Johnson & JohnsonS
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The Covid-19 single-dose vaccine was effective “in the demographic subgroups” in a late-stage study, U.S. Food and Drug Administration scientists plan to tell a group of medical specialists on Friday to assess the impact.
FDA officials, in other testimonies prepared for the advisory committee, also said that the agency intends to continue studying the vaccine to assess its effectiveness in certain populations, the duration of protection against Covid-19 offered by the shot and its potency against new virus strains.
The committee meeting is the last step before US health regulators decide whether to authorize the use of a third vaccine. 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 US Food and Drug Administration on experimental vaccines. Voted to recommend Pfizer photos Inc.
and partner BioNTech SE and Moderna Inc.
before the agency authorizes them in December.
In other testimonies prepared for the panel, the U.S. Centers for Disease Control and Prevention said that preliminary safety data results for Pfizer-BioNTech and Moderna vaccines did not show a statistically significant risk of increased adverse events among those who received these photos. .
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During the full public meeting, FDA and J&J representatives will discuss the safety and efficacy of the company’s vaccine in a study of 44,000 people, according to an agenda, and how effective the J&J vaccine is in preventing new cases caused by variants.
Respecting questions and answers can be valuable in building public confidence in the film, FDA officials say.
The vaccine was 66% effective in protecting people from moderate to severe Covid-19, found an FDA review and even more effective in preventing severe disease.
J&J, citing preliminary evidence in an FDA-published analysis, said the vaccine was 65.5% effective in preventing asymptomatic infections in a subset of study subjects.
Health officials have looked into whether Covid-19 shots can stop asymptomatic people from transmitting the virus, as the virus was spread mostly by infected people, but who did not realize it because they had no symptoms.
As highly transmissible coronavirus variants travel the world, scientists are struggling 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 the spike protein, which gives the coronavirus an unmistakable shape. Illustration: Nick Collingwood / WSJ
The launch of J&J vaccine doses could add – by about 20% in March – to the total number available, as health authorities are picking up vaccinations and trying to inoculate enough people as quickly as possible so that businesses, schools and others units to be able to reopen completely.
J&J said it will deliver about 20 million doses for US 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 if they are authorized for widespread use.
The J&J vaccine appeared to be safe in its essential study, the FDA found, in addition to being effective.
The vaccine has been less effective in South Africa, where a more transmissible variant of Covid-19 has grown than in the US. J&J is one of the companies working on new photos of the new strain, which several current vaccines do not appear to have. work as well against.
J & J’s Covid-19 image was, however, very effective against severe and critical cases in South Africa. The vaccine was 73.1% effective in preventing such cases occurring 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 is based on a different mechanism for conferring immunity than traditional vaccines.
Traditional vaccines
1. In conventional 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 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 him and help neutralize him.
Johnson & Johnson vaccine
Scientists have isolated the genes in the coronavirus responsible for producing these spike proteins. The genes are combined into weak, harmless versions of other viruses.
Instead of using the whole virus to generate an immune response, these vaccines use only the top proteins of the coronavirus, which are the antibodies used to recognize the virus.
Virus weakened with
spike protein genes
When injected into a patient, genetically modified viruses enter healthy cells where they produce peak coronavirus proteins.
The spike proteins produced by the cells cause the immune system to mount a defense, just like in the case of traditional vaccines.
Vaccine-generated antibody response
1. In conventional 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 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 him and help neutralize him.
Johnson & Johnson vaccine
Scientists have isolated the genes in the coronavirus responsible for producing these spike proteins. The genes are combined into weak, harmless versions of other viruses.
Instead of using the whole virus to generate an immune response, these vaccines use only the top proteins of the coronavirus, which are the antibodies used to recognize the virus.
Virus weakened with
spike protein genes
When injected into a patient, genetically modified viruses enter healthy cells where they produce peak coronavirus proteins.
The spike proteins produced by the cells cause the immune system to mount a defense, just like in the case of traditional vaccines.
Vaccine-generated antibody response
1. In conventional 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 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 him and help neutralize him.
Johnson & Johnson vaccine
Scientists have isolated the genes in the coronavirus responsible for producing these spike proteins. The genes are combined into weak, harmless versions of other viruses.
Instead of using the whole virus to generate an immune response, these vaccines use only the top proteins of the coronavirus, which are the antibodies used to recognize the virus.
Virus weakened with
spike protein genes
When injected into a patient, genetically modified viruses enter healthy cells where they produce peak coronavirus proteins.
The spike proteins produced by cells cause the immune system to mount a defense, just like in the case of traditional vaccines.
Vaccine-generated antibody response
1. In conventional 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 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 him and help neutralize him.
Johnson & Johnson vaccine
Instead of using the whole virus to generate an immune response, these vaccines use only the top proteins of the coronavirus, which are the antibodies used to recognize the virus.
Scientists have isolated the coronavirus genes responsible for producing them
protein spike. The genes are combined into weak, harmless versions of other viruses.
Virus weakened with
spike protein genes
When injected into a patient, genetically modified viruses enter healthy cells where they produce peak coronavirus proteins.
The spike proteins produced by the cells cause the immune system to mount a defense, just like in the case of traditional vaccines.
Vaccine-generated antibody response
Write to Thomas M. Burton at [email protected] and Peter Loftus at [email protected]
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