The HTAC retains its recommendation for DOH to finance and include Sputnik V in the Philippine National Deployment and Vaccination Plan for COVID-19 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 implementation of the technology and PhilHealth can include it in the COVID benefit package.
Sputnik V was issued an EUA last 19 March 2021:
What is the recommendation of HTAC for Sputnik V as part of homologous primary series vaccination?
Based on the updated evidence summary of Sputnik V last 14 December 2021, the HTAC retains its recommendation for DOH to finance and include Sputnik V in the Philippine National Deployment and Vaccination Plan for COVID-19 for the general population aged 18 years and above. However, the relatively high cost of this vaccine, documented issues of delayed deliveries, and challenges experienced during roll out (e.g., stringent and longer time of preparation for the administration of the vaccine and decreased viability due to ambient air requirement) need to be considered in the procurement plans.
Is Sputnik V affordable for the implementation among the general population in 2022?
The price of Sputnik V offered to the Philippine government is equal to or better than the price offered to all countries outside Russia, and lower than the price range for which it is available among low to middle income countries, according to the Department of Finance (DOF) and the UNICEF COVID-19 Vaccine Market Dashboard. Based on the costing analysis of HTAC, Sputnik V is considered affordable since the budget for the purchase and use of Sputnik V for the target number of vaccinees has been allocated.
What is the basis of the HTAC Recommendation?
Based on current available evidence, Sputnik V 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
- Affordable and feasible in terms of vaccine implementation
- Possess most 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
Will the HTAC have a recommendation for the use of Sputnik V 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.
Sputnik V Gam-COVID-Vac Covid-19 Vaccine [Internet]. Food and Drug Administration Philippines. 2021 [cited 2021 December 21]. Available from: https://www.fda.gov.ph/sputnik-v-gam-covid-vac-covid-19-vaccine/
Link to Evidence Summary: https://bit.ly/HTACRecomm_SputnikV_Dec2021Updates
Guidance for the Health Care Providers: https://hta.doh.gov.ph/2021/12/29/htac-guidance-for-health-care-providers-covid-19-vaccine-sputnik-v/