Johnson & Johnson's single-shot vaccine proved effective, says FDAtext_fields
Johnson & Johnson's single-shot vaccine has been proved to be effective and safe, said the U.S. Food and Drug Administration (FDA) staff in a document published on Wednesday.
The decision of approving the vaccine for emergency use will be made in the meeting of the FDA's advisory panel of independent experts on Friday. Though the FDA is not bound to consider its experts' opinion, it had done so while approving Moderna and Pfizer vaccine in 2020.
Unlike other vaccines that require the administration of two doses, J&J's vaccine requires only one dose, which makes the inoculation process much easier.
The vaccine effectively reduced the risk of Covid-19 and prevented the PCR test-confirmed Covid-19 at least 14 days after the vaccination. J&J's vaccine effectiveness varied from 72 per cent in the United States to 66 per cent in Latin America and 57 per cent in South Africa.
The company said the vaccine prevented 100 per cent of hospitalizations and deaths, and the FDA staff documents show that the vaccine was 64 per cent effective in South Africa after about a month, where the new B.1.351 variant of Covid-19 is rapidly spreading.
According to the FDA, the most common side effects of the vaccine were headaches and fatigue, followed by muscle aches, nausea and fever. When analyzed by age, race and comorbidities, no other major safety concerns were identified, and the vaccine effectiveness was the same in all of them. There were also no reports of anaphylaxis, a severe and potentially life-threatening allergic reaction.
J&J is seeking authorization for use in people aged 18 and older. If approved, J&J's vaccine would be the third Covid-19 vaccine authorized for emergency use in the U.S.