In a new analysis, the Food and Drug Administration questioned the strength of the evidence Johnson & Johnson provided in its application for booster shots. A key test used by the company probably wasn’t sensitive enough, the agency suggested, adding that it didn’t have enough time to independently assess much of the raw data from the studies.
The document, released ahead of a Friday meeting of the agency’s vaccine advisers, could have a significant impact on whether the 15 million Americans who received the single-dose vaccine should receive a second shot, or whether they will instead. are urged to get a different brand of vaccine for added protection.
The agency’s analysis follows a report released Tuesday in which Johnson & Johnson argued for a booster, with data from a number of studies.
“A booster dose is recommended after 6 months or later, based on the strength of immune responses,” the company wrote.
But on Wednesday, the FDA said the test used by the company to measure the immune response of a six-month boost — known as a psVNA assay — isn’t sensitive enough for the task. The agency also wondered if the increase in immune response was as great as the data suggested.
“It is likely that the observed results are due to the low sensitivity of the psVNA assay used,” the FDA stated in its report.
The FDA saw a potential improvement in the protection of a J. & J. booster given two months after the first injection, based on a large trial sponsored by the company.
“While not independently confirmed by the FDA from data sets, summaries of the data suggest that there may be a benefit in a second dose administered approximately 2 months after the primary dose,” the agency said in its report.
The fact that the FDA had not independently confirmed key data was a departure from previous briefing documents for other vaccines. The FDA said it didn’t have time to review much of Johnson & Johnson’s material before the meeting later in the week.
The agency scheduled the meeting of its outside advisors before the company even submitted its application for a booster dose — an unusual move, some public health experts said.
“Except where noted, the data sets were not submitted in a timely manner for the FDA to conduct an independent review to verify the sponsor’s analyses,” the FDA said in its report.
A Johnson & Johnson spokesperson did not immediately respond to a request for comment.
The FDA has already approved an additional injection of the Pfizer-BioNTech vaccine for people over the age of 65, or with health conditions or job exposure that puts them at higher risk. Moderna has also filed for a booster to be reviewed by FDA advisors on Thursday. It may also be allowed to, despite limited evidence that the protection offered by an initial two doses of Moderna is waning.
When Johnson & Johnson’s vaccine was approved in February, it had several advantages over the other two. As a single injection, it was more convenient than the two-dose formulation of Moderna and Pfizer-BioNTech. It also didn’t need to be frozen to remain viable. But it also offered less robust protection.
What you need to know about Covid-19 booster shots
The FDA approved booster shots for a select group of people who received their second dose of the Pfizer-BioNTech vaccine at least six months ago. That group includes: Pfizer recipients who are 65 years of age or older or live in long-term care facilities; adults at high risk of severe Covid-19 due to an underlying medical condition; health professionals and others whose jobs endanger them. People with weakened immune systems are eligible for a third dose of Pfizer or Moderna four weeks after the second injection.
Regulators have not yet authorized booster shots for recipients of the Moderna and Johnson & Johnson vaccines, but an FDA panel is scheduled to meet to weigh booster shots for adult recipients of the Moderna and Johnson & Johnson vaccines vaccines.
The CDC has said the conditions that qualify a person for a booster injection are: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney, or liver disease; dementia and certain disabilities. Pregnant women and (ex-)smokers are also eligible.
The FDA approved boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The CDC says that group includes: medical workers; education workers; food and agricultural workers; factory workers; corrections employees; US Postal Service workers; employees in public transport; grocery store workers.
It is not recommended. For now, recipients of the Pfizer vaccine are advised to get a Pfizer booster shot, and recipients of Moderna and Johnson & Johnson will have to wait until booster doses from those manufacturers are approved.
Yes. The CDC says the Covid vaccine can be administered without regard to the timing of other vaccines, and many pharmacies allow people to schedule a flu shot at the same time as a booster dose.
A clinical trial showed that one dose of J. &. J. had a 66 percent efficacy rate against moderate to severe Covid-19 worldwide and 74 percent in the United States. Its efficacy against serious or critical illness was stronger, at 85 percent worldwide.
Johnson & Johnson included in its booster application the results of another large-scale trial that began in November, where they gave half of their volunteers a second dose two months after the first. The other half received a placebo.
In August, the company announced that in its portion of the study that took place in the United States, efficacy rose to 94 percent. But in its report, the FDA focused on the global results, with the increase more modest, reaching 75 percent.
Against severe to critical Covid-19, two shots had 100 percent efficacy. But regulators warned in the analysis posted Wednesday that there was little data from that trial on the Delta variant, which now causes the vast majority of infections in the United States.
“The small number of acquired cases confirmed to be caused by the Delta variant precludes any conclusion about efficacy against that variant,” they wrote.