(WXYZ) — Johnson & Johnson is one giant step closer to offering America a third vaccine for COVID-19. Documents released by the FDA indicate that the single-dose shot meets the requirements for Emergency Use Authorization.
This is great news and a critical step that really paves the way for approval. Now the FDA’s analysis says that there were no specific safety concerns and that side effects mainly consisted of headache, fatigue, and arm pain. The report is for the group of independent medical experts that are scheduled to meet tomorrow.
The Vaccines and Related Biological Products Advisory Committee will comb through the research from Johnson & Johnson’s clinical study – just like they did for Pfizer and Moderna. And if the committee believes that the evidence is strong enough, they’ll give the FDA a thumbs up. Then, it's up to the FDA to decide if they’ll accept the recommendation and grant Emergency Use Authorization.
I expect they’ll make a decision very soon, possibly over the weekend.
The efficacy rate did vary. Here in the US, Johnson & Johnson’s vaccine was found to 72% effective. In Latin American, it was 66%, and in South Africa, it was 57%. But looking at how well it did globally - with roughly 44,000 participants - the FDA’s analysis found that Johnson & Johnson’s vaccine was 66.1% effective at preventing moderate to severe COVID-19. And that was 28 days after getting the single-dose shot.
But when it came to the most serious symptoms, the vaccine was found to be 85% effective at preventing severe disease. And best of all, zero participants who got the shot died from COVID-19.
Johnson & Johnson’s vaccine effectiveness is not 94.1 or 95% effective like Moderna’s and Pfizers. But those trials were completed before we had widespread variants. So it’s possible that those numbers may not be quite as high given today’s situation.
Regardless, the bottom line is that Johnson & Johnson’s vaccine exceeded what the FDA originally set for vaccine efficacy – which was 50%. And it’s been shown to be effective against severe disease which is what most people, including my patients, are really worried about.
Now other advantages the vaccine offers:
- it’s just a single dose and not two doses so it’s a simpler process for both patients and vaccine providers
- it doesn’t have to be stored at ultra-cold temperatures and that makes it easier to transport and distribute
- and if approved, it’ll help get millions more Americans vaccinated
This means we could get our lives back and return to some sort of normalcy at a faster pace.