FDA Is Skeptical About Need for Johnson & Johnson, Moderna COVID-19 Booster Shots

The agency has a 2-day meeting scheduled for this week for an independent advisory panel to discuss the available data.

New reports from the FDA suggest that there may not be a need for COVID-19 booster shots from Johnson & Johnson and Moderna, with a 2-day meeting scheduled later this week for an independent advisory panel to discuss the available data.

A briefing document released in advance of the meeting questions the data from Johnson & Johnson supporting its booster shot, suggesting that a key test was not sensitive enough. Furthermore, the document says that FDA officials did not have enough time to independently review all the raw data from the trials.1

The FDA indicated that there was not enough evidence of the booster shot in relation to the Delta variant or benefits for older patients.2

Johnson & Johnson used a psVNA assay to measure the immune response of patients who received the 6-month booster shot, which officials say has low sensitivity.1

One dose of the Johnson & Johnson vaccine was consistently less effective than the 2-dose mRNA vaccines, but “still affords protection against severe COVID-19 disease and death in the United States,” according to the briefing.1

Data submitted by Moderna shows that an additional half-dose of the vaccine administered 6 months after the second can increase antibody levels. However, the briefing document does not suggest whether FDA officials think that a third shot is necessary.3

Moderna submitted the request stating that the vaccine potency wanes overtime, so a booster shot would neutralize antibodies 6 to 8 months after the second dose.3

There was no indication from the company as to whether the booster would be necessary in preventing severe disease or hospitalization. Moderna focused on preventing infection.4

The data showed the mean antibody levels of participants was 1.8 times higher after the third dose compared with the second dose, but the booster raised neutralizing antibodies by at least fourfold in 87.9% of patients and failed to meet the FDA’s requirement of 88.4%.4

The expected benefit of the booster vaccines is that they will affect the reduction of disease in relation to the primary doses.1

Janssen submitted a request to amend the emergency use authorization (EUA) for the purpose of a booster shot on October 4, 2021. Moderna submitted a request to amend the EUA for a booster shot on September 3, 2021.

Additionally, results of a new study show that the Johnson & Johnson vaccine’s effectiveness can be strengthened by a booster from either the Moderna or Pfizer-BioNTech vaccines.5

The results of a study sponsored by the National Institutes of Health show that there is evidence to support that booster shots increase the immune response after the initial doses of a vaccine but by how much is not known, because of the small study size.5

Individuals who got the 2-dose Moderna vaccines followed by a Moderna booster dose appeared to have the best immune response. However, patients who got the Johnson & Johnson vaccine fared better after an mRNA as their booster dose compared with another Johnson & Johnson dose.5

An FDA advisory panel of experts will examine the data of both the Johnson and Johnson and Moderna vaccines in a 2-day meeting starting October 14, 2021. The vote will not be final, though the FDA usually relies heavily on the results.

References

  1. FDA Report. Vaccines and Related Biological Products Advisory Committee October 14-15, 2021, Meeting Presentation. FDA. October 15, 2021. Accessed October 13, 2021. https://www.fda.gov/media/153037/download
  2. Lovelace Jr B. FDA scientists strike favorable tone on J&J Covid booster shots ahead of vote this week. CNBC. October 13, 2021. Accessed October 13, 2021. https://www.cnbc.com/2021/10/13/jj-covid-booster-shot-fda-scientists-strike-favorable-tone-ahead-of-vote-this-week.html
  3. Vaccines and Related Biological Products Advisory Committee meeting. FDA. October 14, 2021. Accessed October 13, 2021. https://www.fda.gov/media/152991/download
  4. Johnson & Johnson vaccine Booster. The New York Times. October 13, 2021. Accessed October 13, 2021. https://www.nytimes.com/2021/10/13/health/johnson-vaccine-booster-fda.html
  5. Stein, R. A study of COVID vaccine boosters suggests Moderna or Pfizer works best. NPR. October 13, 2021. Accessed October 13, 2021. https://www.npr.org/sections/health-shots/2021/10/13/1045485935/study-of-covid-vaccine-boosters-suggests-moderna-or-pfizer-works-best