HTAC Recommends the Use of Pfizer-BioNTech (10ug/dose) COVID-19 Vaccine for Children 5 to 11 Years Old: Guidance and Conditions for Implementation

 

Released on 11 February 2022

Link to Evidence Summary: https://bit.ly/HTACRecom_PediaVacc_5to11_2022

 

COVID-19 Vaccines under Emergency Use Authorization (EUA)

The Philippine Food and Drug Administration (FDA) issues an EUA for vaccines and drugs during public health emergencies which shortens the period of review for health technologies so that they can become available to affected populations. Before an EUA is issued, regulatory agencies consider the quality, safety, and efficacy of the technology.

Following the issuance of an EUA, a positive HTAC recommendation means that the National Immunization Program (NIP) can implement the technology and PhilHealth can include it in the COVID benefit package. The FDA recently issued the EUA for Pfizer-BioNTech (10μg/dose) for the pediatric population ages 5 to 11 years old. 

What is the recommendation of the HTAC for the pediatric population ages 5 to 11 years?

In line with the Department of Health’s (DOH) ongoing efforts to expand the coverage of COVID-19 vaccination following the DOH COVID-19 Vaccination Prioritization Framework,  the HTAC recommends the financing of Pfizer-BioNTech COVID-19 Vaccine for the pediatric population ages 5 to 11 years old. 

 

Basis of the HTAC Recommendation

What is the impact of COVID 19 among children?

The HTAC noted that COVID-19 cases (110,609 cases) and hospitalization (1,916 confirmed hospitalization) among children 5 to 11 years old contributed 3.49% and 0.06% of total COVID 19 cases (3.1 million cases) in the Philippines from March 2020 to January 2022, respectively, with a notable increase during the Omicron wave observed in January 2022. 

While it is difficult to determine the real burden in the pediatric population due to limited testing and contact tracing capacity, poor reporting, and other possible issues like the different community exposure of children because of reduced mobility, the HTAC deemed that the burden is substantial due to potential adverse health outcomes. These include severe COVID-19 leading to hospitalization and deaths as well as rare, but adverse complications such as multisystem inflammatory syndrome (MIS-C) and “long COVID” or the persistence of COVID-19 symptoms even after recovery among children.  

Due to the unnatural circumstances of isolation of children with limited socialization and no physical school attendance since the pandemic started, it is also difficult to predict how COVID-19 could potentially affect this population if the restrictions are lifted. 

Nonetheless, in countries with greater child mobility, significant increases in child morbidity and mortality were observed especially during the Delta and Omicron waves. In the US, total cases reached more than 1.9 million cases (01 March 2020 to 10 October 2021) in this age group with a hospitalization rate of 0.5 per 100,000 population (21 March 2020 to 23 October 2021) and 94 COVID-19 deaths or 1.7% of all deaths among US children in this age group (01 January 2020 to 16 October 2021).  It was also noted that the incidence of MIS-C is highest in the 5 to11 age group among other age groups with an incidence of 1 MIS-C case in approximately 3,200 COVID-19 cases. 

In Israel, 43% of cases (223,850) as of late October 2021 comprise ages 5 to 11 years. As the immunization rate of adults and adolescents increased, cases among ages 5 to 11 years increased. They also noted that although COVID-19 morbidity and mortality are significantly lower in children than in adults, the risk of severe COVID-19 is not negligible even among children without pre-existing comorbidities. Of the 5 to 11 age group in Israel, 54% of patients with moderate-to-severe COVID-19, and 88% with MIS-C were previously healthy. In addition, they were able to estimate the rate at which severe clinical outcomes of COVID-19 disease occur in children. Hence, HTAC deems there is a need to vaccinate the said age group given the impact of COVID-19 among children ages 5 to 11 years. 

Apart from potential adverse health outcomes, the HTAC also considered the other negative impacts of COVID-19 among children, their caregivers, and households, such as educational disruptions, decreased socialization, and mental health issues (e.g., anxiety). There is limited local data on acceptability wherein the only available data is the survey conducted by Johns Hopkins Center for Communication Program on 01 to 15 January 2022 on the acceptability of vaccinating children below 18 years old. The results from the survey showed an acceptability rate of 81% among Filipino parents/guardians; however,  the data was not disaggregated for the 5 to 11 age group.

Given this, HTAC can only recognize the social impact of vaccination in this age group in terms of supporting the attainment of occupations of children which include social learning achieved through peer interaction. Vaccination among this population can reduce restrictions, and will have consequent favorable impact on parental stress, and the mental and psychological development of children.

 

What are the likely benefits of vaccinating children 5-11 years with the Pfizer-BioNTech mRNA vaccine?

The Pfizer-BioNTech vaccine can reduce a significant number of infections in the pediatric population ages 5 to 11, including symptomatic and severe COVID-19, and MIS-C resulting from COVID-19 infection.   The vaccine may also contribute to achieving herd immunity in the general population assuming sufficient vaccine coverage. vaccination will likely protect children against MIS-C resulting from COVID-19 infection based on evidence from the US showing that none of the fully-vaccinated MIS-C patients required life support compared to the unvaccinated MIS-C patients.

Vaccination of the said age group could also improve the quality of life within the households when caregivers of children are relieved of the anxiety of dealing with the consequences of COVID-19 infection. 

It also has the potential to enable reopening of schools, thereby allowing more mobility, minimizing disruption of education of school-age children, and improving the psychosocial well-being of the said age group.

Moreover, the health, economic, and social benefits of using Pfizer-BioNTech  in children 5 to 11 years old outweigh the cost of  its introduction and implementation. The HTAC also noted that the total vaccine budget to be used for the vaccination of the said age group is still proportionate to the doses to be procured for the different vaccination policies being implemented.

 

How safe is the Pfizer-BioNTech mRNA vaccine among children? 

Based on short term data, the most common adverse effects following vaccination are local and systemic reactions like pain at injection site, fever and body pain among others which are mostly mild, tolerable and self-limiting resolving after a few days.Long-term safety data is still being studied as the vaccine is still under EUA.  Given the best available data on safety in the US which administered the vaccine among 8,082,264 children with at least one dose, according to the US CDC, there were only 11 verified adverse event reports of myocarditis among children ages 5-11 years, and the cases were mild and self-limiting. Therefore, the HTAC ruled that the potential benefits outweigh the risks. 

 

What are the other recommendations of HTAC in terms of implementation?

Considering the need to complete the vaccination of children 5 to 11 years old in accordance with the DOH COVID-19 Vaccination Prioritization Framework, the HTAC recommends that the following conditions be taken into account prior to the vaccination rollout for the said age group:

  • For regions where pediatric vaccination for ages 5 to 11 years will be rolled out, primary series coverage of priority groups (A1 to A3) must be at least 40%; 
  • The rollout should not prejudice the efforts to complete the primary series vaccination and booster vaccination of A1 to A3 priority groups

Proper safeguards should be placed for the implementation, such as the following:

  • More careful health screening
  • Increased rigor and transparency of pharmacovigilance activities
  • Stakeholder consultation
  • Free and prior informed consent signed by the parent/guardian, and the assent shall be given by the vaccine recipient
  • Respect for the autonomy of the parents, guardians and the pediatric vaccinee

Finally, the HTAC reiterates that its recommendations are interim, and is actively on the watch for evidence as it is rapidly evolving. The HTAC shall update the evidence summaries and recommendations when new information becomes available.