Johnson & Johnson’s single-dose COVID-19 vaccine effective, safe: FDA analysis

The analysis of the trial data published by the Food and Drug Administration on Wednesday shows that Johnson & Johnson’s single-dose coronavirus vaccine is effective at preventing moderate and severe cases of COVID-19.

The U.S. Food and Drug Administration found that Johnson & Johnson’s single-dose Covid-19 vaccine was 66.1% effective in preventing moderate to severe virus disease and appeared safe.

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More precisely, it is more than 85 percent effective at the prevention of severe cases of COVID-19 and entirely prevents hospitalizations and deaths.

There were seven deaths in the trial altogether, all in the placebo group.

Johnson & Johnson initially publicized the 66 percent effectiveness last month in a press release but had not yet released results from the trial.

The information was published ahead of an FDA advisory committee meeting Friday, which will discuss about granting the vaccine emergency authorization. The encouraging information gives expectations that a third COVID vaccine could be authorized as soon as this weekend.

Even though the other coronavirus vaccines which are already available may appear to be more effective than Johnson & Johnson’s, experts say it is hard to compare them head-to-head.

The test for the vaccine was made in a clinical trial that included 44 000 people across the U.S., Brazil, and South Africa geographic regions, all of which have seen mutated versions of the virus.

The review found that the efficacy was lower against moderate to severe/critical disease endpoints observed in South Africa compared to the United States and Brazil, but vaccine efficacy against severe or critical COVID-19 infections was “similarly high in all 3 countries,”.

Yet, the varying efficacy is a sign to be cautious about mutations, particularly from the variant found in South Africa. The effectiveness against moderate to severe illness lowered from 72 percent in the United States to 57 percent in South Africa, where a new COVID-19 variant is widespread.

In a subgroup of adults older than 60 with underlying conditions the vaccine was less effective, but regulators noted there were no casualties or cases requiring medical intervention a month after those people received vaccines.

The most commonly reported local adverse reaction was injection site pain, with younger participants aged 18 to 59 reporting it more than people older than 60.

America won’t see an important increase in available vaccine supply if the vaccine is authorized. The company has said it will have about 4 million doses ready to ship at once after the emergency authorization. As the company executive told Congress, by the end of March it expects to provide 20 million doses and 100 million by summer.

However, the shot could ease the complicated logistics of the U.S. vaccine rollout. Johnson & Johnson’s vaccine can be stored in a normal refrigerator for several months, rather than at ultra-cold temperatures, which is not the case with Moderna and Pfizer vaccines.

Moreover, the concern about scheduling or having enough supplies for a second dose will be eliminated, because it is a single shot.

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Source: CBS News 

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