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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]

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



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Dow Slips Amid New Travel Curbs


The index of blue-chip stocks fell 200.94 points, or 0.7%, to 30015.51, marking its largest one-day point and percentage decline in December. The S&P 500 slid 7.66 points, or 0.2%, to 3687.26 to extend its losing streak to a third session.

The tech-heavy Nasdaq Composite, in contrast, rose 65.40 points, or 0.5%, to 12807.92, a new all-time high.

Much of the stock market has lost steam this week as some nations began taking steps to curtail travel in an effort to contain the emergence of a fast-spreading variant of coronavirus from England. The U.K. imposed stringent restrictions on social and business activity, prompting concern that more countries may be required to adopt measures that would hamper the global economic recovery.

“It would be a brave man to suggest this will just remain a U.K.-specific issue,” said

Derek Halpenny,

head of research for global markets in the European region at MUFG Bank. “Are we going back into another phase of more pronounced global lockdowns again?”

Oil prices slipped for a second day amid growing worries over the new restrictions imposed on travelers from the U.K. to other countries. Brent crude futures, the benchmark in international energy markets, dropped 1.6% to $50.08 a barrel.

Meanwhile, the yield on the 10-year note ticked down to 0.917%, from 0.941% Monday, as some investors looked to the relative safety of U.S. government bonds. Yields fall when prices rise.

Investors are trying to gauge whether the new strain of Covid-19 will impact the efficacy of vaccines that are being rolled out this month.

BioNTech

Chief Executive

Ugur Sahin

said the vaccine developed by his company, in partnership with

Pfizer,

would likely work against the new variant and is being tested. If a new mutation would make the current vaccine ineffective, BioNTech can develop another tailored to the new variant in six weeks, he said.

Technology stocks traded higher on Nasdaq, in contrast to declines for the S&P and Dow.



Photo:

Michael Nagle/Bloomberg News

“The big unknown is to what degree could the new strain make the efficacy of the vaccine lower,” said

Peter Garnry,

head of equity strategy at Saxo Bank. “If it just turns out to be more infections, and it doesn’t have an effect on the vaccine, then the market will be less concerned.”

Late Monday, a fresh $900 billion fiscal stimulus package was passed by Congress, ending weeks of anticipation from investors about whether lawmakers could end their stalemate. The bill, which includes direct checks to households and relief for small businesses, is expected to be signed by

President Trump.

Even so, the bill’s passage wasn’t enough to propel the broader stock market higher.

“We’ve had the positive news on the vaccines and the fiscal deal, so there’s probably not a catalyst to drive stocks meaningfully higher in the next few weeks,” said

Brian Levitt,

global market strategist at Invesco.

When Is the Market on Holiday?

Select stock-market closures through year’s end

  • Thurs. Dec. 24: U.S. stock market closes at 1 p.m. ET
  • Fri. Dec. 25: Markets closed
  • Mon. Dec. 28: London stock market closed
  • Fri. Jan. 1: Markets closed

Still, Mr. Levitt noted that he maintains a positive outlook on equities.

“In my opinion, betting against stocks over the next year and beyond is betting against medicine, science and policy makers,” he said. “And I’m not willing to make those bets.”

In corporate news,

Apple

rose $3.65, or 2.9%, to $131.88 after Reuters reported that the iPhone maker intends to move forward with its own self-driving car technology.

Exercise-equipment maker

Peloton Interactive

gained $16.82, or 12%, to $161.21, hitting a new all-time-high, after it agreed to buy commercial fitness-equipment provider Precor for $420 million in cash.

Travel stocks and shares of energy companies tumbled.

Norwegian Cruise Line Holdings

slid $1.70, or 6.9%, to $23.08.

Chevron

fell for an eighth consecutive day, losing $1.73, or 2%, to $84.36. That marks the longest losing streak for the oil giant since October 2013.

Meanwhile,

Tesla

tumbled $9.52, or 1.5%, to $640.34, extending its losses for the week to nearly 8%. The electric-car maker made its S&P 500 debut Monday.

Moves in stocks could be big and markets may be especially choppy in coming days because fewer people are trading as the holiday period starts, said

Salman Ahmed,

global head of macro at Fidelity International.

The final stretch of trading in December is historically positive for the stock market. But this week’s losses may be a sign that investors are starting to take profits after a blockbuster year, especially as they consider the possibility of tax changes after President-elect

Joe Biden

takes office, said

JJ Kinahan,

chief market strategist at TD Ameritrade. The S&P 500 is up 14% in 2020, and the Nasdaq Composite has catapulted 43% higher.

Footage shows empty supermarket shelves while trucks bearing cargo get stuck at the border after France imposed a travel ban on Britain following the spread of a new coronavirus strain. Other countries have also barred passengers from the U.K. Photo: Neil Hall/EPA/Shutterstock

Additionally, Mr. Kinahan noted, Tuesday’s worse-than-expected consumer confidence report may also be weighing on markets.

The Conference Board, a private research group, said its index of consumer confidence dropped to 88.6 in the first two weeks of December, from a revised 92.9 in November. Economists surveyed by The Wall Street Journal had expected a level of 97.5.

Still, there were small signs of optimism. Data from the Commerce Department showed Tuesday that U.S. gross domestic product—the value of all goods and services produced across the economy—increased at an annualized rate of 33.4% in the third quarter, slightly stronger than the previous estimate issued last month.

Overseas, European shares rebounded after Monday’s losses. The pan-continental Stoxx Europe 600 gained 1.2%.

Major stock indexes in Asia closed lower. China’s Shanghai Composite fell 1.9%, and South Korea’s Kospi declined 1.6%.

Write to Caitlin Ostroff at [email protected] and Caitlin McCabe at [email protected]

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



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