Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine

FDAAs of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. 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). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. 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.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that 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. 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.

Right now, these adverse events appear to be extremely rare. 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 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 https://vaers.hhs.gov/reportevent.html.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recordingExternal Link Disclaimer of that media call is available on the FDA's YouTube channel.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Novartis signs initial agreement to reserve capaci…

Novartis has signed an initial agreement with Roche to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient (...

Pfizer acquires Amplyx Pharmaceuticals

Pfizer Inc. (NYSE: PFE) announced today that it has acquired Amplyx Pharmaceuticals, Inc., a privately-held company dedicated to the development of therapies for debilita...

Moderna announces additional investments to increa…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it is making new funding commitments to i...

Moderna announces emergency use listing granted by…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the World Health Organization (WHO) has is...

Sanofi to help manufacture Moderna COVID-19 vaccin…

Sanofi has entered into an agreement with Moderna, under which Sanofi will help manufacture Moderna's COVID-19 vaccine, supporting the COVID-19 pandemic and vaccine suppl...

Valneva switches focus to bilateral discussions to…

Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical n...

Speeding new treatments

A year into the COVID-19 pandemic, mass vaccinations have begun to raise the tantalizing prospect of herd immunity that eventually curtails or halts the spread of SARS-Co...

Pfizer and BioNTech to supply the European Union w…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will supply an additional 100 million doses of COMIRNATY®, the companies' COVID-19 vaccine, to the 2...

Brazilian coronavirus variant likely to be more tr…

Even though more and more vaccines against the coronavirus are being administered all over the world, many countries are still battling with outbreaks and face difficulti...

Patients who are obese or overweight are at risk f…

COVID-19 patients who are overweight or obese are more likely to develop a more severe infection than patients of healthy weight, and they require oxygen and invasive mec...

Updated results on coronavirus vaccination effecti…

Several weeks following the publication of the large real-world COVID-19 vaccine effectiveness study by the Clalit Research Institute in Collaboration with Harvard Univer...

Our immune systems blanket the SARS-CoV-2 spike pr…

The most complete picture yet is coming into focus of how antibodies produced in people who effectively fight off SARS-CoV-2 work to neutralize the part of the virus resp...