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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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It’s 2:30 a.m. in Wyoming: ‘You’re holding a smartphone to let a husband say goodbye to his wife via FaceTime after 60 years of marriage’


The first wave of the pandemic hit New York, and other cities with dense populations. As hospitals were overwhelmed with patients and struggled to access enough personal protective equipment and ventilators, the midwest and south were largely spared the worst of COVID-19.

Then, came the fall.

COVID-19, the disease caused by SARS-CoV-2, started disrupting families and ravaging lives far from the metropolitan counties, especially in the southern and midwestern states such as Texas, North Dakota, South Dakota, and Wyoming.

North Dakota has 167 COVID-19 cases per 100,000, while Wyoming has 140 coronavirus infections per 100,000, followed by South Dakota with 124,000 cases per 100K, according to the Center for Systems Science and Engineering at Johns Hopkins University.


‘You hear stories from Europe and China. You tell yourself it is not going to happen here.’


— Andy Dunn, chief of staff at the Wyoming Medical Center in Casper, Wyo.

As of Monday, there were 72,683 confirmed cases in North Dakota, and 846 deaths, and the population there has 7% positivity rate. New daily cases hit 1,143 over a seven-day period. Wyoming has 28,169 confirmed cases, 176 deaths and a 16.2% positivity rate, and 759 new daily cases.

“Everyone at the frontline has extra hours, extra shifts to keep up with the volume,” said Andy Dunn, chief of staff at the Wyoming Medical Center in Casper, Wyo. “We need more resources, we look for supplies from all over because we are seeing patients from South Dakota, too.”

But the extent of the crisis in Wyoming has still been a shock. A medical doctor from Colorado, Dunn moved to Casper ten years ago. In 2017, he took the role of chief of staff, and he is currently taking a hands-on role, treating COVID-19 patients at the center.

“You hear stories from Europe and China. You tell yourself it is not going to happen here,” he told MarketWatch. “And then, all of a sudden, it is 2:30 a.m., and you are holding a smartphone to let a husband say goodbye to his wife via FaceTime after 60 years of marriage.”

Andy Dunn, chief of staff at the Wyoming Medical Center in Casper, Wyo.

Patients in their 40s and 50s

“We all knew that it was coming, but you don’t get it until it is here, and it hits you. Things are rough at the hospital right now,” he said. Nor are his patients all elderly. At his hospital, several patients are now in their 40s, while numerous others are in their 50s, Dunn said.

The Wyoming Department of Health has recently approved requests from 15 counties to implement mask mandates to slow the spread of COVID-19. But a petition on Change.org asking for end restrictions in Wyoming was signed by 800 people just in a few days.

But some medical professionals in these midwestern states are not pro mask mandates. “If it is not an N95 mask, well, then you won’t be sure that it does protect you properly,” said Lisa Drylie, a nurse working in an operating-room division of the Sanford Hospital in Fargo, N.D.


‘A mask mandate has to be part of the mitigation of spread.’


— Adam Hohman, a 43-year-old nurse practitioner in Fargo, N.D.

“So, no, I don’t think that a mandatory masks mandate is going to help us,” she added. (In a review of studies on masks last month, the journal Nature concluded that “the science supports that face coverings are saving lives during the coronavirus pandemic.”)

It’s preferable to use a high-quality cloth or surgical masks of a plain design instead of face shields and masks with exhale valves, according to an experiment published in September by Physics of Fluids, a monthly peer-reviewed scientific journal covering fluid dynamics.

States like New York used the mandatory mask mandate as one of the main tools to stop the spread and to dodge the second wave in the fall. As of July, New York Gov. Andrew Cuomo, a Democrat, launched the national “Mask Up America” to promote is mask mandate.

But in North Dakota, there are moments of respite. Drylie sometimes hears joyful music from the lower floors of her hospital. It gives her hope. “It happens when they celebrate a patient who has recovered and dismissed,” she said.

Others disagree with Drylie. “A mask mandate has to be part of the mitigation of spread,” said Adam Hohman, a 43-year-old nurse practitioner who lives in Fargo, N.D. “A limited government is good, but we got to a point where we needed to do something more.”

Shortage of health-care workers

But beyond the masks, the shortage of actual health-care workers is another common issue that ties together North Dakota, South Dakota, and Wyoming, along with many other midwestern states across the U.S., according to local reports.

“The biggest problem I am hearing from my colleagues is that they don’t have enough nurses, said Hohman, originally from Minnesota, where he works at a hospital located in a rural area in North Dakota. He has worked 10 to 14 hours a day when the pandemic first hit.

Hohman said that hospitals in North Dakota are increasing their bed capacity by opening some units or converting other wards. “But they are having trouble in finding nurses to keep up with the work load, and to staff those beds,” he said.

Some hospitals in North Dakota even allowed health-care workers with COVID-19, when asymptomatic, to keep working in coronavirus units. And the U.S. Air Force has recently deployed 60 medical personal to help the state hospital staffing crisis.

The shortage of nurses across the U.S. is not a new problem, but the pandemic shed renewed light on the issue as the coronavirus pandemic hit. But North Dakota and Wyoming are actually among the best in the country in rankings of nurse-to-patients ratios.


The pandemic shed renewed light on the shortage of nurses across the U.S.

North Dakota has 16.4 nurses per 1,000 residents, making it the fourth-best equipped state in the country, while Wyoming is No. 1 with 19.9 nurses per 1,000 population, according to the Bureau of Health Workforce, an agency of the Department of Health and Human Services.

If even two of the best-ranked states for U.S. Nurse-to-State Population Ratio are struggling, others like Texas, California, or Montana are suffering even more, according to recent research by STAT, a media company focused on health, medicine, and scientific discovery.

“Public-health infrastructure and disaster planning in the United States remain underfunded and under-appreciated at all levels,”Hohman said. “We remain underprepared for protecting our nation’s health in the setting of current and future pandemics.”

When the pandemic hit New York in March and April, Hohman traveled to New York to help his colleagues. “I saw the worst of the worst up there. I think we underestimated our risk here in North Dakota due to our ruralness and a mentality that we are not New York,” he said.

Related:COVID-19 spread when 5 million people left Wuhan for Chinese New Year, yet 50 million Americans will still travel for Thanksgiving

As of Monday, there were at least 257,549 deaths due to COVID-19 in the U.S. and there have been 12.4 million reported infections of COVID-19 since the pandemic began, according to the John Hopkins University database. Worldwide, there are 59 million cases and almost 1.4 million deaths.

Texas and California both have over 1 million reported cases of COVID-19. Texas has 1,153,612 million cases, 21,013 deaths, and a 10.6% positivity rate, as of Monday. California has 1,114,524 reported infections and 18,726 deaths, with a 5% positivity rate.

New York, which was the epicenter of the pandemic in the U.S. during the early days of the first surge, has the most deaths of any U.S. state (34,319), followed by Texas, California, Florida (17,991), New Jersey (16,761), and Illinois (12,050).

With Thanksgiving weekend looming, the medical community fears that up to 50 million people traveling to see relatives and friends will create even more community transmission. The Centers for Disease Control and Prevention has asked Americans to stay home.

Medical doctors like the Wyoming Medical Center’s chief of staff, Andy Dunn, have one, reminder for Americans, one that will be more likely if they heed advice. “Be boring, stay put,” he said from his office in Casper, Wyo. “Thanksgiving will happen next year.”

This story is part of a MarketWatch series Dispatches from a Pandemic.



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