FDA releases new data on J&J's single-dose coronavirus vaccine, says it is safe and effective
The coronavirus vaccine from Johnson & Johnson is delivered as a single shot, whereas both Pfizer and Moderna require two jabs.
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Detailed Johnson & Johnson coronavirus vaccine data have just been released by US regulators.
The single-dose vaccine is reviewed by an expert panel advising the FDA on Friday.
If OK, J&J will immediately dispatch almost four million doses, and plans to dispense 100 million doses before the end of June.
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The single-dose coronavirus vaccine of Johnson & Johnson has only got one step closer to reaching the public as the United States regulators issued documents to demonstrate that the shot is safe and can help prevent COVID-19.
The Food and Drug Administration's assessment of the data found the shot efficient and safe, and the regulators said no safety issues had been identified to prevent an emergency OK.
J&J is expected to be the third vaccine to reach the American public with COVID-19.
The health giant has claimed that it will have nearly four million doses ready for emergency approval and will deliver 100 million doses to the US by the end of June.
Like the other two US-authorized vaccines, those doses are available to people in the US at no cost.
In August, the US Government agreed to pay J&J $1 billion for 100 million doses, and the medical giant pledged no profit doses during the pandemic.
The FDA will convene on Friday a panel of independent experts to discuss whether or not to recommend J&J's jab in order to regulate OK.
Experts very much expect the committee to vote in favour, and the FDA will take the green light in the next few days.
J&J's overall vaccine was 66% effective, but offered greater protection against serious diseases
Late January, with its 44,000-voluntary clinical trial, J&J announced its success.
The one-dose vaccine is reported to be 66 percent effective in preventing moderate and severe cases of COVID-19 in a press release.
This finding was confirmed by the documents published on Wednesday.
This figure is significantly lower than the efficacy rates of 94% and 95% for Moderna and Pfizer 2-dose vaccines, but it is difficult to directly compare the studies, as it was at various stages in the pandemic and across different geographies.
J&J study in several countries tested the shot when there is widespread circulation of variants of the virus.
The shot was 72 percent in the US, 66 percent in Latin America and 57 percent in South Africa.
Almost all of the infections in South Africa came from the B.1.351 variant.
Other developers of vaccines, like Moderna, Pfizer and Novax, have undertaken research to improve the neutralization of the B.1.351 variant in potential booster shots.
J&J highlighted that the vaccine is highly safe from serious disease, which is true across age groups and geographies.
J&J's ability to avoid hospitalization and death does not appear to be reduced by B.1.351 or other variants.
Other vaccines were not thoroughly tested against these variants, although some evidence suggests that they offer less protection.
Public health experts are looking forward not only to expand the US supply but also for its simplicity, to J&J vaccine.
The 1-dose jab can be stored for several months at typical refrigerator temperatures.
This is a growing story.
For updates, please check back.
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