By PAULO RICARDO MARTINS-FILHO & LORENA G. BARBERIA*
Lives were lost during politically motivated delays and interruptions in the COVID-19 vaccination campaign
Faced with the dynamic and complex scenario of the COVID-19 outbreak, countries around the world are expanding vaccination programs against the disease to include young children. Although hospitalizations and deaths associated with COVID-19 in pediatric populations are less common, the disease has emerged as a new cause of mortality for children and adolescents in poor communities.[I]
In Brazil, the Pfizer-BioNTech COVID-19 vaccine (ComiRNAty) was authorized by the federal health regulator (ANVISA) for adolescents aged 12 to 17 years on June 11, 2021, six months after the start of the campaign. national vaccination. Even so, the Minister of Health Marcelo Queiroga announced on September 16 the intention to suspend vaccination against COVID-19 for adolescents without comorbidities due to a death under investigation and concerns regarding adverse events in this age group, even if more than 3,5 .XNUMX million teenagers have already been immunized.
Despite the doubts raised by President Bolsonaro and Minister of Health Marcelo Queiroga, multiple randomized, controlled clinical trials and surveillance programs have ensured the safety of the vaccine for children and adolescents. Fortunately, immunization in this age group was only temporarily suspended and has since progressed, with at least 25% having now received two doses.
Recently, a new battle against COVID-19 in Brazil has been fought between ANVISA, scientists, anti-vaccines and federal authorities: the vaccination of children aged 5 to 11 years old. Shortly after the authorization of the ComiRNAty vaccine by regulatory authorities, Brazilian President Jair Bolsonaro stated, “children have not died in a way that would justify a vaccine for children”[ii]. This position was also supported by the Ministry of Health, which held an unprecedented public hearing on the vaccination of children against COVID-19, including questions about whether the vaccine should be administered only with parental (or guardian) consent and medical prescription. Regrettably, this recommendation would exclude the poorest and most marginalized children, with reduced access to health services, from the possibility of vaccination.
In his ongoing conflict with the federal health regulator, Bolsonaro has threatened to reveal the names of ANVISA officials responsible for approving the vaccine for children and has consistently cast doubt on the efficacy and safety of COVID-19 vaccines. Despite the minimization of the severity of SARS-CoV-2 infection in Brazilian children by the president, the fragile accusations that vaccines can be dangerous for children and the delay in acquiring the vaccine by the Ministry of Health after approval by ANVISA of its use of ComiRNAty in children aged between 5 and 11 years on December 16, 2021, vaccination of this population began in Brazil on January 15, 2022.
However, logistical changes in delivering pediatric doses to states have made it difficult to transport ComiRNAty doses to storage locations, increasing the risk of lost vaccine batches. On January 20, Brazilian regulators also granted authorization for the emergency use of CoronaVac in children aged 6 years and older. The inactivated virus vaccine, produced by the Butantan Institute in partnership with the Sinovac company, headquartered in Beijing, was also criticized by the president through speeches and social networks.
Despite the available scientific evidence[iii] and the lives lost to COVID-19, a technical note (n°. 2/2022 – SCTIE/MS) published by the Ministry of Health on January 22 classifies hydroxychloroquine as effective and safe for the treatment of COVID-19 and points out that the efficacy and safety of vaccines have not yet been demonstrated. At the same time, the president's allies continue to demand the suspension of vaccine distribution, through the spread of false news on the internet and in messaging applications.
In this context, it is necessary to list five points that underlie the vaccination of children and adolescents in the country: (1) the ComiRNAty vaccine approved by ANVISA is safe, immunogenic and effective against COVID-19 in children aged 5 to 11 years old[iv] and in adolescents aged 12 to 15 years.[v] Furthermore, there is evidence that CoronaVac is well tolerated and safe and it induced humoral responses in children and adolescents aged 3 to 17 years;[vi] (2) recent US Centers for Disease Control and Prevention (CDC) reviews, including over 17,5 million doses of the ComiRNAty vaccine administered to children[vii] and teenagers[viii] reported a total of 13.495 (~0,08%) adverse events, with exceptionally rare (~0,005%) serious reports, including 408 cases of non-fatal myocarditis (~1 case per 1 million doses for children and ~45 cases per 1 million doses for teenagers);
(3) in Brazil, there are approximately 20 million unvaccinated children aged between 5 and 11 years who may become virus hosts as adults reach immune protection and many states cannot achieve high vaccination coverage without broad coverage of this group. Children can carry high viral loads from SARS-CoV-2[ix], which may contribute to community-to-human transmission, in addition to the risks presented by the return to face-to-face activities in schools and day care centers in February 2022; (4) although the proportion of confirmed cases of COVID-19 among children and adolescents is relatively small and deaths are uncommon, there is evidence that the disease has disproportionately affected this age group in Brazil, especially in poorer regions[X]; and, (5) in Brazil, deaths from COVID-19 among children and adolescents exceeded the annual average of deaths from neoplasia, diseases of the nervous system, cardiac causes, and other vaccine-preventable diseases (http://tabnet.data sus .gov.br/cgi/deftohtm.exe?sim/cnv/obt10uf.def).
Accumulated data up to the second week of January 2022 showed that at least 2.530 children and adolescents aged 0 to 19 years old died of COVID-19 in Brazil, of which ~53% were under 9 years old. The overall mortality rate for this age group was estimated at ~4 deaths per 100.000 children and adolescents, with higher rates recorded in the North and Northeast (~5 deaths per 100.000 children and adolescents), considered the poorest regions of the country. Furthermore, the number of deaths from COVID-19 in this age group may be 1,5 times higher than that reported in the official bulletins of the Brazilian states (Table 1).
Unfortunately, these figures suggest that our nation accounts for about 20% of all COVID-19 deaths worldwide and, specifically for this age group, death rates are 4 times higher than those seen in the US.[xi]. Now, community transmission of the Omicron variant has led to a sharp increase in the number of COVID-19 cases and hospitalizations in some Brazilian states since early January of this year, especially among unvaccinated individuals. This catastrophic scenario has already been observed in the pediatric population of the USA and, more recently, in São Paulo and Salvador.
As low as the death rate associated with COVID-19 is in children and adolescents, mothers have lost their children during these politically motivated delays and interruptions in the vaccination campaign. More than a moral obligation, vaccination of children and adolescents in Brazil is a health necessity to control the pandemic and prevent families from seeing their children die due to denial of a vaccine-preventable disease.
*Paulo Ricardo Martins-Filho é professor at the Department of Health Education at the Federal University of Sergipe (UFS).
“Lorena G. Barberia Professor at the Department of Political Science at the University of São Paulo (USP).
Translation: Fernando Lima das Neves.
Originally published on the portal ScienceDirect.
Notes
[I] Martins-Filho PR, Quintans-Júnior LJ, de Souza Araújo AA, et al. Socio-economic inequalities and COVID-19 incidence and mortality in Brazilian children: a nationwide register-based study. Public Health. 2021; 190: 4-6.
[ii] Brazilian president Jair Bolsonaro says he will not vaccinate his 11-year-old daughter against Covid. Independent. 2021.https://www.independent.co.uk/news/world/americas/brazil-bolsonaro-daughter-covid-vaccine-b1983152.html. Accessed on December 28, 2021.
[iii] Martins-Filho PR, Ferreira LC, Heimfarth L, et al. Efficacy and safety of hydroxychloroquine as pre- and post-exposure prophylaxis and treatment of COVID-19: a systematic review and meta-analysis of blinded, placebo-controlled, randomized clinical trials. Lancet Reg Heal – Am. 2021; 2:100062.
[iv] Walter EB, Talaat KR, Sabharwal C, et al. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2022; 386: 35-46.
[v] Frenck RW, Klein NP, Kitchin N, et al. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. N Engl J Med. 2021; 385: 239-250.
[vi] Han B, Song Y, Li C, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomized, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021; 21:1645-1653.
[vii] Hause AM, Baggs J, Marquez P, et al. COVID-19 vaccine safety in children aged 5-11 Years-United States, November 3-December 19, 2021. MMWR Morb Mortal Wkly Rep. 2021; 70: 1755-1760.
[viii] Hause AM, Gee J, Baggs J, et al. COVID-19 vaccine safety in adolescents aged 12-17 Years-United States, December 14, 2020-July 16, 2021. MMWR Morb Morb Wkly Rep. 2021; 70: 1053-1058.
[ix] Yonker LM, Neilan AM, Bartsch Y, et al. Pediatric severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): clinical presentation, infectivity, and immune responses. J Pediatr. 2020; 227: 45-52.e5.
[X] Ver note 1.
[xi] Provisional COVID-19 Deaths: Focus on Ages 0-18 Years. Hyatts-ville (MD): National Center for Health Statistics [updated Jan 12, 2022]. https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Focus-on-Ages-0-18-Yea/nr4s-juj3. Accessed January 15, 2022.
