Following Robust Study Results on Its COVID-19 Booster, J&J Likely to Be Next to Seek Booster Approval

Johnson & Johnson (J&J) is poised to be the next company to jockey for approval for its COVID-19 vaccine booster, just days after FDA’s vaccine experts voted no on Pfizer-BioNTech’s booster for the general population.

The company released new data this week showing that its booster shot provides robust protection against COVID-19 at two months and six months, and that its single-shot vaccine provides high levels of immunity for at least five months.

J&J said the booster shot along with antibodies already in the system from the first shot provided 94 percent protection against COVID-19 in the U.S. when given two months after the initial one-dose shot. Antibody levels rose to four to six times higher than observed after the single shot, the company said.

When a booster was given six months after the initial shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster, irrespective of the age of the recipient, J&J said.

“We now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly,” said Paul Stoffels, the company’s chief scientific officer.

J&J has sent the data to the FDA and says it plans to submit it to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide.

The data are from two sources — a phase 3 trial the company conducted and “the largest real-world evidence study for a COVID-19 vaccine reported to date” with 390,000 people who got the J&J vaccine vs. approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity conducted from March to late July 2021, the company said. J&J said the results it got from the real-world evidence study on boosters mirror results from its phase 3 study.

Though the data look favorable, J&J may have a hard road ahead for approval of a booster shot. Last week, an FDA advisory panel voted no on a booster from Pfizer-BioNTech for the general population, saying the FDA needed to see more evidence that a booster is needed for everyone. Pfizer-BioNTech relied heavily on a large observational study from Israel as their evidence (DID, Sept. 20).

Among the dissenting panelists were the FDA’s Marion Gruber and Phil Krause, who recently penned a paper in The Lancet arguing that while evidence about boosters is still being gathered, it makes more sense to ensure that unvaccinated populations get vaccinated first than to provide boosters to those who have already gotten shots (DID, Sept. 14).

Both Gruber and Krause announced their resignation in recent weeks, hinting at internal conflicts over the booster program (DID, Sept. 1).

The FDA’s advisory panel voted no on Pfizer-BioNTech’s booster just days before the Biden administration had hoped to start administering boosters to the general public (DID, Aug. 20).

For populations at high risk, however, the FDA is all in on boosters. In August, the FDA granted Emergency Use Authorization (EUA) for a booster shot of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for the immunocompromised (DID, Aug. 12).

And at the FDA advisory panel meeting last week, the panel voted 18-0 in favor of having the EUA encompass healthcare workers, those over the age of 65 and those at high risk because of existing comorbidities. The FDA usually approves of the recommendations of the advisory panel although it doesn’t have to. And the boosters issue will also very soon be reviewed by a panel of experts at the Centers for Disease Control and Prevention.

J&J’s just released real-world evidence study demonstrated stable vaccine effectiveness of 79 percent for J&J’s single-shot vaccine and 81 percent for COVID-19-related hospitalizations, with no evidence of reduced effectiveness over the five months of the study, including when the Delta variant became dominant in the U.S., the company said.

The J&J single-shot COVID-19 vaccine was developed by its subsidiary, Janssen. It got an EUA in the U.S. on Feb. 27, 2021, and conditional marketing authorization from the European Commission on March 11. — Suz Redfearn