Johnson & Johnson’s is set to be approved by US regulators later this week (Picture: Reuters)
Johnson & Johnson’s one-shot Covid vaccine is ‘safe and effective’, according to US regulators.
America’s Food and Drug Administration (FDA) made the encouraging comments today and is now lined up to approve the vaccine for emergency use.
The vaccine has shown to be between 66% and 88% effective after only a single dose, and FDA officials will meet on Friday to decide on whether or not to give it approval for mass public use.
While it is not bound to follow the advice of its experts, the FDA usually does and has authorized vaccines from Pfizer and Moderna.
The UK has ordered 30 million doses of the vaccine and Johnson & Johnson says it plans to make one billion doses this year.
The manufacturer said in documents submitted to the FDA, earlier this month, that its data suggested its vaccine was effective at preventing asymptomatic infections.
The jab has shown to be between 66% and 88% effective (Picture: Getty/AFP)
It said that in a preliminary analysis of its vaccine trial, the company found 16 cases of asymptomatic cases in the placebo group and only two in the vaccine group, giving the jab an 88% efficacy rate.
The reduction of asymptomatic cases means the shot can also cut transmission of the disease.
Last month Johnson & Johnson said its vaccine was 66% effective in preventing Covid against multiple variants, in a global trial involving nearly 44,000 people.
The company’s analysis shows its effectiveness varied from 72% in the United States to 66% in Latin America and 57% in South Africa, where a new variant has spread, though the vaccine was 85% effective overall in stopping severe cases of the disease.
Fourteen days after injection, only two vaccine recipients developed Covid severe enough to need medical intervention, compared with 14 in the placebo group. After 28 days, no vaccine recipients developed severe enough symptoms 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 analysis did not raise any specific safety concerns.
The FDA said the most common solicited adverse reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2% and myalgia at 33.2%. Other side effects included a fever in 9% of participants and a high fever in 0.2% of those who received the vaccine.
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