Johnson & Johnsonsay
JNJ -2.00%
a single-dose Covid-19 vaccine was effective ‘across demographic subgroups’ in a late-stage study, U.S. Food and Drug Administration scientists plan to meet with a panel of medical specialists meeting Friday to discuss the shot to evaluate.
The FDA officials, in other evidence 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 shot and its potency against new strains of the virus.
The committee meeting is the final step before U.S. health regulators decide whether to approve the use of a third survey. 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 vaccinations. It voted to recommend shots from Pfizer Inc.
and partner BioNTech SE and Moderna Inc.
before the agency approved them in December.
In other evidence prepared for the panel, the U.S. Centers for Disease Control and Prevention said the preliminary safety data results for the Pfizer-BioNTech and Modern vaccines showed no statistically significant increased risk of adverse events among people who had the shots. did not get.
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During the public meeting, representatives of the FDA and J&J will discuss the safety and efficacy of the company’s vaccine throughout the day in a subject study of more than 44,000, according to an agenda, as well as how effective the J&J vaccine is in new cases. prevent. caused by variants.
The FDA officials may find the giving and taking of questions and answers valuable in boosting public confidence in the lap.
The vaccine was 66% effective in protecting people from moderate to severe Covid-19, an FDA review found, and even more effective in preventing serious diseases 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 authorities have looked at whether Covid-19 shots can stop people without transmitting symptoms of the virus, because the virus was largely spread by infected people, but did not realize it because they had no symptoms.
Because coronavirus variants are transmissible around the world, scientists are trying to understand why these new versions of the virus are spreading faster, and what they could mean for vaccine use. New research says the key may be the vein protein, which gives the coronavirus its unmistakable shape. Illustration: Nick Collingwood / WSJ
Rolling out the doses of the J&J vaccine could – by an estimated 20% during March – contribute to the total number of available quantities, as health authorities pick up the rate of vaccinations and try to vaccinate enough people as quickly as possible so that reopen businesses, schools and other institutions.
J&J said they would deliver about 20 million doses for US use by the end of March.
The FDA often convenes public meetings of outside experts to investigate experimental drugs, devices, and vaccines for agency approval, in part to promote public acceptance of the products should they be approved for widespread use.
The FDA’s vaccine appears to be safe in its core study, except that it is effective.
The vaccine was less effective in South Africa, where a more transmissible Covid-19 variant thrived, than in the US, J&J is among the companies shooting new shots aimed at the new strain, several current vaccines do not work. good against.
However, J & J’s Covid-19 shot was very effective against serious and critical cases in South Africa. The vaccine was 73.1% effective to prevent such cases at least 14 days after vaccination, and 81.7% effective to prevent such cases at least 28 days after vaccination.
How viral vector vaccines work
Johnson & Johnson’s vaccine depends on a different mechanism of immunity than traditional vaccines.
Traditional vaccines
In classic vaccines, such as against measles and polio, the patient is vaccinated with attenuated 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’s vaccination
Scientists have isolated the genes in the coronavirus that are responsible for producing these ear proteins. The genes are cut into attenuated, harmless versions of other viruses.
Instead of using the whole virus to generate an immune response, these vaccines use only the outer ear proteins of the coronavirus, which use antibodies to recognize the virus.
Attenuated virus with
peak protein gene
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus vein proteins.
The stimulant proteins produced by the cells lead the immune system to a defense, just like with traditional vaccines.
Vaccine-generated antibody response
In classic vaccines, such as against measles and polio, the patient is vaccinated with attenuated 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’s vaccination
Scientists have isolated the genes in the coronavirus that are responsible for producing these ear proteins. The genes are cut into attenuated, harmless versions of other viruses.
Instead of using the whole virus to generate an immune response, these vaccines use only the outer vein proteins of coronavirus, which use antibodies to recognize the virus.
Attenuated virus with
vein protein gene
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus vein proteins.
The stimulant proteins produced by the cells lead the immune system to a defense, just like with traditional vaccines.
Vaccine-generated antibody response
In classic vaccines, such as against measles and polio, the patient is vaccinated with attenuated 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’s vaccination
Scientists have isolated the genes in the coronavirus that are responsible for producing these ear proteins. The genes are cut into attenuated, harmless versions of other viruses.
Instead of using the whole virus to generate an immune response, these vaccines use only the outer vein proteins of coronavirus, which use antibodies to recognize the virus.
Attenuated virus with
peak protein gene
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus vein proteins.
The stimulant proteins produced by the cells lead the immune system to a defense, just like with traditional vaccines.
Vaccine-generated antibody response
In classic vaccines, such as against measles and polio, the patient is vaccinated with attenuated 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’s vaccination
Instead of using the whole virus to generate an immune response, these vaccines use only the outer vein proteins of coronavirus, which use antibodies to recognize the virus.
Scientists have isolated the genes in the coronavirus that are responsible for producing them
ear proteins. The genes are cut into attenuated, harmless versions of other viruses.
Attenuated virus with
vein protein gene
When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus vein proteins.
The stimulant proteins produced by the cells lead the immune system to a defense, just like with traditional vaccines.
Vaccine-generated antibody response
Write to Thomas M. Burton at [email protected] and Peter Loftus at [email protected]
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