Clinical trials on the Johnson & Johnson (Janssen) vaccine have shown 100% efficacy against severe Covid-19 after two doses and 75% after a single dose. This is what Johnson & Johnson (J&J) itself declares in a note.
The company therefore communicated its intention to submit to the European Medicines Agency (EMA) the authorization request for a complete package that includes the single dose plus a booster dose. The Jannsen vaccine is currently authorized for single dose administration.
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“Several studies by Rwe have been published that report a range of efficacy estimates for the single dose of Johnson & Johnson’s vaccine against covid-19. Clinical practice includes studies published by the CDC (60% -84%, United States ), the Janssen-Aetion study (81%, United States), the Sisonke (67% -71%, South Africa), the Dutch Ministry of Health General Population Study (91%, Netherlands) and the General Population Study of the state of New York (85.5-82.8%, USA) on the efficacy of the vaccine against hospitalization. All methodologies are different and do not always demonstrate a complete picture of efficacy. To date, they have not been conducted clinical trials comparing clinical efficacy between authorized covid-19 vaccines “.
“Johnson & Johnson is aware that data is circulating that can cause confusion. We want to be sure that the most reliable and complete dataset on the effectiveness of our vaccine is understood. More and more robust evidence – they explain from the company – supports a program of vaccination with a licensed vaccine that provides benefits to individuals based on the risks associated with Covid. Data shows that the vaccine provides protection when given as a single dose for an effective response in times of pandemic emergency. When a booster dose is given, the strength of the protection further increases, especially against symptomatic positives. Clinical studies have shown efficacy of 75% against severe / critical forms of Covid-19 with a single dose, and 100% after a second dose “.
The first data emerge, the company recalls, from the Phase 3 Ensemble clinical study, while the Phase 3 Ensemble 2 study found that a second dose administered 56 days after the first dose provided 100% protection against severe forms. / criticism at least 14 days after the last vaccination. Evidence in clinical practice has shown 81% efficacy against Covid-related hospitalizations: “Furthermore, the efficacy estimates have remained stable,” adds the company.
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J&J, the note continues, “continues to evaluate all clinical practice data as they become available. It is important to consider the methodologies used on data in clinical practice studies, especially in creating a control group that is comparable to the active group. Critical factors in establishing a correct control group include ensuring comparable dates for virus circulation, matching risk factors between individuals, such as comorbidities and localization, as well as accurately measuring vaccination status . It is important that clinical practice data studies also transparently provide full details on the statistical methodology applied. Janssen and the research partners have committed to providing full transparency of the studies and have made themselves available to collaborate with other independent researchers in sharing access to data and the platform on which it was conducted to research “.
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