Findings from U.S. Food and Drug Administration staff likely mean Johnson & Johnson’s single-dose vaccine will be approved for emergency use later this week.
Johnson & Johnson’s one-shot COVID-19 vaccine has been shown to be safe and effective in trials, U.S. Food and Drug Administration (FDA) staff said in documents released Wednesday, paving the way for approval of the vaccine for emergency use.
The FDA’s independent expert panel is meeting on Friday to decide whether or not to approve the shot. Although it is not required to follow the advice of its experts, the FDA generally does and has cleared the vaccines from Pfizer and Moderna.
J&J said in documents submitted to the FDA that his data suggested his vaccine was effective in preventing asymptomatic infections. He said in a preliminary analysis of his trial, he found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, an efficacy rate of 88%.
While asymptomatic infection was not the primary focus of the trial, which investigated the vaccine’s ability to stop moderate to severe COVID-19, reducing asymptomatic cases means that the vaccine can also reduce transmission. of disease.
J & J’s vaccine was 66% effective in preventing COVID-19 against several variants in a global trial involving nearly 44,000 people, the company said last month.
Its effectiveness ranged from 72% in the United States to 66% in Latin America and 57% in South Africa, where a new variant has spread, although the vaccine was overall 85% effective in stopping severe cases of disease.
The vaccine has been effective in reducing the risk of COVID-19 and preventing confirmed COVID-19 PCR testing at least 14 days after vaccination, the FDA said in its backgrounders.
Fourteen days after the injection, only two vaccines developed COVID-19 severe enough to require medical intervention, compared to 14 in the placebo group. After 28 days, no vaccine recipient developed COVID severe enough to require medical intervention, unlike seven in the placebo group.
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 emergency use authorization from being issued. .
The FDA said the most common solicited side effects were injection site pain at 48.6%, headache at 39%, fatigue at 38.2%, and myalgia (muscle pain) at 33. , 2%. 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 a case of pericarditis (inflammation of the heart tissue) may have been caused by the vaccine. He said cases of a rare neurological disorder, Guillain-Barre syndrome, were unlikely to be related to the vaccine, although there was insufficient data to determine whether or not the vaccine caused these side effects.
J&J had yet to release details of its clinical trial data beyond efficacy rates.