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Updated on July 3, 2022 2:10 am
All countries
Updated on July 3, 2022 2:10 am
All countries
Updated on July 3, 2022 2:10 am

Global Statistics

All countries
Updated on July 3, 2022 2:10 am
All countries
Updated on July 3, 2022 2:10 am
All countries
Updated on July 3, 2022 2:10 am
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What Is In The Johnson And Johnson Covid Vaccine

Reporting A Possible Side Effect Or Serious Reaction

In-depth: How the Johnson & Johnson coronavirus vaccine works

Contact your health care provider if you experience:

  • a side effect following vaccination with a COVID-19 vaccine
  • any persistent, new or worsening symptoms

Health care providers must report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.

Reported allergic reactions and side effects to COVID-19 vaccines are published weekly in our Reported side effects following COVID-19 vaccination report.

Dont Compare The Three Vaccines

Dont get caught up necessarily on the numbers game, because its a safe and effective vaccine and what we need is to have as many effective vaccines as possible, said Dr. Irons. Rather than focusing on efficacy rates, accept the fact that now you have three highly effective vaccines.

These vaccines have not been tested head to head, so its impossible to do a really accurate comparison, she said. What matters most is they are all effective at preventing the most severe COVID outcomes, including hospitalization and death.

All three vaccines far exceeded FDAs 50% efficacy threshold, said Dr. Fryhofer.

The Advisory Committee On Immunization Practices Interim Recommendation For Use Of Janssen Covid

Weekly / March 5, 2021 / 70 329â332

MMWR Early Release.

Sara E. Oliver, MD1 Julia W. Gargano, PhD1 Heather Scobie, PhD1 Megan Wallace, DrPH1,2 Stephen C. Hadler, MD1 Jessica Leung, MPH1 Amy E. Blain, MPH1 Nancy McClung, PhD1 Doug Campos-Outcalt, MD3 Rebecca L. Morgan, PhD4 Sarah Mbaeyi, MD1 Jessica MacNeil, MPH1 José R. Romero, MD5 H. Keipp Talbot, MD6 Grace M. Lee, MD7 Beth P. Bell, MD8 Kathleen Dooling, MD1

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This Is How The Vector Vaccine Works

COVID-19 Vaccine Janssen® by Johnson & Johnson consists of a so-called vector virus a well-researched virus that is incapable of reproducing in the vaccinated persons body. In the case of this vaccine, it is an adenovirus that contains the genetic information for a single coronavirus protein: the so-called spike protein.

The function of the vector virus is to transport the information into the body, where the cells read it and are subsequently able to manufacture the spike protein themselves. The immune system recognises the spike proteins thereby manufactured by the body as foreign proteins and consequently produces antibodies and defence cells against the coronavirus. This is how a protective immune response comes about.

Good to know: The spike protein on its own is incapable of causing a SARS-CoV-2 infection. Furthermore, the body breaks down the vector virus after a short period of time, after which the virus protein is no longer produced.

How Effective Was The Vaccine In Testing

Johnson &  Johnson

Based on clinical trials, Johnson & Johnson reports the vaccine as 66 percent effective in preventing moderate to severe COVID-19 illness and 85 percent effective in preventing severe COVID-19 illness from the original form of COVID-19. This effectiveness varied by region, with effectiveness in preventing moderate and severe illness reaching 72 percent in the United States. The Johnson & Johnson vaccine also appears to be effective against some of the new SARS-CoV-2 variants, including B.1.351 in South Africa.

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How Effective Is The Johnson & Johnson Vaccine Against Covid

Its completely normal for viruses to mutate. When this occurs, new variants can emerge.

So far, several different variants of the novel coronavirus have been identified. Some of these have caused concern amongst public health officials. This is because the variants may be more contagious or escape the immune response.

The J& J vaccine clinical trial can give us some indication of how effective the vaccine is against these variants. This is because the trial was carried out at a time when viral variants were very common in some locations.

At the time of the trial, 95 percent of sequenced COVID-19 cases in South Africa were caused by the B.1.351 variant. The efficacy of the J& J vaccine at this location was 52 percent for mild to moderate COVID-19 and 73.1 percent for severe to critical COVID-19.

Similarly, in Brazil, 69 percent of the sequenced COVID-19 cases were caused by the P.2 lineage. The efficacy of the J& J vaccine in Brazil was 66.2 percent for mild to moderate COVID-19 and 81.9 percent for severe to critical COVID-19.

How Well The Vaccine Works

  • The J& J/Janssen COVID-19 Vaccine was 66.3% effective in clinical trials at preventing laboratory-confirmed COVID-19 infection in people who received the vaccine and had no evidence of being previously infected. People had the most protection 2 weeks after getting vaccinated.
  • In the clinical trials, the vaccine had high efficacy at preventing hospitalization and death in people who did get sick. No one who got COVID-19 at least 4 weeks after receiving the J& J/Janssen COVID-19 Vaccine had to be hospitalized.
  • CDC will continue to provide updates as we learn more about how well the J& J/Janssen COVID-19 Vaccine works in real-world conditions.

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Does The Vaccine Have Side Effects

In some persons, yes. Included among the symptoms are swelling at the injection site, headache, joint and muscle pain, fever, fatigue, and nausea. The side effects are usually transient and mild, and can be taken as evidence that the vaccine is working to create an immune response. Severe side effects, such as allergic reactions, are rare.

The vaccine was temporarily paused in April 2021 for further analysis of blood clotting concerns. Women under the age of 50 should be aware of the risk of a rare blood clotting syndrome associated with the vaccine. If you are concerned about a possible allergic or severe reaction, please consult with your medical provider prior to receiving the vaccine.

Are These Vaccines Authorized

Johnson & Johnson coronavirus vaccine | What you need to know

The Pfizer-BioNTech, Moderna, and J& J COVID-19 vaccines are currently authorized in the United States by the FDA under an emergency use authorization . This is a little bit different than a typical FDA approval.

Simply put, an EUA is a method through which the FDA can allow unapproved medical products to be used during a public health emergency, like a pandemic.

When reviewing a product for an EUA, the FDA must decide that the overall benefits of the product outweigh its potential risks.

Heres what happens during this process:

  • Submitting for EUA. A company needs to submit both safety and efficacy results from a phase 3 clinical trial to the FDA. Its possible for this trial to still be in progress during submission as long as it meets certain milestones set by the FDA.
  • Internal review. FDA scientists comb through the clinical trial data that the company has submitted.
  • External advisory panel review. An external advisory panel of scientists and public health experts also goes over and discusses the data.
  • A decision is made. The FDA considers the feedback from both the internal review and the external advisory panel review when deciding to grant EUA to a product.
  • In addition to the United States, these three COVID-19 vaccines have been authorized or approved in a variety of other countries around the world.

    Its important to note that additional authorizations or approvals may occur rapidly.

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    What Should You Know About The Fda Warning Labels Attached To J& js Vaccine

    All three vaccines available in the United States have had their setbacks, including reports of adverse events, but these have been rare. The FDA added warnings to the Pfizer and Moderna vaccines following reports of rare cases of myocarditis and pericarditis after mRNA vaccination, particularly in male adolescents and young adults.

    For people who got Johnson & Johnson, the FDA has added two warnings to the vaccine. The first was this past April, after the vaccination was linked to a small number of cases of an uncommon, but potentially serious blood clotting disorder, prompting the agency to put a two-week pause on the vaccine while the issue was investigated. The second was in July, after reports linked the vaccine to Guillain-Barré syndrome, a rare neurological disorder. In both cases, the agency said the incidence was very rare, and the benefits of the vaccine still outweighed the risks.

    Should Pregnant Women Be Vaccinated

    WHO recommends the use of the COVID-19 vaccine in pregnant women only if the benefits of vaccination to the pregnant woman outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy.

    Who is the vaccine not recommended for?

    Individuals with a history of anaphylaxis to any component of the vaccine should not take it.

    Anyone with a body temperature over 38.5ºC should postpone vaccination until they no longer have a fever.

    The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies in that age group.

    Whats the recommended dosage?

    SAGE recommends the use of Janssen Ad26.CoV2.S as one dose given intramuscularly.

    There should be a minimum interval of 14 days between the administration of this vaccine and any other vaccine against other health conditions. This recommendation may be amended as data on co-administration with other vaccines become available.

    Is it safe?

    How efficacious is the vaccine?

    Very common > 1/10

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    Johnson & Johnson Vaccine And Covid

    Recent news has continued to discuss the need for ongoing vigilance because of the significance of the emerging COVID-19 variants. While Pfizer and Moderna vaccines have not been fully studied against the variants, the Johnson & Johnson vaccine clinical trials were conducted in South Africa and Brazil when the new variants had become prevalent. In South Africa, approximately 95 percent of the circulating virus was the B.1.351 variant and in Brazil, roughly 69 percent of the circulating virus was a P1/P2 variant at the time of the trial.

    While the overall efficacy of the Johnson & Johnson vaccine is significantly lower, it is known to protect against the variants that are now being seen in the United States. Individuals who receive or already received the Pfizer or Moderna vaccine may have to receive a booster shot to protect themselves against the new variants. Current development is underway for those booster vaccines.

    The Vaccine At A Glance

    US recommends
    • Name: COVID-19 Vaccine Janssen®
    • : Janssen-Cilag International NV
    • Vaccine type + mode of action: Vector vaccine based on an attenuated cold virus that was modified so as to introduce a blueprint of the virus into the bodys cells, inducing its immune system to produce antibodies to SARS-CoV-2.
    • Efficacy: In the marketing authorisation studies, the COVID-19 Vaccine Janssen® showed approximately 65% efficacy in protecting against COVID-19 infections. In addition, the vaccine provides almost full protection against severe cases of disease requiring hospitalisation. You can find more information on the efficacy of the vaccine in the product summary .
    • STIKO vaccine recommendation: Based on the currently available data, the vaccine is recommended for persons over the age of 60. Persons under the age of 60 may be administered this vaccine after being informed by a doctor and individually accepting the risks.
    • Some typical vaccine reactions include: headaches, pain at the injection site, fatigue or flu-like symptoms.
    • Administration: by injection into the muscle of the upper arm
    • Vaccination schedule: single dose
    • Storage: When stored in the freezer at between -25 °C and -15 °C, the unopened vaccine has a shelf-life of two years between 2 °C and 8 °C, the unopened vaccine has a shelf-life of 3 months. Once thawed, the vaccine may not be refrozen, however.

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    Do Johnson & Johnson Recipients Need A Booster Shot

    Some worry that giving boosters to people in wealthy nations will waste precious doses that could be given to unvaccinated people in poorer countries. To prevent this, the World Health Organization called for a moratorium on boosters until at least the end of September.

    On Aug. 25, 2021, Johnson & Johnson announced that people who initially received a single shot vaccine and then received the same shot as a booster produced a much stronger antibody response than after receiving a single dose. This new study provides data to support a booster for those who received the single-dose Johnson & Johnson vaccine despite the larger controversy and uncertainty.

    On Aug. 22, 2021, U.S. Surgeon General Dr. Vivek Murthy said that Johnson & Johnson recipients will likely need a booster. The government needs more information before making a recommendation about the need for a booster shot, and since the vaccine was rolled out three months after the mRNA vaccines, key studies are still in progress.

    One important question is whether someone who received the Johnson & Johnson shot should get a second Johnson & Johnson dose or mix and match get a second dose of a different vaccine.

    Why Did The Fda Question The Strength Of J& js Data

    Even though the FDA advisory panel unanimously recommended authorization, the FDA had questioned a test Johnson & Johnson used in the trial to support its application for authorization. Regulators questioned the accuracy of a test called pseudovirus neutralization assay , which is used to measure antibodies, suggesting that the low-test sensitivity could have affected the results of the clinical trial.

    The upshot, though, is that despite the concern for low sensitivity of the psVNA, the advisory panel still recommended the second dose, says Dr. Sude. They feel that everyone who received a first dose should be given the option to optimize protection based on the best data available at this time.

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    We Saw This Beforewith The Astrazeneca Vaccine

    A small number of serious blood clots also were reported in people who received the AstraZeneca vaccine, which is not authorized for use in the United States. In March, countries in Europe and elsewhere put a pause on that vaccine after a handful of peoplemostly women younger than 60also developed CVST and low platelet counts. The European Medicines Agency investigated the situation and concluded that these complications should be listed as very rare side effects of the AstraZeneca vaccine, and said the benefits still outweighed the risks. But several countries now are administering that vaccine only to older people.

    The FDA released the Johnson & Johnson vaccine after they reviewed the data. I certainly agree with their advice.Yale Medicine hematologist Robert Bona, MD

    Both the AstraZeneca and Johnson & Johnson vaccines, as well as the Sputnik V vaccine in Russia are carrieror vectorvaccines, which instruct human cells to make the SARS CoV-2 spike protein. For this vaccine technology, scientists engineer a harmless inactivated common adenovirus into a sort of Trojan Horse that carries genetic code to a vaccine recipients cells. The code then instructs the cells to produce a spike protein that trains the bodys immune system, which then creates antibodies and memory cells to protect against an actual SARS-CoV-2 infection.

    Expect The Same Side Effects

    Mayo Clinic Insights: What you should know about the Johnson & Johnson COVID-19 vaccine

    Aside from the extremely rare blood clots discussed above, the side effects for the J& J vaccine are very similar to those for the mRNA vaccines, including injection-site pain, headache, fatigue, fever, chills and muscle aches, said Dr. Fryhofer.

    With most of the side effects occurring within one to two days following vaccination, Dr. Fryhofer recommends choosing a day or two when you dont have a lot of important stuff going on, because you might not feel well.

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    In A Sea Of Skeptics This Physician Was One Of Fibromyalgia Patients Few True Allies Or Was He

    Language added to the fact sheets provided to health care professionals about each vaccine says the shots may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The language does not appear to offer any preference at all for having people receive a booster of their original vaccine.

    It remains to be seen if the CDC on the advice of the ACIP turns that permissive recommendation into a preferential one, urging people who got the J& J vaccine to get an mRNA dose as their booster shot. The committee has been concerned for some time about the situation people who got the J& Js one-and-done vaccine find themselves in, given that the vaccine is less effective than the mRNA vaccines at protecting against Covid infection.

    This story was updated with additional comment and information.

    Whats Troubling About The Reported Clots

    A blood clot is what it sounds likea gel-like clump of blood. Small blood clots form whenever you cut or scrape your skin to plug up the injured area and stop the bleeding. But they are dangerous when they form within a blood vessel, where they can cause thrombosis , a condition that kills up to 100,000 people a year in the United States. Those clots typically occur in people who are bedridden or hospitalized, or have other medical issues related to inflammation or infection or cancer, says Yale Medicine hematologist Robert Bona, MD. They are also more likely to occur in women who are pregnant or on oral contraceptives, or in people who have hereditary disorders that predispose them to blood clotting.

    The type of blood clot developed by a small number of Johnson & Johnson vaccine recipients was a particularly rare and dangerous blood clot in the brain, known as cerebral venous sinus thrombosis , because it appears in the brains venous sinuses. Yale doctors diagnose only about a couple of patients a year with CVSTits usual causes include dehydration, inherited disorders, and infections or obstructions in the brain, Dr. Bona says.

    But another concern is that these same vaccine recipients also developed thrombocytopenia, a condition characterized by abnormally low platelet levels in their blood. This is unusual in someone with a major blood clot because platelets are colorless blood cells that have the function of helping blood clot.

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