Johnson and Johnson Vaccine Covid-19: What you need to know

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July 13 2021 : Food and medicine management (FDA) announced the Johnson Covid vaccine update -19 Label in relation to the high risk observed from GuillainCarr syndrome after vaccination.

This announcement follows the previous joint statement released on April 23,2021 FDA and centers to control and prevent diseases and prevents at the Johnson Johnson Kwid19 Administration Pause After the agencies examined six registered cases of rare, but heavy clots,They occurred in two weeks after people received a vaccine.The agencies came to the conclusion that the possibility of this serious event is very rare and recommended that vaccination of a curriculum with additional warnings, especially for women under 50.

February 27, Johnson Johnson Vaccine Vaccine against Disease Coronavirus (Covid-19) It became the third VACCOTO COVID-19 to obtain an extraordinary use permit (USA) of the FDA.

The company worked with your Janssen pharmaceutical hand to develop a vaccine with the name of the set of projects and Ensemble 2.The company registered the participants later observes in September and reviewed its vaccine with two different doses.

After it was found that a dose should be effective in clinical trials, Johnson Johnson filed an US request for a dose.Now, this is the first COVID-19 vaccine, which should be shown in a dose in the United States and is authorized for adults over 18 years of age.

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Images Tang Ming Tung / Getty

How it works

The Johnson Johnson vaccine is a single-channel adenovirus vaccine.This is a viral vector vaccine using a weakened live pathogen (adenovirus) as a delivery method (vector) for transporting a recombinant vaccine for COVID-19.

Recombinant vaccines Use a small piece of genetic material from the virus to cause an immune response. This genetic material for Covid-19 is not a replicate in the body.You can direct a specific piece of virus, and recombinant vaccines are common and, as a rule, are safe for use in a large popular population of people who are with chronic health problems or are immunocompromised.

There may be some drawbacks for the recombinant vaccine. However, the examples are that reinforcement shots may be required over time.Examples of recombinant vaccines are pneumococcal vaccines and vaccines for meningococcal diseases . . for the animals.Adenovirus-based vaccines can also present some problems that adenovirus is so common that the vaccine may not be as effective when the doses of the amplifier are shown, or that some people already have immunity to the virus used in the vaccine.

How effective is it?

Johnson Johnson announced that his dose vaccine was 66%, more efficiently to prevent moderate disease to Severa from Covid-19 and 85%, efficient to prevent severe diseases. This efficiency in the phase 3 test was achieved 28 days after vaccination.

The test was a temporary delay in October, when it is suspended by an inexplicable disease, although there was no There are specific details provided what happened due to the patient’s confidentiality.The regulators determined that the event was not associated with a vaccine, and the court was safe for renewal.

Efficiency against moderate to strong, varied Covid-19 infection, varied from the region in court.The United States had 72% in the United States, 68% in Latin America and 64% in South Africa.

The vaccine was also found completely protective by hospitalization and death, and protection against severe diseases.Multiple options for Covid-19, including B.1.The option 351 is located in South Africa.

Efficiency against the Delta option )

Currently there They are limited data that show how effective it is in the protection of the vaccine against the Delta variant (B.1,617.2).

According to the information published by Johnson Johnson, it was found that the vaccine should be an effective 85% against Heavy Diseases / COVID-19 criticism, including which caused a delta version. Data from the clinical study, published in Magazine Magazine New England also supports this finding. .The dose of the vaccine suggests that it depends on up to 95% effective to prevent the death of the Delta version and up to 71% effective against hospitalization. Although, although promising, these new test data still have to be considered or published in the scientific journal.

Additional studies are needed to further determine the effectiveness of the vaccine against this particular option.

When will it be available?

The Johnson Johnson vaccine received the authorization of emergency situations with the FDA for its dose vaccine. From April 28, 2021, Johnson Johnson established 17 .6 million doses in the United States and more than 8 million people received a vaccine, according to the CDC Control and Prevention Center.

In August 2020, Johnson Johnson announced that he had a contract with a contract with 100 million dose (equivalent to $ 10 per dose) and the ability to acquire 200 million additional doses. In March 2021The President Biden announced plans to acquire 100 million additional doses, providing up to 200 million doses.

The government of the United States announced association with Merck to help accelerate the production of the Johnson Johnson vaccine. Merck will receive up to $ 268.8 million.From the Biomedical Advanced Biomedical Research and Development Organs (BARDA) to adapt and provide its production facilities for the production of Johnson Johnson Vaccine Covid-19.

How much does the cost of the Vaccine Covid-19 cost?

Any dose acquired by the government of the United States is free for its citizens.While an object or agency offered by a vaccine may request compensation for insurance plans or public health program for an administrative fee,Nobody can be loaded any fee for obtaining Covid19 vaccines or deny the vaccine if they do not have health insurance.

Who can get the Johnson Johnson vaccine?

The 18 and older now have the right to the Johnson Johnson vaccine, according to CDC. .

Johnson Johnson The vaccine is no exception. The vaccine is authorized in adults over 18, and its tests in stage 3 were carried out in adults of 18 years and until a significant presentation of individuals over 60 years.

Side and unfavorable effects Events

In each clinical study, participants are asked to write any reaction they have after obtaining a medication or a vaccine.Adverse reactions are considered the reactions of the drugs caused by the vaccine, while the side effect is a physical reaction to the medication.

Initial information on the safety issued for the vaccine shows that the most common reactions were introduced after the introduction of the vaccine:

  • Injection pain, redness,or edema
  • fatigue
  • muscle pain
  • fever

people who are immunocominated, including those who receive immunosuppressive therapies, There may be a reduced immune response to the vaccine, according to the FDA.

Risk of thrombosis with thrombocytopenia

The April 13, 2021,FDA and CDC recommended temporary pause at the Johnson Johnson19 Vaccine COVID Administration while the agencies investigated six recorded cases of rare, but severe blood type, which affects the brain,Called brain venous sinus thrombosis (CVST), which is happening together with Taa Thrommocytopenia (low platelet count). It can complicate the condition for the treatment of the condition.

In its revision of CDC and FDA, they constitute nine additional cases of rare blood clots, connected to a low platelet number, which takes a total of up to 15 of 8 million doses introduced.Most cases occurred in women from 18 to 49 years of age of one or two weeks of vaccination. The agencies came to the conclusion that the potential benefits exceed this very rare risk and raised a pause after 10 days.

Warning was added to the facts of the facts for health care providers and the beneficiaries of vaccines and guardians about the rare risk of thrombosis in the cerebral venous sinus and other sites (including blood vessels in theStomach and the Nizhegocondunce veins) Together sparespar Low after receiving the vaccine.

Health providers were warned than the treatment of a suspicious case of this state (known as thrombosis with thrombocytopenia) with a blood diluent heparin can be harmful and can be harmful and can Require alternative procedures.With consultation of hematology ssocialists.

Symptoms of warning

seek emergency medical attention,If you are experiencing any of the following symptoms:

  • Lack of breath
  • chest pain
  • swelling of the leg
  • Pain resistant stomach
  • heavy or resketherapy pain
  • Blurred vision
  • Easy bruises or small bloods under the skin (out of the injection)

Risk GILNASInder Barr July 13, 2021, the FDA announced another Johnson Johnson Covid19 Vaccine label against the high risk observed of Guilllain-Carr Syndrome (GBS) within 42 days after vaccination. GBS is an extremely rare autoimmune disorder of the peripheral nervous system, in which its own body immune system attacks the peripheral nerves and spinal cord,Causing weakness of muscles and possible paralysis of the body in severe cases. Most people who develop this disorder are completely recovered.

According to the data presented in the government’s adverse event reporting system (VAERS), 12 million doses of Johnson Johnson Johnson Covid-19, which are shown in the United States. There are about 100 cases of cases of people who develop GBS. Most cases occurred in men of 50 years and older and approximately two weeks after receiving vaccination.

Although these data offer a reference between the vaccine and a small high risk of GBS, the state of the FDA is not enough to establish causal relations.Cancellation and FDA and cases of syndrome CDC monitoring, emphasize that the potential benefits of the vaccine continue to surpass this very low risk.

Symptoms of warning

seek immediate medical care If you experience any of the following symptoms:

  • weakness or tingling, especially on the legs or arms,Wit off or distributed
  • difficulties, walking
  • difficulties with the movements of the face, including talking, chewing,or swallow
  • double vision or inability to move the eyes
  • the difficulties with the function of the blade or the control function of the bladder or the intestinal function

Financing andDevelopment

Johnson Johnson co-financed the development of the vaccine during the speed of the warp operation, the public-private partnership initiated by the United States.The Government promotes and accelerates the development of Vaccine against Covid-19, production and distribution of Vaccines COVID-19, with funds from advanced biomedical research and development agencies (BARD) A ..Government program aimed at promoting the manufacture and distribution of vaccines to combat Covid-19. Johnson Johnson stated that one billion dollars were invested in the vaccine project as a company and bard.

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