Johnson & Johnson’s Single Shot COVID-19 Vaccine Is Effective And Safe – FDA Staff By Reuters

(Reuters) – Johnson & Johnson’s (NYSE 🙂 single-shot COVID-19 vaccine appeared safe and effective in trials, staff at the U.S. Food and Drug Administration (FDA) said in published documents. on Wednesday, paving the way for approval for emergency use.

The FDA’s independent expert panel meets Friday to decide whether to approve the injection. While it is not required to follow the advice of its experts, the FDA generally does and has licensed vaccines for Pfizer (NYSE 🙂 and Modern (NASDAQ :).

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% 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% effective in preventing COVID-19 against multiple variants in a global trial that involved 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 85% effective overall in stopping severe cases of the disease .

The vaccine was effective in reducing the risk of COVID-19 and preventing PCR-confirmed COVID-19 for 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 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 in 48.6%, headache in 39%, fatigue in 38.2% and myalgia in 33.2%. Other side effects included fever in 9% of the participants and high fever in 0.2% 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.