Johnson & Johnson’s Covid-19 Vaccine Gets Green Light From CDC

Johnson & Johnson’s Covid-19 Vaccine Gets Green Light From CDC

CDC Director Rochelle P. Walensky gave the go-ahead Sunday after a panel of advisers voted in support of adults in the U.S. getting the one-dose vaccine. The Advisory Committee on Immunization Practices voted 12-0 in favor with one recusal.

The steps concluded a review process before the shot reaches wider use, which is expected this week.

“In the midst of this tragedy we do have some reason for optimism,” said committee member Dr.

Matthew Daley,

senior investigator at the Institute for Health Research with Kaiser Permanente Colorado. “How very grateful I am that we now have three safe and highly effective vaccines.”

The U.S. Food and Drug Administration authorized use of the single-dose shot on Saturday based on its 66% effectiveness at preventing moderate to severe Covid-19 disease in a large study that also showed it was safe.

Vaccines’ Effectiveness

Efficacy against

severe disease

Efficacy in people

65 and older

J&J said after the FDA clearance that it had started to ship doses of its vaccine for allocation and distribution by the federal government. The doses are expected to start reaching vaccine providers in the U.S. in the coming days, with vaccinations starting soon afterward.

It was the third Covid-19 vaccine cleared by the FDA, after the agency’s clearance in December of shots from

Pfizer Inc.


PFE -0.98%

with its partner

BioNTech SE


BNTX -2.94%

and from

Moderna Inc.


MRNA 4.33%

The addition of the J&J vaccine is expected to boost the mass vaccination campaign aiming to bring the pandemic under control. Demand for the previously authorized vaccines has outpaced supply so far.

More than 75 million of the 96.4 million doses distributed nationwide have been administered, according to the CDC.

J&J expects to ship about four million doses right away, and to deliver another 16 million by the end of March. By the end of June, J&J expects to provide a total of 100 million doses for use in the U.S.

The federal government has purchased the doses and is making them available free to people.

The new supplies should help more people get vaccinated, especially after J&J increases its output. Yet health authorities don’t expect the availability of three shots will mean that many people will start having a choice among them soon.

Each of the three authorized shots works well, according to the authorities, who encourage people to get whichever vaccine they can get.

The CDC’s vaccine advisory committee members—physicians, public-health officials and infectious-disease specialists—discussed the clinical evidence for J&J’s vaccine during an online meeting.

Members of the committee generally had favorable comments about the vaccine, but some expressed concerns.

One concern was that in the large clinical trial, J&J’s vaccine appeared to be less effective among people age 60 and older who had certain medical conditions such as diabetes and hypertension.

How Viral Vector Vaccines Work

Johnson & Johnson’s vaccine relies 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 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 and help neutralize it.

Johnson & Johnson’s Vaccine

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

Instead of using the whole virus to generate an immune response, these vaccines rely upon producing only coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Weakened virus with

spike protein genes

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

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

Vaccine-generated antibody response

1. In classic 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 and help neutralize it.

Johnson & Johnson’s Vaccine

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

Instead of using the whole virus to generate an immune response, these vaccines rely upon producing only coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Weakened virus with

spike protein genes

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

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

Vaccine-generated antibody response

1. In classic 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 and help neutralize it.

Johnson & Johnson’s Vaccine

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

Instead of using the whole virus to generate an immune response, these vaccines rely upon producing only coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Weakened virus with

spike protein genes

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

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

Vaccine-generated antibody response

1. In classic 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 and help neutralize it.

Johnson & Johnson’s Vaccine

Instead of using the whole virus to generate an immune response, these vaccines rely upon producing only coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Scientists have isolated the genes in coronavirus responsible for producing these

spike proteins. The genes are spliced into weakened, harmless versions of other viruses.

Weakened virus with

spike protein genes

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

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

Vaccine-generated antibody response

J&J’s

Macaya Douoguih,

head of clinical development and medical affairs with J&J’s Janssen pharmaceuticals unit, said those results should be interpreted with caution because they are based on a relatively small number of Covid-19 cases in that subgroup. She said it wasn’t in line with the rest of the trial data, which support that the vaccine provides protection.

The efficacy among American Indian and Alaska Natives also was lower than the overall efficacy in the study.

Committee members also began to wrestle with the potentially difficult task of comparing the three authorized vaccines and giving guidance about whether people should choose one over the others. The question has arisen partly because the overall efficacy of J&J’s vaccine in a large trial was lower than that for Pfizer’s and Moderna’s from separate trials.

For now, the committee isn’t expressing a preference, with members saying it is tough to compare and contrast the vaccines across different trials, and that all three were generally safe and effective.

“We want to make sure the public understands the best vaccine is the one they can get access to,” said Dr.

Jason Goldman,

a liaison to the committee from the American College of Physicians.

STAY INFORMED

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Write to Peter Loftus at peter.loftus@wsj.com

Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Source: WSJ – US News

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