The Food and Drug Administration announced Thursday it will restrict the use of the Johnson & Johnson one-shot COVID-19 vaccine after an investigation revealed that those who got the jab were at increased risk of developing life-threatening blood clots.
The agency is now only authorizing the pharmaceutical giant’s Janssen COVID vaccine to people 18 or older for whom other authorized or approved vaccines are not accessible or clinically appropriate, and to those 18 years or older who otherwise would not get a COVID vaccine.
The decision comes following an investigation into reports of thrombosis and thrombocytopenia syndrome (TTS) – a rare and potentially life-threatening disease that creates blood clots and creates low levels of blood platelets – from those who have received the vaccine.
There have been 60 confirmed cases, including nine fatalities, through March 18, 2022 from the nearly 19 million doses administered nationwide. The FDA determined that the reporting rate of TTS is 3.23 per million doses of the vaccine administered, and the reporting rate of TTS deaths is 0.48 per million doss of vaccines administered.
Symptoms began in the confirmed cases about one to two weeks after the individual received the vaccine.
‘We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,’ Peter Marks, the director of FDA’s Center for Biologic Evaluation and Research said in a statement.
‘We’ve been closely monitoring the Janssen COVID-19 vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the [Emergency Use Authorization,’ he continued.
‘The agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all other vaccines and, as has been the case throughout the pandemic, will thoroughly evaluate new safety information.’
The company did not immediately respond to DailyMail.com’s request for comment.
J&J’s stock price slid 1.9 percent – before the decision was announced after the market closed. It’s shares are trading at $176.76.
The FDA is recommending anyone over the age of 18 receive a mRNA COVID-19 vaccine like the Pfizer or Moderna
It has found 60 confirmed cases of thrombosis and thrombocytopenia syndrome (TTS), including nine fatal cases, from people who have received the Johnson and Johnson COVID-19 vaccine through March 18, 2022
The FDA announced Thursday it is limiting the use of the Jansen COVID-19 vaccine to those who cannot get an mRNA vaccine and to those who would not otherwise get a COVID jab
Shares of Johnson and Johnson were down 1.9 percent to close the day at $176.76 per share
The FDA has been aware of the risk for TTS for about two years.
It first authorized the Johnson and Johnson vaccine for emergency use on February 27, 2021.
Since then, data shows, 18.7 million people have received the vaccine.
Thrombosis and Thrombocytopenia Syndrome – the vaccine-induced life-threatening disease
Thrombosis and Thrombocytopenia Syndrome (TTS), also known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) or vaccine-induced immune thrombotic thrombocytopenia (VITT) is a rare syndrome characterized by the formation of blood clots combined with low platelet counts.
It can be classified into two categories based on the location, with Tier 1 occurring in uncommon sites of thrombosis – like the brain or the gut, and Tier 2 occurring in more common sites.
Symptoms include persistent headaches, visual changes, seizures, confusion, abdominal pain, chest pain, leg pain, bleeding or bruising.
Severe cases can also lead to coma or death.
But on April 13, the FDA paused its authorization of the Johnson and Johnson vaccine after six women were found to have developed blood clotting after receiving the shot.
All had pre-existing conditions that put them at an increased risk of developing the clots.
Ten days later, on April 23, usage of the vaccine was resumed, though the label was advised with a warning to women under the age of 50 about the blood clotting.
The agencies determined at the time that a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System, including the six reported cases, out of 8 million doses administered.
Still, they continued to investigate the level of risk for TTS, and as more cases were reported in December, the Advisory Committee on Immunization Practices made a preferential recommendation for use of the mRNA vaccines over the one-shot Johnson and Johnson for everyone over the age of 18.
They said at the time that it could still be considered when a person has a contraindication to mRNA vaccines – like the Moderna and Pfizer jabs, when someone would otherwise remain unvaccinated due to limited access to the mRNA vaccine and when a person wants to receive the Johnson and Johnson vaccine despite the concerns.
In its new guidance, the FDA said, it has considered the fact that people with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate.
The agency also considered the availability of other COVID vaccines, which have not been shown to present a risk for TTS.
As part of the syndrome, blood clots form within the veins in the outer layers of the brain, and can block the blood from draining from the brain to the heart.
In the worst cases, it can cause a person to suffer a stroke, that could lead to death.
It remains unclear, the FDA noted, how the vaccine causes the syndrome.
Cerebral venous sinus thrombosis (CVST) is a rare but potentially deadly condition that restricts the brains ability to drain blood and could cause a stroke
Former Secretary of the Department of Health and Human Services Alex Azar invoked the Public Readiness and Emergency Preparedness Act in 2020 to shield pharmaceutical companies from any lawsuits for their COVID-19 vaccines. He is pictured here giving a briefing in August 2020
Anyone who is diagnosed with TTS, however, cannot take legal recourse against Johnson and Johnson or the federal government.
In 2020, then-Department of Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act to shield pharmaceutical companies from any lawsuits for their COVID vaccines.
The 2005 law empowers the Department of Health and Human Services secretary to provide such protection to companies making or distributing critical medical supplies – like vaccines or treatments – unless there’s ‘willful misconduct’ by the company, CNBC reports.
Under Azar’s guidance, the legal protection for the pharmaceutical companies lasts until 2024 – meaning that for the next two years, these companies ‘cannot be sued for money damages in court’ over injuries related to the administration or use of products to treat or protect against COVID.
Additionally, the Food and Drug Administration is shielded from any possible lawsuits due to its sovereign immunity, and anyone who was mandated to get a COVID vaccine by their employer cannot hold them accountable if they require inoculation as a condition of employment, Azar ruled.
Among those who have died from the syndrome are Sandra Jacobs, 60, left, and Jessica Berg Wilson, 37, right
Still, the damage has been done to several families – including those of Sandra Jacobs, 60, and Jessica Berg Wilson, 37.
Jacobs, of Michigan, died on April 21, 13 days after she received the single-shot Johnson and Johnson vaccine at a CVS on April 8 – just five days before federal health officials temporarily paused the vaccine administration as they investigated the blood clotting disorder, according to MLive.
She had originally been opposed to getting the COVID vaccine, her daughter, Tatum Strieter-Byron, told the outlet, but she traveled frequently for her job as vice president of sales and marketing at Saline Lectronics, an electronics manufacturing service.
Streiter-Byron said she guessed her mother had chosen the Johnson and Johnson vaccine because it was more convenient.
But in the days following her jab, Streiter-Byron said, Jacobs complained of a constant headache, fatigue, chills, dizziness and nausea.
She eventually contacted her doctor, who recommended she take Motrin and prescribed her an anti-nausea medication.
By April 20, Streiter-Byron said, her mother had told her she regretted getting the vaccine, as she continued to get worse – to the point where friends and family offered to take her to the hospital, but she assured them she could sleep it off.
Then, on April 21, Jacobs, who was divorced and lived alone, did not go into the office and stopped responding to messages, inciting panic.
A friend with a key was ultimately enlisted to check on her, and found her dead on her bed.
By September, Michigan Medicine Pathologist Dr. Michael Caplan completed his autopsy report of Jacobs, concluding she succumbed to a ‘rare but nevertheless documented’ complication associated with the vaccine.
He noted that Jacobs was also obese with a body mass index of 33.3 (a healthy one is 18.5 to 24.9), had high blood pressure, chronic migraines and a common colon condition.
Additionally, she had ben diagnosed with Multiple Sclerosis, a potentially disabling disease of the brain, for which she was taking medication, but the coroner’s report notes there were ‘no definitive identifiable neuropathological features’ of the disease.
Several months later, in September Jessica Berg Wilson, died from TTS.
She had received the vaccine on August 27, Oregon Live reports, and died 12 days later on September 7.
An obituary submitted to The Oregonian on behalf of Wilson’s family by a Seattle funeral home harshly criticized the vaccine mandates, saying she felt forced into getting the jab.
It said she had been ‘vehemently opposed to getting the vaccine, knowing she was in good health and of a young age, and thus not at risk for serious illness.’
Eventually, though, she got vaccinated because she wanted to be a ‘Room Mom’ and involved in her children’s education.
Medical records obtained by Oregon Live show a woman of Wilson’s age went to the Emergency Room two days after getting the COVID vaccine, when she was feeling sick and experiencing back pain.
Hospital tests were run on the woman and she was sent home, according to the case description in a federal database.
But the next day, she returned by ambulance with hemorrhaging and bleeding, and died two days later.
‘This idea that it’s safe for everybody, it’s not,’ Jacobs’ daughter, Strieter-Byron said of the COVID vaccines.