Johnson & Johnson’s single-dose vaccine fully protects against hospitalization and death with COVID-19 approximately one month after administration. This is also true for countries where mutant variants of the coronavirus are common. J&J Chief Scientist Paul Stoffels said this, commenting on the publication of primary data from phase III clinical trials in the New England Journal of Medicine.
According to him, the results of a study involving 44,325 volunteers (including 14,672 over 60 years old) are the same for different races, ethnicities, ages, locations and comorbidities.
The vaccine is 85% effective against severe and critical illness (67% protection against moderate to severe 14 days after vaccination, and 66% protection against such a course 28 days after vaccination).
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According to the authors, the effectiveness began to be monitored one week after the injection for severe and critical illness, and two weeks after vaccination – also for moderate and severe.
Reactogenicity (reaction to the shot) was higher with the vaccine compared to the placebo shot, but these reactions were usually mild to moderate and resolved quickly.
In South Africa, dominated by a strain that partially escapes immunity to the original corona strain, vaccine efficacy was maintained at 64% against moderate, severe and critical illness, and 81.7% against severe and critical on 28 days after vaccination.
Vaccine efficacy also persisted in participants from Brazil (with another mutant strain common there): 68.1% against moderate, severe and critical cases, and 87.6% against severe and critical cases.
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In the United States, there have been 6 reported cases of blood clots with low platelet counts in people who received the J&J vaccine. out of more than 7,900,000 doses administered.
A multinational, randomized, double-blind, placebo-controlled clinical trial involving persons aged 18 years and older is being conducted in eight countries on three continents. 44% of participants are from the USA, 41% are Argentina, Brazil, Chile, Colombia, Mexico, Peru, 15% – South Africa. Among the participants, 59% are white / Caucasian, 45% are Hispanics and related groups, 19% are black / African American, 9% are South American and Alaska / American Indian, and 3% are Asian.
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In total, 41% of the participants had comorbidities associated with an increased risk of developing severe / critical COVID-19. Obesity – 28.5%, type II diabetes – 7.3%, hypertension – 10.3%, HIV – 2.8%.
This vaccine remains stable for two years at –20 ° C and for a maximum of three months at 2–8 ° C. It cannot be re-frozen if kept at 2-8 ° C.