Biden administration expects J&J boosters in coming weeks

Johnson & Johnson plans to seek authorization for a booster dose for its unique COVID-19 vaccine earlier this week, according to a New York Times report.

J&J is the latest to seek recall authorization among the manufacturers of the three COVID-19 vaccines used in the United States. Still, it’s the reminder 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 delivered as a single injection. Its effectiveness lagged behind other vaccines throughout the pandemic.

Yet Moderna and Pfizer-BioNTech, both mRNA-based vaccines, have already submitted recall requests to US regulators. On September 22, the Food and Drug Administration authorized a booster dose of the Pfizer-BioNTech vaccine for certain groups of people. The decision was tense, with experts questioning whether a booster for the highly effective vaccine was badly needed.

Days later, Director Rochelle Walensky of the Centers for Disease Control and Prevention canceled her agency’s expert advisers by expanding the availability of the recall. A Pfizer-BioNTech recall is currently available in the United States for people 65 years of age and older, people living in long-term care facilities, people with underlying health conditions and those at high risk of dementia. ‘exposure.

The use of a Moderna COVID-19 booster can be even more controversial. The company announced on September 1 that it had filed an application with the FDA for a booster dose. But recent data suggests that its initial two doses offer the highest protection of any of the three available vaccines. A real-world study released by the CDC on September 24 found that the Moderna vaccine was 93% effective against hospitalizations due to COVID-19, while the Pfizer-BioNTech vaccine was 88% effective. Experts suspect that the higher effectiveness of Moderna may be explained by its higher dosage than the Pfizer-BioNTech vaccine and a longer interval between the first two doses (four weeks instead of three).

Another shot

J & J’s vaccine, meanwhile, was 71 percent effective against hospitalization. It is still considered a very effective vaccine, but it is inferior to the other options.

Two weeks ago, J&J announced it could boost protection with a second dose. If the second dose is given two months after the first, the vaccine’s efficacy increases to 94% against symptomatic infection and 100% against severe or critical illness. The levels of antibodies against the pandemic coronavirus also quadrupled in participants. When the booster is given even further, six months after the initial dose, antibody levels have increased twelve-fold, Johnson & Johnson reported.

The Biden administration and the FDA are wasting no time in making more boosters available. In an unusual move, the FDA scheduled a meeting for its advisory board to review a J&J booster last week, before the company submitted its request. The meeting is scheduled for October 15. The committee will likely be grappling with when a J&J booster should be given as well as vaccine combination strategies, for which there is currently little data. The committee will review Moderna’s recall on October 14.

In an interview on SiriusXM’s “Doctor Radio Reports” Friday, CDC director Walensky said the administration had “not forgotten all of those who got J&J and all of those who got Moderna.” She said she and the administration “anticipate that we will have our next steps in our booster vaccination campaign for these people in a few weeks.”