Johnson & Johnson’s Janssen applies for emergency use authorization of its COVID-19 vaccine in PH

ABS-CBN News

Posted at Apr 05 2021 11:00 AM | Updated as of Apr 05 2021 11:57 AM

MANILA — The Philippines’ Food and Drug Administration on Monday confirmed that Johnson & Johnson’s pharmaceutical company Janssen has applied for an emergency use authorization of its COVID-19 vaccine.

FDA Director General Eric Domingo told ABS-CBN News in a text message that the company sent in its application on Wednesday.

He said the documents are now under evaluation.

The EUA application is for Janssen’s viral vector vaccine that only requires one dose. It is already being used for adults in South Africa and has received emergency or limited use approval in territories like the United States, European Union and Canada.

Because the vaccine has secured EUAs from countries with Stringent Regulatory Authorities recognized by the World Health Organization, its EUA in the Philippines can be expedited and processed within 21 days.

Having an EUA from an SRA (reference: https://www.who.int/medicines/regulation/sras/en/), can bolster a company’s application.

Health Undersecretary Maria Rosario Vergeire confirmed the EUA application of Johnson & Johnson.

So far, the country has approved the EUAs for 4 vaccine developers — Pfizer, AstraZeneca, Sinovac and Gamaleya Institute of Russia.

Domingo said Moderna and Novavax, two other developers expected to supply vaccines to the Philippines, have yet to apply for an EUA. 

Janssen has previously been allowed to run clinical trials in the Philippines. Vergeire said last month that it is to check for the long-term efficacy of its vaccine. It is unclear if the clinical trial involves a two-dose regimen but Domingo said the study is still ongoing.

There is a lot of interest on Johnson & Johnson’s vaccine since it is said to be easier and cheaper to administer since it only has one dose. 

The company also expanded its phase 2A clinical trials to include adolescents aged 12 to 17 years old. It is also planning to run trials for pregnant women and children in the “near future.” A New York Times article said the future studies may involve newborns as well. (Reference: https://www.jnj.com/johnson-johnson-expands-phase-2a-clinical-trial-of-covid-19-vaccine-candidate-to-include-adolescents)

As of April 1, the Philippines has administered 740,000 COVID-19 vaccine shots out of the 2.5 million doses it has. The government has been repeatedly criticized for its slow vaccine rollout, especially since it plans to inoculate 70 million Filipinos by the end of the year to reach herd immunity.

- With a report from Raphael Bosano and Kristine Sabillo, ABS-CBN News

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