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J&J Single-Dose Covid-19 Vaccine Gains Backing From FDA Advisory Panel


Johnson & Johnson’s


JNJ -2.64%

single-dose Covid-19 vaccine worked safely and should be authorized for use in the U.S., a panel of experts advised federal health regulators Friday.

The advisory committee’s vote in support of the vaccine’s authorization is the last step before the U.S. Food and Drug Administration issues a decision, which is expected Saturday.

The panel, a group of 22 medical specialists in fields like internal medicine, pediatrics, vaccines and epidemiology, regularly advises the FDA about experimental vaccines. It voted to recommend shots from

Pfizer Inc.


PFE -0.98%

and partner

BioNTech


BNTX -2.94%

SE and

Moderna Inc.


MRNA 4.33%

before the agency authorized them in December.

During the all-day public meeting, representatives from the FDA and J&J discussed the safety and effectiveness of the company’s vaccine in a 44,000-plus subject study, as well as how effective the J&J vaccine is in preventing new cases caused by variants.

The give-and-take of questions and answers can be valuable in bolstering public confidence in the shot, according to FDA officials.

The vaccine was 66% effective at protecting people from moderate to severe Covid-19, an FDA review found, and even more effective at preventing severe disease alone.

“If authorized, Janssen’s vaccine candidate would play a pivotal role in the global effort to fight Covid-19,”

Johan Van Hoof,

global head of vaccines research at J&J’s Janssen pharmaceutical unit, said during the panel’s meeting. “A single-dose regimen offers the ability to vaccinate a population faster.”

As highly transmissible coronavirus variants sweep across the world, scientists are racing to understand why these new versions of the virus are spreading faster, and what this could mean for vaccine efforts. New research says the key may be the spike protein, which gives the coronavirus its unmistakable shape. Illustration: Nick Collingwood/WSJ

A rollout of the J&J vaccine could add enough shots in the U.S. by the end of March to boost the total number of people vaccinated by 20%. Health authorities are pushing to inoculate enough people as quickly as possible so that business, schools and other establishments can fully reopen.

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J&J has said it would deliver about 20 million doses for U.S. use by the end of March.

The FDA often convenes public meetings of outside experts to scrutinize experimental drugs, devices and vaccines up for agency approval, in part to boost public acceptance of the products should they be cleared for wide use.

J&J’s vaccine appeared to be safe in its pivotal study, the FDA found, aside from being effective.

“The known and potential benefits of Ad26 outweigh the known and potential risks,” Macaya Douoguih, head of clinical development and medical affairs at J&J’s Janssen unit, said during Friday’s meeting, using a code name for J&J’s vaccine.

FDA medical officer Yosefa Hefter said there are still unknowns about the vaccine, including the duration of immune protection and the safety and effectiveness in children.

An FDA analysis for the committee meeting also said rare cases of deep vein clots and of blockages in lung arteries were slightly more common in vaccine recipients than in placebo patients, and that the FDA considers these as “of clinical interest.”

The vaccine was effective “across demographic subgroups,” the FDA said. The demographic subgroups in the large study of J&J’s vaccines included racial and ethnic groups such as Black, Latino and Asian people, and age groups such as those 60 years and older.

Researchers also assessed efficacy in people who had underlying medical conditions including obesity and high blood pressure before entering the clinical trial. Sometimes vaccines don’t work as well in older people because of weakened immune systems.

One exception was that the vaccine appeared to be less effective in people 60 and older who had certain underlying medical conditions like diabetes and high blood pressure.

The Pfizer-BioNTech and Moderna vaccines also worked effectively across various demographic subgroups.

The vaccine was less effective in South Africa, where a more-transmissible Covid-19 variant has thrived, than in the U.S. J&J is among the companies working on new shots targeting the new strain, against which several current vaccines don’t appear to work as well.

J&J’s Covid-19 shot 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

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 use 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 use 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 use 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 use 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, 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 been watching whether Covid-19 shots can stop people without symptoms from transmitting the virus. The virus has largely been spread by people who were infected but didn’t realize it because they had no symptoms.

The vaccine was less effective in South Africa, where a more-transmissible Covid-19 variant has thrived, than in the U.S. J&J is among the companies working on new shots targeting the new strain, which several current vaccines don’t appear to work as well against.

Write to Thomas M. Burton at [email protected] and Peter Loftus at [email protected]

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States ranked by percentage of COVID-19 vaccines administered: Jan. 25


North Dakota has administered the highest percentage of COVID-19 vaccines it has received, according to the CDC’s COVID-19 vaccine distribution and administration data tracker.

The CDC’s data tracker compiles data from healthcare facilities and public health authorities. It updates daily to report the total number of COVID-19 vaccines that have been distributed to each state and the total number each state has administered.

As of 6 a.m. EST Jan. 24, a total of 41,411,550 vaccine doses have been distributed in the U.S., and 21,848,655 have been administered, or 52.76 percent. That means about 6.66 percent of the U.S. population has been vaccinated. Additionally, 18,502,131 people have received their first dose of the vaccine, and 3,216,836 have received the full two doses. 

Below are the states ranked by the percentage of COVID-19 vaccines they’ve administered of those that have been distributed to them. Some numbers may not reflect the actual number of vaccines administered, as coding problems and data lags have hindered efforts to accurately count and publicly report how many doses are administered daily in some states. 

  1. North Dakota
    Doses distributed to state: 86,750
    Doses administered: 73,175
    Percentage of distributed vaccines that have been administered: 84.35
  2. West Virginia
    Doses distributed to state: 243,100
    Doses administered: 202,883
    Percentage of distributed vaccines that have been administered: 83.46
  3. New Mexico
    Doses distributed to state: 257,075
    Doses administered: 200,141
    Percentage of distributed vaccines that have been administered: 77.85
  4. South Dakota
    Doses distributed to state: 106,575
    Doses administered: 80,441
    Percentage of distributed vaccines that have been administered: 75.48
  5. Connecticut
    Doses distributed to state: 492,850
    Doses administered: 321,737
    Percentage of distributed vaccines that have been administered: 65.28
  6. Oklahoma
    Doses distributed to state: 496,350
    Doses administered: 322,810
    Percentage of distributed vaccines that have been administered: 65.04
  7. Montana
    Doses distributed to state: 119,500
    Doses administered: 76,590
    Percentage of distributed vaccines that have been administered: 64.09
  8. Kentucky
    Doses distributed to state: 471,000
    Doses administered: 299,493
    Percentage of distributed vaccines that have been administered: 63.59
  9. Michigan
    Doses distributed to state: 1,095,675
    Doses administered: 695,273
    Percentage of distributed vaccines that have been administered: 63.46
  10. Colorado
    Doses distributed to state: 692,700
    Doses administered: 434,496
    Percentage of distributed vaccines that have been administered: 62.72
  11. South Carolina
    Doses distributed to state: 453,250
    Doses administered: 278,795
    Percentage of distributed vaccines that have been administered: 61.51
  12. Louisiana
    Doses distributed to state: 543,700
    Doses administered: 334,086
    Percentage of distributed vaccines that have been administered: 61.45
  13. Alaska
    Doses distributed to state: 155,700
    Doses administered: 94,257
    Percentage of distributed vaccines that have been administered: 60.54
  14. Utah
    Doses distributed to state: 341,725
    Doses administered: 202,729
    Percentage of distributed vaccines that have been administered: 59.33
  15. Arkansas
    Doses distributed to state: 368,650
    Doses administered: 214,240
    Percentage of distributed vaccines that have been administered: 58.11
  16. Oregon
    Doses distributed to state: 492,450
    Doses administered: 285,922
    Percentage of distributed vaccines that have been administered: 58.06
  17. Wyoming
    Doses distributed to state: 70,750
    Doses administered: 40,803
    Percentage of distributed vaccines that have been administered: 57.67
  18. Vermont
    Doses distributed to state: 90,000
    Doses administered: 51,872
    Percentage of distributed vaccines that have been administered: 57.64
  19. Texas
    Doses distributed to state: 3,070,825
    Doses administered: 1,763,299
    Percentage of distributed vaccines that have been administered: 57.42
  20. New Hampshire
    Doses distributed to state: 162,950
    Doses administered: 93,338
    Percentage of distributed vaccines that have been administered: 57.28
  21. New York
    Doses distributed to state: 2,395,950
    Doses administered: 1,365,404
    Percentage of distributed vaccines that have been administered: 56.99
  22. Maine
    Doses distributed to state: 178,450
    Doses administered: 99,815
    Percentage of distributed vaccines that have been administered: 55.93
  23. Nebraska
    Doses distributed to state: 238,100
    Doses administered: 132,846
    Percentage of distributed vaccines that have been administered: 55.79
  24. Delaware
    Doses distributed to state: 116,325
    Doses administered: 64,186
    Percentage of distributed vaccines that have been administered: 55.18
  25. New Jersey
    Doses distributed to state: 989,900
    Doses administered: 535,625
    Percentage of distributed vaccines that have been administered: 54.11
  26. Tennessee
    Doses distributed to state: 838,825
    Doses administered: 452,042
    Percentage of distributed vaccines that have been administered: 53.89
  27. Florida
    Doses distributed to state: 2,908,275|
    Doses administered: 1,544,794
    Percentage of distributed vaccines that have been administered: 53.12
  28. Washington
    Doses distributed to state: 846,625
    Doses administered: 449,385
    Percentage of distributed vaccines that have been administered: 53.08
  29. Nevada
    Doses distributed to state: 286,950
    Doses administered: 152,203
    Percentage of distributed vaccines that have been administered: 53.04
  30. Indiana
    Doses distributed to state: 841,725
    Doses administered: 446,029
    Percentage of distributed vaccines that have been administered: 52.99
  31. Iowa
    Doses distributed to state: 361,475
    Doses administered: 191,183
    Percentage of distributed vaccines that have been administered: 52.89
  32. Ohio
    Doses distributed to state: 1,233,075
    Doses administered: 647,104
    Percentage of distributed vaccines that have been administered: 52.48
  33. North Carolina
    Doses distributed to state: 1,246,600
    Doses administered: 636,439
    Percentage of distributed vaccines that have been administered: 51.05
  34. Wisconsin
    Doses distributed to state: 610,100
    Doses administered: 308,290
    Percentage of distributed vaccines that have been administered: 50.53
  35. Mississippi
    Doses distributed to state: 358,100
    Doses administered: 177,636
    Percentage of distributed vaccines that have been administered: 49.61
  36. Illinois
    Doses distributed to state: 1,417,250
    Doses administered: 699,072
    Percentage of distributed vaccines that have been administered: 49.33
  37. Georgia
    Doses distributed to state: 1,235,775
    Doses administered: 604,067
    Percentage of distributed vaccines that have been administered: 48.88
  38. Massachusetts
    Doses distributed to state: 859,175
    Doses administered: 419,806
    Percentage of distributed vaccines that have been administered: 48.86
  39. Idaho
    Doses distributed to state: 181,100
    Doses administered: 87,128
    Percentage of distributed vaccines that have been administered: 48.11
  40. Missouri
    Doses distributed to state: 661,400
    Doses administered: 317,737
    Percentage of distributed vaccines that have been administered: 48.04
  41. Pennsylvania
    Doses distributed to state: 1,564,125
    Doses administered: 744,591
    Percentage of distributed vaccines that have been administered: 47.60
  42. Minnesota
    Doses distributed to state: 680,700
    Doses administered: 321,180
    Percentage of distributed vaccines that have been administered: 47.18
  43. Arizona
    Doses distributed to state: 829,500
    Doses administered: 390,623
    Percentage of distributed vaccines that have been administered: 47.09
  44. Alabama
    Doses distributed to state: 521,225
    Doses administered: 243,737
    Percentage of distributed vaccines that have been administered: 46.76
  45. Maryland
    Doses distributed to state: 742,175
    Doses administered: 338,544
    Percentage of distributed vaccines that have been administered: 45.62
  46. Rhode Island
    Doses distributed to state: 149,225
    Doses administered: 67,566
    Percentage of distributed vaccines that have been administered: 45.28
  47. California
    Doses distributed to state: 4,906,525
    Doses administered: 2,199,908
    Percentage of distributed vaccines that have been administered: 44.84
  48. Hawaii
    Doses distributed to state: 191,575
    Doses administered: 84,792
    Percentage of distributed vaccines that have been administered: 44.26
  49. Kansas
    Doses distributed to state: 348,175
    Doses administered: 151,249
    Percentage of distributed vaccines that have been administered: 43.44
  50. Virginia
    Doses distributed to state: 1,069,725
    Doses administered: 451,668
    Percentage of distributed vaccines that have been administered: 42.22

More articles on public health:
Mixing COVID-19 vaccine doses OK in rare situations, CDC says
Some evidence indicates UK strain is more deadly, Boris Johnson says
COVID-19 hospitalizations by state: Jan. 25

 


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