JANSSEN Pharmaceutical Companies of Johnson & Johnson has applied for emergency use of its coronavirus vaccine, the Food and Drug Administration (FDA) said on Monday.
FDA Director-General Rolando Enrique D. Domingo said Janssen submitted its application on Wednesday. “It is now under evaluation,” he said in a mobile phone message.
The local drug regulator has approved the emergency use of the vaccines developed by Pfizer, Inc., China’s Sinovac Biotech Ltd., the UK’s AstraZeneca Plc and Russia’s Gamaleya Research Institute of Epidemiology and Microbiology.
The vaccine developed by Janssen was authorized for emergency use by the US FDA in February, according to Johnson & Johnson’s website. The vaccine can be given to people 18 years old and above, it said.
The third phase of its clinical trial showed that the vaccine resulted in a 67% reduction in symptomatic cases among participants two weeks after vaccination, Johnson & Johnson said in a statement in March.
The vaccine was also 85% effective in preventing a severe disease, hospitalization and death, 28 days after vaccination.
The World Health Organization last month listed the vaccine for emergency use and for rollout under a global initiative for equal access. — Vann Marlo M. Villegas