Staff cautioned that data was limited for second dose of J&J vaccine
Food and Drug Administration staff gave their evaluation of J&J booster data as part of the agency’s review of the company’s request for authorization of a second dose.
After authorizing boosters for seniors and some high-risk people who have received the COVID-19 vaccine from Pfizer Inc.
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The FDA is now considering whether to approve additional doses of shots from J&J and Moderna. It is also being weighed whether dosages can be mixed between different vaccines.
FDA released its staff evaluation, along with other materials, regarding J&J’s booster request.
In a J&J analysis, a booster dose given six months after the original vaccine increased the level of neutralizing antibodies since the first dose, including the delta version. But FDA staff said the data was based on only 17 study subjects, and there were other confounding factors that limited the agency’s ability to assess the data.
In its request, J&J recommends that the booster be given six months or more after the first, although it can be given only after the first two months.
The FDA did not specify in its report whether it thought a two-month or six-month interval was better.
In another, much larger study, two doses of J&J vaccine, two months apart, were 75% effective against moderate to severe COVID-19 cases, FDA employees said.
FDA staff said efficacy was stronger for people ages 18 to 59, versus 77.6%, versus 66.2%.
“Although not independently confirmed by the FDA from the dataset, the summary of the data suggests that there may be benefit in a second dose administered approximately two months after the primary dose, when compared to the efficacy observed in the main study.” which tested only one dose of the vaccine, FDA staff said.