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What the FDA panel vote means, what’s next – NBC Chicago

A U.S. Food and Drug Administration advisory panel approved the administration of low-dose booster doses of the Moderna vaccine on Thursday, but what does this mean for those who have received the vaccine and what should- is it still happening?

The panel vote is the first step in a review process that also includes approval from the leadership of the FDA and the Centers for Disease Control and Prevention.

Last month, the FDA cleared booster shots of Pfizer’s vaccine for older Americans and other groups with increased vulnerability to COVID-19.

Moderna and Johnson & Johnson have both submitted requests for authorization of emergency use of their COVID vaccine booster injections, although discussions are still ongoing as to whether or not they will be authorized.

Here’s what you need to know:

Who would be eligible for Moderna boosters once they are authorized?

FDA health advisers have debated whether millions of Americans who have received Moderna vaccines should be boosted, this time using half the initial dose.

U.S. officials stress that the priority is to vaccinate the 66 million unvaccinated Americans who are eligible for vaccination – 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 like Pfizer’s: for people 65 years of age and older, or adults with other health concerns, jobs, or life situations that put them at risk increase in severe coronavirus – once they have at least six months past their last dose.

Still, the CDC will have to offer more details on who should get one.

What would the dosage be and why is it different?

The first two Moderna injections everyone receives each contain 100 micrograms of the vaccine. But Moderna says a single shot of 50 micrograms should be enough for a booster. The company said it would trigger fewer uncomfortable reactions such as fever and body aches, while leaving more vaccines available for global supply.

A Moderna study involving 344 people found that the booster dose caused a significant increase in anti-virus antibodies, including those able to target the delta mutant.

What else needs to happen before Moderna boosters are available?

The final green light is not expected for at least a week.

The FDA will use the recommendations of its advisers to decide whether or not to authorize Moderna boosters. If so, there’s yet another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more details on who should get one.

The CDC advisory committee is scheduled to meet on October 20-21 to discuss boosters.

If both agencies give the green light, Americans could start getting J&J and Moderna boosters later this month.

While the FDA and CDC have so far approved Pfizer boosters for specific groups only, Biden administration officials, including Dr.Anthony Fauci, have suggested that additional injections would eventually be recommended for most Americans. .

Who is already eligible?

Here’s a full breakdown of who’s eligible so far, according to the CDC:

  • People 65 years of age and over and residents in long-term care facilities should receive a booster of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • People aged 50 to 64 with underlying health problems should receive a booster of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • People aged 18 to 49 with underlying health problems may receive a booster 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 to 64 who are at increased risk of exposure and transmission to COVID-19 due to their professional or institutional environment may receive a booster 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 an eligible underlying medical condition? Here is a list from the CDC:

  • Cancer
  • Chronic kidney disease
  • Chronic lung disease including COPD, asthma (moderate to severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
  • Dementia or other neurological disorders
  • Diabetes (type 1 or type 2)
  • Down Syndrome
  • Heart disease (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

In addition to Pfizer’s clearance, authorities have also cleared booster doses of the Pfizer and Moderna vaccines for people with weakened immune systems.

According to the CDC, immunocompromised groups include people who have:

  • You have received active cancer treatment for tumors or cancers of the blood
  • Has received an organ transplant and is taking medicine to suppress the immune system
  • You have had a stem cell transplant within the past 2 years or are taking medicines to suppress the immune system
  • Moderate or severe primary immune deficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high dose corticosteroids or other medicines that may suppress your immune response

The agency notes that “people should talk to their health care provider about their condition and whether an extra dose is right for them.”

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