Pharmaceutical developer Johnson & Johnson is seeking emergency use authorization from the Food and Drug Administration for its COVID-19 booster vaccine for people 18 years and older.
The company claims that a booster dose given six months after the initial one-dose regimen increases antibodies 12 times during the first month following administration of the booster and is 94% effective against symptomatic infection.
“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” Mathai Mammen, global head of research and development with Johnson & Johnson, said in a Tuesday statement. “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
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In September, the company submitted data showing a booster shot administered two months after the initial vaccination resulted in a four- to sixfold increase in antibody levels compared with those produced by a single shot, but the inoculation remained a single-dose regimen — unlike the two-shot schedules offered by Pfizer and Moderna.
Johnson & Johnson is the third pharmaceutical company to request authorization for booster shots, with the Centers for Disease Control and Prevention giving emergency authorization last month to Pfizer boosters for individuals 65 years or older and adults with underlying conditions. The approval was fraught with tension, however, as a CDC panel split with the FDA on whether front-line workers should be eligible, with the CDC panel voting “no” and FDA voting “yes.” CDC Director Rochelle Walensky overruled her agency’s panel on the matter.
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Moderna began submitting data to the FDA in early September in hopes of also being approved for boosters, but the company has yet to gain approval for the additional shots. President Joe Biden, who has been advocating for a prompt rollout of widely available boosters, received his third dose of the Pfizer vaccine on camera on Sept. 27.
Of the 185.8 million U.S. residents who are fully vaccinated against COVID-19, 5.7 million have received booster shots and 15 million have received Johnson & Johnson’s one-shot inoculation, according to the CDC.
