FDA scientists say Covid-19 single-dose J&J vaccine is effective in all demographic groups

Johnson & Johnson‘s

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the single-dose Covid-19 vaccine was effective “in all demographic subgroups” in a final phase study, scientists from the U.S. Food and Drug Administration plan to report it to a group of medical specialists meeting Friday to assess the shot.

FDA officials, in another testimony prepared for the advisory committee, also said the agency plans to continue studying the vaccine to evaluate its effectiveness in specific populations, the duration of protection against Covid-19 provided. by the firing and its potency against new strains of the virus.

The committee meeting is the last step before U.S. health regulators decide whether to use a third feature. The decision is expected on Saturday.

The group, which includes 22 medical specialists in fields such as internal medicine, pediatrics, vaccines and epidemiology, regularly advises the U.S. Food and Drug Administration on experimental vaccines. Voted recommended photos of Pfizer Inc.

and partner BioNTech SE and Moderna Inc.

before the agency authorized them in December.

In other testimonies prepared for the group, the U.S. Centers for Disease Control and Prevention said preliminary results from safety data for Pfizer-BioNTech and Moderna vaccines did not show a statistically significant increase in event risk. adverse events among people who received these vaccines.

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During the all-day public meeting, FDA and J&J representatives will discuss the safety and efficacy of the company’s vaccine in a study of more than 44,000 subjects, according to an agenda, as well as the effectiveness of the vaccine. J&J in the prevention of new cases caused by variants.

Responses and responses can be valuable in building public confidence in the shot, FDA officials say.

The vaccine was 66% effective in protecting people from moderate to severe Covid-19, according to an FDA review, and even more effective in preventing serious illness alone.

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

Health authorities have been looking into whether Covid-19 traits can prevent asymptomatic people from transmitting the virus, because the virus has been transmitted largely by infected people but they have not noticed it because they had no symptoms.

As highly transmissible coronavirus variants spread around the world, scientists are rushing to understand why these new versions of the virus are spreading faster and what it can mean for vaccination efforts. New research says the key may be the ear protein, which gives the coronavirus its unmistakable shape. Illustration: Nick Collingwood / WSJ

The deployment of J&J vaccine doses could add – approximately 20% during March – to the total number available, as health authorities pick up the pace of vaccinations and try to inoculate enough people as quickly as possible so that businesses, schools and other establishments may. it reopens completely.

J&J has said it would deliver about 20 million doses for U.S. use by the end of March.

The FDA often convenes public meetings of external experts to examine experimental drugs, devices, and vaccines for agency approval, in part to increase public acceptance of products in case they are authorized for use. wide.

The J&J vaccine appeared to be safe in its core study, the FDA found, aside from being effective.

The vaccine was less effective in South Africa, where a more transmissible variant of Covid-19 has thrived than in the US. J&J is one of the companies working on new shots aimed at the new strain, which seems like several current vaccines don’t work as well against them.

J&J’s Covid-19 feature was, however, very effective against serious and critical cases in South Africa. The vaccine was 73.1% effective in preventing cases from occurring at least 14 days after vaccination and 81.7% to prevent such cases at least 28 days after vaccination.

How viral virus vaccines work

The Johnson & Johnson vaccine is based on a different mechanism for conferring immunity than traditional vaccines.

Traditional vaccines

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that adapt to recognize the virus.

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

Johnson & Johnson vaccine

Scientists have isolated the coronavirus genes responsible for producing these cutting-edge proteins. Genes bind to harmless and weakened versions of other viruses.

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

Virus weakened with

spike protein genes

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

The cutting-edge proteins produced by cells drive the immune system to defend itself, as it does with traditional vaccines.

Antibody response generated by vaccines

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that adapt to recognize the virus.

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

Johnson & Johnson vaccine

Scientists have isolated the coronavirus genes responsible for producing these cutting-edge proteins. Genes bind to harmless and weakened versions of other viruses.

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

Virus weakened with

spike protein genes

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

The cutting-edge proteins produced by cells drive the immune system to defend itself, as it does with traditional vaccines.

Antibody response generated by vaccines

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that adapt to recognize the virus.

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

Johnson & Johnson vaccine

Scientists have isolated the coronavirus genes responsible for producing these cutting-edge proteins. Genes bind to harmless and weakened versions of other viruses.

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

Virus weakened with

spike protein genes

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

The cutting-edge proteins produced by cells drive the immune system to defend itself, as it does with traditional vaccines.

Antibody response generated by vaccines

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that adapt to recognize the virus.

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

Johnson & Johnson vaccine

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

Scientists have isolated the coronavirus genes responsible for producing them

ear proteins. Genes bind to harmless and weakened versions of other viruses.

Virus weakened with

spike protein genes

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

The cutting-edge proteins produced by cells drive the immune system to defend itself, as it does with traditional vaccines.

Antibody response generated by vaccines

Write to Thomas M. Burton at [email protected] and Peter Loftus at [email protected]

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