U.S. Food and Drug Administration (FDA) scientists on Wednesday gave a more positive view towards Johnson & Johnson
"Although not independently confirmed by FDA from datasets, summaries of the data suggest there are may be a benefit in a second dose administered approximately 2 months after the primary dose, when compared to the efficacy seen in the pivotal study COV3001," FDA staff wrote in a 54-page document released on the agency's website Wednesday.
FDA staff also noted that one dose J&J was consistently less effective compared to other authorized COVID vaccines developed by Pfizer-BioNTech and Moderna in both clinical trials and real-world studies; J&J's vaccine was found to by 72% effecting in the U.S., while Pfizer-BioNTech and Moderna's vaccines boast efficacy rates around 90%. This can be due in part to the J&J shot using a different vaccine technology, with the company using a modified adenovirus to induce an immune response against COVID-19, while Pfizer-BioNTech and Moderna use messenger RNA (mRNA), which "trains" the body's immune system to attack the COVID-19 virus.
A second dose of J&J's vaccine boosts the shot's effectiveness to be on par with its mRNA competitors, offering 94% protection against symptomatic infection when administered two months after the first dose in the U.S., the company said recently.
Overall, as with both Pfizer-BioNTech and Moderna's shots, FDA staff concluded that data shows a single dose of the J&J vaccine "still affords protection against severe COVID-19 disease and death in the United States," according to the report. The report is meant to brief the agency's Vaccines and Related Biological Products Advisory Committee ahead of their scheduled meeting on Friday to discuss the safety and effectiveness of an additional J&J COVID dose for adults.
If the agency's advisory panel votes to recommend a second dose, the FDA could make a final decision within the next few days following Friday's meeting. From there, the Centers for Disease Control and Prevention's (CDC) own vaccine advisory committee will vote, and, if they approve, the CDC will make the final decision, which will likely happen next week.
