Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA analysis finds J&J’s single-dose COVID-19 vaccine is safe, effective

By Sean Whooley | February 24, 2021

Johnson & JohnsonAn FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective.

The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA application for the vaccine developed by its Janssen unit on Feb. 4.

According to the FDA briefing, the J&J vaccine candidate is 66% effective at preventing moderate and severe cases of COVID-19, falling within the administration’s standards for authorization, while it is also safe to use. The vaccine proved to be 85.4% effective in preventing severe cases while completely preventing hospitalizations and deaths. There were seven deaths in J&J’s Ensemble Phase 3 clinical trial, all of which occurred in the placebo group.

Should J&J’s vaccine candidate receive EUA, it would be the third, following those developed by Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE). However, it would be the first single-dose vaccine, as the previously authorized ones require two shots administered weeks apart.

The single-dose COVID-19 vaccine is estimated to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). J&J plans to ship it using the same cold chain technologies it uses to transport other medicines.

FDA’s analysis did reveal lower efficacy for the vaccine in South Africa, where a major variant of COVID-19 originated, as the U.S. efficacy came in at 72% compared to 57% in South Africa. Additionally, reduced efficacy was observed in a subgroup of adults over 60 years old with underlying conditions, but no deaths or cases requiring medical intervention occurred a month after those in the group received vaccines.

Johnson & Johnson expects to have product available to ship immediately following FDA authorization, as well. Johnson & Johnson set its target to produce 1 billion doses in 2021 and expand production after that. The company has committed to not-for-profit pricing during the pandemic assuming its single-dose vaccine is authorized by FDA and other regulators. J&J is also investigating a two-dose regimen for its vaccine.

The Hill reported that the company said it will have about 4 million doses prepared for immediate shipping after authorization, with a plan to provide 20 million doses by the end of March and 100 million by the summer.


Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease
Tagged With: coronavirus, covid-19, COVID-19 vaccine, COVID-19 vaccine trial, FDA, Johnson & Johnson
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

Diversity
Making diversity in clinical research more than a talking point
psychedelic medicine discussed at SXSW
5 headwinds and 5 tailwinds for psychedelic medicine
lab microscope
Accelerating R&D with FAIR data
Kallyope
Kallyope’s focus on the gut-brain axis yields a diverse portfolio

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Medtech100 Index
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50