US FDA: Single-shot Johnson & Johnson Vaccine Safe and Effective

The vaccine was found 66% effective at preventing COVID-19 cases


The US Food and Drug Administration on Wednesday certified that the single-dose Johnson & Johnson Covid-19 vaccine is safe and effective making it eligible for emergency use starting this week.

Documents published by the US FDA showed that the Johnson & Johnson vaccine is safe and effective based on trials and completely protective against hospitalizations and deaths.

The third American vaccine will be up for approval by the regulator’s independent panel of experts on Friday to decide whether it gets approved for use in the United States starting next week.

While the FDA is not bound to follow the advice of its experts, the agency did so when authorizing the use of Pfizer and Moderna vaccines late last year.

The approval of a third vaccine side from those of Pfizer and Moderna comes as a welcome development in efforts to ramp up immunizations after news of threat of virus variants continues to swirl.

Since the pandemic started last year, the coronavirus has already killed more than a half-million people in the United States alone.

Based on documents, FDA experts found that the Johnson & Johnson vaccine was 85% effective at preventing severe illness in clinical trials.

The vaccine was also 66% effective at preventing COVID-19 cases with any symptoms in preventing COVID-19 against multiple variants in a global trial involving nearly 44,000 people.

The recent FDA data also shows the vaccine works against all variants.

FDA data also showed that the Johnson & Johnson vaccine was effective at preventing asymptomatic infections.

In the preliminary analysis of its trial, the FDA data analysis found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88 percent efficacy rate.

Its effectiveness varied from 72 percent in the US to 66 percent in Latin America and 57 percent in South Africa, where a new variant has spread, though the vaccine was 85 percent effective overall in stopping severe cases of the disease.

However, the vaccine was less effective at preventing symptomatic illness in South Africa, where the variant first detected there is dominant, but it was still highly effective at preventing severe disease when tested there.

The Johnson & Johnson shot was also well-tolerated in trials, with no reports of severe allergic reactions which have been recorded in rare cases for the Pfizer and Moderna shots.

Mild to moderate reactions, like injection-site pain, headache, fatigue, and muscle pains were more likely to occur in younger participants than older. There were also no reported deaths in the vaccine group, but five in the placebo group.

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JM Agreda
JM Agreda is a freelance journalist for more than 12 years writing for numerous international publications, research journals, and news websites. He mainly covers business, tech, transportation, and political news for Businessner.