The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have lifted the suspension of the use of the Janssen (Johnson & Johnson) Covid-19 Vaccine in the country.
The decision followed a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, according to a press release issued by the two agencies on April 23.
The pause imposed on April 13 was recommended after reports of six cases of a rare and severe type of blood clot out of more than 6.8 million who received this vaccine.
Called cerebral venous sinus thrombosis (CVST), this type of blood clot was seen in combination with low levels of blood platelets (thrombocytopenia).
So far, the agencies said they can confirm that a total of 15 cases of TTS have been reported, 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.
The Johnson & Johnson’s single-dose Covid-19 vaccine was found to be 66 per cent effective overall in preventing moderate to severe Covid-19, 28 days after vaccination.
It is one of the vaccines Rwanda has secured through the AU-backed African Vaccine Acquisition Task Team (AVATT) to further its anti-Covid-19 vaccination drive.
Rwanda’s composition of 2.6 million doses is made up of about 500,000 from Pfizer’s Covid-19 vaccine, about 1 million doses from Johnson & Johnson and about 1 million AstraZeneca doses expected to inoculate about 1.8 million Rwandans.
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 large blood vessels of the abdomen and veins of the legs) along with thrombocytopenia, or low blood platelet counts.
"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 numbers 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,” said Janet Woodcock, M.D., Acting FDA Commissioner.
"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,” he indicated.
The conclusions
The FDA and CDC said they determined that the use of the Janssen Covid-19 Vaccine should be resumed in the United States, and that they 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.
CDC Director Dr. Rochelle P. Walensky said their 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,” Walensky said.