A U.S. Food and Drug Administration advisory panel on Thursday endorsed administering lower-dose booster shots of the Moderna vaccine, but what will that mean for those who got the vaccine and what still needs to happen?
The panel's vote is the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention.
Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19.
Both Moderna and Johnson & Johnson submitted requests for emergency use authorization of their booster shots of the COVID vaccines, though discussions are still ongoing on whether or not they will be authorized.
Here's what you should know:
Who would be eligible for Moderna booster shots once they are authorized?
The health advisers to the FDA debated if millions of Americans who received Moderna vaccinations should get a booster shot -- this time, using half the original dose.
U.S. officials stress that the priority is to get shots to the 66 million unvaccinated Americans who are eligible for immunization -- those most at risk as the extra-contagious delta variant of the coronavirus has burned across the country.
Moderna is seeking FDA clearance for a booster used just like Pfizer’s: For people 65 and older, or adults with other health problems, jobs or living situations that put them at increased risk of serious coronavirus -- once they are at least six months past their last dose.
Still, the CDC will need to offer more specifics on who should get one.
What would the dosage be and why is it different?
The first two Moderna shots that everyone receives each contain 100 micrograms of vaccine. But Moderna says a single 50-microgram shot should be enough for a booster. The company said that would trigger fewer uncomfortable shot reactions such as fever and achiness while also leaving more vaccine available for the global supply.
A Moderna study of 344 people found the booster dose spurred a big jump in virus-fighting antibodies, including those able to target the delta mutant.
What still needs to happen before Moderna booster shots are available?
The final go-ahead is not expected for at least another week.
The FDA will use its advisers’ recommendations in deciding whether to authorize Moderna boosters. If it does, 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.
The CDC's advisory committee is next scheduled to meet on Oct. 20 and 21 to discuss the boosters.
If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
While the FDA and CDC so far have endorsed Pfizer boosters for specific groups only, Biden administration officials, including Dr. Anthony Fauci, have suggested that extra shots will eventually be recommended for most Americans.
Who is already eligible?
- People 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
- People aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine atleast 6 months after their Pfizer-BioNTech primary series,
- People aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
- People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.
What counts as a qualifying underlying health condition? Here's a list from the CDC:
- Chronic kidney disease
- Chronic lung diseases, including COPD, asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
- Dementia or other neurological conditions
- Diabetes (type 1 or type 2)
- Down syndrome
- Heart conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension)
- HIV infection
- Immunocompromised state (weakened immune system)
- Liver disease
- Overweight and obesity
- Sickle cell disease or thalassemia
- Smoking, current or former
- Solid organ or blood stem cell transplant
- Stroke or cerebrovascular disease, which affects blood flow to the brain
- Substance use disorders
In addition to the Pfizer authorization, officials have also cleared booster doses of both the Pfizer and Moderna vaccines for people with weakened immune systems.
According to the CDC, immunocompromised groups include people who have:
- Been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
The agency notes that "people should talk to their healthcare provider about their medical condition, and whether getting an additional dose is appropriate for them."