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FDA Places Strict Limits on the Use of Johnson & Johnson COVID-19 Vaccine

The FDA places strict limits on the use of Johnson & Johnson COVID-19 Vaccine in its Thursday announcements for people aged 18 and older who choose J&J because they can’t get other vaccines.

On Thursday the FDA announced that there will be strict limits on the use of Johnson & Johnson/Janssen COVID-19 vaccine for people 18 and older who are only able to get COVID-19 because they cannot access other vaccination.

Thrombosis with thrombocytopenia syndrome (TTS) is an uncommon and potentially deadly illness that can occur after receiving the vaccine, according to an FDA statement.

“We have used updated information from our safety surveillance systems to revise the EUA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “We have been closely monitoring the Janssen COVID-19 Vaccine and the occurrence of TTS following its administration.” “It is our understanding that the Janssen COVID-19 Vaccine continues to play a role in the current pandemic response in the United States and around the world. It is clear that our safety monitoring systems are effective, and that we are committed to using science and statistics to drive our decisions.”

There is a new approval for booster doses as well, according to a statement from the FDA.

There are certain persons for whom the benefits of the J&J vaccination outweigh the dangers, according to the FDA’s assessment. People like the following, for example, may still benefit from the vaccine:

A significant allergic reaction to a Pfizer/BioNTech or Moderna mRNA vaccination is a red flag.

Without the J&J vaccination, those who had personal concerns about the mRNA vaccines would not get inoculated.

Who can benefit from mRNA? The Covid-19 vaccinations

According to the US Centers for Disease Control and Prevention, 18.7 million doses of the J&J vaccine have been provided in the United States as of Thursday. 7.7 percent of people who have been immunized to the fullest extent received this vaccination.

“Preferential recommendation for the use of the mRNA COVID-19 vaccination over Janssen adenoviral-vectored COVID-19 vaccine in all persons aged under 18 years in the United States,” according to the CDC’s vaccine advisory group, which met in December.

Similar issues were raised by the committee.

Due to instances of TTS, the CDC and FDA have both previously advised against the use of this vaccination. A warning about the infrequent clotting incidents was included with the lifting of the pause.

At the time, Johnson & Johnson issued the following statement: “Our primary concern is for the health and safety of anyone who will be exposed to our products. A tiny number of people who received our COVID-19 vaccine have developed an extremely unusual illness involving blood clots and low platelets…. With the help of medical specialists and health authorities, we firmly advocate open dissemination of this information to healthcare providers as well as the general public.”

The FDA reports that 15 percent of TTS instances have resulted in death in a newly released fact sheet on the vaccination.

The Vaccine Adverse Events Reporting System (VAERS) database has been updated to cover instances reported through March 18, according to the CDC. Nine people have died as a result of TTS, according to the FDA.

The overall risk of TTS is extremely low: about three cases for every million vaccine doses administered. There has been the largest incidence of TTS in women between the ages of 30 and 49. Women in this age range have been the target of eight out of every million doses of the vaccination provided.

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One to two weeks following vaccination, cases of TTS are common. There are a variety of signs and symptoms associated with an adverse reaction to the vaccine, including shortness of breath, chest pain, leg swelling, chronic abdomen pain, and neurological symptoms such as headaches or blurred vision.

Warning: “The Janssen Covid-19 vaccine (TTS) may cause thrombosis and may be life-threatening” is written on the vaccine’s fact page.