A Centers for Disease Control and Prevention panel voted to approve more COVID-19 booster shots Thursday, one day after the Food and Drug Administration signed off on extending boosters to Americans who got the Moderna or Johnson & Johnson vaccine.
The key advisory committee discussed booster shots of Moderna and Johnson & Johnson's vaccine as well as whether people can mix and match the companies' shots.
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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.
The FDA’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month.
CDC advisers on Thursday endorsed extra doses of all three of the nation’s vaccines — and said people could choose a different company’s brand for that next shot.
Certain people who received Pfizer vaccinations months ago already are eligible for a booster and now advisers to the Centers for Disease Control and Prevention say certain Moderna and Johnson & Johnson recipients should qualify, too. And in a bigger change, the panel opened the option of “mixing and matching” that would allow a different vaccine for the extra dose than the kind people first received.
Though the panel issued a recommendation, CDC Director Dr. Rochelle Walensky will still need to sign off. If she does, booster shots of both vaccines could begin immediately for eligible people.
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?
Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.
For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.
The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.
FDA recommended that everyone who’d gotten the single-shot J&J vaccine get a booster since it has consistently shown lower protection than its two-shot rivals. And several independent FDA advisers who backed the booster decision suggested J&J’s vaccine should have originally been designed to require two doses.
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.
- 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."
Should you mix and match your booster doses?
As for mixing and matching, the CDC and FDA said it's OK to use any brand for the booster regardless of which vaccination people got first.
The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time.
FDA's acting commissioner Dr. Janet Woodcock said the agency wanted to make its booster guidance as flexible as possible, given that many people don't remember which brand they first received. In other cases, some people may want to try a different vaccine if they previously experienced common side effects like muscle ache or chills.
Still, regulators said it's likely many people will stick with the same vaccine brand.
The decision was based on preliminary results from a government study of different booster combinations that showed an extra dose of any type revs up levels of virus-fighting antibodies. That study also showed recipients of the single-dose J&J vaccination had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second J&J shot. The study didn't test the half-dose Moderna booster.
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.
What are the side effects for booster shots?
The Centers for Disease Control and Prevention on Thursday published data listing the most common side effects people reported after receiving boosters of Pfizer or Moderna's vaccine or a second dose of Johnson & Johnson's.
The data, presented to the agency's Advisory Committee on Immunization Practices, is based on submissions to the agency's text messaging system v-safe and the Vaccine Adverse Event Reporting System, a national vaccine safety surveillance program.
The most common side effects reported after getting a third shot of an mRNA vaccine were pain at the injection site, fatigue, muscle pain, headache and fever, followed by chills and nausea, according to the CDC data.
Side effect rates were similar to those seen after the second dose of an mRNA vaccine, according to the data.
The data available for J&J was more limited, but people reported fever, fatigue and headache after receiving a second dose of that vaccine, according to the agency. In a separate presentation, Dr. Macaya Douoguih, head of clinical development and medical affairs for J&J's vaccines division Janssen, said there is no data to suggest people are at increased risk of a rare, but serious, blood clot condition after receiving a second dose.
The majority of people who received an additional dose of any booster were white women over the age of 50, according to the v-safe data.