World news – J&J Covid-19 Single-Dose Vaccine Receives Endorsement From FDA Advisory Panel

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Johnson & Johnsons

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The Covid-19 single-dose vaccine was safe and should be approved for use in the United States. A group of experts advised the federal health authorities on Friday.

The unanimous vote of the advisory committee in support of the vaccine approval is the final step before the US Food and Drug Administration makes a decision, which is expected on Saturday.

The panel, a group of 22 medical specialists in areas such as internal medicine, pediatrics, vaccines, and epidemiology, regularly advises the FDA on experimental vaccines. It was voted to recommend taking pictures of

Pfizer Inc.

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BioNTech

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SE and

Moderna Inc.

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before the agency approved these two-dose vaccines in December.

The vaccine’s efficacy and safety results were « well above the bar, » said the panel member

Eric Rubin,

Who is the Editor in Chief of the New England Journal of Medicine. « The demand is so great that this vaccine clearly has a place. »

Arnold Monto,

The board’s acting chairman and professor of public health and epidemiology at the University of Michigan said people should welcome J&J to be shot if approved. « Everything you can get in this environment is what you get, » he said.

During the all-day public meeting, representatives from the FDA and J&J discussed the safety and efficacy of the company’s vaccine in a study of over 44,000 subjects Effectiveness of the J&J vaccine in preventing new cases caused by variants.

The give and take of questions and answers, according to FDA officials, may increase public confidence in the shot.

The vaccine was 66% effective at protecting people from moderate to severe Covid-19, an FDA review found, and even more effective at preventing serious illnesses on its own.

« If approved, Janssen’s vaccine candidate would play a pivotal role in the global efforts to fight Covid-19. « 

Johan Van Hoof,

J&J’s Global Head of Vaccine Research at Pharmaceutical Division Janssen said during the panel meeting. « A single dose is an opportunity to vaccinate a population faster. »

With the introduction of the J&J vaccine, enough vaccinations could be obtained in the US by the end of March to increase the total number of people vaccinated by 20%. Health officials are urging to vaccinate enough people as soon as possible to allow businesses, schools and other facilities to fully reopen.

J&J has announced that it will ship approximately 20 million doses for use in the US by the end of March.

The FDA frequently convenes public meetings of external experts to review experimental drugs, devices, and vaccines for regulatory approval, in part to increase public acceptance of the products if they are approved for widespread use .

J&J’s vaccine appeared to be safe in its key study, the FDA noted that it was not only effective.

« The known and potential benefits of Ad26 outweigh the known and potential risks, » said Macaya Douoguih, director of clinical development and medical affairs at J&J in Janssen, during the meeting on Friday using a code name for the vaccine by J&J.

FDA Doctor Yosefa Hefter said there are still unknowns about the vaccine, including how long it has immune protection and how safe and effective it is for use in children.

* Based on a small number severe cases in the study. Note: The results are based on the different clinical studies and methods used by the companies.

An FDA analysis for the committee meeting also found that rare cases of deep vein clots and blockages in pulmonary arteries were slightly more common in vaccine recipients than in placebo patients, and that the FDA considers these to be « of clinical interest. »

The vaccine was effective « across demographic subgroups, » the FDA said. Demographic subgroups in the large study of J&J’s shot included racial and ethnic groups such as blacks, Latinos, and Asians, and ages such as 60 years and older. The researchers also rated its effectiveness in people with underlying conditions such as obesity and high blood pressure before they entered the clinical trial. Sometimes vaccines don’t work as well in the elderly due to a weakened immune system. The J&J vaccine appeared to be less effective in people aged 60 and over with certain conditions, such as diabetes and high blood pressure.

The J&J vaccine was less effective in South Africa than in the US. J&J is among companies working on new shots for a more transmissible variant of Covid-19 that is thriving in South Africa and against which several current vaccines appear to be ineffective.

However, J&J’s shot was very effective against severe and good critical cases in South Africa. The vaccine was 73.1% effective in preventing cases that occurred at least 14 days after vaccination and 81.7% effective in preventing such cases at least 28 days after vaccination.

1 With classic vaccines such as measles and polio, the patient is vaccinated with weakened or inactivated versions of the virus. This causes the immune system to produce specialized antibodies that are adapted to recognize the virus.

2. After vaccination, the antibodies remain in the body. If the patient is later infected with the actual virus, the antibodies can identify it and help neutralize it.

Scientists have isolated the genes in the coronavirus that are responsible for the production of these spike proteins. The genes are spliced ​​into weakened, harmless versions of other viruses.

Instead of using the entire virus to generate an immune response, these vaccines only use the coronavirus’ outer spike proteins, which antibodies use to recognize the virus. </ When injected into a patient, the genetically modified viruses enter healthy cells, where they produce coronavirus spike proteins.

The spike proteins produced by the cells induce the immune system to act as it does with conventional Defend vaccines.

1. With classic vaccines like measles and polio, the patient is vaccinated with weakened or inactivated versions of the virus. This causes the immune system to produce specialized antibodies that are adapted to recognize the virus.

2. After vaccination, the antibodies remain in the body. If the patient is later infected with the actual virus, the antibodies can identify it and help neutralize it.

Scientists have isolated the genes in the coronavirus that are responsible for the production of these spike proteins. The genes are spliced ​​into weakened, harmless versions of other viruses.

Instead of using the entire virus to generate an immune response, these vaccines only use the coronavirus’ outer spike proteins, which antibodies use to recognize the virus. </ When injected into a patient, the genetically modified viruses enter healthy cells, where they produce coronavirus spike proteins.

The spike proteins produced by the cells induce the immune system to act as it does with conventional Defend vaccines.

1. With classic vaccines like measles and polio, the patient is vaccinated with weakened or inactivated versions of the virus. This causes the immune system to produce specialized antibodies that are adapted to recognize the virus.

2. After vaccination, the antibodies remain in the body. If the patient is later infected with the actual virus, the antibodies can identify it and help neutralize it.

Scientists have isolated the genes in the coronavirus that are responsible for the production of these spike proteins. The genes are spliced ​​into weakened, harmless versions of other viruses.

Instead of using the entire virus to generate an immune response, these vaccines only use the coronavirus’ outer spike proteins, which antibodies use to recognize the virus. </ When injected into a patient, the genetically modified viruses enter healthy cells, where they produce coronavirus spike proteins.

The spike proteins produced by the cells cause the immune system to defend themselves, exactly as with conventional vaccines.

1. With classic vaccines such as measles and polio, the patient is vaccinated with weakened or inactivated versions of the virus. This causes the immune system to produce specialized antibodies that are adapted to recognize the virus.

2. After vaccination, the antibodies remain in the body. If the patient is later infected with the actual virus, the antibodies can identify it and help neutralize it.

Instead of using the entire virus to generate an immune response, these vaccines only use the outer spike proteins of the coronavirus, which antibodies recognize the virus.

When injected into a patient, the genetically modified viruses enter healthy cells, where they produce coronavirus spike proteins.

The spike proteins produced by the cells Cause the immune system to defend itself like traditional vaccines.

J&J, citing preliminary evidence in an analysis released by the FDA, said the vaccine was 65.5% effective in preventing asymptomatic infections in a subset of subjects .

Health officials have been watching whether Covid-19 shots can stop people without symptoms from transmitting the virus. Most of the virus was spread by people who were infected but didn’t notice because they didn’t have symptoms.

Ref: https://www.wsj.com

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