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WASHINGTON: Johnson & Johnson’s single-shot COVID-19 vaccine appeared safe and effective in trials, staff from the U.S. Food and Drug Administration (FDA) said in documents released Wednesday (May 24). February), paving the way for approval for emergency use.
The FDA’s independent expert panel meets Friday to decide whether to approve the injection. While you are not required to follow the advice of its experts, the FDA generally does and has licensed Pfizer and Moderna vaccines.
J&J said in filings with the FDA that its data suggested its vaccine was effective in preventing asymptomatic infections.
He said that in a preliminary analysis of his trial, he found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88 percent efficacy rate.
While asymptomatic infection was not the primary goal of the trial, which looked at the vaccine’s ability to stop moderate to severe COVID-19, reducing asymptomatic cases means that the injection can also cut transmission of the disease.
J & J’s vaccine was 66 percent effective in preventing COVID-19 against multiple variants in a global trial that involved nearly 44,000 people, the company said last month.
Its efficacy ranged from 72 percent in the United States to 66 percent in Latin America and 57 percent in South Africa, where a new variant has spread, although the vaccine was 85 percent overall effective in stopping severe cases. of the illness.
White House coronavirus response coordinator Jeff Zients told reporters that, if authorized, the federal government would seek to distribute three to four million doses next week.
“Johnson and Johnson has announced that it aims to deliver a total of 20 million doses by the end of March,” he continued, adding that the government was trying to accelerate the delivery of the contracted 100 million doses, which the company has promised by the end of June.
READ: Johnson & Johnson requests WHO COVID-19 vaccine emergency use list
The vaccine was effective in reducing the risk of COVID-19 and preventing the polymerase chain reaction (PCR) confirmed COVID-19 at least 14 days after vaccination, the FDA said in its information documents.
Fourteen days after the injection, only two vaccine recipients developed COVID-19 severe enough to need medical intervention, compared with 14 in the placebo group.
After 28 days, no vaccine recipients developed COVID-19 severe enough to require medical intervention, while seven in the placebo group did.
Three vaccine recipients had serious side effects in the trial that were likely related to the vaccine, but the FDA said its analysis did not raise any specific safety concerns that would prevent the issuance of an emergency use authorization.
The FDA said the most common requested adverse reactions were injection site pain by 48.6 percent, headache by 39 percent, fatigue by 38.2 percent, and myalgia by 33.2 percent. Other side effects included fever in 9 percent of the participants and high fever in 0.2 percent of those who received the vaccine.
The regulator said a case of pericarditis, a heart disease, may have been caused by the vaccine. He said the cases of a rare disorder, Guillain-Barré syndrome, were unlikely to be related to the injection, although the data was insufficient to determine whether or not the vaccine caused these side effects.
J&J had not previously released details of its clinical trial data beyond efficacy rates.
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