Johnson & Johnson plans to seek authorization for a booster dose for its one-shot COVID-19 vaccine early this week, according to a report by The New York Times.
J&J is the last to apply for booster authorization among the makers of the three COVID-19 vaccines used in the US. Yet, it is the booster that many health officials are most eager to see. The vaccine, which uses a viral vector strategy rather than an mRNA-based design, is the only available COVID-19 vaccine given as just one shot. Its efficacy has lagged behind the other vaccines throughout the pandemic.
Still, Moderna and Pfizer-BioNTech, both mRNA-based vaccine, have already submitted booster applications to US regulators. On September 22, the Food and Drug Administration granted authorization for a booster dose of the Pfizer-BioNTech vaccine for certain groups of people. The decision was tense, with experts torn over whether a booster for the highly effective vaccine was widely needed.
Days later, Director Rochelle Walensky of the Centers for Disease Control and Prevention overruled her agency’s expert advisors by widening availability of the booster. A Pfizer-BioNTech booster is currently available in the US to people 65 years and older, people living in long-term care settings, people with underlying medical conditions, and people with high risk of exposure.
Use of a Moderna COVID-19 booster may be even more contentious. The company announced September 1 that it had initiated an FDA submission for a booster dose. But recent data suggests its initial two doses provide the highest protection of any of the three available vaccines. A real-world study published by the CDC September 24 found that the Moderna vaccine was 93 percent effective against hospitalization from COVID-19, while the Pfizer-BioNTech vaccine was 88 percent effective. Experts suspect Moderna’s higher efficacy may be explained by its higher dosage than the Pfizer-BioNTech vaccine and longer interval between the first two doses (four weeks rather than three).
J&J’s vaccine, meanwhile, was 71 percent effective against hospitalization. That’s still considered a very effective vaccine, but it is lower than the other options.
Two weeks ago, J&J announced that it could boost protection with a second dose. If the second dose is given two months after the first, vaccine efficacy rises to 94 percent against symptomatic infection and 100 percent against severe or critical disease. Antibody levels against the pandemic coronavirus also increased in participants by fourfold. When the booster is given even farther out—six months after the initial dose—antibody levels jumped twelvefold, Johnson & Johnson reported.
The Biden administration and the FDA are not wasting any time in making more boosters available. In an unusual move, the FDA scheduled a meeting for its advisory committee to review a J&J booster last week, before the company has submitted its application. The meeting is scheduled for October 15. The committee will likely grapple with when a J&J booster should be given as well as vaccine mix-and-match strategies, for which there is little data currently. The committee will review Moderna’s booster October 14.
In an interview Friday on SiriusXM’s “Doctor Radio Reports,” CDC director Walensky said the administration has “not forgotten about all of those who have gotten J&J, and all of those who have gotten Moderna.” She said that she and the administration “anticipate we will have our next steps in our booster vaccination campaign for those people in a few short weeks.”