Johnson & Johnson submitted data to the Food and Drug Administration to receive emergency use authorization for its COVID-19 vaccine booster shots.
With additional booster shots nearing an important milestone this week, what will that mean for those who could soon become eligible?
The Food and Drug Administration's panel of experts is expected to evaluate boosters for both Moderna and Johnson & Johnson later this week to determine if they will recommend them for emergency use.
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 have submitted requests for emergency use authorization of their booster shots of the COVID vaccines.
The FDA is convening its outside panel of advisers Thursday and Friday to review the booster data from Moderna & J&J. The group is expected to focus on Moderna Thursday and J&J Friday.
It’s 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. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
"So Oct. 14, the FDA advisory committee will start considering Moderna boosters," Chicago Department of Pubic Health Commissioner Dr. Allison Arwady said. "So I would expect by... a week or two after that we should have guidance for people who got Moderna as their first series and similarly J&J probably. They'll consider these, I would guess, together so I'd say... before the end of October, I would expect that we would have guidance."
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The CDC's advisory committee is next scheduled to meet on Oct. 20 and 21 to discuss the boosters.
More than 7 million Americans have received a booster dose in the U.S. as of Saturday, according to the latest data available from the CDC.
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Here's who currently qualifies for a booster shot, according to the CDC:
- 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:
- Cancer
- 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
- Pregnancy
- 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
The U.S. has also already approved both Pfizer and Moderna boosters for certain people with weakened immune systems, such as cancer patients and transplant recipients.
According to the CDC, the list includes 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."
