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Deciding which recipients of the Moderna and Johnson & Johnson coronavirus vaccine should receive booster shots can end up being even more complicated than the process for recipients of Pfizer.
Why is this important: More Americans may very well need another round of vaccines, especially the elderly and those who have received the single-dose J&J vaccine. But regulators have had issues with the amount of data available for the recall with Pfizer, and there is even less – at least publicly available for now – for the other two vaccines.
The big picture: The United States has relied heavily on data from other countries when it comes to making recall decisions, particularly Israel.
- Israel provided real data on the effect of the booster shots, as it started giving them to some people long before the United States. But these data only concerned the Pfizer vaccine.
- “If we had national data from the United States, the whole country, or even all healthcare workers, we would have been successful. But we have such poor data aggregation in this country,” Topol said, executive vice president of Scripps Research.
- “We don’t have Israel for Moderna or J&J, and that’s really unfortunate,” Topol added.
Between the lines: There are two main types of data regarding the recall process: data on the effectiveness of the initial dose over time and data on the effectiveness of a booster. The latter is more problematic.
- An FDA advisory committee ended up drastically reducing its Pfizer recall recommendation from what the company originally requested, saying there was not enough data to warrant a third injection for all. adult age groups.
- It was with real-world Israeli data, in addition to data submitted by the company.
- That same committee will review Moderna and J&J data, potentially in a few weeks. It’s unclear what data the companies will have submitted to the FDA by then, or what international data will be available by then.
- “The problem is, it extrapolates from many data sets the decline without evidence that the booster restores efficacy,” Topol said. “And we have a bunch of purists on these committees who don’t like to extrapolate a lot.”
Where he is : Moderna requested permission for a third shot for its recipients, but with a dose twice as small as the original two.
- J&J recently issued a press release describing the results of its clinical trials evaluating a second injection two and six months after the first.
- But it’s not clear whether full six-month data will be available by the time the FDA reviews the J&J boosters, according to a source familiar with the discussions. A second source familiar with the situation said full clinical trial results of a second dose of J&J after six months are not expected until early November.
- This could be problematic, as six months more reflects the difference in doses that most recipients of J&J would have. “Most of these people who’ve had the one-shot and done – they’re well over two months old right now,” Topol said. “What does that mean?”
- J&J declined to comment.
Yes, but: Even though regulators end up having less data to consider – which is still a big if – it may not matter much to the outcome.
- “It’s almost unimaginable now that they won’t approve the extra doses of Moderna and J&J. It would add more chaos to what has been a pretty lawless situation over the past few months,” the Cornell virologist said. John Moore.
The bottom line: If regulators got together today to decide on boosters for Moderna and J&J recipients, they would have less data to work with than a few weeks ago – and that could be a big deal.
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