Johnson & Johnson has announced that a second dose of their COVID-19 vaccine had increased its effectiveness against moderate to severe forms of the disease in the United States to 94%.
This is comparable to the 70% single-dose protection.
The facts help J&J to support its argument for a booster shot by the U.S. regulators, even though the company underlines its one-shot vaccination as a tool to reduce the global pandemic.
In spite of the rising hospitalizations caused by the Delta variant, President Joe Biden is pressing for booster shots and J&J, the only drug manufacturer approved in the USA for a single-shot COVID-19 vaccine, is under pressure for evidence of the efficiency of an extra dose.
Dr. Paul Stoffels, J&J’s chief scientific officer, said in a statement The company has now “generated evidence that a booster shot further increases protection against COVID-19.”
A booster shot given two months after the first dose elevated antibody levels by four to six times, according to J&J. Antibody levels increased twelvefold when given six months after the first treatment, according to findings presented last month, implying a significant improvement in protection with the extended time between doses.
The side effects of two doses were comparable to those found in single-dose immunization studies. The data has not yet been peer-reviewed, but it will be published in the coming months.
Only Pfizer Inc/BioNTech SE has provided enough data for US authorities to determine if booster injections are necessary ahead of the Biden Administration’s Sept. 20 deadline for distributing booster shots. This week, a decision on the vaccine is expected.
An FDA advisory committee decided on Friday to recommend emergency approval of extra Pfizer doses for Americans 65 and older and those at risk of serious sickness, but not for broader approval, citing a lack of data.
J&J claimed that the FDA has supplied data and plans to submit information in order to advise their decision-making to other agencies, the World Health Organization, and other vaccine consultant groups worldwide.
In a two-dose Phase 3 trial of 30,000 people a second dose of 56 days after the first was effectively evaluated in adults 18 years of age and over.
Although the study revealed that two doses of the J&J vaccine were 94% effective in the US in preventing moderate or serious sickness, just 1 case in the vaccine group and 14 in the placebo group resulted in a wide interval of confidence and asked questions about whether the outcome was certain.
According to J&J, the trial included a brief 36-day follow-up, but it showed a second dose was well tolerated, according to the business.
Tuesday, the company also stated that evidence from the separate real-world study conducted in the United States with almost 400,000 individuals having the J&J shot revealed that the vaccine was 79% effective in preventing COVID-19 infections and 81% efficient in hospitalization prevention, compared to 1,52 million non-vaccinated persons of similar age, gender and health concerns.
J&J stated that there was no evidence that the duration of the trial was reduced by the effects of the delta variation throughout March to July.
The efficacy of vaccines is varied by age in the real-world study. The vaccine was 86% effective for those under 60 years of age against 78% for those under the age of 60.
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