An independent advisory body, tasked to guide the Department of Health, recommended the use of Pfizer-BioNTech and AstraZeneca COVID-19 vaccines for priority groups.
The two brands were earlier approved for emergency use by the country’s Food and Drug Administration.
In a statement on Tuesday, the DOH announced that the Health Technology Assessment Council (HTAC) released the recommendations of these vaccines for the priority groups, “pending long-term effectiveness and safety data.”
“Based on existing evidence from ongoing trials, the HTAC has determined that positive health impacts from vaccination outweigh short-term risks,” the DOH said.
“As new information emerges, the Council will continue to update its recommendations and provide policy-makers, health providers and the Filipino public evidence-based guidance,” it added.
The post also attached a link to the page where the public can read HTAC’s summary reports.
Tony Leachon, former consultant of the National Task Force against COVID-19, lauded this progress and hoped related government agencies would step up next.
“Philippines ready for vaccination this month with Pfizer and AstraZeneca based on HTAC of DOH and local FDA EUA approval. More vaccines to come. That’s science based. It’s time for IATF, the NTF-COVID-19, and DOH to execute well to end this pandemic and reopen the economy,” he said.
Dr. Antonio Dans of the Healthcare Professionals Alliance Against COVID-19 likewise said the vaccination distribution is now up to the DOH.
“Now it’s DOH’s turn to distribute efficiently and equitably!” he said.
How does it differ from the FDA approval?
FDA’s emergency use authorization, similar to the EUA of other countries, only provides for the vaccine’s use in a public health emergency, that is, the ongoing novel coronavirus pandemic.
As stated under FDA Circular No. 2020-036, the EUA is “an authorization issued for unregistered drugs and vaccines in a public health emergency. The EUA is not a Certificate of Product Registration (CPR) or a marketing authorization.”
The HTAC, meanwhile, reviews how the vaccines can be administered and monitored as part of the national government’s vaccination program.
In its summary reports for Pfizer-BioNTech and AstraZeneca vaccines, HTAC agreed with the policy question:
“Should the vaccine brand be recommended for emergency use to reduce COVID-19 cases, severe infection, and deaths?”
The reports further specified that the priority groups comprise individuals aged 16 to 18 years old and above.
HTAC is created under the Republic Act 11223 or the Universal Health Care Act.
Its overall role is to provide “guidance to the DOH and the Philippine Health Insurance Corporation (PhilHealth) on the coverage of health interventions and technologies to be funded by the government.”
What are their recommendations?
For Pfizer-BioNTech’s COVID-19 vaccine
In the summary report, HTAC noted the high efficacy of the vaccine brand observed across age and groups who are inflicted with other diseases or with co-morbidities.
However, the group noted that more studies are needed for the long-term results and its cost-effectiveness “in terms of preventing COVID-19 mortality, lowering hospitalization, and reducing the incidence of asymptomatic cases.”
“Nonetheless, the HTAC emphasizes that, based on best available evidence, the clinical benefits such as decreased symptomatic infection outweigh known short-term risks,” the report said.
For the AstraZeneca’s COVID-19 vaccine
HTAC noted the lack of direct evidence regarding the efficacy and safety of this vaccine for individuals aged 56 and above.
Still, the report considers AstraZeneca vaccine acceptable for elderlies’ use.
“Protection is expected given the immunogenicity profile seen in this age group and based on the experience of other countries with other vaccines, according to the European Medicines Agency (EMA). Using COVID-19 Vaccine AstraZeneca for the population aged 56 years and above is deemed acceptable,” it said.