The HTAC recommends the DOH financing and inclusion of Covaxin in the Philippine National Deployment and Vaccination Plan for COVID-19 (NDVP) for the general population aged 18 years and above.
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 finance the implementation of the technology and PhilHealth can include it in the COVID benefit package.
Covaxin was issued an EUA last 21 June 2021: https://www.fda.gov.ph/whole-virion-inactivated-corona-virus-vaccine-covaxin/
What is the recommendation of HTAC for Covaxin as part of homologous primary series vaccination?
The HTAC recommends the DOH financing and inclusion of Covaxin in the Philippine National Deployment and Vaccination Plan for COVID-19 for the general population aged 18 years and above, given that it has passed the safety, efficacy and other criteria of HTAC and provided that there is sufficient budget to cover its implementation after pending supply negotiations for 2022.
What is the basis of the HTAC Recommendation?
Based on current available evidence, Covaxin has the following characteristics for use in the general population aged 18 years and above:
- Efficacious in reducing severe and symptomatic COVID-19
- Has potential in reducing a significant number of symptomatic infections, assuming sufficient vaccine coverage;
- Safe, although more data is needed to establish its long-term safety
- Can reduce the out-of-pocket expenses due to averted costs of isolation and treatment from COVID-19 infection
- Possess characteristics desired by key stakeholders, according to national surveys and based on conducted focus group discussions
- Does not aggravate health inequities due to non-stringent logistic requirements
Is Covaxin affordable for the implementation among the general population in 2022?
HTAC cannot assess the afforability of Covaxin due to lack of information on the allocated budget and target number of doses to be procured. The HTAC deems, however, that the health, economic, and social benefits of using Covaxin may lessen the negative impacts of COVID-19, such as deaths, medical costs, loss of productivity, social disruption and unprecedented challenges in the health system.
Will the HTAC have a recommendation for the use of Covaxin in the adolescent population (12-17 years old)?
As evidence is rapidly evolving, the HTAC is actively on the watch for evidence and shall update its recommendation on the adolescent population when new information becomes available.
Whole virion, Inactivated Corona Virus Vaccine [Covaxin] [Internet]. Food and Drug Administration Philippines. 2021 [cited 2021 December 15]. Available from: https://www.fda.gov.ph/whole-virion-inactivated-corona-virus-vaccine-covaxin/
Link to Evidence Summary: bit.ly/HTACRecomm_Covaxin_2021
Guidance for Health Care Providers: https://hta.doh.gov.ph/2021/12/29/htac-guidance-for-health-care-providers-covid-19-vaccine-covaxin/