FDA limits authorized use of Johnson & Johnson vaccine over blood clot concerns



The U.S. Food and Drug administration announced limits on the authorized use of the Johnson & Johnson COVID-19 vaccine on Thursday, citing concerns over rare and potentially life-threatening blood clots that can be a side effect of the vaccine.

The authorized use of the vaccine is now limited to individuals 18 and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and to adults who choose to receive the Johnson & Johnson vaccine because they do not want to take another one.

According to the FDA, an analysis of reported vaccine side effects has determined there is a risk of thrombosis with thrombocytopenia syndrome (TTS), which causes blood clots in combination with low levels of blood platelets. Symptoms of the side effect can appear approximately one to two weeks after an individual receives the Johnson & Johnson vaccine, the FDA said.

But there are some people the FDA says should still be eligible to receive the Johnson & Johnson vaccine, such as those who have had a severe allergic reaction to the mRNA vaccines manufactured by Pfizer/BioNTech or Moderna, those who object to taking an mRNA vaccine, or those with limited access to mRNA COVID-19 vaccines.

“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. 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," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. 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 EUA," 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,” Marks said.

The Johnson & Johnson COVID-19 vaccine received FDA emergency use authorization on Feb. 27, 2021. Months later on April 13, 2021, the FDA and the CDC issued a call to "pause" the administration of the vaccine over concerns of blood clotting. At the time, the agency wanted to investigate six reported cases of TTS after nearly 7 million doses of Johnson & Johnson's single-dose vaccine had been administered. The pause was lifted on April 23, 2021, after the FDA and CDC conducted a safety evaluation.

In December, the CDC's Advisory Committee on Immunization Practices issued a "preferential recommendation" stating that unvaccinated adults should get one of the mRNA COVID-19 vaccines before they consider taking the Johnson & Johnson vaccine.

A fact sheet provided by the FDA says that TTS cases have been reported in males and females, in a wide range of individuals age 18 years and older. The highest reported rate of TTS was approximately 8 cases per 1,000,000 vaccine doses administered among females ages 30-29 years. The FDA says that approximately 15% of reported TTS cases have been fatal.

As of Friday, more than 18.7 million people have received the Johnson & Johnson COVID-19 vaccine, according to the U.S. Centers for Disease Control and Prevention. The FDA says it has confirmed 60 cases of TTS, including nine deaths. The FDA estimates the reporting rate of TTS is 3.23 cases per million vaccine doses administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

Johnson & Johnson reportedly stops production of COVID-19 vaccines



Johnson & Johnson quietly stopped production on its COVID-19 vaccine over the last couple of months, according to a Tuesday report from the New York Times.

What are the details?

The company, according to the report, shut down its sole plant responsible for manufacturing its COVID-19 vaccine in late 2021.

Johnson & Johnson instead has reportedly been using the facility to develop an experimental — but "potentially more profitable" — vaccine that has nothing to do with the COVID-19 pandemic, but the report did not elaborate on the purported project.

The stoppage is reportedly temporary, and the plant will allegedly resume COVID-19 vaccine production in the coming months.

A spokesperson for the company told Insider that the company currently maintains "millions" of COVID-19 vaccine doses in its storehouse and neither confirmed nor denied the allegations of the halt in production.

"Our manufacturing sites produce multiple products as we have an obligation to supply life changing medicines to patients around the world and bring forward our innovative pipeline of new medicines and vaccines," the spokesperson said. "We manage our production planning accordingly and are currently supplying from our extensive global network based on the demand for our vaccine and the needs of our patients and customers."

Anything else?

The move "blindsided" officials at two of the company's biggest customers — the African Union and Covax — and sparked concern, the Times said.

Dr. Ayoade Alakija, co-head of the African Union’s vaccine delivery program, told the outlet that this is "not the time" to be "switching production lines of anything" as lives of people the world over currently "hang in the balance."

Poorer countries are said to be heavily reliant on the vaccine, which does not require subzero storage temperatures.

“In many low- and middle-income countries, our vaccine is the most important and sometimes only option,” Dr. Penny Heaton, a Johnson & Johnson executive, said in December of the vaccine. “The world is depending on us.”

Dr. Seth Berkley at Covax said he is disappointed in the company's move.

“We really needed their doses in 2021, and we were counting on them,” Berkley said. “They didn’t deliver. So we had to find other doses to meet the countries’ needs.”

FDA to announce new warning on Johnson & Johnson vaccine, linking it to rare neurological condition



The Food and Drug Administration will soon announce a new warning about the Johnson & Johnson coronavirus vaccine, linking the shot to increased risk of a rare neurological condition known as Guillain-Barré syndrome, which can cause permanent nerve damage.

Both the Washington Post and the New York Times reported Monday that about 100 suspected cases of Guillain-Barré syndrome have been detected among recipients of Johnson & Johnson's COVID-19 vaccine. The cases were reported about two weeks after vaccination and were mostly among men age 50 and older, according to the Centers for Disease Control and Prevention's preliminary findings.

For context, the CDC says 12.8 million doses of Johnson & Johnson's vaccine have been administered. The risk of developing the disease is low, but still the data indicates it is three to five times higher for those who received the Johnson & Johnson vaccine than the general population. So far, there is no evidence linking the Pfizer-BioNTech and Moderna vaccines to Guillain-Barré cases.

Guillain-Barré syndrome is a rare neurological disorder in which the body's immune system attacks part of its peripheral nervous system by mistake. The causes of the condition are still unknown, but according to the National Institute of Neurological Disorders and Stroke, when an immune attack is initiated to fight an infection, some chemicals on infecting bacteria and viruses resemble those on nerve cells. The body's immune cells might become confused and attack the nerve cells in addition to the infection.

Symptoms can range from mild cases of weakness to severe cases of paralysis. Each year, an estimated 3,000 to 6,000 people will develop the disease in the United States. Most people recover, even from the severe cases, but rarely some may have permanent nerve damage, which could lead to weakness. People over age 50 are at the greatest risk.

The Biden administration is expected to make an announcement about the new warning as early as Tuesday. Officials will emphasize that the benefits of vaccination against COVID-19 strongly outweigh the risk and that the Johnson & Johnson vaccine is safe for the vast majority of people.

Still, the new warning is unlikely to instill public confidence in a vaccine that has already faced intense public scrutiny. The benefit of the Johnson & Johnson vaccine compared to its competitors from Pfizer and Moderna is that it only requires one dose, not two, meaning more people could be vaccinated against COIVD-19 quickly with widespread use. However, confidence in Johnson & Johnson's vaccine plummeted last April after the FDA and CDC called for an immediate pause in its use because of concerns about six women who developed blood clotting issues after taking the vaccine. The suspension was lifted after government agencies conducted an extensive safety review, though a warning label was added to the vaccine.

The mRNA vaccines are not without their own side effects. Late last month, the FDA added a warning to the Pfizer and Moderna coronavirus vaccines about an increased risk of heart inflammation following vaccination mostly found in young adult males.

Vaccine hesitancy prevented the Biden administration from meeting its goal of having 70% of U.S. adults vaccinated by the Fourth of July. Currently, about 47% of adults in the U.S. are fully vaccinated. Public health experts say 70%-90% of adults need to be vaccinated to beat the pandemic.

President Joe Biden said last week that his administration will start a door-to-door effort to encourage more Americans to get vaccinated.

"Now we need to go to community by community, neighborhood by neighborhood, and often times door to door— literally knocking on doors to get help to the remaining people, protected from the virus," Biden said.

The CDC and the Department of Health and Human Services, as well as various other public health organizations, continue to strongly recommend that everyone 12 and older get vaccinated because the risks of disease and death from COVID-19 are far greater than potential side effects from the vaccines.