J&J COVID-19 Vaccinations Paused in the USA
The US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration issued a ‘pause’ recommendation for future vaccinations in the USA with the experimental Johnson & Johnson - Janssen COVID-19 Vaccine.
The CDC and FDA confirmed they are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Janssen vaccine. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.
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).
‘Right now, these adverse events appear to be extremely rare,’ stated the CDC’s announcement.
Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots.
In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
The CDC confirmed it is convening a meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14, 2021, to review these cases further and assess their potential significance.
In Europe, the European Medicines Agency announced a similar thromboembolic event alert regarding the Janssen COVID-19 vaccine on April 9, 2021.
The FDA stated it too would review the analysis as it also investigates these cases.
‘Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,’ stated these US government agencies.
‘This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.’
‘COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.’
‘People who have received the J&J vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.’
‘Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at VAERS.'
The CDC verified it intends to provide additional information and answer questions later at a media briefing on April 13th. A recording of that session will be available on the FDA’s YouTube channel.
The Johnson and Johnson Janssen COVID-19 single-shot experimental vaccine leverages Janssen's technologies. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.
Adenoviruses are a group of viruses that can cause the common cold, says the CDC.
On February 27, 2021, the FDA issued an emergency use authorization allowing the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
As of April 13, 2021, this COVID-19 vaccine has not been ‘Approved’ by the FDA.
Note: These agency statements are attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
PrecisionVaccinations publishes research-based news.
Updated for relevancy.