Food and Drug Administration (FDA) Director General Eric Domingo reported on Monday night that the evaluation for the emergency use authorization (EUA) for Janssen COVID-19 vaccine may be completed this week.
The product has already been granted EUA in the United States, European Union, Canada, and Switzerland. It was also included in the World Health Organization’s emergency use listing (EUL).
“Ito po ang ongoing evaluation natin and we hope to finish all of these within the week [This is our ongoing evaluation and we hope to finish all of these within the week],” Domingo told President Duterte.
Johnson & Johnson submitted its application for emergency use approval of the single-dose vaccine on March 31.
“If I were to be asked, sasabihin ko [I would say], we need two doses not one. Pero kung talagang kulang ang supplies [But if there is supply shortage], maybe we can adopt that,” Vaccine expert panel head Dr. Nina Gloriani said.
Aside from its EUA application, its one-year clinical trial is ongoing in the Philippines which involves around 700 individual participants. Two doses will be given to each participant aged 18 years-old and above
“All of these vaccinees or participants will be monitored as required so you know that they have the study protocol,” Gloriani explained.
“‘Yun ‘yung susundan kung ano ‘yung nilagay doong [What will be followed are the stated]
endpoints or monitoring period and everything else.”
The Janssen product is a viral vector vaccine that requires 2 to 8 degrees Celsius storage temperature. It has a reported 66.9% efficacy rate to prevent moderate to severe COVID-19.
Vaccine Czar Carlito Galvez Jr. relayed that the government is aiming to buy around 6 million doses of the vaccine. – Report from Mark Fetalco/AG-jbb
