Regena Spratling, PhD, RN, APRN, CPNP, FAANP

The US Food and Drug Administration (FDA) has approved emergency use authorization (EUA) of 3 coronavirus disease 2019 (COVID-19) vaccines to fight the severe acute respiratory coronavirus 2 (SARS CoV-2) pandemic in the United States.

 The Pfizer and Moderna vaccines were approved for a 2 dose series.

 On February 27, 2021, the FDA approved EUA for the Johnson & Johnson® single-dose vaccine sponsored by Janssen Biotech, Inc® also to prevent moderate and severe illness and death from COVID-19 caused by SARS-CoV-2.

Vaccine hesitancy, unfortunately, remains at the forefront of these vaccines, despite the severe morbidity and mortality caused by COVID-19 and the crippling of daily life around the world in attempts to battle transmission of SARS-CoV-2. Vaccine hesitant individuals and groups have raised questions about the ‘warp speed’ development of the Pfizer and Moderna COVID-19 vaccines; the vaccine safety and efficacy; and whether “it is good for me and my family to take the COVID-19 vaccines?” With the FDA EUA for the single dose Johnson & Johnson® vaccine, 1 question being asked is whether the 1 dose is equivalent to the 2 doses of the Pfizer and Moderna vaccines especially by those who were not in the initial priority groups to receive COVID-19 vaccines. Because Pfizer studies included adolescents aged 16 years and older in their studies, the FDA EUA included this age group as eligible to receive the Pfizer vaccine determining that the benefits of receiving the vaccine outweigh the risks.1 Thus, teenagers and their parents will seek the advice of their pediatricians and pediatric nurse practitioners (PNPs), as well as other pediatric health care providers to make an informed decision about vaccinating their adolescents aged 16 years and older and perhaps themselves, as well.

Additionally, because Pfizer and Moderna have started clinical trials in the United States for children aged 6 months to 17 years, parents will be asking for the opinions of pediatricians and PNPs on whether to enroll their children in a trial or to wait for the outcomes of these clinical trials. As the vaccine clinical trials for children are completed, parents will be asking many questions about the vaccines and the opinions of pediatricians and PNPs on whether to vaccinate their younger children. On March 31, 2021, Pfizer reported the results of their clinical trial in children.

 Preparing to answer multiple questions from parents and adolescents in advance, based on the scientific evidence from the randomized control trials (RCTs), is key to reducing vaccine hesitancy and vaccine refusal and to the successful return to the new normal lifestyles for infants, children, and adolescents.

Key talking points developed from the authors’ previous review of the RCTs for the Pfizer and Moderna COVID-19 vaccines are presented.

 We also compare the 2 dose Pfizer and Moderna vaccines to the 1 dose Johnson & Johnson vaccines. We highlight vaccine messaging supportive of accepting any of the vaccines as a safe and efficacious way for stopping severe to critical COVID-19 disease in infants, children and adolescents. Additionally, we believe that administration of the COVID-19 vaccine to all school-age children as part of safe return to school initiatives is a critical component of a safe school environment for all.

The Johnson & Johnson vaccine is known as Ad26.COV2.S or JNJ-78436725, and is a recombinant vector vaccine that uses human adenovirus type 26 to encode a stabilized variant of the SARS-CoV-2 spike protein.

 The phase 1-2a trial consisted of a low dose and a high dose vaccine which was shown to be immunogenic after either the low or high dose at a dose of 5×10

 viral particles (high dose) per milliliter.

 Vaccine safety and efficacy for the Johnson & Johnson vaccine in Phase 1-2a trial after 1 dose of the vaccine was considered to be excellent in all populations producing an antibody and T-cell response that continued to improve 28 days after the 1 dose.

 Thus, the Phase 3 trial for the Johnson & Johnson vaccine began as a 1 dose vaccine.

 The phase 3 RCT consisted of a double blind and placebo controlled trial of a single dose of 5x 1010 viral particles (low dose) with over 40,000 participants aged eighteen years and older.

 Currently a longer term trial comparing the 1 dose vaccine regimen to a 2 dose regimen is underway for the Johnson and Johnson vaccine.

Reports from returned diary cards postvaccination were returned by 402 study participants in Cohort 1 (participants aged 18 to 55 years old) and 403 study participants in Cohort 3 (participants aged 65 years old and older) which included both those who received the high and low dose Johnson & Johnson vaccine.

 Data analysis showed that the majority of the adverse reactions (labeled as adverse in this study and in the Pfizer and Moderna studies) were pain at the injection site. Other symptoms reported after dose 1 included fatigue, headache, myalgia, nausea, and pyrexia.

 All of which were also reported by study participants in the Pfizer and Moderna clinical trials.

Study efficacy was evaluated in the United States, Latin America, and the South African populations who were a part of the phase 3 study.

 One study endpoint was to assess for the prevention of moderate to severe COVID-19 disease in both the intervention group (vaccine) and the control group (placebo) received 28 days post injection. Data analysis showed the following efficacy: United States = 72%; Latin America = 62%; and South Africa = 57%. Across all geographic locations 85% of the vaccine recipients were protected from severe and critical COVID-19 disease.

 These data support the value of offering the 1 dose Johnson & Johnson vaccine to the US populations, as the efficacy of preventing severe and critical disease in all populations studied provides optimism for the overarching goal of emerging from the COVID-19 pandemic to a more normal lifestyle.

Additionally, the Johnson & Johnson vaccine was 77% effective in preventing severe or critical COVID-19 infections that occurred at least 14 days after vaccination with a total of 14 severe or critical cases in the vaccinated group versus 60 in the placebo group.

 At least 28 days after vaccination, the vaccine was 85% effective in preventing severe or critical infection with 5 severe or critical cases in the vaccine group versus 34 cases in the placebo group.

 Information about the severe or critical cases in the vaccination group were not provided in regards to health status prior to vaccination, and demographic factors.

Johnson and Johnson vaccine use of fetal tissue

The Johnson and Johnson vaccine used PER.C6, a fetal retinal cell originally isolated from fetal tissue from 1985, in various stages of vaccine development and manufacturing.

 The use of fetal cell lines is a very sensitive topic with religious individuals and faith-based communities, and also an ethical dilemma about how the fetal tissue is derived (eg, electively aborted fetal tissue from decades ago).

On March 11, 2021, Bishops in the Catholic Church, highly influential faith-based leaders, voiced moral concerns about taking the Johnson & Johnson vaccine.

 However, on March 24, 2021, the US conference of Catholic Bishops openly supported having the members of the Roman Catholic faith receive the Johnson & Johnson COVID-19 vaccine.

Comparison of Pfizer and Moderna vaccines to the Johnson & Johnson Vaccine

The Pfizer and Moderna vaccines are messenger ribonucleic acid (mRNA) vaccines with benefits of not generating infectious components or causing infection, and not affecting the genes or genome of the person or host cells.

 The Pfizer BNT162b2 mRNA vaccine is a lipid nanoparticle-formulated vaccine that encodes a spike protein of the SARS-CoV-2 virus.

 The Moderna mRNA-1273 vaccine also encodes the spike protein and is similar to the Pfizer vaccine.

 Once these vaccines are administered, the mRNA protein is processed by immune cells that produce the targeted protein and activate B cells and T cells to recognize the newly produced viral protein and make antibodies against SARS-CoV-2.

 These vaccines can be rapidly produced in a large-scale to treat mass populations, but do require freezer storage until shortly before administration.

 A 2-dose regimen are recommended for both the Pfizer and Moderna vaccines.

 Vaccine efficacy for the Pfizer and Moderna vaccines were both high with evidence of near complete protection in phase 3 clinical trials. The vaccine efficacy for Pfizer was 95% and the vaccine efficacy for Moderna was 94% and both vaccines were 100% effective in prevention of severe or critical COVID-19 cases.

 No fetal tissue is used in development or production of vaccine.

In comparison to the Pfizer and Moderna vaccines, the Johnson and Johnson vaccine is a recombinant vector vaccine that uses a modified adenovirus vector that can no longer replicate and result in illness to express the SARS-CoV-2 spike protein.

 This vaccine is a single dose that can be stored in a refrigerator for months.

COVID-19 vaccine clinical trials for children and adolescents

In July 2020, Pfizer began enrolling children aged 12 years and older in clinical trials with approximately 1000 between the ages of 12 to 15 years and 754 adolescents aged 16 to 17 years.

 In March 2021, Pfizer began enrolling children aged 6 months to 11 years in a Phase 1/2/3 clinical trial to determine if the vaccine can produce an immune response in young children and if it is safe.

 In addition, Pfizer is currently enrolling pregnant women in a RCT, as the EUA did not include pregnant women and left that decision to the women and their health care providers.

 In addition, Pfizer is studying phase 1 participants by administering a third dose 6 months after the completion of the original 2 doses were completed to understand the immunity against the variants that have emerged after the initial RCT.

On March 31, 2021, Pfizer provided a press release on the results of their clinical trial in adolescents aged 12 to 15-years. They enrolled 2260 adolescents in the United States in the clinical trial and plan to submit as an amendment the results to the FDA for EUA within the next few weeks. They reported on the phase 3 results of the clinical trial for the adolescent study participants who entered the study with or without previous exposure to COVID-19 disease. The press release reported 100% efficacy and a robust antibody response to the vaccine and exceeded the results of the clinical trials that enrolled 16- to 25-year-old adolescents and young adults.

The RCT for children aged 6 months to younger than 12 years has been registered on the National Institutes of Health US Library of Medicine Clinical Trials website for the Moderna mRNA-1273 COVID-19 vaccine.

 They are planning to enroll 6750 children. In Part 1 of the clinical trial, they will determine the dosage for the Moderna vaccine for the children. In Part 2, they will enroll participants into the RCT clinical trial with the treatment group to receive 2 doses of the dosage selected from the Part 1 dose investigation and dose 2, 29 days later. The control group will receive 2 doses of 0.9% sodium chloride injections, 29 days apart.

Janssen Biotech, the maker of Johnson & Johnson vaccine, announced shortly after receiving FDA EUA approval for its 1 dose COVID-19 vaccine for adults aged 18 years and older, that they plan to conduct clinical trials on children. The first trial will be for children aged 12 years and older, followed by trials for infants aged 6 months to 11 years. Details about the plans for the RCT for infants and children have not been published at this time.

Adolescents and young adults entering college are confronted, in some states, with mandates to return to school fully vaccinated in the Fall 2021 semester, and parents are contemplating whether their adolescents and young adults should be vaccinated and whether to vaccinate their younger children when the vaccines become available to them. Pediatricians and PNPs need to share 1 forward thinking message for adolescents and parents. Vaccines recommended by the FDA and the newly EUA COVID-19 vaccines are safe and effective and everyone who is eligible for the COVID-19 vaccine should take the vaccine without hesitation. 

Safe and effective vaccines are available to prevent SARS-CoV-2 and fight the pandemic. However, vaccine hesitancy remains a barrier to effective vaccination of the community. Knowledgeable health care providers who provide clear messaging on the COVID-19 vaccine and the vaccines available, currently Johnson and Johnson, Pfizer, and Moderna and likely others in the future, should educate adolescents and their parents and encourage vaccine acceptance. In addition, all manufacturers are currently conducting RCTs for these vaccines in children.

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Articles

Tackling vaccine hesitancy for the coronavirus disease 2019 (COVID-19) is going to be an important component of achieving the herd immunity needed to end the pandemic.

Analysis of COVID-19 clinical trials: A guide to reducing vaccine hesitancy

On the topic of ‘return to school’ this year, anxiety abounds for parents and children, as well as teachers, school staff and nurses, nurse practitioners (NPs), departments of health and legislators.

 Since school is considered “the work of children,”

 we must carefully consider all aspects of ‘return to school’ in light of the current, unprecedented COVID-19 pandemic. Many compelling questions emerge, but first and foremost the question to address is: 

Can children return to school and be in classroom environments that assure health and well-being for all?

The National Parent Union conducted an online COVID-19 survey of 500 parents with children from kindergarten through 12th grade on May 4 and 5, 2020.

 Lowe’s data revealed a significant level of anxiety among parents concerning return to school for their children. A 

 article reported that 6 of 10 parents are considering continuing with home learning rather than sending their children to school in Fall 2020.

 Some of the parental anxiety and decision making by parents may be attributed to uncertainty as the pandemic remains a viable threat throughout our country.

Planning, testing and masks are a critical component for safe return to school

Guidance from the Centers for Disease Control and Prevention (CDC) for opening schools was posted on the CDC website on March, 19, May 19, June, 3, and July 23, 2020.

 The guidance emphasizes the importance of school officials and administrators collaborating with local health officials for decision making regarding return to school and decisions about closing schools, while the most recent statement did stress the importance of reopening schools. The initial interim CDC guidelines

 did not address two major issues, masks and testing, that must be resolved either locally, or nationally by implementation of best available scientifically based health safety measures prior to any child’s/adolescents return to school. However, the CDC guidance on July 23, 2020 does recommend masks for children and staff in school settings, except those under 2 years old, and those with some medical conditions. Since wearing masks has been met with controversy, the work of health care professionals (HCPs) is to gain the support of parents, children and school personnel to wear masks during school. And, while recommendations presented in this paper are consistent with CDC guidelines and supports wearing masks, it also provides more stringent considerations for testing school personnel and children. All HCPs realize the ever evolving and changing health care recommendations as the pandemic moves across the country and the world. Thus, what is considered best practice today based on the available evidence, may be shown to be incorrect tomorrow. Making reasonable changes to tackle the twists and turns that emerge every day in this pandemic is a major challenge. Health care professionals at the local, state, regional, in helping non-HCPs make sensible decisions based on scientific data to protect all individuals. Return to school decisions must be based on the science with the overall goal of the health and well-being of the children/adolescents, the school personnel and the community as a whole. One size and one decision will not fit all.

The CDC guidance on COVID-19 from July 23, 2020 supports using “cloth face coverings” to prevent the spread of the COVID-19 virus, and includes in their practical recommendations that schools put “cloth face coverings on school supply lists and provide cloth face coverings as needed to students, teachers, staff, or visitors who do not have them.”

 Indeed, the scientific evidence from COVID-19 public health measures supports wearing masks as the new norm for all adults and for all children older than 2 years. Thus, we believe that wearing masks is an essential component of safe return to school. However, children with chronic illnesses, including pulmonary conditions, and those with disabilities may be advised by their physicians and NPs, not to wear face masks. Thus, some protection for children, who are too young to tolerate wearing a mask or are unable to wear masks, may be provided by other children and school personnel who can safely wear face masks in school settings.

The CDC guidance of July 23, 2020 also states that “[The CDC] does not currently recommend universal symptom screenings to be conducted by schools.”

 School NPs and school nurses are educated on public health screening measures and are ideally suited to appropriately screen students and all school personnel prior to entering school for the purpose of preventing exposure of individuals with COVID-19 or any communicable disease symptoms from spreading the virus to contacts at the school. The value of having a school nurse for every school was supported by the AAP policy statement in June 2016.

 In this pandemic, the school nurse is an essential part of the healthcare team (eg, private practice physicians, school based health centers, community clinics, and the department of health) overseeing the health of the children and school personnel and should be employed in every school.

Another major concern identified in the original CDC guidance

 is the recommendation to close schools for 2 to 5 days when there is a confirmed case of COVID-19 in the school system. Opening and closing schools for 2 to 5 days will be disruptive to everyone. Testing prior to return to school may prevent schools from opening and closing in a chaotic fashion.

Plans to reopen schools must be based on local and state public health data as well as primary and secondary prevention strategies that minimize the potential for viral spread, and avoid a cycle of frequent opening and closing of school systems due to outbreaks of COVID-19.

 The authors believe that testing of students and school personnel prior to reopening schools is the cornerstone of primary and secondary prevention strategies. And while the most recent CDC guidance does not recommend universal testing of children and staff, it however, proposes other testing strategies based on local and state data.

When the pandemic began, data from other countries led health care providers to believe that children were less affected by COVID-19 but may be asymptomatic carriers.

However, as the pandemic spread in the United States and Italy, there were news reports of chronically ill children hospitalized with severe symptoms. The most troubling occurrence is the new presentation of the COVID-19 complication of the syndrome, Multisystem Inflammatory Syndrome in children (MIS-C).

 The etiology of MIS-C remains unclear. According to reports from the CDC, children who developed MIS-C may have been infected weeks before the appearance of MIS-C symptoms, and/or were symptomatic carriers.

Thus, based on these presentations of COVID-19 in children, testing strategies for children must be considered on all levels to protect all children, school personnel, and the communities in which they live. As of this writing, data for widely testing children for COVID-19 in the United States is non-existent.

Innovation is an outcome of a crisis. New, non-invasive methods for testing for COVID-19 in children should be developed. Saliva sample testing may be a reasonable solution that can be developed, and, as of this writing, is under investigation as a point-of-care test.

Once testing policies and methods are in place, only then can we proceed with developing other policies that address a safe school environment for children and adolescents, and all school personnel that work every day to educate and care for our children/adolescents.

Screenings are critical to safely reopen schools

Children have been out of school since March 2020 and may not have had their usual access to health care throughout this pandemic. Screenings to identify problems in physical, emotional, social, and behavioral health are a critical strategy for the design and implementation of effective strategies for healthy children. Thus, we encourage all HCPs, including school nurses, to assume a leadership role in the design and implementation of screenings for the identification of children and school personnel who may present with problems that may have arisen during stay-at-home orders (eg, anxiety, school phobia, etc.).

Screening is a critical part of the process for prevention of transmission of COVID-19 within school systems. An innovative, reliable method for screening children and school personnel prior to going to school each day should be implemented. Some health care systems and other clinical practices have already implemented the use of a web-based application or ‘app’ that can be used to screen for temperature and emerging symptoms one-hour before reporting to work each day. This screening tool asks the individual to report the morning temperature, and also asks other pertinent questions about symptoms and possible exposure to an individual with COVID-19. If negative, the employee reports to work. If any portion of the screening is positive, the individual does not report to work that day. For parents who do not have access to cell phones or apps on their devices, a plan should be in place for the parents to call into the school and report the information to be reviewed by the school nurse prior to the children leaving for school. Once at work (school) and before entering the workplace (school environment), a second temperature screening is recorded. Such an app for school-based screenings for children and school personnel can easily be developed and implemented as best practice for early identification of possible COVID-19 exposure and/or infection for healthy children.

It has been theorized that COVID-19 viral shedding may persist for longer periods of time through the gastrointestinal tracts of in children.

 It is believed that children may be asymptomatic carriers and may shed the virus for days or even weeks, but too little testing has been done. Schools must be vigilant in preparation of the bathroom space of children and school personnel, preparing for the worst-case scenario. It is important for school systems to be proactive, rather than reactive. Leadership of school nurses and nurse practitioners is essential in policy preparation and enactment of policies for bathroom use.

Frequent cleaning and maintenance of modern bathrooms will reduce risks shedding and must be instituted prior to opening schools, and continue throughout the school day. Measures to help children become comfortable in the bathroom must be part of the curriculum. Soap, running water, and a clean toilet must be established.

 Bathrooms may increase risk of disease transmission without structural change (proper toilet design, adequate soap and water, frequent cleanings). Proper implementation of a plan will enable children and staff to better understand how to prevent other diseases (including influenza and other common gastrointestinal diseases), which should also help change attitudes and establish new norms.

COVID-19 brought to the forefront nationwide educational inequality. As HCPs, we know the importance of being lifelong learners and the importance of early childhood education and continued excellence in education throughout the K through 12 years. It was distressful to hear many parents report that their children did not have access to computers, tablets and/or the internet at home to continue their education virtually. To achieve meaningful societal change, social justice and educational parity, we encourage educators, parents, and all community members to analyze the local educational needs and to plan accordingly to meet the needs of all students.

As Erik Erickson said, “School is the work of children.”

 We value the education our children receive throughout the US each year preparing the children to develop into healthy, kind, valuable, innovative and productive members of society in whatever careers and professions they choose. The immediate closing of schools at the onset of the COVID-19 pandemic has further enlightened everyone on the value of educators and the school systems. All HCPs want children to return to school safely and free of the threats of contracting COVID-19 within the school environment. Thus, our recommendations are based on the best available evidence as of this date and time. Screening, non-invasive testing, masks for all children over 2-years old, eye protection, social distancing, cleaning, transportation, and bathroom use are critical to the health and well-being of the children, all school personnel, their parents, family members and the community in which they live and grow.

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https://www.the74million.org/new-poll-two-thirds-of-parents-support-keeping-schools-closed-until-they-are-certain-there-is-no-health-risk/

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https://www.nytimes.com/2020/06/06/opinion/coronavirus-schools-reopen.html?referringSource=articleShare

4. Center for Disease Control and Prevention. Interim Guidance for Administrators of US K-12 Schools and Child Care Programs Plan, Prepare, and Respond to Coronavirus Disease 2019 (COVID-19). Published April 12, 2020. Accessed June, 3 2020 

https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/guidance-for-schools.html

5. Center for Disease Control and Prevention. National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. Coronavirus Disease 2019 (COVID-19). Considerations for Schools. Published May 19, 2020. Accessed June 3, 2020. 

https://www.cdc.gov/coronavirus/2019-ncov/community/schols-childcare/schools.html

6. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). K-12 Schools and child care program. Published June 3, 2020. Accessed June 17, 2020. 

https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools-faq.html?deliveryName=USCDC_2067-DM29945

7. AAP Council on School Health. Role of the School Nurse in Providing School Health Services. Pediatrics. Published June 2016. Accessed July 12, 2020. Accessed from 

https://pediatrics.aappublications.org/content/137/6/e20160852

8. Center for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Interim considerations for K-12 school administrators for SARS-CoV-2 testing. Published June 30, 2020. Accessed July 12, 2020. 

https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12-testing.html

9.Center for Disease Control and Prevention. For Parents: Multisystem Inflammatory Syndrome in Children (MIS-C) associated with COVID-19. Published May 20, 2020. Accessed June 10, 2020. 

https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/children/mis-c.html

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. 2020:17(5):259. doi:10.1038/s41575-020-0295-7

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https://apps.who.int/iris/handle/10665/274273

As fall approaches, one of the biggest questions is: Can children return to school and be in classroom environments that assure health and well-being for all?

Regena Spratling, PhD, RN, APRN, CPNP, FAANP

Articles

Analysis of COVID-19 clinical trials: A guide to reducing vaccine hesitancy

Safe return to school: A call to action