CMAAO CORONA FACTS and MYTH J and J vaccine

Dr K Aggarwal, President CMAAO, HCFI, With input from Dr Monica Vasudev

India

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New Delhi, January 31, 2021 :

J&J COVID-19 Vax Effective Against Severe Disease

1. Johnson & Johnson’s COVID-19 one-dose vaccine candidate was 66% effective overall against moderate to severe COVID-19 in a multinational phase III trial, and 72% effective in the U.S. cohort
2. Interim data showed 468 symptomatic cases of COVID-19 from 43,783 adult volunteers in the U.S., Latin America and South Africa, who comprised the phase 3 ENSEMBLE trial. The one-dose vaccine met its co-primary endpoints, which was protection against symptomatic COVID-19 at day 14 and day 28 following vaccination.
3. The primary outcome did not count mild COVID-19 cases, whereas the vaccines now in distribution from Pfizer/BioNTech and Moderna did while achieving efficacy rates close to 95%.
4.  The new trial had co-primary endpoints of moderate-severe illness assessed at 14 days and 28 days after dosing.
5.  ENSEMBLE trial defined moderate COVID as a positive PCR test plus at least one of the following: evidence of pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation above 93%, or respiratory rate ≥20); or two or more systemic symptoms suggestive of COVID-19.
6. Moderna and Pfizer, on the other hand, defined cases more liberally; a cough plus positive PCR test was enough to count toward their primary endpoints.
7.  Criteria for severe COVID-19 in ENSEMBLE included “signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors,” as well as a positive PCR test
8.  There were no deaths in the vaccine group, and five deaths in the placebo group related to COVID-19, and 13 deaths in the placebo group and three deaths in the vaccine group overall.
9.  The vaccine uses an adenoviral vector to deliver genetic material encoding coronavirus spike protein elements. It is stable for months at refrigerator temperatures.
10. The company is also conducting another phase III trial called ENSEMBLE 2 in which participants will receive two doses, about 2 months apart.
11. For combined endpoints, protection in the U.S. was 72%, with 66% in Latin American countries and 57% in South Africa, where most cases were due to the South African variant.
12. The vaccine reportedly showed 85% protection against severe disease, even in regions such as South Africa with variants, and said this had “important domestic and public health implications.”
13. The vaccine provided “100% protection against hospitalization and death” post-day 28 of vaccination. It also showed “continued, sustained holding of immunity at 28 days, and may get better with time.
14. The vaccine showed protection across all age groups, comorbidities, races and ethnicities in the trial.

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