2023-04-30 09:52:30
30 april 2023 – 19:50
A world-leading international study into strengthening the immune system with the help of the tuberculosis vaccine BCG has shown that this vaccine does not protect against COVID-19. The BRACE study, which examined whether the BCG vaccine protects healthcare workers on the front lines of the pandemic against COVID-19, found that the risk of developing COVID-19 was not reduced. UMC Utrecht coordinated the European part of the study.
It Bacillus Calmette-Guérin (BCG) vaccine was originally developed to prevent tuberculosis and is given to over 130 million babies worldwide each year for that purpose. The BRACE-studie was based on previous research, which showed that BCG also increased ‘first-line’ immunity in infants and that the vaccine protected against respiratory infections in adolescents and adults. Doctors hoped that the vaccine could also be used to buy important time in the early days of the corona pandemic until specific corona vaccines were developed and tested. The research, which was published this week in the New England Journal of Medicineinvolved an analysis of data from 3,988 healthcare workers enrolled in the study at 36 sites across Australia, Europe and South America.
Stronger immune response
The risk of symptomatic COVID-19 was 14.7 percent in the BCG group and 12.3 percent in the placebo group during the first 6 months after the start of the study. The study was unable to determine whether the vaccine reduced hospitalizations or deaths due to the low number of participants with severe COVID-19. Prof. Nigel Curtis (Murdoch Children’s Research Institute and the University of Melbourne), lead researcher at BRACE, said that symptomatic COVID-19 observed slightly more often in the BCG group could be explained by the stronger immune response elicited by the vaccine: “When we tested the immune cells of our healthcare workers analyzed, we saw that the BCG vaccine changed the immune response to COVID-19. The symptoms reflect that the immune system is working hard to fight off the virus. A stronger BCG-induced response could be beneficial to kill the virus more quickly and protect against progression to more severe disease. There was some evidence of this in participants over 60 years of age, whose COVID-19 symptoms were shorter in the BCG-vaccinated group.”
Professor Curtis said fewer participants had been recruited than originally planned. The reason for this was that the COVID-19 vaccines had been developed and rolled out at lightning speed and that healthcare workers had been given priority in the vaccination sequence. As a result of the lower number of participants, the team was unable to study whether the BCG vaccine protected against hospitalization and death from COVID-19. A study published last year using blood samples from BRACE participants also found that the BCG vaccine produced an immune response consistent with protection against severe COVID-19.
Importance of large-scale studies
Studies of this size and complexity normally take 8 to 12 months to organize and recruit, but BRACE was able to start within 3 weeks thanks to the dedicated researchers and support teams at the study sites, along with generous financial support from the Bill & Melinda Gate Foundation. Prof. Marc Bontencoordinator of the European part of the BRACE trial: “This trial highlights the importance of large-scale randomized controlled trials to test hypotheses and rapidly evaluate the effectiveness of new or repurposed drugs or vaccines.”
The analysis of the study data is ongoing and further results on the effect of BCG vaccination are expected later this year, including the effect of the vaccine on other infections, such as respiratory infections and the response to the COVID-19 vaccine. The research team is also using participants’ blood samples to discover biomarkers of COVID-19 risk.
Publication
Pittet LF, Messina NL, Orsini F, Moore CL, Abruzzo V, Barry S, Bonnici R, Bonten M, Campbell J, Croda J, Dalcolmo M, Gardiner K, Gell G, Germano S, Gomes‐Silva A, Goodall C,[ PMC free article ][ PubMed ][ Cross Ref ]Gwee A, Jamieson T, Jardim B, Kollmann TR, Lacerda MVG, Lee KJ, Lucas M, Lynn DJ, Manning L, Marshall HS, McDonald E, Munns CF, Nicholson S, O’Connell A, de Oliveira RD, Perlen S , Perrett KP , Pratt‐Aymerich C , Richmond PC , Rodriguez‐Baño J , dos Santos G , da Silva PV , Teo JW , Villanueva P , Warris A , Wood NJ , Davidson A , Curtis N , for the BRACE Trial Consortium Group. Randomized Trial of BCG Vaccine to Protect Against Covid-19 in Health Care Workers. New England Journal of Medicine 2023;388:1582-96. DOI: 10.1056/NEJMoa2212616.
Source: UMC Utrecht
Editorial Medicalfacts/ Janine Budding
I studied physiotherapy and Health Care business administration. I am also a registered independent client support worker and informal care broker. I have a lot of experience in various positions in healthcare, the social domain and the medical, pharmaceutical industry, nationally and internationally. And have broad medical knowledge of most healthcare specialties. And of the care laws from which the care is regulated and financed. Every year I attend most of the leading medical conferences in Europe and America to keep my knowledge up-to-date and to keep up with the latest developments and innovations. Currently I am doing a Masters in Applied Psychology.
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