Johnson and Johnson Vaccine Resumes
As of Apr. 25, 2021, the CDC and the U.S. Food and Drug Administration recommended the resumption of distribution of the Johnson and Johnson Janssen Covid-19 Vaccine.
The CDC and FDA released a joint statement on Apr. 13, 2021 stating that they were reviewing the data of six reported U.S. cases of blood clots in individuals after receiving the J&J vaccine. Although the cases are rare, they recommended the pause in distribution out of an abundance of caution.
The cases occurred among women between the ages of 18 and 48. They showed symptoms of the clot 6 to 13 days after vaccination. Usually heparin, an anticoagulant drug, is administered for treatment but in these cases, administering the drug may be dangerous and other treatments have to be given.
“A review of all available data at this time shows that the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks,” the CDC said in their statement recommending the resumption of distribution.
Although the CDC and FDA recommend the resuming of the vaccine, they do recommend womens younger than 50 years old especially to be aware of the rare but increased risk of the Johnson and Johnson vaccine. They noted in the statement that womens should be aware of the other Covid-19 vaccines available where this risk has not been seen.
“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,” the CDC and FDA said in their joint statement when pausing the use of the vaccine.
The CDC had an advisory panel meeting about the clotting issue to determine whether they would recommend the distribution of the vaccine. The panel voted 10 to 4 in favor of resuming use of the vaccine with a warning label. Those who voted against wanted a more prominent warning about the risk of the vaccine and push other Covid vaccines that do not have the same risks. The panel analyzed 15 cases, including three deaths.
On Apr. 13, 2021, Johnson and Johnson released a statement on their Covid-19 vaccine being put on pause.
“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 in combination 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,” Johnson and Johnson said in their Covid-19 vaccine statement.
The Johnson and Johnson vaccine pausing halted distribution into some hard to reach areas. The vaccine only requires one shot and is much easier to store and distribute because it does not need to be stored at cold temperatures. The Pfizer and Moderna vaccines on the other hand have to be stored at extremely cold temperatures so it is harder to get them to hard to reach areas.
The type of blood clot, cerebral venous sinus thrombosis was seen in a combination with low levels of blood platelets. It occurs when a blood clot forms in the brain’s venous sinuses. The clot prevents blood from draining out of the brain. Blood cells may break and leak blood into the brain tissues as a result. These chain of events are a part of a stroke that can occur in adults and children.
Although the Johnson and Johnson vaccine is resuming use, it is important for women ages 18 to 49 to understand the rare but potential risks of getting the vaccine.