WASHINGTON (Reuters) – Johnson & Johnson’s one-time COVID-19 vaccine appears safe and effective in trials, US Food and Drug Administration (FDA) officials said in documents released Wednesday (February 24), paving the way for its emergency use. .
The FDA’s independent team of experts met on Friday to decide whether to approve the shot. Although it is not obligated to follow the advice of its experts, usually the FDA does and has licensed vaccines from diffuse and modern.
J&J said in documents submitted to the FDA that its data suggested that its vaccine was effective in preventing asymptomatic infections.
He said in an initial analysis of his trial, he found 16 cases of asymptomatic cases in the placebo group compared to two in the vaccine group, or an 88 percent efficacy rate.
While asymptomatic infection was not the primary objective of the trial, which investigated the vaccine’s ability to discontinue moderate to severe COVID-19, a reduction in asymptomatic cases suggests that the injection may also cut the transmission of the disease.
The company said last month that J & J’s vaccine was 66% effective in preventing COVID-19 against multiple versions.
Its effectiveness ranges from 72 percent in the United States to 66 percent in Latin America and 57 percent in South Africa, where a new version has spread, although the vaccine has been effective at a total of 85 percent in stopping severe cases of the disease.
White House Response Coordinator John Ziantes, Coron Response, told reporters that if approved, the federal government would seek to distribute three to four million portions next week.
“Johnson and Johnson have announced that they intend to deliver a total of 20 million doses by the end of March,” he continued, adding that the government is trying to speed up the delivery of the 100 million doses contracted by the company by the end of June.
Read: Johnson & Johnson appeals to WHO to register emergency use of COVID-19 vaccine
The vaccine was effective in reducing the risk of COVID-19 and in preventing a polymerase chain reaction (PCR) test. COVID-19 was approved at least 14 days after the vaccine, the FDA said in its briefing documents.
14 days after injection, only two vaccine recipients developed COVID-19 severe enough for medical intervention, compared with 14 in the placebo group.
After 28 days, none of the vaccine recipients developed COVID-19 severe enough to require medical intervention whereas seven in the placebo group did.
Three vaccine recipients had severe side effects in the trial that were likely related to the vaccine, but the FDA said its surgery did not raise any specific safety concerns that prevent approval for emergency use.
The FDA said the most common adverse reactions were injection site pain at 48.6 percent, headache at 39 percent, fatigue at 38.2 percent and myalgia at 33.2 percent. Other side effects included fever in 9 percent of participants and high fever in 0.2 percent of those who received the vaccine.
The regulator said that one case of pericarditis, heart disease, may have been caused by the vaccine. He said cases of a rare disorder, Gillin-Bar syndrome, are unlikely to be linked to the injection, although the data are insufficient to determine whether the vaccine caused these side effects or not.
J&J has not previously published details on its clinical trial data beyond efficacy rates.
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