FDA reviewing Janssen’s application to register COVID vaccine – DOH
FILE PHOTO: Vials of Johnson and Johnson’s Janssen coronavirus disease (COVID-19) vaccine are seen in an undated photograph. Johnson and Johnson/Handout via REUTERS
MANILA, Philippines — The Department of Health (DOH) on Tuesday announced that the Food and Drug Administration (FDA) is reviewing an application from Janssen Biotech Inc. of Johnson and Johnson (J&J) for its COVID-19 vaccine.
“According to the FDA as of August 9, isa pa lang po na manufacturer ang nakapag-apply ng CPR sa kanila and this would be Janssen from J&J,” said DOH officer-in-charge Maria Rosario Vergeire during a media briefing.
(According to the FDA, as of August 9, only one manufacturer has applied CPR to them; this would be Janssen from J&J.)
Vergeire said that the FDA is currently “reviewing and exercising the necessary work” for the application of Janssen.
A CPR, according to Vergeire will allow manufacturers to sell their products to the public even after lifting the state of calamity for COVID-19.
It can be recalled that the FDA approved Janssen’s COVID-19 vaccine emergency use authorization (EUA) in April 2021.
Meanwhile, Vergeire in the same briefing also bared factors that the DOH recommended the government consider before lifting the state of calamity in the country due to COVID-19.
This is about the state of calamity declared by former President Rodrigo Duterte, which will only last until September 2022.
The first consideration she said was the ongoing COVID-19 vaccination program. If the state of calamity is lifted, Republic Act 11525 or the act establishing the COVID-19 vaccination program will cease to exist.
It will also terminate existing EUAs for other vaccines, only allowing those with CPRs to be used.
“Sa ngayon wala pa ho tayong ganung kadaming manufacturers applying so we need to work with our FDA and the other concerned agencies para may magapply na ng CPR,” said Vergeire.
(Right now, we don’t have that many manufacturers applying, so we need to work with our FDA and the other concerned agencies so that more can apply for CPR.)
“Eventually pag nagkaroon na ng CPR we will have our own certified vaccines na mga bakuna na pwede na gamitin kahit wala nang state of calamity,” she added.
(Eventually, when there is CPR, we will have our certified vaccines that can be used even if there is no state of calamity.)
She added that the government’s emergency procurement program will also be lifted, “and we won’t be able to expedite the medicines or vaccines we need when cases increase in hospitals.”
It will also lift tax exemptions on vaccine donors and manufacturers, price caps on testing kits and COVID-19 medicines, and the healthcare worker benefits due to COVID-19.
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For more information on COVID-19, call the DOH Hotline: (02) 86517800 local 1149/1150.
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