philippines fda issued an eua for sputnik vaccine
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Posted On: 06/22/2022 9:28:44 PM
philippines fda issued an eua for sputnik vaccine march 19,2021 cant beat their palming/payola imo
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:
https://www.fda.gov.ph/sputnik-v-gam-covid-va...9-vaccine/
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.
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:
https://www.fda.gov.ph/sputnik-v-gam-covid-va...9-vaccine/
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.
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