FDA expected to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder

The agency plans to cite a link to a small number of Guillain-Barré cases after vaccination but will say the shot’s benefits outweigh the risk

The Johnson & Johnson coronavirus vaccine is a single shot, making it especially useful in areas where it might be harder to administer two shots. (Narendra Shrestha/EPA-EFE/Shutterstock)

The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which the immune system attacks the nerves, according to four individuals familiar with the situation.

About 100 preliminary reports of Guillain-Barré have been detected in vaccine recipients after the administration of 12.8 million doses of Johnson & Johnson vaccine in the United States, the Centers for Disease Control and Prevention said in a statement Monday. The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older. Most people fully recover from Guillain-Barré.

The warning on the Johnson & Johnson vaccine will be the latest blow to a shot that had been eagerly anticipated because of its ease of use — it requires only a single dose, which makes it especially helpful in immunizing harder-to-reach populations and regions. But the vaccine has been plagued by problems, including massive stumbles at its U.S. manufacturing plant.

The latest development comes at an especially fraught moment, as the highly transmissible delta variant sweeps the country and fuels an increase in coronavirus cases in many states. And the new warning could complicate Biden administration efforts to ramp up inoculations in areas where skepticism regarding coronavirus vaccines remains high and the vaccine rate is low.

Available data do not show a pattern suggesting a similar increased risk of Guillain-Barré with the Pfizer-BioNTech and Moderna vaccines. More than 321 million doses of those vaccines — developed with a technology different than what is used to make the Johnson & Johnson vaccine — have been administered in the United States.

The Guillain-Barré cases are expected to be discussed as part of an upcoming meeting of the CDC’s Advisory Committee on Immunization Practices, the agency said.

Guillain-Barré syndrome usually occurs at a rate of about 60 to 120 cases each week, according to CDC data. While the cause is not fully understood, it often follows infection with a virus, including influenza, or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop the illness.

People older than 50 are at greatest risk. About two-thirds of people who develop the syndrome experience symptoms several days or weeks after they have fallen ill with diarrhea or a lung or sinus illness.

Federal health officials are expected to emphasize that the Johnson & Johnson vaccine is safe and that its benefits clearly outweigh the potential risks, according to the people familiar with the situation.

Johnson & Johnson and the FDA declined Monday to comment.

Reports of Guillain-Barré in vaccine recipients are rare, the CDC said, “but do likely indicate a small possible risk of this side effect following” the Johnson & Johnson vaccine. Reports of the syndrome were made to an early-warning safety network run by the CDC and FDA, the Vaccine Adverse Events Reporting System. It collects information about possible side effects or health problems after vaccination. The system looks for unusual or unexpected patterns that require a closer look. Anyone can report a reaction or injury.

Experts said the latest news about the Johnson & Johnson shot may complicate vaccination efforts, especially in parts of the country where rates remain under 50 percent.

Jeanne Marrazzo, director of infectious-diseases at the University of Alabama at Birmingham, said the absolute risk of Guillain-Barré remains so rare that “it should not deter people from getting vaccinated,” she wrote in an email. If people are concerned, they can still get a Pfizer or Moderna vaccine with no risk, adding: “This news does not provide an excuse to remain unvaccinated!!!!”

But the expected warning on the Johnson & Johnson shot “quite possibly” will make it harder for health-care providers to persuade people to roll up their sleeves, Marrazzo said.

“When a person is hesitant to get a vaccine, any additional safety signal, even if very rare, just adds to their own database that fuels their reluctance,” Marrazzo wrote.

Paul A. Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, said he did not think the latest news will make much difference because the U.S. vaccination effort has “hit a wall.” The Biden administration has already done “as good a job as we could possibly hope for on how to mass produce, mass distribute and mass vaccinate” the country, Offit said.

Now, Offit said, it’s time for the next step: the government needs to compel vaccination. The Supreme Court has already ruled twice that public health authorities can take these measures in face of outbreaks, he said. Without such a step, the virus is “going to continue to mutate, continue to create variants” and result in another surge in late fall and winter, he said.

Just three months ago, federal officials paused use of the Johnson & Johnson vaccine after it was linked to another rare side effect — severe blood clots. That pause was lifted within days after an extensive safety review by the FDA and CDC, and a warning was added to the vaccine’s label.

The vaccine also has been hobbled by production problems at Johnson & Johnson’s subcontractor, Emergent BioSolutions, the only U.S. manufacturer of the vaccine. The Baltimore plant was shut down in April after federal officials discovered millions of doses had been contaminated with Astra Zeneca vaccine, which was also being made there.

Johnson & Johnson had to throw away the equivalent of about 75 million doses of the vaccine because of the problems at the Baltimore plant. About 40 million doses have been released for use. In response to the contamination, the Biden administration removed AstraZeneca manufacturing from the plant and put Johnson & Johnson in direct control of vaccine production there. But Emergent has not received authorization from the FDA to resume manufacturing the Johnson & Johnson product.

Other vaccines also have been associated with rare adverse events. The FDA in late June decided to add a warning to the Pfizer and Moderna coronavirus vaccines about extremely unusual cases of myocarditis — heart inflammation — in some young adults and teens after vaccination. Federal health officials said there was “a likely association,” and that the problem appears most likely to occur in young men after they receive two doses of the vaccine.

The CDC and the Department of Health and Human Services, together with 15 of the country’s leading medical and public health organizations, issued a joint statement in June saying they “strongly encourage everyone 12 and older” to get the Pfizer and Moderna shots because the benefit of vaccination far exceeds potential harm.

In June, the American Neurological Association reported that two studies published in the journal Annals of Neurology had found 11 cases of Guillain-Barré syndrome two to three weeks after vaccination with the AstraZeneca vaccine. The cases, which were from England and India, involved an unusual variant of the disease that caused severe facial weakness, the organization said. An accompanying editorial described a similar case involving a Boston man who received the Johnson & Johnson vaccine.

Vaccine safety officials in Europe have recommended that a warning be added about Guillain-Barré to the AstraZeneca vaccine. But the European safety committee said that while cases have been reported following vaccinations, “at this stage the available data neither confirms nor rules out a possible association with the vaccine.”

In 1976, there was a small increased risk of the syndrome after people received swine flu vaccine, which was a special flu shot for a potential pandemic strain of flu virus. A National Academy of Medicine review in 2003 found that people who received the 1976 swine flu vaccine had an increased risk of Guillain-Barré, with about one additional case for every 100,000 people who got the swine flu vaccine. The reason for the link remains unknown.

The CDC monitors for Guillain-Barré syndrome each flu season. The agency says the data on an association between seasonal influenza vaccine and the illness varied from season to season. When there has been an increased risk, it has consistently been in the range of one or two additional cases per 1 million flu vaccine doses administered. Studies also suggest it is more likely that a person will get Guillain-Barré after getting the flu than after vaccination, according to the CDC.

COVID-Infected Woman, 76, Believed to Be Dead, Wakes Up And Starts Crying Minutes Before Her Cremation

An undertaker walks by burning pyres for victims who died of Covid-19 at an open-air crematorium in BangalorePhoto: AFP / Manjunath Kiran

In a shocking incident, a COVID-19 infected woman, who was declared dead, woke up minutes before her cremation. 

The 76-year-old woman’s family found her alive when they took her to a crematorium in Baramati, located in the western Indian state of Maharashtra.

The victim, identified as Shakuntala Gaikwad, had tested positive for COVID-19 a few days back and was in home isolation. Later, her symptoms became severe due to her age, News18 reported. Her family took her to a hospital in an ambulance but they were struggling to secure a bed for her. Gaikwad fell unconscious and the ambulance staff declared her dead. The incident took place on May 10 but it was reported Sunday.

The victim’s relatives were informed and she was taken back to her village. Gaikwad woke up when the family members were about to light the funeral pyre. They were shocked as the woman opened her eyes and began crying, Khaleej Times reported.

Gaikwad was immediately rushed to a local hospital for further treatment, local authorities said. The current condition of the woman remains unknown.

The incident takes place as most states in India continue to be under lockdown amid an increasing number of COVID-19 cases. Hospitals across the country have been reporting shortage of oxygen and beds. Early Monday, India recorded more than 280,000 COVID-19 cases.

In a similar incident last month, a 72-year-old woman who was declared dead by doctors was found alive minutes before her cremation. The elderly woman was rushed to a hospital in the state of Chhattisgarh but she died on the way. The woman was admitted to a local hospital with some health issues. Doctors were unable to find her vital signs and declared her dead. The woman had tested negative for COVID-19. At the crematorium, the woman’s granddaughter found that the victim’s body was not cold. She decided to call another doctor to check her vitals. It was later found that the woman was alive.

China reportedly gave American diplomats anal COVID-19 tests

A medical worker collects a swab sample from a resident at a community COVID-19 testing site in Qiaoxi District of Shijiazhuang, capital of north China’s Hebei Province.ZUMAPRESS.com

The Chinese government has used anal swabs to test US diplomats for COVID-19 – but Beijing insisted to Washington that the butt checks were made “in error,” according to a report.

“The State Department never agreed to this kind of testing and protested directly to the Ministry of Foreign Affairs when we learned that some staff were subject to it,” a State Department rep told VICE World News on Wednesday.

Washington complained that the rather invasive procedure was undignified, according to the report.

The State spokesperson said Beijing had assured Washington that the tests were given “in error” — and that diplomats were exempt from the test, which was required for incoming travelers in some parts of China.

“We have instructed staff to decline this test if it is asked of them, as was done in the past,” the rep told VICE World News, which noted it was unclear how many diplomats or their family members had undergone the procedure.

Meanwhile, Chinese Foreign Ministry spokesman Zhao Lijian on Thursday denied Beijing had even asked American diplomats to undergo the anal tests.

“To my knowledge…China has never required US diplomatic staff stationed in China to conduct anal swab tests,” Zhao told a daily news briefing in Beijing, Reuters reported.

In an email to Reuters, a State Department spokesperson said it was “committed to guaranteeing the safety and security of American diplomats and their families, while preserving their dignity.”

Officials in China have used anal swabs to test people it considers at high-risk of contracting the illness, including residents of neighborhoods with confirmed cases as well as some international travelers, according to AFP.

Tests using anal swabs can avoid missing infections as viral traces in fecal samples or anal swabs could remain detectable for longer periods than in those from the respiratory tract, Li Tongzeng, a respiratory diseases doctor in Beijing, told state TV recently.

Stool tests also may be more effective in detecting infections in kids as their waste carries a higher viral load than adults, researchers at the Chinese University of Hong Kong said in a paper published last year.

China’s National Health Commission said in an online post that in some cases, the deadly bug can be more easily detected in anal samples than in throat and nasal samples.

According to the commission’s instructions, the samples are collected by inserting a cotton swab about one to two inches into the rectum.

A traveler from Australia to China who was tested with anal swabs in September told VICE World News the procedure felt like having diarrhea.

Prominent US megachurch pastor fighting for his life after contracting Covid-19

A well-known US televangelist has become gravely ill from Covid-19, promoting a global outpouring of prayer for his recovery. Pastor Frederick K.C. Price, who founded the 28,000-strong Crenshaw Christian Center in Los Angeles, is thought to be battling heart, lung and kidney issues after being hospitalised with the virus. 

In a statement posted to Facebook at the week, one of the church’s ministers, Baltimore Scott, called for prayer:

“This morning in prayer, I called on Father God to remember His faithful son and servant, Frederick K.C. Price and the beacon of light and truth in teaching the Word that Apostle has been to the body of Christ and to the world. I said that our church family, the Body of Christ and the world need Apostle Price more than ever to remain with us as that true beacon of the Father’s Word and example of integrity and truth the world needs so badly now.”

The 89-year-old Price and his wife, Betty, contracted Covid-19 more than a month ago, according to his son – Pastor Fred Price Jr – who is now the senior leader of the church. 

“Happy 89th birthday Dad, I love you and honor you for the measuring stick of a man you’ve been my entire life,” Pastor Price Jr wrote in a post on January 4th. “As many of you know my parents both tested positive for Covid-19. Once the frustration and annoyance passed, I reminded myself of their faith and the many challenges they’ve overcome. Coronavirus is just another notch on their belts. Thanks for all your prayers; much love and appreciation to you all.”

Price Jr later revealed that the situation had become more “taxing”, but did not disclose any further details on his father’s condition.

“I figured I’d also use this as an opportunity to thank everyone for their prayers for Dad as we continue to stand and fight the good fight of faith,” he wrote. “I just haven’t been in a social media mood lately…I’ve honestly only felt like praying and studying the word with an occasional praise break these past few weeks.” 

Pastor Price is known for his “Ever Increasing Faith Ministries” broadcast, which dates back to 1978. He is a proponent of the prosperity gospel.

13 people suffer facial paralysis after coronavirus vaccine – report

Doctors in the health system estimate that in practice the number of cases is higher.

A HEALTHCARE worker prepares a COVID-19 vaccine at a vaccination center in Rehovot on Monday.
(photo credit: YOSSI ALONI/FLASH90)

Some 13 people have experienced mild facial paralysis as a side effect after taking the COVID-19 vaccine, the Health Ministry reported, and estimates are that the number of cases could be higher.Health officials have raised questions about whether or not to administer the second dose to these individuals, but the Health Ministry is recommending that the second dose be given. “For at least 28 hours I walked around with it [facial paralysis],” one person who had the side effect told Ynet. “I can’t say it was completely gone afterwards, but other than that I had no other pains, except a minor pain where the injection was but there was nothing beyond that.”As for receiving the second dose, he admits he is undecided, but says that “it is important to note that this is something rare, and I don’t want people to avoid getting vaccinated. It’s important.””I recently came across, for example, someone vaccinated who was dealing with paralysis, and decided not to give her a second dose,” Prof. Galia Rahav, director of the Infectious Diseases Unit at Sheba Medical Center stated, told Ynet. “It is true that it can be given according to the Health Ministry, but I did not feel comfortable with it.”She added that, “No one knows if this is connected to the vaccine or not. That’s why I would refrain from giving a second dose to someone who suffered from paralysis after the first dose.”The Health Ministry stated, however, that the second dose should of course be only provided if and when the paralysis passes, Ynet reported.

Covid camps? Put disease ‘carriers’ in DETENTION CENTERS, proposed New York law suggests

A man exits the Metropolitan Detention Center (MDC) in Brooklyn, New York, US, December 8, 2020. © REUTERS/Brendan McDermid

A New York state lawmaker has introduced a bill that would allow the government to detain people deemed a potential public health risk, amid concerns that the Covid-19 crisis is being allegedly used to usher in authoritarianism.

Authored by a Democratic member of the New York State Assembly N. Nick Perry, Bill A416 calls for the “removal and/or detention” of individuals who are identified as a “case, contact or carrier” of a contagious disease. 

Such person or group of persons shall be detained in a medical facility or other appropriate facility or premises.

The sweeping powers would be employed in the event of the state government declaring a health emergency due to an epidemic of any communicable disease, the bill proposes. The legislation states that the government must provide “clear and convincing evidence” that the health of others is in danger before ordering a person or group to be detained. People being “removed” will have the right to legal representation and are allowed to supply the telephone numbers of friends or family to receive notification of the individual’s detention.

The law apparently allows the governor or health official to unilaterally approve such detentions but a court order is required within 60 days of confinement, and judicial review is also required if the individual is still in detention after 90 days. 

Citizens that are placed in detention will be released once health authorities determine that they are no longer contagious, the proposed law states. 

The bill also allows the governor or relevant health authorities to require people deemed potential health risks to submit to medical examinations as well as undergo a “prescribed course of treatment, preventative medication or vaccination.”

The law does not specifically mention coronavirus. On his website, Perry says A416 “Relates to the removal of cases, contacts and carriers of communicable diseases who are potentially dangerous to the public health.”

In fact, the Democratic lawmaker introduced a nearly identical bill during the 2015-2016 legislative session, but it appears to have gone nowhere.

The current iteration of the proposed law will be reviewed by the assembly’s health committee next week.

Although the legislation is still a long way off from adoption, it caused considerable consternation on social media.

“I knew Cuomo was a bit of an authoritarian anti-Semite but I never thought the state would go literal Nazi,” Conservative commenter Ian Miles Cheong wrote, referring to New York governor Andrew Cuomo. The governor has previously been accused of imposing draconian crackdowns on New York City’s Jewish community, which has resisted many of the Covid-19 restrictions imposed across the state.

“This was a conspiracy theory, like many other things, 9-10 months ago,” noted a similarly outraged Twitter user.

This isn’t the first time that New York state lawmakers have been accused of promoting naked authoritarianism. Last month, Manhattan Democrat Linda Rosenthal introduced legislation that makes Covid-19 vaccinations compulsory “in certain situations.” It was specified later that any such mandate would apply to “all individuals or groups of individuals who, as shown by clinical data, are proven to be safe to receive such vaccine.”

Like this story? Share it with a friend!

Fauci admits to LYING about Covid-19 herd immunity threshold to manipulate public support for vaccine, moves goal post to 90%

Follow RT onDr. Anthony Fauci, the epidemiologist revered almost religiously as a hero by mainstream media outlets and Democrat politicians, has admitted that he lied to Americans to manipulate their acceptance of a new Covid-19 vaccine.

The intentional deception involved estimates for what percentage of the population will need to be immunized to achieve herd immunity against Covid-19 and enable a return to normalcy.

Earlier this year, Fauci said 60-70 percent – a typical range for such a virus – but he moved the goalposts to 70-75 percent in television interviews about a month ago. Last week, he told CNBC that the magic number would be around “75, 80, 85 percent.”

When pressed on the moving target in a New York Times interview, Fauci said he purposely revised his estimates gradually. The newspaper, which posted the article on Thursday, said Fauci changed his answers partly based on “science” and partly on his hunch “that the country is finally ready to hear what he really thinks.”

“When polls said only about half of all Americans would take a vaccine, I was saying herd immunity would take 70 to 75 percent,” Fauci said. 

Then, when newer surveys said 60 percent or more would take it, I thought, ‘I can nudge this up a bit,’ so I went to 80, 85.

Fauci added that he doesn’t know the real number but believes the range is 70-90 percent. He said it may take nearly 90 percent, but he won’t give that number because Americans might be discouraged, knowing that voluntary acceptance won’t be high enough to reach that goal.

New York State Bar Passes Mandatory COVID-19 Vaccination Recommendation

New York State Bar Passes Mandatory COVID-19 Vaccination Recommendation | 07 Nov 2020 | The New York State Bar Association on Saturday passed a resolution urging the state to consider making it mandatory for all New Yorkers to undergo COVID-19 vaccination when a vaccine becomes available, even if people object to it for “religious, philosophical or personal reasons.” The resolution, which was passed by a majority of the bar association’s 277-member House of Delegates and which speaks on behalf of the 70,000-lawyer organization, includes conditions limiting its scope. Those include that the state government should only consider making COVID-19 vaccinations mandatory if voluntary vaccinations fall short of producing needed levels of population immunity; that an assessment of the health threat to various communities be made so that perhaps the mandate can be targeted; and that a mandate only be considered after there is expert consensus regarding the vaccine’s safety and efficacy…The report had recommended that it should be mandatory for all Americans to undergo COVID-19 vaccination, despite people’s objections, with the one exception being the doctor-ordered medical reason for not being vaccinated. There was no language about the mandate being limited to New York state residents, and no language saying that a public recommendation made to the government should only be for a government to “consider” employing the mandate. [*We’ll take your shot after you take ours.*]

Stella Immanuel’s theories about the relationship between demons, illness and sex have a long history

Matfre Ermengaud’s ‘Temptation by Lechery’ from a 14th-century manuscript. The British Library

President Donald Trump has a new favorite doctor

On July 27, the president and his son Donald Trump, Jr. tweeted a viral video featuring Dr. Stella Immanuel, in which the Houston pediatrician rejected the effectiveness of wearing face masks for preventing the spread of COVID-19 and promoted hydroxychloroquine to treat the disease.

Journalists quickly dug into Immanuel’s background and found that she’s also claimed that having sex with demons can cause illnesses like cysts and endometriosis.

These beliefs don’t come out of thin air, and she’s far from the only person who holds them.

As a scholar of biblical and apocryphal literature, I’ve researched and taught how these beliefs have deep roots in early Jewish and Christian stories – one reason they continue to persist today. 

Hints of demons in the Bible

As in many religions, demons in Judaism and Christianity are often evil supernatural beings that torment people.

Although it’s difficult to find a lot of clarity about demons in the Hebrew Bible, many later interpreters have understood demons to be the explanation for the “evil spirit” that haunts King Saul in the first book of Samuel.

Another example appears in the book of Tobit. This work was composed between about 225 and 175 BCE and isn’t included in the Hebrew Bible or accepted by all Christians. But it is considered part of the Bible by religious groups like Roman Catholics, Orthodox Christians, Beta Israel and the Assyrian Church of the East.

Tobit includes a narrative about a young woman named Sarah. Although Sarah doesn’t suffer any physical affliction, Asmodeus, the demon of lust, kills every man betrothed to her because of his desire for her.

The Christian gospels are full of stories linking demons and illness, with Jesus and several of his early followers casting out demons who afflict their victims. In one of the most prominent stories told in the Gospel of Mark, Jesus encounters a man possessed by a group of demons who call themselves “Legion” and sends them into a nearby herd of pigs who stampede off a cliff.

Demon lore spreads far and wide

Demons pervade biblical apocrypha, which are stories about biblical subjects that were never included in the canonical Bible and include various associations between demons, illness and sex. 

The early Christian text “Acts of Thomas” was likely composed in the third century and became hugely popular, as it was eventually translated into Greek, Arabic and Syriac. It tells the story of the apostle Thomas’ travels to India as an early Christian missionary. Along the way, he encounters a number of obstacles, including people who have been possessed by demons.

In the fifth act, a woman comes to him and pleads for help. She tells the apostle how, one day at the baths, she encountered an old man and talked to him out of pity. But when he propositioned her for sex, she refused and left. Later that night, the demon in the guise of an old man attacked her in her sleep and raped her. Although the woman attempted to escape the demon the next day, he continued to find her and rape her every night, tormenting the woman for five years. Thomas then exorcises the demon.

Astaroth rides a winged beast and clutches a snake.
A 19th-century drawing of Astaroth. Louis Breton

Another demon story is found in the “Martyrdom of Bartholomew,” which probably dates back to the sixth century. Bartholomew also travels to India, where he finds that the inhabitants of a city worship an idol named Astaroth who has promised to heal all of their illnesses. But Astaroth is actually a demon who causes afflictions that he then pretends to cure in order to gain more followers. Bartholomew reveals the farce and performs several miracles to prove his own spiritual prowess. After forcing the demon to confess to his deceit, Bartholomew drives him into the wilderness.

Apocrypha like the “Acts of Thomas” and “Acts of Bartholomew” were popular in the medieval period, and even those who couldn’t read or write knew these stories. They also helped fuel the “witch craze” of the 16th and 17th centuries, in which zealous Christian leaders persecuted and killed thousands of people – mainly women – for their beliefs, often concocting claims that they consorted with demons.

Beliefs that persist today

It’s clear that Immanuel has profited from her beliefs in the supernatural, especially in right-wing and religious circles. She has over 9,000 followers on Facebook and over 94,000 on Twitter, with a dedicated platform as a pastor. In fact, she casts herself as a prophet and destroyer of demons.

It isn’t difficult to find other modern Christians who connect demons, sex and health issues. The conservative Christian magazine Charisma published a story claiming that sex with demons causes homosexuality. And researchers recently were able to show that belief in supernatural evilcould predict negative attitudes toward abortion, homosexuality, premarital sex, extramarital sex and pornography. 

[Deep knowledge, daily. Sign up for The Conversation’s newsletter.]

Meanwhile, many evangelical Americans believe that Trump is God’s chosen one, who has been tasked with fighting actual demons. Trump’s personal minister, Paula White, is just one conservative figure known to espouse these views.

If anything, the coronavirus pandemic has shown how many on the religious right continue to rely on faith over scienceStudies have already emerged showing how the tension between faith and science has influenced many conservative Christians to resist the use of masks and other public health responses to the pandemic.

With many conservative Christians sharing some of the same views about demons as Immanuel – and conservative Christians forming a core base of support for the president – Trump’s promotion of the doctor’s beliefs makes perfect sense. 

He’s preaching to the choir.