The Indian firm Bharat Biotech needs to submit more documents for its COVID-19 vaccine, Covaxin before it would be allowed to enter the Philippines, Health Undersecretary Maria Rosario Vergeire said on Wednesday.
The Philippine Food and Drug Administration only granted a conditional emergency use authorization (EUA) to Covaxin because it has yet to submit documents such as a certificate of good manufacturing practice and a risk management plan.
“Hindi po kailangang mangamba o mag-agam agam ang ating mga kababayan dahil binigyan naman ng conditional na EUA ang Bharat Biotech” (The public should not worry because the Bharat Biotech has been given a conditional EUA), Vergeire said in an online briefing.
She added, “[Ngunit] hindi pa rin po nila pwedeng ipasok ang kanilang mga bakuna dito sa ating bansa hanggang hindi po kumpleto ang kanilang requirements” (However, the Bharat Biotech cannot bring its vaccines into our country until the requirements are fully complied with).
FDA said on Tuesday that it has already given the EUA the Janssen vaccine of American company Johnson & Johnson and Covaxin of Bharat Biotech from India.
Covaxin needs to submit more documents before it could enter PH: DOH
Prior to that, the EUA had previously granted to Pfizer, AstraZeneca, Sputnik V, and Sinovac.
Covaxin showed 81% efficacy in preventing symptomatic COVID-19 infection in an interim analysis of data from a late-stage trial in India.
“COVAXIN demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” Bharat Biotech Chairman Krishna Ella said.
Reuters reported that only about 11% of the more than 10 million Indians vaccinated had taken the Bharat Biotech as of March.
Meanwhile, DOH said the government would hire more vaccinators as the country continues its COVID-19 mass inoculation program. The P368 million fund would be coming from Bayanihan To Recover As One Law (Bayanihan 2).
“We have Bayanihan 2 funds valid until June 2021 and this is P368 million which we have given to our regional offices to hire COVID-19 vaccinators and this is up to June 31, 2021, but we are requesting the extension of Bayanihan 2,” Health Undersecretary Myrna Cabotaje said in a joint hearing of the House Committees on Health and Trade and Industry.