Pfizer recently released a press statement that their COVID-19 vaccine is safe and effective for children aged 5 to 11. Now that data is available, and will be submitted to regulators shortly, we must do everything in our capacity to quickly approve and vaccinate our children.
As experts and science communicators, we’ve been watching the Delta variant sweep through much of the U.S., causing a surge in child hospitalizations, ICU admissions and deaths. In the first week of September, there were over 250,000 new pediatric cases in America. This represented nearly 27 per cent of the week’s COVID-19 cases. In Israel, which has a highly vaccinated population, new cases of COVID-19 went from zero on May 1 to 7,000 per day a few months later, thanks in large part to massive school outbreaks.
Despite the some claims that COVID-19 is not a threat to children, data shows a small but significant proportion of children can fall severely ill, and some develop long-term disabling symptoms even in cases that were initially mild. COVID-19 has killed over 500 children in the U.S., and while 1 in 4 pediatric COVID-19 deaths occur in previously healthy children, those with underlying conditions had their lives shortened by several decades.
A large study from the U.K found that 4.4 per cent of children with COVID-19 reported persistent symptoms at 28 days. Severe post-acute and multi-system inflammatory syndromes (MIS-C) is a disastrous complication that can occur weeks after mild COVID. There have been more than 4000 MIS-C cases in the U.S. alone. 90 per cent of pediatric MIS-C cases have complications involving at least four organ systems, and 58 per cent are admitted for intensive care.
This month, children returned to in-person school in Canada, during a renewed pandemic of variants. Across much of the country, we see more relaxed COVID-19 policies in schools that focus on a “return to normal,” with large cohort sizes congregating for several hours every day in poorly ventilated spaces. This is likely to bring about wide-scale outbreaks of COVID-19 among children, especially those under the age of 12 who are largely unvaccinated.
It’s also important to note that Canada has a significantly lower pediatric hospital and ICU capacity per capita than the U.S. Our pediatric acute care system — which operates at capacity under normal conditions — would be overwhelmed by a much smaller COVID-19 outbreak than currently occurring in south of the border. We are seeing this play out currently in Alberta, with Alberta Children’s Hospital triaging pediatric patients, shutting down 75 per cent of operating rooms and limiting care to only ‘life and limb procedures’. We are sleepwalking into a horrific reality in which children who are sick (both with COVID-19 and with unrelated illnesses) cannot be properly cared for.
Though concerns about the uncommon vaccine side-effect of myocarditis, a condition that leads to heart inflammation, are justifiable, it is important to put into context that these are rare occurrences that can actually occur more frequently with COVID-19 infections, and typically within 4 weeks of receiving the vaccine. Concerns about this led the FDA to recommend that the pediatric trials increase the number of participants and increase the duration of safety data collection from two to six months. Pfizer is still in negotiations with the FDA on both trial size and safety duration, whereas Moderna increased its trial size from 6,975 to 13,275 participants and is not expected to report results for at least a few months.
What is yet to be determined is whether the FDA would grant an Emergency Use Authorization (EUA) based on the original trial size and duration, and in Canada, how the recent expiry of the Interim Order Pathway — intended for any COVID-19 related drug or vaccine — will impact the approval process for pediatric vaccines. Critically, the American Academy of Pediatrics penned a strong letter to push the FDA for expedited approval of the vaccine for children, given the risk the Delta variant poses to children and the totality of evidence already available. If the original data is accepted, then we can expect approval by the end of October for the five to 11 age cohort, and by the end of the year for the younger age groups.
Regulators are facing an unenviable dilemma. Act too slowly, and some children may suffer illness and death from a disease that could have been preventable. Acting more quickly, though prudent, might give the appearance of having rushed the process of approval. Public trust is hard-won and easily lost, particularly amidst a dogged anti-vaccine disinformation campaign.
As experts and science communicators, we urge:
1. Just as Health Canada showed leadership by approving COVID-19 vaccines in children ages 12-15 before the FDA, they can be proactive and act independently of the FDA by reviewing existing data post-haste and expediting approval.
2. Prepositioning the procurement of pediatric COVID-19 vaccines to allow immediate distribution once Health Canada approves the vaccine and NACI puts forth their recommendations for use.
3. Should there be delays in procurement of pediatric vaccines, allow off-label preparation of pediatric doses using adult vaccines for immediate needle-into-arms upon approval.
So, as we await the pediatric vaccine rollout in Canada, what can we do to help keep kids safe?
We can make it standard to require COVID-19 vaccination of all eligible staff, educators, and students inside schools, provide high-quality masks for all in schools, improve ventilation in classrooms, keep cohorts small, plan to eat outdoors whenever possible, employ the use of rapid tests, and continue to keep social contacts outside of schools as low as possible.
It is critical to remain nimble and resilient during a pandemic. With a significant portion of the adolescent and adult population vaccinated, our focus must be redirected to keeping our children safe.
Children have already paid a huge price during the last year and a half. It is time we prioritize their health and well-being. We must do everything in our capacity to avert a pediatric crisis across Canada.
Article From: The Star
Author: Sabina Vohra-Miller, Orli Nadel, Kashif Pirzada
