The Johnson & Johnson single-dose vaccine is effective against novel variants of the SARS-CoV-2 coronavirus from South Africa and Brazil, a study published in the New England Journal of Medicine shows.
These are the conclusions of the Phase III clinical trial under the acronym ENSEMBLE, which involved a total of 43 participants aged 783 and over.
In the studied group, 44 percent. were people from the United States, 41 percent. from Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15 percent. from South Africa.
The variants observed in the study included variant B.1.351 (20H / 501Y.V2), which was identified in 95 percent of COVID-19 cases in South Africa, and the P2 variant, which was identified in 69 percent of COVID-19 cases in Brazil.
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In South Africa, the vaccine’s effectiveness was estimated at 64%. against moderate to severe COVID-19 and nearly 82 percent. against severe and very severe (critical) disease 28 days after vaccination. Efficiency was also maintained for participants in Brazil – from 68 percent. effective against moderate to severe disease and about 88 percent. effective against severe and very severe disease.
Overall, the vaccine was shown to have 85% vaccine coverage. effective in preventing severe COVID-19. The onset of efficacy was evident seven days after vaccination for severe disease and 14 days after vaccination for moderate to severe disease. 28 days after vaccination, she prevented hospitalization (but also admission to the intensive care unit, the need for mechanical ventilation or extracorporeal blood oxygenation by ECMO) and deaths in all study participants. Importantly, the vaccine’s effectiveness continued to increase approximately eight weeks after vaccination.
The study also found that the effectiveness of the vaccine was independent of race and ethnicity, age, place of residence, and comorbidities.
As Tomasz Skrzypczak, the managing director of Janssen Polska (the producer of the vaccine), informed in a press release sent to PAP, the vaccine provides protection against the most serious effects of the disease also in the group of people over 60 years of age. As much as 34 percent. ENSEMBLE participants belonged to this age group.
Phase XNUMX participants in the study are still followed up for up to two years to assess the safety and effectiveness of the preparation.
Skrzypczak recalled that the Johnson & Johnson single-dose vaccine is based on replication-defective human adenovirus. It serves as a carrier of genetic material – DNA, which codes for the sequence of the coronavirus spike protein. “The body starts to produce antibodies in response to the virus protein it produces. This allows our immune system to defend itself in the future when it comes into contact with the pathogen, ”he explained.
The same technology has previously been used to develop and produce the recently approved Ebola vaccine and vaccine candidates against Zika, RSV and HIV.
Johnson & Johnson single-dose vaccine is stable for two years at minus 20 degrees Celsius and a maximum of three months at refrigerated temperatures from 2 to 8 degrees C. (PAP)
Author: Joanna Morga
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