J&J Covid-19 Single-Dose Vaccine Effective in All Demographics, FDA Scientists Say


Johnson and Johnson‘s

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The single-dose Covid-19 vaccine was effective “in all demographic subgroups” in a late-stage study, as scientists from the US Food and Drug Administration plan to report to a panel of medical specialists that will meet Friday to evaluate the injection.

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

The committee meeting is the final step before US health regulators decide whether to authorize the use of a third injection. The decision is expected on Saturday.

The panel, which includes 22 medical specialists in fields such as internal medicine, pediatrics, vaccines and epidemiology, regularly advises the US Food and Drug Administration on experimental vaccines. Voted to Recommend Pfizer Outlets Inc.

and partner BioNTech SE and Moderna Inc.

before the agency cleared them in December.

In other testimony prepared for the panel, the U.S. Centers for Disease Control and Prevention said that preliminary results from safety data for the Pfizer-BioNTech and Moderna vaccines did not show a statistically significant increased risk of adverse events among people who received those vaccines.

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

The exchange of questions and answers can be valuable in bolstering public confidence in the vaccine, FDA officials say.

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

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 at whether Covid-19 injections can prevent people without symptoms from transmitting the virus, because the virus has largely been transmitted by people who were infected but did not realize it because they had no symptoms.

As highly communicable coronavirus variants spread across the world, scientists are racing to understand why these new versions of the virus are spreading faster and what this could mean for vaccination efforts. New research says the key may be spike protein, which gives the coronavirus its unmistakable shape. Illustration: Nick Collingwood / WSJ

The launch of the J&J vaccine doses could add, by an estimated 20% during March, to the total number available, as health authorities accelerate the pace of vaccines and try to inoculate enough people as quickly as possible for them to companies, schools and other establishments can reopen completely.

J&J has said it will deliver about 20 million doses for US use by the end of March.

The FDA often convenes public meetings of outside experts to review experimental drugs, devices, and vaccines for agency approval, in part to drive public acceptance of the products should they be authorized for widespread use.

J & J’s vaccine appeared to be safe in its pivotal study, the FDA found, as well as 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 among companies working on new injections targeting the new strain, which several current vaccines do not appear to be. function. well against.

However, J & J’s Covid-19 injection was very effective against serious and 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.

How Viral Vector Vaccines Work

The Johnson & Johnson vaccine relies on a different mechanism to confer 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 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 later becomes infected with the actual virus, the antibodies can identify it and help neutralize it.

Johnson & Johnson vaccine

Scientists have isolated the coronavirus genes responsible for producing these spike proteins. Genes splice into harmless, weakened versions of other viruses.

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

Weakened virus with

spike protein genes

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

The spike proteins produced by cells cause the immune system to mount a defense, just like with traditional vaccines.

Antibody response generated by the vaccine

1. In classic vaccines, such as those against measles and polio, the patient is inoculated 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 later becomes infected with the actual virus, the antibodies can identify it and help neutralize it.

Johnson & Johnson vaccine

Scientists have isolated the coronavirus genes responsible for producing these spike proteins. Genes splice into harmless, weakened versions of other viruses.

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

Weakened virus with

spike protein genes

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

The spike proteins produced by cells cause the immune system to mount a defense, just like with traditional vaccines.

Antibody response generated by the vaccine

1. In classic vaccines, such as those against measles and polio, the patient is inoculated 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 later becomes infected with the actual virus, the antibodies can identify it and help neutralize it.

Johnson & Johnson vaccine

Scientists have isolated the genes in the coronavirus responsible for producing these spike proteins. Genes splice into harmless, weakened versions of other viruses.

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

Weakened virus with

spike protein genes

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

The spike proteins produced by cells cause the immune system to mount a defense, just like with traditional vaccines.

Antibody response generated by the vaccine

1. In classic vaccines, such as those against measles and polio, the patient is inoculated 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 subsequently infected with the actual virus, the 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 spike proteins of the coronavirus, which are what antibodies use to recognize the virus.

Scientists have isolated the genes in the coronavirus responsible for producing these

spike proteins. Genes splice into harmless, weakened versions of other viruses.

Weakened virus with

spike protein genes

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

The spike proteins produced by cells cause the immune system to mount a defense, just like with traditional vaccines.

Antibody response generated by the vaccine

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

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