Documents released by the Food and Drug Administration on Wednesday indicate that Johnson & Johnson’s Covid-19 vaccine is overall safe and highly effective against the most severe disease outcomes.
The favorable review comes two days before a panel of independent FDA advisers are scheduled to discuss the company’s request for emergency use. The Advisory Committee on Vaccines and Related Biologics, or VRBPAC, is generally expected to vote to recommend vaccine approval.
The FDA is not obligated to follow the committee’s recommendation, but it generally does.
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Five Covid-19 vaccine makers, including Johnson & Johnson, told Congress on Tuesday that they are working to speed up the rollout of vaccine doses in the weeks and months to come.
Assuming the FDA clears the Johnson & Johnson vaccine for emergency use, the company said it would be able to deliver 20 million vaccines by the end of next month, with an additional 100 million doses to the during the summer.
The company reported the results of its Phase 3 clinical trials at the end of January, concluding that in the United States, the vaccine was 72% effective in preventing moderate to severe disease – essentially, preventing people from hospital and dying of Covid-19.
When the company only looked at the vaccine’s effect on preventing serious illness, it was 85% effective.
Globally, however, the vaccine’s effectiveness against moderate to severe disease was lower: 66 percent. This is due to a decrease in efficacy against the variant first found in South Africa. In this country, the effectiveness of the vaccine has fallen to 57%.
Side effects were generally limited to arm pain, headaches, and fatigue. No deaths were reported among study participants who received the vaccine and no hospitalizations were reported after 28 days.
Johnson & Johnson’s vaccine, manufactured in partnership with Janssen Pharmaceuticals, is given as a single injection; the other two vaccines used by Moderna and Pfizer-BioNTech require two doses, spaced three to four weeks apart.
The Johnson & Johnson shot requires only basic refrigeration for storage.
It uses an inactivated virus called adenovirus to train the body’s immune system to recognize and fight SARS-CoV-2, the virus that causes Covid-19.
The vaccines made by Pfizer-BioNTech and Moderna use a different type of technology, using genetic material called messenger RNA or mRNA.
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