MANILA, Philippines — Barely three weeks after it was listed for emergency use against COVID-19 by the World Health Organization (WHO), Janssen of Johnson & Johnson has filed an application for emergency use authorization (EUA) with the Food and Drug Administration (FDA).
According to FDA director general Eric Domingo, they received the application last March 31 for Janssen’s single-dose vaccine against COVID-19.
“The application will be evaluated by our experts,” he said yesterday.
This made Janssen the fifth vaccine maker to be granted EUA, following Pfizer, AstraZeneca, Sinovac and Gamaleya-Sputnik V.
Janssen is currently conducting a clinical trial in the country for its COVID-19 vaccine.
Data show some 13.5 million doses of COVID-19 vaccines are expected to arrive in the country during the third quarter of the year. Of this, 1.5 million doses are from Janssen.
Last March 12, WHO had announced that the Janssen vaccine has been included in the list of “safe and effective emergency tool against COVID-19.”
This means that the Janssen vaccine, called Ad26.COV2.S, is now included in WHO’s COVAX Facility, a system that ensures countries’ access to safe and effective vaccines against COVID-19.
WHO said the Janssen vaccine is the first to be listed as a single dose regimen. Data showed that it is effective with an older population.
“While the vaccine needs to be stored at -20 degrees Celsius, which may prove challenging in some environments, it can be kept for three months at 2-8°C and it has a long shelf life of two years,” WHO added.
Meanwhile, the Department of Health (DOH) said yesterday that the EUA issued to Sinovac for its COVID-19 vaccines will have to be amended before these can be given to senior citizens.
At a press briefing, DOH Undersecretary Maria Rosario Vergeire noted they are closely coordinating with Sinovac to get evidence that its vaccine can be given to those 60 years old and above.
“As of yesterday, there was no submission of additional evidence so we are still waiting. We need vaccines because we already ran out of AstraZeneca vaccines,” she maintained.
Based on the EUA granted by the FDA to Sinovac, its vaccine can be administered to those aged 18 to 59 years.
AstraZeneca, on the other hand, can be given to senior citizens under its EUA.
Last week, the Chinese government allowed Sinovac vaccines to be given to its elderly population aged 60 and above.