One-shot Covid-19 Vaccine by Johnson & Johnson deemed safe by FDA

Much awaited One-shot Covid-19 Vaccine by Johnson & Johnson named Janssen has been declared safe and effective by the US Food and Drug Administration (FDA). As per the FDA, Johnson & Johnson has submitted safety and efficacy data from an ongoing multi-national Phase 3 randomized, double-blind and placebo-controlled trial of a single dose (5×1010 vp) of Ad26.COV2.S in approximately 40,000 participants. J&J is inline for being only the third Vaccine to be approved by the FDA after Moderna and Pfizer.

Third Vaccine to be approved by FDA

The FDA on October 22, 2020 approved Moderna brand remdesivir for use in adult and pediatric patients 12 years of age and 10. Later on December 11, 2020, FDA issued approval for the Pfizer-BioNTech COVID-19 vaccine for active immunization for the prevention of COVID-19. Both Vaccines require 2 doses 4 weeks apart while the current Vaccine from Johnson & Johnson is considered a game-changer.  The Johnson & Johnson vaccine also doesn’t require special refrigeration for shipment and storage. The FDA review noted that an international study of about 40,000 people, half of whom got the vaccine and half of whom got a placebo, found the company’s vaccine to be 66% effective overall in preventing moderate to severe COVID-19 disease. The study was conducted in the U.S., Latin America and South Africa.

In clinical trials, the Johnson & Johnson vaccine appears to be 66% effective at preventing moderate to severe cases of COVID-19 — compared to about 95% for Moderna and Pfizer.

As per J&J data, the candidate was 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.