Johnson & Johnson’s vaccine passes the FDA panel of specialists and is predicted to ship 3.9 million doses subsequent week
The numbers Johnson & Johnson provided were the ones at any point in time for patients who had received their vaccine. In particular, these numbers apply to patients who are more than 28 days after vaccination. Beyond this point, however, the numbers continue to improve. In both studies, no patient was hospitalized with a severe case of COVID-19 more than 45 days after vaccination. However, as the experts pointed out, this number could be misleading, in part because few patients were in the study for much longer than 45 days at the time the data was collected, and a significant number had not yet reached this milestone.
Some of the panelist’s discussions stemmed from this schedule and concerns about how Americans might react after vaccination. In every study – including that of Pfizer and Moderna – there were significant numbers of patients who became infected in the first week after vaccination. It seems that some patients respond to the idea of vaccination by lowering their guard almost immediately. However, all of these vaccines will take some time to effectively stop COVID-19. There is evidence that the two mRNA vaccines may be about 85% effective about three weeks after the first dose, even if the second dose is not given. For the Johnson & Johnson vaccine, waiting a full month for the vaccine to achieve 72% effectiveness can be a test that many of the vaccinated patients fail.
Another point of discussion was a second attempt that Johnson & Johnson is currently carrying out. In this study, patients will receive two doses of their current vaccine about a month apart. The study will test whether the second dose increases the level of the immune response in a way that may be more effective against the growing threat of more contagious, virulent, and evasive variants of the SARS-CoV-2 virus. However, Johnson & Johnson does not appear to believe that this will actually become a “two-dose vaccine”. Instead, these efforts appear to resemble the work of Pfizer and Moderna to develop a “booster” against the growing number of variants. The two-dose study is unlikely to be completed before July.
In the meantime, the panel had no problem making a unanimous recommendation for approval. The FDA could issue an EUA as early as Saturday, with the vaccine expected to be available in some locations on Monday.
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