Johnson & Johnson COVID-19 Vaccine Overview

July 13, 2021: The U.S. Food and Drug Administration (FDA) announced an update to the Johnson & Johnson COVID-19 vaccine label to account for the observed increased risk of Guillain-Barré syndrome following vaccination.

Previously, the FDA and the Centers for Disease Control and Prevention issued a joint statement on April 23, 2021, after the agencies investigated six reported cases of rare but severe blood clots that occurred within two weeks of vaccination. The agencies concluded that the chance of such a serious event was very rare and recommended resumption of vaccinations with added warnings, especially for women under 50.

On February 27, Johnson & Johnson’s 2019 coronavirus disease vaccine (COVID-19) became the third COVID-19 vaccine to receive an emergency use authorization (EUA) from the FDA.

The company is working with its pharmaceutical arm, Janssen, to develop vaccines under the project names Ensemble and Ensemble 2. The company recruited its late-stage participants in September and tested its vaccine with two different doses.

After a single dose was found to be effective in clinical trials, Johnson & Johnson applied for a single-dose EUA. It is now the first single-dose COVID-19 vaccine in the U.S. and is authorized for adults 18 and older.

how does this work

Johnson & Johnson’s vaccine is a single-dose adenovirus-based vaccine. It is a viral vector vaccine that uses a live attenuated pathogen (adenovirus) as the delivery method (vector) for the delivery of a COVID-19 recombinant vaccine.

Recombinant vaccines use a small piece of genetic material from a virus to trigger an immune response. This genetic material from COVID-19 does not replicate in the body. Recombinant vaccines are common and generally safe to administer to large numbers of people—even those with chronic health problems or those who are immunocompromised.

Recombinant vaccines may have some disadvantages. An example is the possible need for booster injections over time. Examples of recombinant vaccines are pneumococcal vaccines and meningococcal disease vaccines.

The science behind recombinant adenovirus vector vaccines has been around for a long time, but the only commercially available adenovirus-based vaccine is the rabies vaccine for animals. Adenovirus-based vaccines can also pose some problems because adenoviruses are so common that once a booster dose is given, the vaccine may not be as effective, or some people may have developed immunity to the virus used in the vaccine.

How effective is it?

Johnson & Johnson announced that its single-dose vaccine was 66 percent effective in preventing moderate-to-severe disease caused by COVID-19 and 85 percent effective in preventing severe disease. This efficacy in the Phase 3 trial was reached 28 days after vaccination.

The trial was suspended in October due to an unexplained illness, but no specific details were provided about what happened due to patient privacy reasons. Regulators determined the event was not related to the vaccine and the trial could safely resume.

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Efficacy in moderate-to-severe COVID-19 infections in the trials varied by region. 72% in the US, 68% in Latin America and 64% in South Africa.

The vaccine was also found to have complete protection against hospitalization and death, and protection against severe disease including multiple variants of COVID-19, including the B.1.351 variant found in South Africa.

Effectiveness against Delta variants

Limited data are currently available showing the vaccine’s effectiveness in preventing the Delta (B.1.617.2) variant.

According to information released by Johnson & Johnson, the vaccine was found to be 85% effective against severe/critical illness caused by COVID-19, including those caused by the Delta variant. Clinical study data published in New England Journal of Medicine This finding is also supported.

In December 2021, the Centers for Disease Control and Prevention (CDC) approved updated recommendations from the Advisory Committee on Immunization Practices (ACIP) for the prevention of COVID-19, “expressing an individual’s clinical preference for an mRNA COVID-19 vaccine Johnson & Johnson’s COVID-19 vaccine” 19 Vaccines.”

“This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom,” the CDC said. “Given the current and ongoing pandemic situation around the world, ACIP reiterates that receiving any vaccine is better than not being vaccinated.”

Results from the Sisonke trial, which examined 480,000 South African health workers who received a single dose of the vaccine, showed it was up to 95 percent effective in preventing Delta variant deaths and up to 71 percent effective in hospitalizations. Although promising, this new data from the trial has not yet been peer-reviewed or published in a scientific journal.

Further research is needed to further determine the efficacy of the vaccine against this specific variant.

When will it be available?

Johnson & Johnson’s single-dose vaccine received emergency use authorization from the FDA. According to the CDC, as of April 28, 2021, Janssen has delivered 17.6 million doses of the vaccine to the U.S. and more than 8 million people have been vaccinated.

In August 2020, Johnson & Johnson announced a contract with the U.S. government for 100 million doses (equivalent to $10 per dose), with an 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.

The U.S. government has announced a partnership with Merck & Co to help speed up the production of Johnson & Johnson’s vaccine. Merck will receive up to $268.8 million from the Biomedical Advanced Research and Development Authority (BARDA) to adapt and supply a manufacturing facility for Johnson & Johnson’s COVID-19 vaccine.

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How much does the COVID-19 vaccine cost?

Any dose purchased by the U.S. government is free for its citizens. While the facility or agency that provides the vaccine may require reimbursement of administration fees from an insurance plan or public health program, no one may be charged any fee for a COVID-19 vaccine and must not be denied coverage for vaccination if they do not have a medical condition .​

Who can get the Johnson & Johnson vaccine?

According to the CDC, everyone 18 and older is now eligible for the Johnson & Johnson vaccine.

Most early vaccine efforts for COVID-19 vaccine candidates have focused on the adult population, with vaccine options expected for children and adolescents later in 2021.

The Johnson & Johnson vaccine is no exception. The vaccine is licensed in adults 18 years of age and older, and its Phase 3 trials were conducted in adults 18 and older, with a significant proportion of those over 60 years old.

Side Effects and Adverse Events

In each clinical trial, participants were asked to document any reactions they had after receiving a drug or vaccine. Adverse reactions are considered to be drug reactions directly caused by the vaccine, while side effects are physical reactions to the drug.

Preliminary vaccine safety information released shows that the most common reactions following vaccination include:

  • pain, redness, or swelling at the injection site
  • fatigue
  • headache
  • Muscle pain
  • nausea
  • fever

According to the FDA, immunocompromised people, including those receiving immunosuppressants, may have a weakened immune response to the vaccine.

Thrombosis risk in thrombocytopenia

On April 13, 2021, the FDA and CDC recommended a temporary suspension of the administration of Johnson & Johnson’s COVID-19 vaccine while the agencies investigated six reported cases of a rare but serious brain-affecting blood clot known as cerebral venous sinus thrombosis (CVST). ) occurs with thrombocytopenia (low platelet count), which can make the condition difficult to treat.

In their review, the CDC and FDA counted an additional nine rare cases of blood clots with low platelet counts, bringing the total to 15 of the 8 million doses. Most cases occurred within 1 to 2 weeks after vaccination in women between the ages of 18 and 49. The agencies concluded that the potential benefits outweighed this very rare risk and lifted the moratorium after 10 days.

A warning about the rare risk of thrombosis in the cerebral venous sinuses and other sites, including abdominal and lower extremity veins, and low postoperative platelet counts was added to the fact sheet for healthcare providers, vaccinees, and caregivers. Receive a vaccine.

Healthcare providers have also been warned that treating suspected cases of this condition (thrombosis called thrombocytopenia) with the blood thinner heparin can be harmful and may require alternative treatment and consultation with a hematologist.

warning symptoms

Seek emergency medical care if you experience any of the following symptoms:

  • shortness of breath
  • chest pain
  • swelling of the legs
  • persistent abdominal pain
  • severe or persistent headache
  • blurred vision
  • Easy bruising or tiny blood spots under the skin (outside the injection site)

Risk of Guillain-Barre Syndrome

On July 13, 2021, the FDA announced another update to Johnson & Johnson’s COVID-19 vaccine label regarding the observed increased risk of Guillain-Barre syndrome (GBS) within 42 days of vaccination. GBS is an extremely rare autoimmune disease of the peripheral nervous system. The body’s own immune system attacks the peripheral nerves and spinal cord, causing muscle weakness and, in severe cases, general paralysis. Most people with this disorder make a full recovery.

Of the 12 million doses of Johnson & Johnson’s COVID-19 vaccine delivered in the United States, about 100 cases of GBS have been reported, according to data submitted to the government’s Vaccine Adverse Event Reporting System (VAERS). Most cases occur in men 50 years of age and older who have been vaccinated for about two weeks.

Although the findings suggest a link between the vaccine and a small increase in GBS risk, the FDA says it’s not enough to establish cause and effect. 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.

warning symptoms

Seek immediate medical attention if you experience any of the following symptoms:

  • Weakness or tingling, especially in the legs or arms, that seems to get worse or spread
  • difficulty walking
  • Difficulty with facial movements, including speaking, chewing, or swallowing
  • double vision or inability to move your eyes
  • Difficulty with bladder control or bowel function

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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, manufacture, and distribution of a COVID-19 vaccine by Funded by the Biomedical Advanced Research and Development Authority (BARDA), a U.S. government program to facilitate the manufacture and distribution of vaccines to combat COVID-19. Johnson & Johnson said the company and BARDA have invested $1 billion in the vaccine program.