Newsman: A Food and Drug Administration advisory panel “Vaccine and Related Biological Products Advisory Committee”, voted Thursday to recommend Moderna booster shots for emergency use authorization.
The panel voted unanimously in favor of authorizing the shots. The decision will go to the FDA, which is expected to make a final ruling in the coming days.
The panel’s recommendations followed the blueprint it established last month for booster shots of Pfizer-BioNTech’s vaccine: For people who were initially vaccinated with Moderna, the booster would be authorized for adults ages 65 and up, people in long-term care facilities and people ages 18-64 with underlying medical conditions and who areat high risk of exposure to the coronavirus because of their job. Such people would be eligible at least six months after their second shots.
Moderna’s booster dose would be given as a half-dose of 50 micrograms, compared to the 100 micrograms given in the initial vaccination series. (By contrast, Pfizer’s booster is the same 30-microgram dosage as its initial series.)
Jacqueline Miller, the therapeutic area head for infectious diseases at Moderna, said in her presentation to the committee that the company chose the half-dose because it wanted to use the lowest dose possible needed to induce an immune response.
Miller noted that using a lower-dose booster has worked well for other vaccines, including the DTaP vaccine, which protects against tetanus, diphtheria and whooping cough.
The meeting was less contentious than the group’s discussion last month about Pfizer, when the advisers rejected authorizing Pfizer boosters for all adults 18 and up six months after their initial vaccinations and instead opted to limit eligibility.
In a discussion after the vote, the panel largely agreed that boosters were not yet needed for the broader population, which would include all adults 18 and up.
The booster dose led to higher antibody levels, including antibodies against the delta variant. But still, a handful of breakthrough infections — 20 cases —were reported among people who received boosters.
Dr. Doran Fink, a deputy director of the FDA’s division of vaccines, said it’s still unknown what levels of antibodies are needed for protection.
Both Moderna’s presentation and the FDA’s analysis found the booster to be safe, although several committee members said they wanted to see more safety data from the company.
Side effects from the booster were similar to those seen after the second dose. They included arm pain, fatigue, headache and muscle aches.
However, the booster trial didn’t include enough participants to evaluate whether the extra dose raised the risk for myocarditis, Fink said.
Myocarditis, or inflammation of the heart muscle, has been linked to both Moderna’s and Pfizer’s Covid-19 vaccines. The condition is rare and mostly commonly seen in men under 30.
The same group of advisers discuss a booster shot of Johnson & Johnson’s Covid vaccine, Friday. It will also reviewed the results of a National Institutes of Health study of “mixing and matching” Covid vaccines. The study found that giving people who initially received the Johnson & Johnson vaccine booster doses of either Pfizer’s or Moderna’s vaccine led to a stronger immune response than a second Johnson & Johnson dose.
Next week, a group of advisers to the Centers for Disease Control and Prevention will take up the question of who should receive the Moderna and Johnson & Johnson booster shots. If the boosters are recommended, the CDC director, Dr. Rochelle Walensky, would then sign off, and shots could start going into arms.
