Johnson & Johnson‘s
JNJ -2.18%
a single dose of Covid-19 vaccine was effective “in all demographic subgroups”. At a late stage in an investigation, scientists at the U.S. Food and Drug Administration plan to tell a panel of medical specialists meeting Friday to evaluate the shot.
The FDA officials also said in another testimony prepared before the advisory committee that the agency plans to continue to study 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 virus.
The meeting of the committee is the last step before the US health authorities decide whether to allow the use of a third shot. The decision is expected on Saturday.
The panel, which includes 22 medical specialists in areas such as internal medicine, pediatrics, vaccines, and epidemiology, regularly advises the U.S. Food and Drug Administration on experimental vaccines. It voted to recommend shots from Pfizer Inc.
and partner BioNTech SE and Moderna Inc.
before the agency gave them permission in December.
In other testimonials prepared for the panel, the U.S. Centers for Disease Control and Prevention said preliminary results of safety data for the Pfizer-BioNTech and Moderna vaccines did not show a statistically significant increased risk of side effects in people who received these injections .
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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 the prevention of new cases. caused by variants.
Giving and taking questions and answers can be valuable in building public confidence in the shot, FDA officials say.
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 illness alone.
J&J, citing preliminary evidence in an FDA analysis, said the vaccine was 65.5% effective in preventing asymptomatic infections in a subset of subjects.
Health authorities have looked at whether Covid-19 injections can stop people without symptoms from transmitting the virus, because the virus has been spread largely by people who were infected but didn’t realize it because they had no symptoms.
As highly transmissible coronavirus variants fly around the world, scientists are rushing 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 its unmistakable shape. Illustration: Nick Collingwood / WSJ
The introduction of the J&J vaccine doses could contribute – by an estimated 20% in March – to the total number available as health authorities speed up the pace of vaccinations and try to inoculate enough people as soon as possible so that businesses, schools and other institutions can do that. reopen completely.
J&J has said it would deliver approximately 20 million doses for use in the US by the end of March.
The FDA often convenes public meetings of outside experts to investigate experimental drugs, devices and vaccines that must be approved by the agency, in part to drive public acceptance of the products if they are approved for general use.
J & J’s vaccine appeared to be safe in its pivotal study, the FDA found, except it was effective.
The vaccine was less effective in South Africa, where a more transmissible Covid-19 variant thrived, than in the US. J&J is one of the companies working on new injections targeting the new strain, several of which current vaccines don’t seem to work. good against.
However, J & J’s Covid-19 shot was 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% 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 classic vaccines, such as those against measles and polio, the patient is inoculated with attenuated or inactivated versions of the virus. This prompts the immune system to produce specialized antibodies that are adapted to recognize the virus.
2. The antibodies remain in the body after vaccination. If the patient later becomes infected with the actual virus, the antibodies can identify it and help neutralize it.
Johnson & Johnson’s Vaccine
Scientists have isolated the genes in the coronavirus responsible for the production of these spike proteins. The genes are split into weakened, harmless versions of other viruses.
Rather than using the whole virus to elicit an immune response, these vaccines use only the proteins from the outer spines of the coronavirus, which use antibodies to recognize the virus.
Attenuated virus with
spike protein genes
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce spike proteins from the coronavirus.
The peak proteins produced by the cells trigger the immune system to build a defense, just like traditional vaccines.
Vaccine Generated Antibody Response
1. In classic vaccines, such as those against measles and polio, the patient is inoculated with attenuated or inactivated versions of the virus. This prompts 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’s Vaccine
Scientists have isolated the genes in the coronavirus responsible for the production of these spike proteins. The genes are split into weakened, harmless versions of other viruses.
Rather than using the whole virus to elicit an immune response, these vaccines use only the proteins from the outer spines of the coronavirus, which use antibodies to recognize the virus.
Attenuated virus with
spike protein genes
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce spike proteins from the coronavirus.
The peak proteins produced by the cells trigger the immune system to build defenses, just like traditional vaccines.
Vaccine Generated Antibody Response
1. In classic vaccines, such as those against measles and polio, the patient is inoculated with attenuated or inactivated versions of the virus. This prompts the immune system to produce specialized antibodies that are adapted to recognize the virus.
2. The antibodies remain in the body after vaccination. If the patient later becomes infected with the actual virus, the antibodies can identify it and help neutralize it.
Johnson & Johnson’s Vaccine
Scientists have isolated the genes in the coronavirus responsible for the production of these spike proteins. The genes are split into weakened, harmless versions of other viruses.
Rather than using the whole virus to elicit an immune response, these vaccines use only the proteins from the outer spines of the coronavirus, which use antibodies to recognize the virus.
Attenuated virus with
spike protein genes
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce spike proteins from the coronavirus.
The peak proteins produced by the cells trigger the immune system to build a defense, just like traditional vaccines.
Vaccine Generated Antibody Response
1. In classic vaccines, such as those against measles and polio, the patient is inoculated with attenuated or inactivated versions of the virus. This prompts 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’s Vaccine
Rather than using the whole virus to elicit an immune response, these vaccines use only the proteins from the outer spines of the coronavirus, which use antibodies to recognize the virus.
Scientists have isolated the genes in the coronavirus responsible for its production
spike proteins. The genes are split into weakened, harmless versions of other viruses.
Attenuated virus with
spike protein genes
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce spike proteins from the coronavirus.
The peak proteins produced by the cells trigger the immune system to build a defense, just like traditional vaccines.
Vaccine Generated Antibody Response
Write to Thomas M. Burton at [email protected] and Peter Loftus at [email protected]
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