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J&J files for Janssen vaccine EUA

Republika

Johnson & Johnson’s pharmaceutical division Janssen, has applied for emergency use authorization (EUA) in the country from the Food and Drug Administration (FDA).


The American corporation’s Ad26.CoV2.S vaccine is the world’s first and only single dose defense against Covid19.


According to interim recommendations from the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE), Janssen’s vaccine has an effectiveness rate of 66.9% against moderate to severe Covid19 infection and a rate of 85.4% against severe disease, 28 days from inoculation. (Note: The Johnson & Johnson vaccine has been paused in the US, following development of blood clots in six out of almost 7 million recipients, within two weeks of vaccination. One recipient died while another has been hospitalized and is in critical condition. The vaccine’s rollout in Europe is also paused.)


SAGE has also stated that the vaccine is safe for use on individuals 18 years old and above.


According to FDA Director-General Eric Domingo, approval may take up to three weeks.


If granted, the Belgium-based subsidiary of J&J would become the fifth vaccine manufacturer with EUA in the country along with Pfizer, AstraZeneca, Gamelaya, and Sinovac.


An estimated 1.5 million doses of the single shot vaccine are expected to arrive by the year’s third quarter.


Meanwhile, the Chinese-manufactured Sinovac’s EUA may undergo amendment should the Philippines’ Department of Health (DOH) obtain sufficient evidence from the manufacturer indicating its safety for use on individuals 60 years old and above.


DOH Undersecretary Maria Rosario Vergeire has stated that looking into Sinovac for the senior populace comes as the country is now out of AstraZeneca doses, which are authorized for use on seniors.


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