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The Covid-19 single-dose vaccine was effective “in demographic subgroups” in a final stage study, scientists from the Food and Drug Administration plan to tell a panel of medical experts meeting on Friday to evaluate the injection.
FDA officials, in another statement prepared for the advisory committee, also said the agency plans to continue studying the vaccine to assess its effectiveness in specific populations, the duration of protection against Covid-19 provided by the injection and its potency against new strains of the vaccine. 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 by Saturday.
The panel, which includes 22 doctors specializing in areas such as internal medicine, pediatrics, vaccines and epidemiology, regularly informs the U.S. Food and Drug Administration about experimental vaccines. Voted to recommend Pfizer photos Inc.
and partner BioNTech SE and Moderna Inc.
before the agency authorized them in December.
In another testimony prepared for the panel, the US Centers for Disease Control and Prevention said that preliminary results of safety data for the Pfizer-BioNTech and Moderna vaccines did not show a statistically significant increase in the risk of adverse events among people who received these vaccines.
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During the full-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 J&J vaccine in preventing new ones. cases caused by variants.
The giving and receiving of questions and answers can be valuable in increasing public confidence in the photo, say FDA officials.
The vaccine was 66% effective in protecting people against moderate to severe Covid-19, an FDA review concluded, and even more effective in preventing serious illness alone.
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 study subjects.
Health officials have noted whether Covid-19 vaccines can prevent people without symptoms from transmitting the virus, because the virus was widely spread by people who were infected, but they did not realize why they had no symptoms.
As highly transmissible coronavirus variants spread around the world, scientists are racing to understand why these new versions of the virus are spreading more quickly and what this could mean for vaccine efforts. New research says the key may be the peak protein, which gives coronavirus its unmistakable shape. Illustration: Nick Collingwood / WSJ
The release of doses of the J&J vaccine could increase – by about 20% during March – the total number available, as health authorities increase the rate of vaccinations and try to inoculate enough people as quickly as possible for companies , schools and other establishments can reopen fully.
J&J said it will deliver about 20 million doses for use in the United States by the end of March.
The FDA frequently calls public meetings of external experts to examine experimental drugs, devices and vaccines for approval by the agency, in part to increase public acceptance of the products if they are released for wide use.
The J&J vaccine appeared to be safe in its main study, the FDA found, in addition to being effective.
The vaccine was less effective in South Africa, where a more communicable Covid-19 variant thrived, than in the United States. J&J is among the companies working on new injections for the new strain, which several current vaccines do not seem to work with. well against.
The J&J Covid-19 injection was, however, very effective against serious 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 depends on a different mechanism for conferring immunity than traditional vaccines.
Traditional Vaccines
1. In classic vaccines, such as against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This activates the immune system to produce specialized antibodies that are adapted to recognize the virus.
2. After vaccination, antibodies remain in the body. If the patient is later infected with the real virus, the antibodies can identify him and help neutralize him.
Johnson & Johnson Vaccine
The scientists isolated the coronavirus genes responsible for producing these peak proteins. The genes are combined into weakened and harmless versions of other viruses.
Instead of using the entire virus to generate an immune response, these vaccines use only peak coronavirus external proteins, which are what antibodies use to recognize the virus.
Virus weakened with
peak protein genes
When injected into a patient, the genetically modified viruses enter healthy cells, where they produce peak coronavirus proteins.
The peak proteins produced by the cells stimulate the immune system to mount a defense, just as with traditional vaccines.
Antibody response generated by vaccine
1. In classic vaccines, such as against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This activates the immune system to produce specialized antibodies that are adapted to recognize the virus.
2. After vaccination, antibodies remain in the body. If the patient is later infected with the real virus, the antibodies can identify him and help neutralize him.
Johnson & Johnson Vaccine
The scientists isolated the coronavirus genes responsible for producing these peak proteins. The genes are combined into weakened and harmless versions of other viruses.
Instead of using the entire virus to generate an immune response, these vaccines use only peak coronavirus external proteins, which are what antibodies use to recognize the virus.
Virus weakened with
peak protein genes
When injected into a patient, the genetically modified viruses enter healthy cells, where they produce peak coronavirus proteins.
The peak proteins produced by the cells stimulate the immune system to mount a defense, just as with traditional vaccines.
Antibody response generated by vaccine
1. In classic vaccines, such as against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This activates the immune system to produce specialized antibodies that are adapted to recognize the virus.
2. After vaccination, antibodies remain in the body. If the patient is later infected with the real virus, the antibodies can identify him and help neutralize him.
Johnson & Johnson Vaccine
The scientists isolated the coronavirus genes responsible for producing these peak proteins. The genes are combined into weakened and harmless versions of other viruses.
Instead of using the entire virus to generate an immune response, these vaccines use only peak coronavirus external proteins, which are what antibodies use to recognize the virus.
Virus weakened with
peak protein genes
When injected into a patient, the genetically modified viruses enter healthy cells, where they produce peak coronavirus proteins.
The peak proteins produced by the cells stimulate the immune system to mount a defense, just as with traditional vaccines.
Antibody response generated by vaccine
1. In classic vaccines, such as against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This activates the immune system to produce specialized antibodies that are adapted to recognize the virus.
2. After vaccination, antibodies remain in the body. If the patient is later infected with the real virus, the antibodies can identify him and help neutralize him.
Johnson & Johnson Vaccine
Instead of using the entire virus to generate an immune response, these vaccines use only peak coronavirus external proteins, which are what antibodies use to recognize the virus.
Scientists have isolated the coronavirus genes responsible for producing these
peak proteins. The genes are combined into weakened and harmless versions of other viruses.
Virus weakened with
peak protein genes
When injected into a patient, the genetically modified viruses enter healthy cells, where they produce peak coronavirus proteins.
The peak proteins produced by the cells stimulate the immune system to mount a defense, just as with traditional vaccines.
Antibody response generated by vaccine
Write to Thomas M. Burton at [email protected] and Peter Loftus at [email protected]
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