With input from Dr Monica Vasudev

1341: J&J COVID-19 Vaccine Effective Against Severe Disease

1. Johnson & Johnsons single dose vaccine candidate against COVID-19 has been found to be 66% effective against moderate to severe COVID-19, reported a multinational phase III trial. The vaccine efficacy was 72% in the U.S. cohort.
2. According to interim data, there were 468 symptomatic cases of COVID-19 among 43,783 adult participants in the U.S., Latin America and South Africa, included in the ENSEMBLE trial. The vaccine met the co-primary endpoints - protection against symptomatic COVID-19 at day 14 and day 28 after vaccination.
3. The primary outcome did not count mild COVID-19 cases, while the vaccines from Pfizer/BioNTech and Moderna did while reporting efficacy rates of nearly 95%.
4. The new trial included co-primary endpoints of moderate-severe illness that were evaluated at 14 days and 28 days following vaccination.
5. In the ENSEMBLE trial, moderate disease was defined as a positive PCR test with at least one of the following: pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation >93%, or respiratory rate ≥20; or two or more systemic symptoms indicating COVID-19.
6. Severe COVID-19 was characterized by signs of severe systemic illness, ICU admission, respiratory failure, shock, organ failure or death, among other factors, and a positive PCR test.
7. No deaths were reported in the vaccine group, while there were five deaths in the placebo group that were related to COVID-19. Overall, there were 3 deaths in the vaccine group and 13 in the placebo group.
8. This vaccine uses an adenovirus vector to deliver the genetic material that encodes coronavirus spike protein elements. It can remain stable for months at refrigerator temperatures.
9. Another phase III trial - ENSEMBLE 2 - is being conducted wherein participants will be given two doses, at a gap of about 2 months.
10. For combined endpoints, protection in the U.S. was reported to be 72%; it was 66% in Latin America and 57% in South Africa, where a vast majority of cases was due to the South African variant.
11. The vaccine yielded 85% protection against severe disease, even in regions with variants.
12. The vaccine yielded 100% protection against hospitalization and death after day 28 of vaccination. There was sustained holding of immunity at 28 days.
13. Protection was observed across all age groups, comorbidities, races and ethnicities.[Source: Medpage Today]

 Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA