More documents from Bharat Biotech needed for Covaxin entry in the Philippines, according to a DOH official.
A Department of Health (DOH) official on Wednesday said that more documents from Bharat Biotech needed for Covaxin entry in the Philippines.
Health Undersecretary Maria Rosario Vergeire said that the national government was still awaiting some documents from Bharat Biotech before its Covaxin COVID-19 vaccine will be allowed to enter the Philippines.
In an online briefing, Vergeire said that Covaxin was only granted a “conditional emergency use authorization (EUA)” because it had yet to submit documents such as a risk management plan and a certificate of good manufacturing practice.
“Hindi po kailangang mangamba o mag-agam agam ang ating mga kababayan dahil binigyan naman ng conditional na EUA ang Bharat Biotech. [Ngunit] hindi pa rin po nila pwedeng ipasok ang kanilang mga bakuna dito sa ating bansa hanggang hindi po kumpleto ang kanilang requirements,” Vergeire said.
Officials announced earlier this week that Covaxin had secured an emergency use authorization from the Philippine Food and Drug Administration (FDA).
To recall, Bharat Biotech filed its EUA application for its COVID-19 vaccine last January.
In a report on GMA News Online, Covaxin showed 81 percent efficacy in preventing symptomatic coronavirus infection in an interim analysis of data from a late-stage clinical trial in India.