October 14, 2021 – The U.S. Food and Drug Administration (FDA) has found potential benefit to a second dose of the Johnson & Johnson COVID-19 vaccination. According to a report from The Washington Post, the FDA released a data review with the results, potentially suggesting that a Johnson & Johnson booster could be warranted over additional doses of the other coronavirus vaccines.
FDA staff wrote, “Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose.” Because much of the data wasn’t submitted in time, large parts of the FDA’s review will depend on the company’s analysis. Many experts believed the one-shot Johnson & Johnson vaccine would require a second dose since the beginning of the vaccine push. This review opens the door for discussions about the safety and necessity of a booster dose.
One study found that two doses 56 days apart were “75% effective, and 100% effective against severe disease.” Another study found that antibodies increase from a booster after two to three months, but still not as much as when the booster was given six months later. The FDA has asked an expert panel to “whether a second shot should be authorized at two months, or with at least a six month gap,” among other things.
In its initial trial, the Johnson & Johnson vaccine was less effective than the messenger RNA vaccines developed by Pfizer-BioNTech and Moderna. Additionally, there were reports of a slim risk of blood clotting. Even with a lower level of efficacy, Johnson & Johnson still protects people against severe symptoms and death.
While the FDA hasn’t made an official decision on the necessity of booster doses for Moderna or Pfizer-BioNTech, this new data suggests that the FDA sees more of a need for a Johnson & Johnson booster.