Johnson & Johnson Issued COVID-19 Vaccine Update

New Jersey-based Johnson & Johnson (J&J) issued a statement on April 13, 2021, saying, 'The health authorities advise people who have received our experimental (Janssen) COVID-19 vaccine and develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.'

Additional excerpts from the J&J statement are below:

'The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots combined with low platelets in a small number of individuals who have received our COVID-19 vaccine.

The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.

In addition, we have been reviewing these cases with European health authorities. We have decided to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials. At the same time, we update guidance for investigators and participants.

We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public. The CDC and FDA have made information about proper recognition and management due to the unique treatment required with this type of blood clot.

The Janssen COVID-19 was Authorized for emergency use and has not been Approved by the U.S. FDA. For more information on the Janssen COVID-19 vaccine, click here.