May 5, 2022: Due to a rare risk of potentially life-threatening blood clots in combination with low levels of blood platelets, the Food and Drug Administration (FDA) has limited the authorized use of the Johnson & Johnson COVID-19 vaccine to people 18 years and older for whom other approved COVID-19 vaccines are not accessible or clinically appropriate, and to those 18 and older who elect to receive the Johnson & Johnson COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
Blood clots with low levels of platelets following the Johnson & Johnson COVID-19 vaccine have been reported in males and females, across a wide age range of individuals 18 years and older; reporting has been highest in females ages 30 through 49 years.
July 13, 2021: The FDA announced an update to the Johnson & Johnson COVID-19 vaccine label regarding an observed increased risk of Guillain-Barré syndrome following vaccination.
On February 2020, Johnson & Johnson's vaccine against the coronavirus disease 2019 (COVID-19) became the third COVID-19 vaccine to receive emergency use authorization (EUA) from the FDA.
The company worked with its pharmaceutical arm Janssen to develop the vaccine under the project names Ensemble and Ensemble 2. The company enrolled participants for its late-stage in September 2020 and tested its vaccine with two different doses.
After a single dose was found to be effective in clinical trials, Johnson & Johnson applied for the EUA for the single dose. Now, it's the first COVID-19 vaccine to be given in one dose in the U.S. and is authorized for adults ages 18 and older.
How It Works
Johnson & Johnson's vaccine is a single-dose adenovirus-based vaccine. It is a viral vector vaccine that uses a weakened live pathogen (adenovirus) as the delivery method (vector) for transporting a recombinant vaccine for COVID-19.
Recombinant vaccines use a small piece of genetic material from the virus to trigger an immune response. This genetic material for COVID-19 does not replicate in the body.A specific piece of the virus can be targeted, and recombinant vaccines are common and generally safe to use in a large population of people—even those with chronic health problems or who are immunocompromised.
There can be some drawbacks to recombinant vaccines. One example is that booster shots may be required over time. Examples of recombinant vaccines are pneumococcal vaccines and vaccines for meningococcal disease.
The science behind recombinant adenoviral vector vaccines has been around for a long time, but the only commercially available adenovirus-based vaccine is a rabies vaccine for animals. Adenovirus-based vaccines may also pose some problems in that the adenovirus is so common that the vaccine may not be as effective once booster doses are given, or that some people may already have immunity to the virus used in the vaccine.
How Effective Is It?
Johnson & Johnson announced that its single-dose vaccine was 66% percent effective at preventing moderate to severe disease from COVID-19 and 85% effective at preventing severe disease. This effectiveness in the Phase 3 trial was reached 28 days after vaccination.
The trial had a temporary delay in October 2020 when it was paused due to a patient reporting an unexplained illness, although no specific details were provided about what happened due to patient privacy. Regulators determined that the event was not related to the vaccine and the trial was safe to resume.
The efficacy against moderate to severe COVID-19 infection varied by region in the trial. It was 72% in the United States, 68% in Latin America, and 64% in South Africa.
The vaccine was also found to be fully protective against hospitalization and death, and the protection against severe disease included multiple variants of COVID-19, including the B.1.351 variant found in South Africa.
Effectiveness Against the Delta Variant
There is currently limited data available showing how effective the vaccine is at protecting against the Delta (B.1.617.2) variant.
According to information released by Johnson & Johnson, the vaccine was found be 85% effective against severe/critical disease from COVID-19, including that caused by the Delta variant. Data from a clinical study published in The New England Journal of Medicine also supports this finding.
In December 2021 the Centers for Disease Control and Prevention (CDC) endorsed updated recommendations made by the Advisory Committee on Immunization Practices (ACIP) for the prevention of COVID-19, “expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine over Johnson & Johnson’s COVID-19 vaccine.”
“This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom,” said the CDC. “Given the current state of the pandemic both here and around the world, the ACIP reaffirmed that receiving any vaccine is better than being unvaccinated.”
Results from the Sisonke trial, which examined 480,000 South African health workers who received the one-dose vaccine, suggest that it is up to 95% effective in preventing death from the Delta variant and up to 71% effective against hospitalization. Although promising, this new data from the trial has yet to be peer-reviewed or published in a scientific journal.
Additional studies are required to further determine the efficacy of the vaccine against this particular variant.
When Will It Be Available?
The Johnson & Johnson vaccine was granted emergency use authorization from the FDA for its single-dose vaccine. As of April 28, 2021, Johnson & Johnson (Janssen) has supplied 17.6 million doses to the U.S. and more than 8 million people have received the vaccine, according to the CDC.
In August 2020, Johnson & Johnson announced it had a contract with the U.S. government for 100 million doses (the equivalent of $10 per dose) and the option to purchase an additional 200 million doses. In March 2021, President Biden announced plans to purchase an additional 100 million doses, bringing the total to 200 million doses.
The U.S. government announced a partnership with Merck to help accelerate the production of the Johnson & Johnson vaccine. Merck will receive up to $268.8 million from the Biomedical Advanced Research and Development Authority (BARDA) to adapt and make available its manufacturing facilities for producing the Johnson & Johnson COVID-19 vaccine.
How Much Will a COVID-19 Vaccine Cost?
Any doses purchased by the U.S. government are free to its citizens. While the facility or agency that offers the vaccine may request reimbursement from insurance plans or a public health program for an administration fee, no one can be charged any fees to receive a COVID-19 vaccine or be denied a vaccine if they do not have health insurance.
Who Can Get the Johnson & Johnson Vaccine?
Everyone 18 and older is now eligible for the Johnson & Johnson vaccine, according to the CDC. However, the FDA has limited the authorized use of the vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to those 18 years and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
Side Effects and Adverse Events
In every clinical trial, participants are asked to record any reactions they have after receiving a medication or vaccine. Adverse reactions are considered to be medication reactions directly caused by a vaccine, whereas a side effect is a physical reaction to a medication.
Initial safety information released for the vaccine shows that the most common reactions after the vaccine was administered included:
- Injection site pain, redness, or swelling
- Muscle aches
People who are immunocompromised, including those receiving immunosuppressant therapies, may have a diminished immune response to the vaccine, according to the FDA.
Risk of Thrombosis With Thrombocytopenia
On May 5, 2022 the FDA limited the authorized use of the Johnson & Johnson COVID-19 vaccine due to a rare, potentially life-threatening risk of thrombosis with thrombocytopenia syndrome (TTS)—blood clots in combination with low levels of blood platelets. The onset of symptoms occurs approximately one to two weeks after administration of the Johnson & Johnson COVID-19 vaccine.
Incidents of TTS following the Johnson & Johnson COVID-19 vaccine have been reported in men and women, in individuals 18 years and older; reporting has been highest in women ages 30 through 49.
This action follows a previous April 13, 2021, FDA and CDC joint recommendation to while the agencies investigated six reported cases of a rare but severe type of blood clot that affects the brain called cerebral venous sinus thrombosis (CVST) occurring along with thrombocytopenia (low platelet count), which can make the condition difficult to treat.
In their initial review the CDC and FDA accounted for nine additional cases of rare blood clots paired with low platelet counts, bringing the total to 15 out of 8 million administered doses. Most cases occurred in women between the ages of 18 to 49 within one to two weeks of vaccination. The agencies concluded that the potential benefits outweigh this very rare risk and lifted the pause after 10 days.
A warning has been added to the fact sheets for healthcare providers and vaccine recipients and caregivers about the rare risk of thrombosis in the cerebral venous sinuses and other sites (including blood vessels in the abdomen and veins of the lower extremities) along with low platelet counts after receiving the vaccine.
Healthcare providers have also been warned that treating a suspected case of this condition (known as thrombosis with thrombocytopenia) with the blood thinner heparin may be harmful and alternative treatments may be needed along with a consultation with hematology specialists.
Seek emergency medical care if you experience any of the following symptoms:
- Shortness of breath
- Chest pain
- Leg swelling
- Persistent abdominal pain
- Severe or persistent headaches
- Blurred vision
- Easy bruising or tiny blood spots under the skin (beyond the injection site)
Risk of Guillain-Barré Syndrome
On July 13, 2021, the FDA announced another update to the Johnson & Johnson COVID-19 vaccine label regarding an observed increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination. GBS is an extremely rare autoimmune disorder of the peripheral nervous system, in which the body's own immune system attacks the peripheral nerves and spinal cord, causing muscle weakness and possible full-body paralysis in severe cases. Most people who develop this disorder recover completely.
Based on data filed with the government's Vaccine Adverse Event Reporting System (VAERS), of the 12 million Johnson & Johnson COVID-19 vaccine doses given in the U.S., there have been about 100 reported cases of people developing GBS. Most cases occurred in men age 50 and older and around two weeks after receiving the vaccination.
Although these findings suggest a link between the vaccine and a small increased risk of GBS, the FDA states it is insufficient to establish a causal relationship. As both the FDA and CDC monitor cases of the syndrome, they emphasize that the potential benefits of the vaccine continue to outweigh this very low risk.
Seek immediate medical attention if you experience any of the following symptoms:
- Weakness or tingling, especially in the legs or arms, that appears to worsen or spread
- Difficulty walking
- Difficulty with facial movements, including speaking, chewing, or swallowing
- Double vision or inability to move the eyes
- Difficulty with bladder control or bowel function
Funding and Development
Johnson & Johnson co-funded the development of the vaccine as part of Operation Warp Speed, a public-private partnership initiated by the U.S. government to facilitate and accelerate the development of a COVID-19 vaccine, manufacturing, and distribution of COVID-19 vaccines, with funding from the Biomedical Advanced Research and Development Authority (BARDA)—a U.S. government program aimed at furthering the manufacture and distribution of vaccines to fight COVID-19. Johnson & Johnson said $1 billion has been invested in the vaccine project by both the company and BARDA.
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.
What you need to know about Johnson and Johnson vaccine? ›
The J&J vaccine provides significant protection against severe illness and death. In global trials, the J&J vaccine showed an 85% efficacy rate in preventing severe disease. Among the people who received the vaccine during the trials, after 28 days no one who contracted COVID-19 was hospitalized.Why is J&J vaccine good? ›
The company reported that, in addition to providing 94% protection against moderate-to-severe COVID-19 in the U.S. (that figure was 75% in all of the countries studied), a booster shot given two months after the initial dose increased antibody levels by four to six times, compared to one dose alone.What are the risks of Johnson and Johnson vaccine? ›
Side effects may include pain or swelling at the injection site, headache, fatigue, muscle aches, nausea, or fever. Side effects should go away within a few days. There are benefits and risks to getting the Johnson & Johnson COVID-19 vaccine, and the benefits of getting vaccinated outweigh the risks.What happened to Johnson and Johnson vaccine? ›
On April 23, the U.S. Food and Drug Administration (FDA) lifted its pause on the use of the Johnson & Johnson vaccine, following a review by a federal vaccine safety review panel.Which COVID vaccine is safest? ›
The Pfizer and Moderna vaccines are strongly recommended as safe and effective at preventing serious illness or death from COVID-19. From December 2020 to December 2021, about 470 million doses of COVID-19 vaccine have been given in the U.S.How long after Johnson vaccine are you fully vaccinated? ›
You are considered up to date with your vaccines after one dose of Johnson & Johnson and a booster shot.Was the Johnson and Johnson vaccine recalled? ›
On April 13, the Centers for Disease Control and Prevention, as well as the Food and Drug Administration, recommended providers pause on administering the Johnson & Johnson/Janssen COVID-19 vaccine after more than 6.8 million people in the United States received the one-dose vaccine.Which COVID vaccine is most effective? ›
The study found the bivalent vaccine to be 58.7% effective against hospitalization compared to 25% for the monovalent one that preceded it; its effectiveness against infection was 61.8% compared to 24.9% for the monovalent.How to treat side effects of Johnson and Johnson vaccine? ›
Apply a clean, cool, wet washcloth to your arm to help reduce pain. It may also help to exercise your arm. If you have a fever, drink plenty of fluids and dress lightly. Over-the-counter medicines like acetaminophen (Tylenol®) or ibuprofen (Motrin® or Advil®) can help with pain, fever, headache, or discomfort.Who should not get the J&J Covid vaccine? ›
If you are allergic to polysorbate, you should not get Novavax or J&J/Janssen COVID-19 vaccine.
Why did Johnson & Johnson stop making the vaccine? ›
In 2021, a manufacturing mishap at an Emergent plant in Baltimore rendered millions of Janssen COVID doses unusable. Meanwhile, the use of J&J's COVID-19 vaccine has been stalled in the US after the Food and Drug Administration (FDA) in May significantly restricted its use due to safety concerns.Why did Johnson and Johnson stop making the Covid vaccine? ›
After mounting a large research and production effort in support of its COVID-19 vaccine, Johnson & Johnson is scaling back production because of low demand, The Wall Street Journal reports.Which COVID vaccine is better for seniors? ›
Getting vaccinated prevents severe illness, hospitalizations and death. People 65 and older who received both doses of either Pfizer or Moderna vaccines showed a 94% reduced risk of COVID-19 related hospitalization.Does Johnson and Johnson need a booster? ›
All those age 18 and older who received the Janssen (Johnson & Johnson) COVID-19 vaccine should receive a booster dose of COVID-19 vaccine.How does Johnson and Johnson vaccine work? ›
Your body makes the spike protein but does not make the virus itself. The proteins that are produced trigger your body to make antibodies. If the virus that causes COVID-19 enters your body, the antibodies will recognize and fight the virus, protecting you from getting sick.How many Janssen vaccines do I need? ›
Primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL). A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months after the primary vaccination with the Janssen COVID-19 Vaccine.