FDA Advisers Recommend Booster of Johnson & Johnson's COVID-19 Vax

An advisory panel for the Food and Drug Administration (FDA) voted unanimously on Oct. 15 to recommend that the agency authorize a booster dose of the Johnson & Johnson COVID-19 vaccine for people ages 18 and older.

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  • An independent panel voted to recommend the use of a J&J booster in people ages 18 and older, at least 2 months after the initial dose.
  • The FDA will decide whether to accept the advisory committee’s recommendation.
  • The need for a booster shot was also prompted by concerns about waning levels of protection after vaccination.

An advisory panel for the Food and Drug Administration (FDA) voted unanimously on Oct. 15 to recommend that the agency authorize a booster dose of the Johnson & Johnson COVID-19 vaccine for people ages 18 and older.

The panel also recommended that the booster be given at least 2 months after the first dose.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19 to zero in favor of the agency issuing an emergency use authorization (EUA) for the J&J booster.

The FDA will decide whether to accept the advisory committee’s recommendation.

After that, the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee will meet on Oct. 21 to discuss COVID-19 vaccine boosters.

More than 15 million Americans have received the single-dose J&J vaccine, according to the CDC.

The FDA has already issued EUAs for boosters of the Pfizer-BioNTech and Moderna-NIAID vaccines. These approvals are restricted to certain adults who are at higher risk of COVID-19 or complications due to infection with the coronavirus.

Some panelists see this as a 2-dose vaccine

At the meeting, J&J representatives presented U.S. clinical trial data that showed that a 2-month boost provided 93.7 percent protection against moderate and severe or critical COVID-19.

This puts it in line with the protection offered by two doses of the mRNA vaccines.

J&J representatives cautioned that the highly transmissible Delta variant was not spreading widely in the United States at the time of this study.

A 2-month boost of the J&J vaccine also offered 100 percent protection against severe or critical COVID-19.

J&J representatives also presented data suggesting that a booster given 6 months after the initial dose provided a stronger immune boost, compared with the 2-month interval.

However, this was based on immunological readings on only 17 people. Several panelists expressed concern about this “scant” amount of data.

Some also suggested that one dose of the J&J vaccine may not offer enough protection, given its lower effectiveness than the full mRNA vaccine regimen.

“I think this frankly was always a two-dose vaccine. It’s hard to recommend this as a one-dose vaccine,” said Dr. Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia.

J&J plans to continue marketing this as a single-dose vaccine.

A single-dose vaccine does have some advantages, especially in reaching populations that may not return for a second dose, such as those who are homeless or living in remote areas.

Concerns about waning protection against infection

The need for a booster was also prompted by concerns about waning levels of protection after vaccination.

Data from the CDC shows that rates of COVID-19 and related deaths are much lower in people who have received one of the three approved vaccines, compared with people who are unvaccinated.

However, studies show that there is an increased risk of infection the further people get from their vaccination date.

Data presented at the meeting showed that a single dose of the J&J vaccine offered 72 percent protection against moderate and severe or critical COVID-19 up to 28 days after vaccination.

By around 4 months, this had dropped to 42.2 percent.

Some of this waning may be due to vaccine-resistant variants in areas outside the United States, FDA scientists said in a briefing document.

During the meeting, the CDC’s Dr. Amanda Cohn suggested that without a booster, the J&J vaccine is not as effective as the mRNA vaccines.

She shared real-world data from the CDC, which showed that a single dose of the J&J vaccine was only 68 percent effective against hospitalization in adults who were not immunocompromised.

“Additionally there was some other data to suggest that real-world effectiveness is hovering more in the 50 percent to 60 percent [range], and this is from some data from a different surveillance system,” she added.

Some panelists felt that people who had received a single dose of the J&J vaccine should be given the opportunity to increase their protection with a booster.

“I would say I agree a second-dose booster is needed to boost immunity back to the 90-plus range,” Dr. Archana Chatterjee, a pediatric infectious diseases expert at Rosalind Franklin University in Chicago, said during the meeting.

This story originally appeared on: Healthline.com - Author:Shawn Radcliffe