Data from federal scientists raises questions about J.&J. booster shots

People who have received a Johnson & Johnson coronavirus vaccine may be better off with a booster shot of Moderna or Pfizer-BioNTech, according to preliminary data from a federal clinical trial published Wednesday.

That finding, along with a mixed Food and Drug Administration review of Johnson & Johnson’s case for an authorization of its booster, could spark a heated debate about how and when to offer additional injections to the 15 million Americans who have received the single dose vaccine.

The agency’s panel of vaccine advisors will meet Thursday and Friday to vote on whether or not to recommend that the agency allow Moderna and Johnson & Johnson to offer booster shots.

Despite questions raised by the new data on the strength of Johnson & Johnson’s boosters, some experts expected the agency to clear the injections anyway, given that the effectiveness of the single vaccine is lower than that of the two doses of mRNA. vaccines made by Moderna and Pfizer-BioNTech. And the wider public may also expect the authorizations, given the Biden administration’s insistence on boosters of all brands.

After the agency approved a booster from Pfizer-BioNTech last month, “the die was cast,” said John Moore, a virologist at Weill Cornell Medicine.

The Pfizer and Moderna vaccines are by far the most widely used in the United States, with more than 170 million people in the United States being fully immunized with one vaccine or the other. When Johnson & Johnson’s was authorized in February, public health experts were eager to implement the “one-time” option, especially in communities with poor access to health care. But the shot’s popularity plummeted when the FDA later stopped using it to investigate rare cases of blood clotting.

For those who have received the Johnson & Johnson vaccine, the timing of a booster authorization — of any brand — is still uncertain. The FDA panel won’t vote until Friday on whether the agency should allow a second dose of the Johnson & Johnson vaccine, a scenario the Centers for Disease Control and Prevention’s own vaccine advisory committee will discuss next week. If both agencies believe that an extra dose should be offered, people can look it up as early as next week.

Whether the FDA could authorize the mix-and-match approach, and how, is unclear. The strategy will be discussed at the Bureau’s Bureau meeting on Friday, but there will be no voting. Ultimately, if regulators believe there is enough scientific support for the approach, they should probably update the authorization language of the Moderna and Pfizer-BioNTech vaccines to allow them to be used in people who initially received Johnson & Johnson’s.

In a study conducted by the National Institutes of Health, researchers organized nine groups of about 50 people each. Each group received one of three approved vaccines, followed by a booster. In three groups, volunteers received the same vaccine for a boost. At the other six they switched to another brand.

The researchers found that those who received a Johnson & Johnson shot followed by a Moderna booster saw their antibody levels rise 76-fold within 15 days, while those who received a new dose of Johnson & Johnson saw only a fourfold increase over the same period. A Pfizer-BioNTech booster injection increased antibody levels in Johnson & Johnson recipients 35-fold.

The authors cautioned about the small size of the study, noting that they did not follow the volunteers long enough to identify rare side effects.

Scott Hensley, an immunologist at the University of Pennsylvania who was not involved in the new study, found the results compelling. However, he noted that the trial only looked at antibody levels, which by themselves are not enough measures of how well different combinations of vaccines would reduce Covid-19 infections and hospitalizations.

“Ultimately, people with the Johnson & Johnson should probably get an mRNA booster,” he said. “It’s just a matter of, how much data does the FDA need before making that recommendation?”

“I wouldn’t want to be in their shoes,” he added.

Some scientists wonder how the federal government is considering boosters of any brand, given the limited data provided not only by Johnson & Johnson, but the other companies as well.

“Some of us would like to see more data,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “And then there are others who just want to move on with boosters.”

Earlier on Wednesday, an FDA analysis questioned an important test used by the company, known as a psVNA assay, and said it may have biased the findings.

“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 regulators also said they didn’t have enough time to independently review much of the raw data from the company’s investigations.

The FDA saw a potential improvement in the protection of a Johnson & Johnson booster given two months after the first injection, based on a large trial sponsored by the company. Some scientists have argued that the vaccine should have been a two-dose injection from the start.

“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 two months after the primary dose,” the agency said in its report.

Johnson & Johnson said in a statement it looks forward to discussing the data on Friday, when panelists will also hear a presentation about the mix-and-match study.

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.

The FDA’s discussion this week about the Johnson & Johnson vaccine has major implications for the future of the injection in the United States, said Jason L. Schwartz, an associate professor of health policy at the Yale School of Public Health. The vaccine was already unlikely to become more accepted in the country in the long term, he said. And when the FDA eventually recommends a booster shot for Johnson & Johnson recipients of a different vaccine, he added, “It’s hard to see what people are going to get at the J.&J. vaccine.”

The FDA has already approved an additional shot of the Pfizer-BioNTech vaccine for people over age 65, or for people ages 18 to 65 with underlying health conditions or job exposures that put them at higher risk. Moderna’s application, which will be discussed Thursday, may also gain authorization despite limited evidence that the protections offered by Moderna’s initial two-dose regimen are diminishing.

Regulators wrote Wednesday that a single injection of the Johnson & Johnson vaccine “still protects against severe Covid illness and death in the United States.” But they also said the highest estimates of protection, including for severe Covid, were “consistently less than the highest estimates of effectiveness” for the Moderna and Pfizer-BioNTech shots.

A clinical trial showed that one dose of J.&.J. had an efficacy rate of 66 percent against moderate to severe Covid 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 2020, 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 the FDA’s report focused on the global results, with the increase more modest, reaching 75 percent.

dr. Hensley cautioned that the efficacy estimates of the studies had a fairly wide range of uncertainty. “What that tells you is that the small changes in effectiveness here could be due to chance,” he said.

Against severe to critical Covid disease, 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 emphasis on improving Johnson & Johnson’s vaccine with a second injection “reflects the fact that our strengthening conversation has shifted in recent weeks to not just preventing serious cases, hospitalizations and deaths. It’s shifted to how we prevent infections, period,” said Dr. Schwartz. “J.&J. was behind from the start.”

In August, when top health officials in the Biden administration announced plans to potentially administer booster shots to recipients of Moderna and Pfizer-BioNTech in September, they said they expected those who received Johnson & Johnson’s injection would also need one. would have, although more data was needed.

That announcement “set unreasonable expectations” for those who had received the Johnson & Johnson vaccine, said Dr. Schwartz, and “made the J.&J. conversation that much more confusing.”

Sharon LaFraniere contributed from Washington.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button