BREAKING: U.S. resumes use of Johnson & Johnson COVID-19 vaccine

The United States of America (USA) will resume use of the Johnson & Johnson Coronavirus disease (COVID-19) vaccine, the the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have said.

The announcement by the FDA and CDC followed a thorough safety review after blood clots were reported from the use of the vaccine, ending the recommended pause.

“The FDA and CDC determined that the recommended pause regarding the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume,” both agencies stated in a joint statement.

Recall the pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine.

During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.

The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

Following the thorough safety review, the two agencies determined that the use of the Janssen COVID-19 vaccine should be resumed in the United States and that the FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.

“The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

“At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk,” a statement by both agencies reads.

Commenting on the development, Janet Woodcock, M.D., Acting FDA Commissioner said the recommended pause was an example of extensive safety monitoring.

Woodcock further stated that the pause was lifted based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices.

“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases.

“We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices.

“We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.

“We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,” the Acting FDA Commissioner said.

Also commenting was CDC Director, Dr. Rochelle P. Walensky, who said health and safety are at the forefront of the decision to lift the pause.

The CDC Director further explained that as more Americans are vaccinated, all signals would be closely watched.

“Above all else, health and safety are at the forefront of our decisions. Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully.

“As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death,” the CDC Director stated.

TNG reports on April 13, the FDA and CDC announced that, out of more than 6.8 million doses administered, six reports of a rare and severe type of blood clot combined with low blood platelet levels occurring in people after receiving the Janssen COVID-19 Vaccine had been reported to VAERS.

In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

“Today, the agencies can confirm that a total of 15 cases of TTS have been reported to VAERS, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between 6 and 15 days after vaccination,” the joint statement by FDA and CDC reads.