VRBPAC Unanimously Supports EUA for Janssen COVID-19 Booster Shot

Update at 1:40 PM: At the committee discussion before the first vote, several panelists interpreted the available data as suggesting that rather than a “booster,” Janssen should be initially administering 2 doses of the vaccine.

Again, some committee members raised concerns that the longevity of a single dose of Janssen makes the vaccine more suited to countries experiencing a vaccine shortage and still in need of primary doses. Fighting COVID-19 on a global scale requires vaccinating as many people as possible to achieve herd immunity before the virus can further mutate.

The panel voted on the question:

“1. Do available data support the safety and effectiveness of Janssen COVID-19 Vaccine for use under EUA as a booster dose in individuals 18 years and older at least 2 months after a single dose primary vaccination?”

All 19 panelists voted “yes.”

Notably, the panel elected to change the wording of the question from “6 months” to “at least 2 months” after the initial dose.

Having approved homologous boosters (2 doses of Janssen at least 2 months apart), VRBPAC moved on to discussing heterologous doses, or “mixing” different original vaccines and booster shots. Committee members were aware that many Americans are doing this anyway, and wanted to open a dialogue on the safety, efficacy, and efficiency of heterologous boosters.

The committee also debated the age range that should be approved for booster shots. Originally 65 years of age and older, some panelists voiced support for lowering the range to 40 years and older.

The 2-day meeting ended earlier than anticipated, with chairman Dr. Arnold Monto calling for the meeting to be closed before 3:30 p.m.

FDA representative Dr. Peter Marks expressed his gratitude to the VRBPAC for their work: “I feel like every member of the committee spoke up, and we got some really great feedback.”

Update at 12:20 PM: During the open public hearing, the Vaccine Considerations Project expressed concerns that the Janssen booster did not elevate immunity significantly enough to justify approving second doses, saying that these vaccines could instead be distributed to less wealthy countries that are still waiting for initial doses. One spokesman for the Vaccine Considerations Project also expressed frustration with the VRBPAC’s “unnecessarily tight deadlines,” which 1 spokesman argued prevent peers from contributing to the discussion; he went on to say that bureaucratic meetings like these “make a mockery of the idea of peer review.”

Another concern raised at the open panel hearing was the Janssen vaccine’s adverse effect of tinnitus, which one study showed to have a coincidence rate of 1 in 156.

A common question among the panel was whether there was even a necessity for a Janssen booster dose, given that unlike the mRNA vaccines, the efficacy remained high over 6 months after the initial dose.

Update at 10:21 AM: Janssen originally submitted their data to the VRBPAC panel on October 4, 2021, and this was formally presented by Dr. Johan Van Hoof at the public meeting. Van Hoof was fundamental in the development of the Janssen COVID-19 vaccine, and he presented trial data suggesting that 1 dose of the vaccine has 75% effective against mild to severe COVID-19 disease from 28 days after administration through at least 6 months.

Dr. Sebastian Schneeweiss supplemented the presentation with real-world evidence that largely matched the trial data. Dr. Dan Barouch advocated for the durability of the Janssen vaccine, which he demonstrated to be superior to the mRNA COVID-19 vaccines over time.

In their trials, Janssen administered a second “booster” vaccine to participants who had already received 1 dose of the Janssen vaccine at 2, 3, or 6 months after the first. Vaccine efficacy was monitored among participants 18-59 years of age and 60 years and older.

Both age groups had a mean increase in Spike-binding antibody titers of 4.6-fold after 2 months, 5.6-fold after 3 months, and 12.0 after 6 months. Thus, Janssen recommended the booster be administered 6 or more months after the first dose to maximize efficacy.

Update at 8:30 AM: The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today, October 15, to discuss potentially recommending Janssen Biotech Inc. for an Emergency Use Authorization (EUA) to allow booster dose administration in adults 18 years and older.

The Janssen (Johnson & Johnson) vaccine was the third COVID-19 vaccine to be granted an EUA, and the only single-dose vaccine approved in the US.

The VRBPAC public meeting is expected to run from 8:30 AM to 5 AM EST, concluding in a vote either supporting or rejecting Janssen’s request. The panel will make their decision after discussing available data, most of which was reported by Janssen after their ENSEMBLE booster dose trials. Janssen reported positive results from these trials, but earlier this week, the FDA questioned whether the trials used a test sensitive enough to accurately measure the immune response of the six-month booster.

With Pfizer-BioNTech approved to administer boosters to at-risk populations last month, and Moderna approved yesterday, Janssen will be hoping for a similar decision.

Follow further developments and discussion from the VRBPAC meeting today on Contagion as we cover the meeting through the panel’s vote this evening.