Moderna, J&J COVID Booster Shots Near Authorization. Here's What to Know

UPDATE: U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially. Latest update here.

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With both the Moderna and Johnson & Johnson vaccines nearing authorization for their COVID booster shots, what still needs to happen and what can you expect?

Here's what we know so far.

What's already happened and what still needs to happen?

A panel of U.S. health advisers on Friday endorsed booster doses of Johnson & Johnson’s single-shot COVID-19 vaccine. On Thursday, the same panel unanimously recommended a half-dose booster of the similar Moderna vaccine for certain groups.

The panel's vote marked the first step in a review process that also includes sign-off from the leadership of both the Food and Drug Administration and the Centers for Disease Control and Prevention.

Federal regulators are also expected to authorize the mixing and matching of COVID-19 booster doses this week and experts have said that announcement from the FDA is likely to come along with authorization for boosters of the Moderna and Johnson & Johnson shots.

The FDA will use its advisers’ recommendations in deciding whether to authorize the additional 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: A panel convened by the Centers for Disease Control and Prevention will need to offer more specifics on who should get one.

The CDC's advisory panel is expected to meet Thursday to discuss booster dose data. Once the panel makes its recommendation, a decision from the CDC is expected to follow soon after.

Illinois' health department said it is already anticipating the CDC will authorize the shots for both vaccines.

Who would be eligible and when for a Moderna or J&J booster shot?

The FDA panel voted unanimously to recommend a Moderna booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19. The doses would be given to those who received their second dose at least six months ago.

But there's no evidence that it's time to open booster doses of either the Moderna or Pfizer vaccine to everybody, the panel stressed — despite initial Biden administration plans to eventually do that.

Meanwhile, 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.

J&J has asked the FDA 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.

Who is already eligible for a COVID booster shot?

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. Though some who are immunocompromised can also get extra doses of the Pfizer and Moderna vaccines.

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."

Should you mix and match your booster doses?

Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week, but who should do it and when?

Mixing and matching refers to giving a booster dose of a vaccine that's different from the vaccine type that was used for the initial vaccination series.

The FDA, however, is expected to say that, especially for the mRNA vaccines from Pfizer and Moderna that have proved most effective against the virus, maintaining consistency in the vaccine course was still preferable. The agency was still finalizing guidance for the single-shot J&J vaccine.

Already, guidance from the Centers for Disease Control and Prevention has advised that mixing and matching booster shots for immunocompromised individuals, particularly those who received mRNA vaccines, was allowed in some situations.

"For people who received either Pfizer-BioNTech or Moderna’s COVID-19 vaccine series, a third dose of the same mRNA vaccine should be used. A person should not receive more than three mRNA vaccine doses," the CDC's website states. "If the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product may be administered."

The National Institutes of Health study, which was released Wednesday and has yet to be peer reviewed, found that people who received the Johnson & Johnson vaccine produced stronger antibody levels after receiving a booster shot made by Moderna or Pfizer, compared to a booster from Johnson & Johnson. Those who were originally vaccinated with the Pfizer or Moderna vaccines and received either company's booster shot produced comparably strong immune responses, the researchers observed.

The findings were presented on Friday to the FDA's advisory committee. The panel met and recommended the authorization of a booster shot of Moderna and Johnson & Johnson.

The advisers didn't vote on whether that should be recommended but told the government to allow flexibility with boosters, saying there were no safety red flags even if it's not yet clear just how much difference, if any, mixing and matching may make in long-term protection.

“In the real world all these kind of combinations are already happening so I think it’s a matter of some urgency for the FDA to help sort out what is admittedly a complicated and challenging scenario,” said Dr. Ofer Levy of Boston Children's Hospital.

Why would Moderna's be a half-dose?

As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster.

The FDA panel wrestled with whether Moderna presented enough evidence backing its low-dose booster.

As the delta variant surged in July and August, a Moderna study found people who were more recently vaccinated had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago.

Another study of 344 people found a six-month booster shot restored virus-fighting antibodies to levels thought to be protective — and that included large jumps in antibodies able to target the delta variant. But that was a small study, and only about half of those people got the exact series of doses that would be offered under a Moderna booster campaign.

“The data itself is not strong but it is certainly going in the direction that is supportive of this vote,” said Dr. Patrick Moore of the University of Pittsburgh.

And several advisers worried that boosting with a lower dose might cost people some of the potential benefit of a full-strength third shot.

“That may actually have a tremendous impact on the durability,” Kurilla said.

Moderna said it chose the lower-dose booster because it triggered fewer uncomfortable shot reactions such as fever and achiness but also leaves more vaccine available for the global supply.

“Now we have twice as much vaccine to go around,” Dr. Robert Murphy,executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, said in a statement. “That’s a big thing. By recommending half a dose, you just doubled the amount of vaccine available. And theoretically there could be fewer side effects with a lower dose.”

Why might people need a booster?

As breakthrough infections are reported, experts say certain at-risk groups in particular show the need for boosters.

“We know that advanced age is a significant factor in COVID-19 breakthrough hospitalizations and deaths, but a booster dose can help provide continued protection,” Illinois Department of Public Health Director Dr. Ngozi Ezike said Tuesday. “While COVID-19 vaccines continue to be effective in reducing the risk of severe disease, hospitalization, and death, scientists and medical experts continue to watch for signs of waning immunity, how well the vaccines protect against variants, and how that data differs across age groups and risk factors. Booster doses recommended for those 65 years and older, and for long-term care residents, can combat waning immunity and help protect those at higher risk of severe illness.”   

Notably, Colin Powell, the first African American to serve as chairman of the Joint Chiefs of Staff and secretary of state, who passed away Monday, died from COVID-19 complications, even though he had been fully vaccinated against the coronavirus.

Powell, 84, was immunocompromised, and in the last few years, he had been treated for multiple myeloma, according to a longtime aide.

Following Powell's passing, doctors at Northwestern Medicine issued a news release in which they explained the 84-year-old's death shows the importance of booster shots.

“I’m afraid people will say the vaccine didn’t help him," Murphy said. "But the mortality rate for vaccinated people is 11 times less than unvaccinated. People still die from the disease, especially if you are 84 and have underlying health risks."

The former secretary of state also underwent prostate cancer treatment in 2003. In announcing his death on social media, Powell's family did not address whether he had any underlying illnesses.

According to the Centers for Disease Control, patients who are older and/or immunocrompised are more vulnerable to contracting COVID with serious complications and death, even if they've been fully vaccinated.

But incidence of death from breakthrough cases still remains eight to 10 times less than unvaccinated persons with the same demographics, according to Northwestern doctors.

Dr. Khalilah Gates, associate professor of medicine in pulmonary and critical care at the Northwestern University Feinberg School of Medicine, said Powell's death enforces what doctors have been encouraging: continued vaccinations in older age groups and booster shots.

"For all of the Colin Powell’s amongst us, in our families, in our communities, we cannot afford to become lax. We’ve come so far since March 2020, but we still have some ways to go together," the doctor said.