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Researchers have demonstrated the actual efficacy of the Johnson & Johnson COVID-19 vaccine

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Researchers in the United States and India have found that a single dose of Johnson & Johnson’s Ad26.COV2.S vaccine is actually effective in preventing infection with Severe Acute Respiratory Syndrome Coronavirus 2, a drug that causes coronavirus disease. We conducted a study to demonstrate sex 2019 (COVID-19 (new coronavirus infection).

The team compared the SARS-CoV-2 infection rate of more than 1,700 individuals who received a single vaccination with the infection rate of more than 17,700 controls with a consistent tendency to be unvaccinated.

“This study is a real-world efficacy assessment that matched the first trends of Ad26.COV2.S,” said the May York Clinic in Rochester, Minnesota, the Cambridge Conference in Massachusetts, and the Conference Institute in Bangalore, Karnataka. The researcher is writing.

Venky Soundararajan et al. Reported that only 0.17% of vaccinated individuals tested positive for SARS-CoV-2 more than 2 weeks after vaccination, compared to 0.72% of unvaccinated individuals. doing. Effectiveness of 76.7%.

“This study provides further evidence that a single dose of Ad26.COV2.S is very effective in preventing SARS-CoV-2 infection and is an urgent need to continue high-dose vaccination efforts worldwide. I reaffirm the need, “the team wrote.

Preprints of research treatises medRxiv* Servers and articles have been peer reviewed.

Already over 6.8 million doses of vaccine

The Johnson & Johnson COVID-19 vaccine received an emergency use authorization from the Food and Drug Administration (FDA) on February 27.thIn 2021, more than 6.8 million doses have been administered in the United States.

Clinical trials in Phase 3 studies have previously shown that the vaccine is safe and 66.9% effective in preventing moderate to severe COVID-19.

“But the interpretation of vaccine test results is essentially limited by how well the study population represents the wider population that will ultimately be vaccinated,” says Soundararajan and colleagues.

In addition, efficacy can be affected by the evolution of viral variants, including mutations that allow escape from the vaccine-induced immune response.

“Continuous real-world efficacy and safety assessments of FDA-approved vaccines are important for increasing transparency, building public confidence, and ultimately improving overall health,” the study said. Is writing.

Schematic showing an analysis of the efficacy of the Ad26.COV2.S (Johnson & Johnson, J & J) vaccine by comparing the vaccinated and unvaccinated cohorts.  (A) Analysis of efficacy in the prevention of SARS-CoV-2 infection. Of the 126,572 adult patients available during the study period (February 27, 2021 to April 14, 2021), 2,195 were vaccinated.  A 1:10 control cohort of 21,950 patients was designed by propensity matching of COVID-19 infection risk (location, etc.). From 15 days after enrollment, 3 of the 1,779 vaccinated patients were SARS-COV-2 (by PCR) positive after vaccination, compared with 17,744 unvaccinated. Of these, 128 achieved 76.7% efficacy two weeks after vaccination.  (B) Analysis of efficacy in the prevention of severe SARS-CoV-2 infection (hospitalization, ICU admission, death). To manage age and comorbidities, a 1:10 management cohort of 130 patients was designed by propensity matching matching 13 vaccinated infected individuals. No difference is seen, but too few events are available at the time of publication to provide sufficient power for this analysis.

Schematic showing an analysis of the efficacy of the Ad26.COV2.S (Johnson & Johnson, J & J) vaccine by comparing the vaccinated and unvaccinated cohorts. (A) Analysis of efficacy in the prevention of SARS-CoV-2 infection. Of the 126,572 adult patients available during the study period (February 27, 2021 to April 14, 2021), 2,195 were vaccinated. A 1:10 control cohort of 21,950 patients was designed by propensity matching of COVID-19 infection risk (location, etc.). From 15 days after enrollment, 3 of the 1,779 vaccinated patients were SARS-COV-2 (by PCR) positive after vaccination, compared with 17,744 unvaccinated. Of these, 128 achieved 76.7% efficacy two weeks after vaccination. (B) Analysis of efficacy in the prevention of severe SARS-CoV-2 infection (hospitalization, ICU admission, death). To manage age and comorbidities, a 1:10 management cohort of 130 patients was designed by propensity matching matching 13 vaccinated infected individuals. No difference is seen, but too few events are available at the time of publication to provide sufficient power for this analysis.

What was included in the current study?

During February 27, researchers conducted a large longitudinal curation of electronic medical records within the Mayo Clinic healthcare system in multiple states (Minnesota, Arizona, Florida, Wisconsin, and Iowa). I used it.th And April 14thth, 2021.

“We have leveraged recent advances in deep neural networks to perform high-throughput machine-extended curation of electronic medical record systems,” the team wrote.

SARS-CoV-2 infection rates were compared between 2,195 individuals who received a single dose of the Ad26.COV2.S vaccine and 21,950 who had a consistent tendency to be unvaccinated.

The team found that 13 of the 2,195 vaccinated individuals (0.59%) were SARS-CoV-2 positive by the polymerase chain reaction (PCR), while 262 of the 21,950 unvaccinated individuals (262). 1.19%) reportedly were positive.

Incidence of SARS-CoV-2 positive tests in the vaccinated and non-vaccinated cohorts was 0.18 and 0.36, respectively, per 1000 man-days, indicating an overall vaccine efficacy of 50.6%. ..

However, “the full effect of Ad26.COV2.S is expected to be achieved in the coming weeks,” the team explains. “Therefore, we then analyzed the incidence of SARS-CoV-2 positive tests starting 15 days after the study enrollment date.”

Of the 1,779 vaccinated individuals for whom at least two weeks of follow-up data are available, only three (0.17%) tested positive for SARS-CoV-2 from day 15 onwards after vaccination. However, there were 128 (0.72%) of 17,744 people who had not been vaccinated. The team states that this corresponds to a 76.7% effectiveness in preventing SARS-CoV-2 infections that develop symptoms at least 2 weeks after vaccination.

The cohort was not large enough to adequately assess the impact of the disease on severity

Researchers say the study data are consistent with the 66.9% efficacy (66.9%) in the prevention of moderate to severe COVID-19 reported in Phase 3 trials.

However, since the use of Ad26.COV2.S has only recently been approved, within this cohort there are enough hospitalizations, ICU hospitalizations to reliably assess the impact of vaccination on the severity of COVID-19. Or there is no death yet. add to.

“These results are continuously evaluated in near real time using our platform,” the team writes.

This information is especially important in the context of new mutants that can escape vaccine-induced immunity, Soundararajan et al.

*Important Notices

medRxiv Publish preliminary scientific reports that should not be considered definitive as they are not peer-reviewed, guide clinical practice / health-related behaviors, and should not be treated as established information.

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