A Food and Drug Administration advisory panel voted Friday to recommend a second shot of Johnson Johnson for emergency use authorization.
The vote for unanimous ballot was in favor, with panel members citing the need to supplement protection in people who were vaccinated with Johnson shot.
The decision will now go to the FDA, expected to make a final judgement in the coming days. The FDA doesn t have to follow the guidance of the advisory panel called the Vaccine and Related Biological Products Advisory Committee, although it usually does.
Authorization of Johnson Johnson's booster means all vaccines in the United States would have booster doses. Thursday the same panel unanimously voted to recommend a Moderna booster for certain individuals.
The Johnson Johnson booster would be available for all the nearly 15 million people ages 18 and up who received that vaccine. That s a departure from the recommendations for Pfizer-BioNtech and Moderna boosters, which are limited to those aged 65 and up, with either underlying health conditions or who are 18 to 64 with both ages, or whose job puts them at high risk of exposure to Covid - 19.
The recommendation timing is also different: The Pfizer booster was provided for at least two months after the initial vaccination, versus six months later for Johnson and Moderna vaccines.
The vote came two days after a highly anticipated study from the National Institutes of Health found that giving people who received the Johnson Johnson vaccine a booster shot of Moderna or Pfizer led to higher antibody levels than when boosting with a second Johnson Johnson dose. That data will be a topic of discussion at the committee meeting on Friday afternoon.
In the lead-up to Friday's meeting, the FDA was critical of Johnson Johnson s submission for a booster dose, with problems in the data.
On Friday the committee agreed that a single dose was warranted, especially given the lower effectiveness of the second shot. The results of Johnson Johnson s Phase 3 study, in which people received a booster shot two months after their initial vaccination, found that the additional dose increased the effectiveness to 94 percent.
In fact, many committee members argued that Johnson Johnson s vaccination regime should simply be a two dose vaccine, just like the Pfizer and Moderna vaccines, rather than a single shot plus a booster.
I m inclined to consider this a two-dose vaccine. That s how it should most likely go forward, said committee member Dr. Michael Kurilla, an infectious disease expert with the National Institutes of Health.
At the same time, Johnson tried to make the argument that their single dose remained effective.
Which drew further point criticism from the FDA. Dr. Peter Marks, Director of the Agency's Center for Biologics Evaluation and Research, went as far as to suggest that the company was not presenting the complete picture, particularly in terms of real-world effectiveness of a single dose.
In its phase 3 clinical trial in the U.S., Johnson Johnson vaccine was shown to be 72 percent effective against moderate to severe illness — lower than the roughly 95 percent effectiveness seen in Pfizer and Moderna clinical trials. The company however said that the effectiveness remained stable and did not wane in the eight month following vaccination.
Dr. Dan Barouch, director of the center for virology and vaccine research at Beth Israel Deaconess Medical CenterIsrael Deaconess Medical Center in Boston, who presented on behalf of Johnson Johnson said that antibody tests to the delta, alpha, and beta variants show substantial decline over time for the mRNA vaccines, or Moderna and Pfizer, while the antibody test to these variants was generally stable for the Johnson vaccine.
Marks on the other hand said that there are data that suggests the effectiveness of this vaccine is actually less robust than the company's presentation here. Dr. Amanda Cohn, Chief Medical Officer of the Centers for Disease Control and Prevention's Covid 19 Vaccine Task Force, said that the agency s data found that the effectiveness or protection with a single dose of J&J vaccine is not equivalent to protection, at present, with either two doses of an mRNA vaccine, and certainly not in those groups who have now been authorized to receive a booster dose of an mRNA vaccine. The rate of breakthrough cases and deaths was higher for Johnson Johnson recipients than recipients of other vaccines, according to the CDC data.
The lower effectiveness of the single shot points to the need for an additional dose, said Dr. Arnold Monto, acting chair of the committee.
There is a public health imperative here, because what we see is that this is a group with overall lower efficacy than we have seen with the mRNA vaccine so there is some urgency to do something, he said.
The Johnson Johnson vaccine has not been without controversy. In April the FDA and the centers for disease control and prevention ordered that vaccinations be paused as they investigated several cases of rare but serious blood clots tied to the vaccine. Over the summer, the FDA added a warning label that the shot could raise the risk of a neurological disorder called Guillain-Barre syndrome.
Defective manufacturing problems have also ended the vaccine rollout. Just under 15 million people have been completely vaccinated in the U.S. with Johnson Johnson, compared to more than 100 million Pfizer and nearly 70 million for Moderna.