The HTAC recommends the DOH financing and inclusion of Sinopharm in the Philippine National Deployment and Vaccination Plan for COVID-19 Vaccines 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.
The three versions of Sinopharm were issued an EUA on the following dates (https://www.fda.gov.ph/covid-19-vaccine-vero-cell-inactivated-covid-19-vaccine-sinopharm/):
- Sinopharm (Beijing) – 10 September 2021
- Sinopharm (Wuhan) – 19 August 2021
- Sinopharm (Hayat-Vax) – 07 October 2021
What is the recommendation of HTAC for Sinopharm as part of homologous primary series vaccination?
The HTAC recommends the DOH financing and inclusion of Sinopharm in the Philippine National Deployment and Vaccination Plan for COVID-19 Vaccines 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 in 2022.
Is Sinopharm affordable for the implementation among the general population in 2022?
The price of Sinopharm offered to the Philippine government is within the global market price range, and is lower compared to those in low to middle income countries where it is available, according to the Department of Finance (DOF) and the UNICEF COVID-19 Vaccine Market Dashboard. Based on the costing analysis of HTAC, Sinopharm is considered affordable, although its procurement and implementation will still depend on the available budget for 2022.
What is the basis of the HTAC Recommendation?
Based on current available evidence, Sinopharm has the following characteristics for use in the general population aged 18 years and above:
- Is efficacious in preventing symptomatic COVID-19 and is likely to provide protection against severe 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
- Affordable and feasible in terms of vaccine implementation
- Possess most of the characteristics desired by key stakeholders, according to national surveys and based on conducted focus group discussions
Will the HTAC have a recommendation for the use of Sinopharm 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.
References
COVID-19 Vaccine (Vero Cell), Inactivated [COVID-19 Vaccine Sinopharm] [Internet]. Food and Drug Administration Philippines. 2021 [cited 2021 December 15]. Available from: https://www.fda.gov.ph/covid-19-vaccine-vero-cell-inactivated-covid-19-vaccine-sinopharm/
Link to Evidence Summary: COVID-19 Vaccine Sinopharm for the Prevention of COVID-19
Guidance for Health Care Providers: HTAC Guidance for Health Care Providers: COVID-19 Vaccine Sinopharm