HTAC notes in a recent recommendation that the DOH can further implement COVID-19 Vaccines Pfizer-BioNTech and Moderna in adolescents aged 12-17 years old for 2022.

Link to HTAC Recommendation:  [Vax 2022] Pedia ES_For HTAC

Link to Filipino Version:  Gabay ng HTAC para sa Pagbabakuna ng Kabataang Pilipino

COVID-19 Vaccines under Emergency Use Authorization (EUA)

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

Following the issuance of an EUA,  a positive HTAC recommendation means that the National Immunization Program can implement the technology and PhilHealth can include it in the COVID benefit package. 

Currently, among priority COVID-19 vaccines for government funding, and requested for HTAC to assess, only Pfizer-BioNTech and Moderna were granted EUAs for the adolescent population. Other vaccines not identified by the government as priorities were not included in the assessments. 

What is the recommendation of HTAC for the adolescent population?

Upon assessment of the available evidence, the HTAC recommends the use of Pfizer-BioNTech and Moderna among adolescents aged 12 to 17 years. Standard vaccination program protocols should be followed in administering vaccines with EUA to adolescents.

Basis of HTAC Recommendations

Current available evidence shows that the two vaccine brands, Pfizer-BioNTech and Moderna are effective, and have potential in reducing symptomatic and severe COVID-19 infection for the adolescent population. Whereas current available evidence shows that these vaccines are safe to use for the adolescent population, more data is needed to establish longer-term safety. 

Based on the Centers for Disease Control and Prevention (CDC) definitions, cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) among mRNA vaccines (i.e., Pfizer-BioNTech, Moderna) have occurred rarely among adolescents. Despite this, the benefits of vaccination (protection from COVID-19 and its complications) far outweigh the rare risk of  myocarditis or pericarditis. Surveillance efforts and safeguards must be in place in order to monitor these adverse events. 

According to information from the Department of Finance and the National Vaccine Operation Centers, there will be sufficient supply to cover both the unvaccinated population and the adolescent population (using Pfizer-BioNTech and Moderna vaccines). These vaccines also have the potential to reduce expenses among Filipino households since isolation and treatment of COVID-19 infections will likely be prevented. The survey by the DOH Health Promotion Bureau also shows that vaccination among adolescents is acceptable to the general population.

How about the use of other vaccines for the adolescent population?

On the other hand, the HTAC was unable to further assess other criteria for COVID-19 Vaccines AstraZeneca, and Janssen since there is currently no evidence on its  safety, efficacy, effectiveness and potential in reducing the magnitude and severity of infection among the adolescent population.  With limited available evidence for Coronavac, further studies are anticipated to conclude its safety, efficacy and effectiveness for the adolescent population. These vaccines have not yet been granted an EUA by the FDA for the adolescent population.

Does the HTAC have a recommendation for adolescents below 12 years old?

The HTAC will revisit the recommendation once data are available for children below 12 years old.

As evidence is rapidly evolving, the HTAC is actively on the watch for evidence and shall update its recommendation when new information becomes available.

References

Adolescent health in the South-East Asia Region [Internet]. World Health Organization – South East Asia. 2021 [cited 27 October 2021]. Available from: https://www.who.int/westernpacific/health-topics/adolescent-health

Boehmer T, Kompaniyets L, Lavery A, Hsu J, Ko J, Yusuf H et al. Association Between COVID-19 and Myocarditis Using Hospital-Based Administrative Data — United States, March 2020–January 2021. MMWR Morbidity and Mortality Weekly Report. 2021;70(35):1228-1232.

Myocarditis and Pericarditis After mRNA COVID-19 Vaccination [Internet]. Centers for Disease Control and Prevention. 2021 [cited 28 October 2021]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html.