covid booster shot

Johnson & Johnson Booster Shots: What FDA Panel Vote Means, What's Next

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A panel of U.S. health advisers on Friday endorsed booster doses of Johnson & Johnson’s single-shot COVID-19 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.

On Thursday, the same panel unanimously recommended a half-dose booster of the similar Moderna vaccine for certain groups.

The push for boosters kicked off last month after the Food and Drug Administration authorized third doses of the Pfizer vaccine for seniors and younger adults with health problems, jobs or living conditions that place them at higher risk from the coronavirus.

But the J&J decision is more complex.

Here's what you should know:

Who would be eligible for J&J booster shots once they are authorized?

The panel backed boosters for anyone who received the J&J vaccine, which is authorized for people 18 and older, marking a shift from what the group recommended for both Pfizer and Moderna.

When would eligible people get the shot following their first dose?

J&J has asked the Food and Drug Administration for flexibility with its booster, arguing the extra dose adds important protection as early as two months after initial vaccination -- but that it might work better if people wait until six months later.

The FDA’s advisory panel voted unanimously that a booster should be offered without setting a firm time. The advisers cited growing worry that recipients of J&J’s vaccination seem to be less protected than people who got two-dose Pfizer or Moderna options — and that most got that single dose many months ago.

What still needs to happen before J&J 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 J&J boosters. The agency isn’t bound by the panel's vote but its ultimate decision could help expand the nation’s booster campaign.

If it approves, 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.

The government says all three U.S. vaccines continue to offer strong protection against hospitalization and death from COVID-19, and that the priority is getting first shots to the unvaccinated. But there’s a growing push to shore up protection against “breakthrough” infections and the extra-contagious delta variant of the coronavirus.

Why would J&J recipients need a booster shot?

J&J’s single-shot vaccine is made with a different technology than the two-shot Pfizer and Moderna vaccines -- and it has consistently shown lower effectiveness levels.

On Friday, J&J executives pitched a booster as a way to strengthen a robust vaccine that they said has retained its protective power over eight months. But FDA scientists pointedly challenged that assertion.

“There are data that suggest the effectiveness of this vaccine is actually less robust than the company’s presentation here," said Dr. Peter Marks, FDA's top vaccines official. “And that is a finding of concern particularly because that’s been seen in minority communities potentially and others.”

The panel's chair said regulators have a responsibility to shore up protection for J&J recipients.

“There is some urgency here to do something,” said Dr. Arnold Monto of the University of Michigan.

Adding another twist, the experts were also expected to discuss preliminary data from a government “mix-and-match” study that suggested J&J recipients may have a far stronger immune response if they get either a Moderna or Pfizer booster rather than a second J&J dose. It wasn't immediately clear if the panel had made a decision on this Friday.

Who is already eligible?

Here's a complete breakdown of who is eligible so far, 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

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."

NBC Chicago/Associated Press
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