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BCG vaccine increased risk of severe COVID-19 in certain populations

BCG vaccine increased risk of severe COVID-19 in certain populations

 


According to the authors of a recent study published in , the Bacillus Calmette-Guerin (BCG) vaccine did not reduce the risk of COVID-19 infection among healthcare workers less than placebo. New England Journal of Medicine (NEJM). Patients who received the BCG vaccine had a 7.6% risk of severe COVID-19 infection at 6 months, compared with a 6.5% risk for placebo.

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“Although confidence intervals were wide and there was no difference between the two groups, the probability of a COVID-19 episode within six months was higher in the BCG group than in the placebo group,” the study authors wrote. There is NEJM article.

Originally, BCG was created for tuberculosis. However, severe he has immunomodulatory ‘off-target’ effects that may protect against other infections such as COVID-19. It was thought that CBG as a pathogen-specific vaccine could enhance her protection against COVID-19.

BCG Danish vaccine (equivalent to 2-8 x 105 colony forming units) [CFUs] Danish strain 1331 of Mycobacterium bovis. AJ Vaccines) reduced the incidence and severity of his COVID-19 in adult patients more than placebo. The primary outcome was symptomatic COVID-19 and his severe COVID-19 assessed at 6 months. Secondary outcomes included time to onset of COVID-19, number of COVID-19 episodes, number of days with onset, days off work, and complications.

The investigative team randomized a modified intention-to-treat population of 3988 participants in the international, double-blind, placebo-controlled, and multistage clinical trial BRACE study. received the intradermal BCG Danish vaccine and 1683 received a saline placebo. The participant was assessed for primary outcomes at his 6 months during the 12-month follow-up.

The data showed an adjusted estimated risk of developing symptomatic COVID-19 of 14.7% in the BCG group and 12.3% in the placebo group. Most of his 7.6% and his 6.5% of participants with severe COVID-19 infection were not hospitalized (he was on BCG and placebo, respectively), and researchers observed no new safety concerns. I did.

The BCG group was more likely to have a COVID-19 episode within the 6-month evaluation period. However, while BCG was associated with a reduction in symptom days in adults aged 60 years or older, there was no significant difference between symptom days in participants aged 40 to 59 years or in participants younger than 40 years. There was no.

Additionally, BCG patients with pre-existing conditions were likely to experience more symptoms than the placebo group. They also likely had severe or symptomatic her COVID-19, so “the results did not rule out a possible increased risk,” the study’s authors wrote in the article.

The study authors noted that study limitations included an inability to employ the planned sample size and reduced observation time, making the study error prone. The study authors also noted that the definitions of “severe” and “syndromic” for COVID-19 are limited and may differ from traditional definitions. Additionally, the study included blinding.

“It is important that our findings are not extrapolated beyond the effects of the BCG-Denmark vaccine against COVID-19 in healthcare workers,” the study authors wrote. We demonstrate beneficial off-target effects of the BCG vaccine in the setting of

reference

Pittet L, Messina N, Orsini F, et al. A randomized trial of the BCG vaccine to protect healthcare workers from Covid-19. N Engl J Med2023. doi:10.1056/NEJ Moa2212616

Sources

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2/ https://www.pharmacytimes.com/view/study-bcg-vaccine-increased-risk-of-severe-covid-19-in-certain-populations

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