicing basketball”, told media outlets that he started to feel swelling and pain in his neck hours after receiving the vaccine, followed by extreme migraines.
In its guidance to recipients and caregivers on its emergency use authorization for the Pfizer vaccine in those 12 years old and older, the FDA said regarding expected side effects including fever, fatigue and injection site pain, “These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 vaccine.
“Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 vaccine is still being studied in clinical trials.”