Johnson & Johnson COVID Booster Gets a Green Light from CDC

Health officials say all adults who got the one-shot vaccine can get a booster dose of any one of the three available vaccines.

Johnson & Johnson COVID Booster Gets a Green Light from CDC

Medically reviewed in October 2021

Updated on October 21, 2021

Americans eligible for a COVID booster now have three options available to them, including the Johnson & Johnson (J&J) vaccine. The Centers for Disease Control and Prevention (CDC) approved the FDA’s decision to authorize a booster for all J&J recipients ages 18 and older who got the jab at least 2 months ago. So, as of October 21, nearly 15 million people who got the J&J shot can roll up their sleeves for an additional shot.

The CDC’s decision follows the recommendation of its Advisory Committee on Immunization Practices (ACIP) as well as a unanimous vote in favor of an additional J&J dose by the FDA’s Vaccine and Related Biological Products Advisory Committee on October 15.

J&J is now one of three COVID boosters authorized for emergency use in the United States. U.S. regulatory officials also authorized boosters for the Pfizer and Moderna COVID-19 vaccines, noting that fully vaccinated people who are eligible for an additional shot can “mix and match,” or choose which vaccine they’d like to receive.

So, those who got the Johnson & Johnson shot can choose to receive another dose of that same vaccine—or they can opt for a booster dose of either the Pfizer or the Moderna mRNA vaccine

What the latest research on boosters shows
The FDA decision to authorize a booster dose of the Pfizer vaccine for certain high-risk groups was based on recent data published in The Lancet, which found that the Pfizer vaccine remained 90 percent effective in preventing hospitalization due to COVID-19 for up to six months. But the effectiveness of the vaccine declined from 88 percent one month after injection to 47 percent five months later.

The data Moderna submitted to federal regulators presented a similar picture, suggesting that people’s immunity declines six months after their second dose and that receiving a half-dose booster increases protection against COVID—including the Delta variant, which is not only more contagious but also associated with more severe infections.  

Unlike the two-dose Pfizer and Moderna mRNA vaccines, studies show the efficacy of the single-shot J&J vaccine hasn’t waned. An October 2021 study published in the New England Journal of Medicine compared immune responses from the J&J vaccine with the Pfizer and Moderna vaccines. The study found that although the J&J vaccine produces a lower immune response, it’s more stable over time. Among those who got the J&J shot, antibody and memory cells were still robust up to eight months after vaccination.

But real-world evidence and Phase 3 trial data show the J&J vaccine is 79 percent effective 28 days after immunization—well below the initial 94 to 95 percent efficacy rates of Pfizer or Moderna.

Ongoing research shows that a booster shot given six months after the first J&J dose results in a 9- to 12-fold increase in antibody levels. J&J trial data also shows that a booster helps bolster protection against the Delta variant.

So, which booster is best?
Being able to mix and match COVID-19 vaccines will now offer people more flexibility in getting boosters, depending on what’s available to them in their local area.

Previously, the CDC advised people that COVID-19 vaccines aren’t interchangeable, and that the second dose in a two-shot series should come from the same manufacturer as the first one did. But as scientists gather more data on the safety and effectiveness of mixing different COVID-19 vaccine types, they’ve agreed that the benefits of mixing and matching likely outweigh the risks. 

Still, “mix-and-match” studies were designed to answer questions about safety and effectiveness—not which booster combination offers the most protection against COVID-19. 

So, right now, one vaccine isn’t recommended over another. Research on that is ongoing. What is clear, however, is that no matter which type of vaccine people got initially or which they get as a booster, antibody levels increase.
Looking ahead, large, randomized controlled trials are needed to determine which of the nine mix-and-match combinations provided the greatest protection for various age and risk groups. More research is also needed to examine how long immunity following boosters lasts over time. Federal officials will continue to scrutinize the data as it becomes available. 

Sources:
Centers for Disease Control and Prevention. "CDC Expands Eligibility for COVID-19 Booster Shots." Oct 21, 2021.
Johnson & Johnson. “Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine.” Oct. 5, 2021.
Johnson & Johnson. “Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.” Sept. 21, 2021.
Centers for Disease Control and Prevention. “Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021.” Apr. 28, 2021.
Centers for Disease Control and Prevention. COVID Data Tracker: COVID-19 Vaccinations in the United States. Accessed Oct. 15, 2021.
U.S. Food & Drug Administration. “FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations.” Sept. 22, 2021.
U.S. Food & Drug Administration. “Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines.” Oct. 20, 2021.
Pfizer. “Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years.” Sept. 20, 2021.
U.S. Food and Drug Administration. “FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children.” Oct. 1, 2021.
Moderna. “Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster.” Sept. 1, 2021.
“Johnson & Johnson’s COVID-19 Vaccine Gets Green Light in U.S.” Sharecare. Feb. 28. 2021.
Centers for Disease Control and Prevention. “COVID-19 Vaccines That Require 2 Shots.” Updated Oct. 4, 2021.
“Mix-and-match COVID vaccines trigger potent immune response.” Nature. May 19, 2021.
Lu S. Heterologous prime-boost vaccination. Curr Opin Immunol. 2009;21(3):346-351.
“Should you mix and match COVID-19 vaccines? Scientists are seeking answers.” Science. Feb. 12, 2021.
“Five things to know about: Mixing and matching coronavirus vaccines.” Horizon: The EU Research & Innovation Magazine. May 5, 2021.
Liu X, Shaw RH, Stuart ASV et al. Safety and Immunogenicity Report from the Com-COV Study – a Single-Blind Randomised Non-Inferiority Trial Comparing Heterologous And Homologous Prime-Boost Schedules with An Adenoviral Vectored and mRNA COVID-19 Vaccine. The Lancet preprint. Jun. 25, 2021.
Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines. Clinicaltrials.gov. Updated Sept. 24, 2021.
The White House. Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials. Sept. 28, 2021.
Centers for Disease Control and Prevention. COVID Data Tracker: Variant Proportions. Accessed Oct. 6, 2021.
“How long do vaccines last? The surprising answers may help protect people longer.” Science. Apr. 18, 2021.
Tartof SY, Slezak JM, Fischer H, et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study. The Lancet. Oct. 4, 2021.
Atmar RL, Lyke KE, Deming ME, et al. Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report (preprint). medrXiv. Posted Oct. 13, 2021.
Bar-On YM, Goldberg Y, Mandel M, et al. Protection Across Age Groups of BNT162b2 Vaccine Booster against Covid-19 (preprint). medrXiv. Posted Oct. 7, 2021.
Choi A, Koch M, Wu K, et al. Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis [published online ahead of print, 2021 Sep 15]. Nat Med. 2021;10.1038/s41591-021-01527-y.
Janssen Biotech, Inc. (a pharmaceutical company of Johnson & Johnson). Briefing Materials, Vaccines and Related Biological Products Advisory Committee. Oct. 15, 2021.

Article sources open article sources

Johnson & Johnson. “Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine.” Oct. 5, 2021.
Johnson & Johnson. “Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.” Sept. 21, 2021.
Centers for Disease Control and Prevention. “Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021.” Apr. 28, 2021.
Centers for Disease Control and Prevention. COVID Data Tracker: COVID-19 Vaccinations in the United States. Accessed Oct. 15, 2021.
U.S. Food & Drug Administration. “FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations.” Sept. 22, 2021.
Pfizer. “Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years.” Sept. 20, 2021.
U.S. Food and Drug Administration. “FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children.” Oct. 1, 2021.
Moderna. “Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster.” Sept. 1, 2021.
“Johnson & Johnson’s COVID-19 Vaccine Gets Green Light in U.S.” Sharecare. Feb. 28. 2021.
Centers for Disease Control and Prevention. “COVID-19 Vaccines That Require 2 Shots.” Updated Oct. 4, 2021.
“Mix-and-match COVID vaccines trigger potent immune response.” Nature. May 19, 2021.
Lu S. Heterologous prime-boost vaccination. Curr Opin Immunol. 2009;21(3):346-351.
“Should you mix and match COVID-19 vaccines? Scientists are seeking answers.” Science. Feb. 12, 2021.
“Five things to know about: Mixing and matching coronavirus vaccines.” Horizon: The EU Research & Innovation Magazine. May 5, 2021.
Liu X, Shaw RH, Stuart ASV et al. Safety and Immunogenicity Report from the Com-COV Study – a Single-Blind Randomised Non-Inferiority Trial Comparing Heterologous And Homologous Prime-Boost Schedules with An Adenoviral Vectored and mRNA COVID-19 Vaccine. The Lancet preprint. Jun. 25, 2021.
Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines. Clinicaltrials.gov. Updated Sept. 24, 2021.
The White House. Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials. Sept. 28, 2021.
Centers for Disease Control and Prevention. COVID Data Tracker: Variant Proportions. Accessed Oct. 6, 2021.
“How long do vaccines last? The surprising answers may help protect people longer.” Science. Apr. 18, 2021.
Tartof SY, Slezak JM, Fischer H, et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study. The Lancet. Oct. 4, 2021.
Atmar RL, Lyke KE, Deming ME, et al. Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report (preprint). medrXiv. Posted Oct. 13, 2021.
Bar-On YM, Goldberg Y, Mandel M, et al. Protection Across Age Groups of BNT162b2 Vaccine Booster against Covid-19 (preprint). medrXiv. Posted Oct. 7, 2021.
Choi A, Koch M, Wu K, et al. Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis [published online ahead of print, 2021 Sep 15]. Nat Med. 2021;10.1038/s41591-021-01527-y.
Janssen Biotech, Inc. (a pharmaceutical company of Johnson & Johnson). Briefing Materials, Vaccines and Related Biological Products Advisory Committee. Oct. 15, 2021.

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