<p>In large clinical trials, the J&J vaccine's efficacy against severe disease was 85.9 percent in the United States, 81.7 percent in South Africa, and 87.6 percent in Brazil.</p><p>Overall, among 39,321 participants across all regions, the efficacy against severe Covid-19 was 85.4 percent, but it fell to 66.1 percent when including moderate forms of the disease.</p><p>Crucially, analyses of different demographic groups revealed no marked differences across age, race, or people with underlying conditions.</p><p>The vaccine was generally well-tolerated, with no reports of severe allergic reactions (anaphylaxis), which have been seen in rare cases for the Pfizer and Moderna shots. </p><p>Mild to moderate reactions, like injection-site pain, headache, fatigue and muscle pains were more likely to occur in younger participants than older.</p><p>There were no reported deaths in the vaccine group, but five in the placebo group.</p><p>"The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization)," the FDA wrote.</p><h1>One dose, fridge storage</h1><p>A third vaccine is seen as a vital means to ramp up the immunization rate in the United States, where more than 500,000 people have lost their lives to the coronavirus. </p><p>Some 65 million people in America have so far received at least one shot of either the Pfizer or Moderna vaccines -- but unlike those, the J&J vaccine requires just one dose, and is stored at fridge temperatures.</p><p>The trade-off is slightly less protection against mild or moderate forms of Covid-19.</p><p>"The vaccine was effective in preventing COVID-19 using a less restrictive definition of the disease and for more severe disease, including COVID-19 requiring medical intervention, considering all cases starting 14 days after vaccination," the FDA wrote in its briefing document.</p><p>"Although a lower efficacy overall was observed in South Africa, where there was a predominance of B.1.3.5 lineage during the time period of this study, vaccine efficacy against severe/critical COVID-19 was similarly high across the United States, South Africa, and Brazil," it added.</p><p>There was a hint, based on preliminary data, that the vaccine might be effective against asymptomatic infection.</p><p>But "this finding needs to be further investigated with additional data," wrote the company in a separate document made available by the FDA.</p><p>The J&J vaccine uses a common-cold causing adenovirus, which has been modified so that it can't replicate, to carry the DNA for a key protein of the coronavirus into human cells. </p><p>This makes those cells produce that protein, which in turn trains the human immune system should it encounter the real virus.</p><p>Other adenovirus vector vaccines against Covid-19 include those made by AstraZeneca-Oxford and Russia's Sputnik V.</p>
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