Johnson and Johnson vaccine

2022 - 5 - 6

Post cover
Image courtesy of "CBS News"

FDA restricts Johnson & Johnson COVID-19 vaccine due to blood ... (CBS News)

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J's vaccine.

But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they're made. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea. Under the new FDA instructions, J&J's vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can't receive an additional dose. At that time, U.S. regulators decided the benefits of J&J's one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. J&J's vaccine was initially considered an important tool in fighting the pandemic because it required only one shot.

FDA Restricts Use Of J&J Covid Vaccine (Kaiser Health News)

After review of rare cases of blood clots, the FDA limits the parameters for who can get Johnson & Johnson's one-dose shot to adults who cannot get either ...

While some 18.7 million doses of J&J’s vaccine have been administered to U.S. adults, according to the Centers for Disease Control and Prevention, almost 31 million doses have been delivered to vaccine sites, suggesting a surplus of unused shots. The agency decided to limit the authorized use of J&J’s shot after conducting an investigation and analysis of reported cases of blood clots in combination with low levels of blood platelets, known as thrombosis with thrombocytopenia syndrome, or TTS, that occurred one to two weeks following administration of the shot. Uptake of the J&J vaccine has paled in comparison to those made by Pfizer Inc. and Moderna Inc., which require two doses for a full regimen. U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine. The decision comes after the agency completed an updated risk analysis of developing thrombosis with thrombocytopenia syndrome, or TTS, a rare and possibly fatal combination of blood clots and low platelet counts one to two weeks after receiving the vaccine, the agency said Thursday. (Foley and Gardner, 5/5) The vaccine is made by J&J’s vaccines division, Janssen. (Branswell, 5/5)

Post cover
Image courtesy of "WABC-TV"

FDA limits Johnson & Johnson vaccine; New York City not ruling out ... (WABC-TV)

There are growing concerns as new data shows hospitalizations and deaths from COVID are tracking higher for the first time in months.

The recommendation was made after reports of rarely occurring but life-threatening blood clots that have appeared in the days or weeks after some have received the Johnson & Johnson shot. The recommendation was made after reports of rarely occurring but life-threatening blood clots that have appeared in the days or weeks after some have received the Johnson & Johnson shot. The FDA said Thursday that the one-shot Johnson & Johnson vaccine should only be given to those who either don't have access to the Moderna or Pfizer vaccines or request only the J & J shot.

Post cover
Image courtesy of "KSBY San Luis Obispo News"

Health experts break down data on J&J vaccine restrictions (KSBY San Luis Obispo News)

Federal regulators have severely restricted who can get the Johnson & Johnson COVID-19 vaccine. The U.S. Food and Drug Administration cites ongoing concerns ...

"Essentially, you lay down a lot of clots in places you shouldn't, in large veins," said Dr. Roberts. "The most worrisome one of the cerebral sinus vein which is a very large vein in the middle of your head and that's the one that's potentially fatal." The U.S. Food and Drug Administration cites ongoing concerns over rare, but serious blood clots. Health experts added that rare blood clots are also an issue with the AstraZeneca vaccine which is being used in Europe. "They refer to it as a rogue response or an abnormal immune response where you have antibodies that are acting inappropriate," said Dr. Roberts. "That's the theory but no one really knows the cause." "What the FDA has done is they've looked at the other vaccines, specifically those from Pfizer/ Moderna and it has shown that the risk profile for J&J while very good, isn't quite as good as the risk profile for Pfizer and Moderna," said Scott Robertson, President, and CEO of Pacific Central Coast Health Centers in Santa Maria. The death rate for that group is about one in a million.

Post cover
Image courtesy of "EyeWitness News"

FDA significantly reduces use of Johnson and Johnson COVID-19 ... (EyeWitness News)

NASSAU, BAHAMAS — The United States Food and Drug Administration (FDA) yesterday limited the use of Johnson and Johnson's COVID-19 vaccine as a “last ...

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals. “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,” FDA’s Center for Biologics Evaluation and Research Director Peter Marks said in a statement. NASSAU, BAHAMAS — The United States Food and Drug Administration (FDA) yesterday limited the use of Johnson and Johnson’s COVID-19 vaccine as a “last resort” for adults who cannot accept a shot from another vaccine manufacturer.

Post cover
Image courtesy of "ABC17News.com"

FDA puts strict limits on Johnson & Johnson Covid-19 vaccine ... (ABC17News.com)

The US Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to ...

Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. Johnson & Johnson said in a statement at the time, “The safety and well-being of the people who use our products is our number one priority. The FDA says it has confirmed 60 cases of TTS, including nine deaths. Cases of TTS typically begin one or two weeks after vaccination. Examples of people who may still get the vaccine include: … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

Post cover
Image courtesy of "CBS Boston"

FDA Puts Strict Limits On Johnson & Johnson COVID Vaccine (CBS Boston)

(CNN) — The US Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 ...

Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. Johnson & Johnson said in a statement at the time, “The safety and well-being of the people who use our products is our number one priority. The FDA says it has confirmed 60 cases of TTS, including nine deaths. Cases of TTS typically begin one or two weeks after vaccination. Examples of people who may still get the vaccine include: … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

Post cover
Image courtesy of "Pharmacy Times"

FDA Limits Use of Johnson & Johnson COVID-19 Vaccine Due to ... (Pharmacy Times)

FDA action was based on an analysis for the risk of thrombosis with thrombocytopenia syndrome, a rare and potentially life-threatening condition that causes ...

The announcement was based on an analysis for the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare and potentially life-threatening condition that causes blood clots combined with low levels of blood platelets. “Johnson & Johnson continues to collaborate with health authorities and regulators around the world to ensure healthcare professionals and individuals are warned and fully informed about reports of TTS, enabling correct diagnosis, appropriate treatment, and expedited reporting. “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.

Post cover
Image courtesy of "AJMC.com Managed Markets Network"

What We're Reading: Global COVID-19 Deaths; J&J Vaccine Limited ... (AJMC.com Managed Markets Network)

New global data put the COVID-19 death toll at just under 15 million; the FDA issues a warning limiting use of Johnson & Johnson vaccine; US sees increase ...

New research shows an aggressive but rare form of uterine cancer may be behind an increase in US death rates among Black women, The Associated Press reports, while over 8 years, figures show deaths from this type rose by 2.7% annually. As of March 18, figures show 60 J&J vaccine recipients developed TTS, 9 of whom died, with rates similar to those seen throughout the vaccine’s rollout. Indirect deaths were defined as patients who were unable to get treatment or preventive care for other health conditions due to the pandemic, while the numbers also take into account prevented deaths resulting from lower traffic and travel.

Post cover
Image courtesy of "WLRN"

FDA limits Johnson & Johnson's COVID vaccine to some people due ... (WLRN)

The US Food and Drug Administration and the Centers for Disease Control and Prevention confirmed a total of 60 cases in which the J&J, Janssen vaccine resulted ...

The Janssen vaccine rollout was first paused last spring after six cases of the rare blood clots were reported. More than 18.7 million doses of the J&J vaccine have been administered in the U.S. since it was first approved for emergency use, the Centers for Disease Control and Prevention reported. Researchers with the FDA and Centers for Disease Control and Prevention found that the vaccine resulted in 60 confirmed cases of thrombosis with thrombocytopenia syndrome.

Post cover
Image courtesy of "GovExec.com"

Coronavirus Roundup: The FDA Limits Johnson & Johnson Vaccine ... (GovExec.com)

The Special Inspector General for Pandemic Recovery office released its quarterly report last week, which says its Office of Investigations is working on 27 ...

Secretary of State Antony Blinken, who is fully vaccinated and boosted, tested positive for coronavirus on Wednesday, making him the latest high-profile government official to do so. The Food and Drug Administration on Thursday limited its authorization of the Johnson & Johnson vaccine to “individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.” The FDA made this decision because of a rare and dangerous clotting condition. The pause was lifted after 10 days and a warning label was added about the potential risks. “A single, five-year term is not enough time to complete the 27 cases that SIGPR is already working, let alone finish additional cases we may unearth in the coming months…therefore [we] respectfully ask Congress to extend SIGPR’s tenure another five years, to March 2030,” Miller wrote. “That budget will allow SIGPR to hire more investigators and auditors. “We are grateful to the president, who has recommended that Congress provide SIGPR $25 million until September 30, 2025,” Miller wrote, referring to President Biden’s fiscal 2023 budget request.

Post cover
Image courtesy of "AARP"

FDA Restricts Use of Johnson & Johnson COVID-19 Vaccine (AARP)

The FDA recommends the Pfizer and Moderna mRNA vaccines over Johnson & Johnson's due to a life-threatening side effect. Learn more about this condition.

The vast majority of vaccinated Americans have been inoculated with the Pfizer and Moderna vaccines, which studies show are more effective against COVID-19 and have not been linked to TTS. But only 18.7 million doses of the J&J vaccine have been administered in the U.S., compared with 340.9 million doses of Pfizer-BioNTech and 217.7 million of Moderna, CDC data shows. More analysis led the FDA to restrict who is eligible to receive the J&J vaccine. The J&J vaccine was authorized in February 2021. About 3.23 cases of TTS have been reported per 1 million J&J doses; some have been fatal. Health officials have since been monitoring and investigating all cases of TTS, which develops when blood clots form and an individual also has low levels of blood platelets.

Post cover
Image courtesy of "nj.com"

N.J. reports 8 COVID deaths, 3387 cases. FDA limits the use of the ... (nj.com)

New Jersey's seven-day average for confirmed cases increased to 2480 on Friday, up 20% from a week ago, and up 133% from a month ago.

The latest numbers follow a major study that reveals even a mild case of COVID-19 can significantly affect the brain. The Garden State has also recorded 316,822 positive antigen or rapid tests, which are considered probable cases. There were at least 131 people discharged in that same 24-hour period ending Thursday night, according to state data. That is the ninth day in a row the seven-day average has reached over 2000. The U.S. has reported the most cases (more than 81 million) and deaths (at least 996,986) of any nation. As of Friday, there have been more than 516 million COVID-19 cases reported across the globe, according to Johns Hopkins University, with more than 6.2 million people having died due to the virus. Since the start of the academic year, there have been 109,723 students and 31,356 school staff members who have contracted COVID-19 in New Jersey, though the state has never had more than two-thirds of the school districts reporting data in any week. More than 6.86 million of the 8.46 million eligible people who live, work or study in New Jersey have received the initial course of vaccinations and more than 7.78 million have received a first dose since vaccinations began here on Dec. 15, 2020. New Jersey has the eighth-most coronavirus deaths per capita in the U.S. — behind Mississippi, Arizona, Oklahoma, Alabama, Tennessee, West Virginia and Arkansas — as of the latest data reported Monday. Last summer, the state still had the most deaths per capita in the country. Two hospitals did not report data. New Jersey has reported 1,964,833 total confirmed COVID-19 cases out of more than 17.6 million PCR tests conducted in the more than two years since the state reported its first known case March 4, 2020. New Jersey on Friday reported eight COVID-19 deaths and 3,387 new confirmed positive tests as the FDA puts a stop to the Johnson & Johnson vaccine in fear of possible blood clots.

Post cover
Image courtesy of "mlive.com"

Regulators limit use of J&J COVID vaccine, citing rare blood clots (mlive.com)

The blood clotting condition TTS has occurred at a rate of about 3.25 cases per million vaccine doses administered.

Although the blood clotting cases remain rare, federal officials continue to recommend prioritization of the Pfizer and Moderna vaccines, which have not produced the same concerns regarding severe blood clotting. To date, more than 6.22 million Michigan residents have gotten at least one dose of COVID vaccine. “We are pleased with the further restrictions placed on the J&J vaccine by the FDA announced yesterday,” said Tatum Strieter-Byron, Jacobs’ daughter. An exception will be made if an adult elects to receive the J&J shot and would otherwise not receive a COVID-19 vaccine. One such fatality is believed to have been Sandra Jacobs, a 60-year-old Saline woman, who died 13 days after she received the single-dose vaccine from a CVS pharmacy. Among those cases, nine individuals died.

Post cover
Image courtesy of "NowThis"

FDA Restricts Who Can Receive Johnson & Johnson Vaccine (NowThis)

The agency said only adults who cannot or will not get the Moderna or Pfizer vaccines should receive the J&J shot, citing new data showing a risk of ...

Though some Americans sought out the J&J vaccine because it only required one dose, there has been an ongoing conversation about the shot’s efficacy and risks. The agency said only adults who cannot or will not get the Moderna or Pfizer vaccines should receive the J&J shot, citing new data showing a risk of ‘life-threatening blood clots.’ The agency said only adults who cannot or will not get the Moderna or Pfizer vaccines should receive the J&J shot, citing new data showing a risk of ‘life-threatening blood clots.’

Post cover
Image courtesy of "Seattle Medium"

FDA Puts Strict Limits On Johnson & Johnson Covid-19 Vaccine (Seattle Medium)

US Food and Drug Administration limiting the emergency use authorization of the Johnson & Johnson vaccine.

Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. Johnson & Johnson said in a statement at the time, “The safety and well-being of the people who use our products is our number one priority. The FDA says it has confirmed 60 cases of TTS, including nine deaths. Cases of TTS typically begin one or two weeks after vaccination. Examples of people who may still get the vaccine include: … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

Post cover
Image courtesy of "WHSV"

UVA Health expert lends insight to Johnson & Johnson vaccine ... (WHSV)

The U.S. Food and Drug Administration has put a limit on the use of the Johnson & Johnson COVID-19 vaccine.

The Blue Ridge Health District no longer offers the Johnson & Johnson shot. He says this restriction is a sign of how carefully they are following the safety of these vaccines. According to UVA Health’s website it is still currently offering the Johnson & Johnson vaccine. One UVA Health doctor says the Johnson & Johnson shot is still a useful tool to have. You can only get the Johnson & Johnson COVID vaccine if you are 18 or older and unable to get Pfizer or Moderna’s mRNA shots. The U.S. Food and Drug Administration has put a limit on the use of the Johnson & Johnson COVID-19 vaccine.

FDA limits use of Johnson & Johnson COVID-19 vaccine (Deseret News)

Vials of the Johnson & Johnson COVID-19 vaccine are pictured at a pharmacy in Denver on Saturday, March 6, 2021. The Food and Drug Administration on ...

Details: Anyone with low blood platelet levels runs the risk of thrombosis with thrombocytopenia syndrome (TTS), an affliction that causes blood clots. The Food and Drug Administration on Thursday limited the use of the Johnson & Johnson/Janssen COVID-19 vaccine to adults who can’t access or refuse to get the Pfizer-BioNTech or the Moderna vaccines, citing concerns over safety. The food and Drug Administration on Thursday limited the use of the Johnson & Johnson vaccine over safety concerns

Post cover
Image courtesy of "CBS Baltimore"

FDA Limits Who Can Receive Johnson & Johnson COVID-19 ... (CBS Baltimore)

The agency is reinforcing its message that Americans choose Moderna or Pfizer because of rare but potentially deadly blood clots that have emerged with the ...

But researchers started to notice extremely rare cases of potentially deadly blood clots. The guidance is really because we have alternatives that don’t have this rare side effect that FDA is, is saying people should get the others instead.”READ MORE: Of the 17 million Americans who got the vaccine, researchers said they found 60 people who got blood clots and as of mid-March of this year, 9 people died.

Post cover
Image courtesy of "WVIR"

UVA Health expert lends insight to Johnson & Johnson vaccine ... (WVIR)

The U.S. Food and Drug Administration has put a limit on the use of the Johnson & Johnson COVID-19 vaccine.

The Blue Ridge Health District no longer offers the Johnson & Johnson shot. He says this restriction is a sign of how carefully they are following the safety of these vaccines. According to UVA Health’s website it is still currently offering the Johnson & Johnson vaccine. One UVA Health doctor says the Johnson & Johnson shot is still a useful tool to have. You can only get the Johnson & Johnson COVID vaccine if you are 18 or older and unable to get Pfizer or Moderna’s mRNA shots. The U.S. Food and Drug Administration has put a limit on the use of the Johnson & Johnson COVID-19 vaccine.

Post cover
Image courtesy of "FOX21News.com"

FDA limits use of Johnson & Johnson vaccine (FOX21News.com)

COLORADO SPRINGS — The Food and Drug Administration (FDA) has limited the authorized use of the Johnson & Johnson vaccine due to rare blood clots.

Post cover
Image courtesy of "CBS News"

Nicole Audia says Johnson & Johnson vaccine sent her health into a ... (CBS News)

The FDA announced strict new restrictions on the vaccine due to the risk of rare and life-threatening blood clots.

Jha says people who got the J&J vaccine a while ago shouldn't worry. Audia says she still strongly supports getting vaccinated, but wishes she would've known the risks before taking this particular shot. So it's not like we're talking about something that would have been easily picked up in a clinical trial," Jha said. "Like a day late and a dollar short. My heart will never be the same, and that stinks," Audia said. It happens about three in a million," said White House COVID-19 response coordinator Dr. Ashish Jha.

Explore the last week