PHILADELPHIA (KYW Newsradio) — The Food and Drug Administration's vaccine advisory committee said Thursday that some Americans who received Moderna’s COVID-19 vaccine should get a half-dose booster to bolster protection against the virus.
The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, adults with other health problems, jobs or living situations that put them at increased risk for COVID-19.
The recommendation is non-binding, but it’s a key step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already getting a booster after the FDA authorized their use last month.
As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster.
The agency convened its experts Thursday and Friday to weigh-in on who should get boosters and when for people that received the Moderna and Johnson & Johnson shots earlier this year.
The FDA will use its advisers’ recommendations in making final decisions for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one.
Dr. Jacqueline Miller with Moderna presented data to the panel showing that there was some waning immunity after the initial two doses. She said a booster shot, given at least six months after the second dose, made a difference in really beefing up antibodies.
As for any side effects, the company says they’re similar to what people have gotten after the second dose. So pain at the injection site, headache and fatigue are most common.
The booster is 50 micrograms, half of what’s given in each of the first two doses.
Moderna, in the briefing document provided to the panel, said its request was consistent with the terms of the Pfizer COVID-19 booster, which was approved in September. That means those who are 65 and above, or adults who have underlying health conditions or work in high-risk settings would be eligible.
On Friday, the panel will then review Johnson & Johnson’s request to authorize a booster shot anywhere from two to six months after the initial dose. The FDA, in its analysis submitted to the panel, seemed favorable to recommending the booster but suggested the data submitted by the company was limited.
Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, is on the advisory committee. Ahead of Thursday's meeting he was not able to publicly comment on how he thinks the panel will vote, but he emphasized that the vaccines out now are safe and highly effective.
"I mean, that’s been shown now for six months post first rolling these vaccines out. It’s been shown for the delta variant. It’s been shown for all age groups. So we have that vaccine already," Offit said. "If the goal of [the vaccines] is to prevent serious illness, the kind of illness that causes you to be very sick or go to the hospital, or go to the ICU or die -- these vaccines already do that."
The panel, on Friday, will also view a presentation on mixing and matching vaccines. A National Institutes of Health study showed that giving a booster of a vaccine that was different than the type of vaccine given for the initial dose or doses, was safe and effective. The study, which has yet to be peer reviewed, found that those who received the Johnson & Johnson vaccine produced more protection against COVID-19 after receiving a Moderna or Pfizer booster than a J&J booster. However, health officials stress that more studies need to be completed.
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In an online review posted Wednesday, FDA scientists didn't reach a firm conclusion about whether there's enough evidence for J&J boosters, citing shortcomings with the company's data and little information on protection against the extra-contagious delta variant of the coronavirus.
A new study out Wednesday raises the prospect that using a different brand as the booster might work better.
Adding to the complexity is whether it's OK to use a booster that's a different brand than someone's initial shots. Preliminary results of a U.S. government study suggest that using a different brand as the booster might work better for J&J recipients. Those people had a stronger immune response if they got either a Moderna or Pfizer shot as their booster than if they received another dose of the J&J vaccine, according to results posted online Wednesday. Mix-and-match is also up for discussion by the FDA panel this week.
Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.
FDA reviewers wrote that a study of the two-month booster plan suggests "there may be a benefit," while pointing to only small numbers of people who got another shot at six months instead.
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For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80% effective against hospitalizations in the U.S.
J&J's single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot's benefits outweighed those risks.
Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies' two-dose shots while less than 15 million Americans got the J&J shot.