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Johnson & Johnson requests approval for COVID-19 vaccine in USA

Johnson & Johnson on Thursday asked US regulators to grant authorization for the first single-shot COVID-19 vaccine, an easier-to-use option that could help address shortages.

J & J’s vaccine was shown to be safe and to offer strong protection against moderate and severe cases of COVID-19, according to preliminary results from a huge international trial.

It wasn’t as effective as the two-app options from Pfizer and Moderna, a finding that might be more insight than reality, considering the differences in the way they were tested.

But the Food and Drug Administration (FDA) has asked its independent advisers to publicly discuss all the data around the single-shot vaccine – in the same way that its competitors were thoroughly scrutinized – before deciding whether to approve a third vaccination option in the United States.

Dr. Peter Marks, the FDA’s director of vaccines, asked to avoid comparisons before he had all the evidence.

“With all the need we have to control this pandemic, I think we cannot ignore any tools in the drawer,” Marks told the American Medical Association last week. “We will have to do our best to try to make sure we find the populations that benefit the most from these vaccines and deploy them in the most thoughtful way.”

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