EDirector’s Note: The Centers for Disease Control and Prevention and the Food and Drug Administration withdrew the break from Johnson & Johnson’s COVID-19 vaccine on April 23, 2021, but the labels and information sheets given to patients will carry a warning about the extremely low risk of developing blood clots. In addition, close monitoring of the J&J vaccine will continue along with Moderna and Pfizer vaccines that were given emergency use authorization. Dr. William Petri, an infectious disease physician and immunologist at the University of Virginia School of Medicine, explains this development and why the agencies decided that the benefits of the vaccine far outweigh the risks.
What concern did Johnson & Johnson’s COVID-19 vaccine have?
The FDA and CDC stopped using the J&J vaccine on April 13, 2021 due to six initial cases of a rare and dangerous blood clot affecting the cerebral venous sinuses, large blood vessels in the brain. This coagulation, also called thrombosis, can also occur in the large blood vessels in the abdomen and legs and is associated with a low platelet count or thrombocytopenia. This condition is called thrombosis with thrombocytopenia syndrome (TTS).
An unusual aspect of these clots is that they occur with a low platelet count. Platelets are blood cells that normally aid in clotting. TTS is likely to be caused by J&J vaccination that rarely causes the production of an antibody against a part of a platelet called Heparin-platelet factor 4. These antibodies induce platelets to cause clots. TTS appears similar to a rare side effect of the blood thinner heparin he called heparin-induced thrombocytopenia.
A group of independent doctors and scientists known as the Advisory Committee on Immunization Practices (ACIP) extensively reviewed the data after the break. After a further review of the total of 7 million doses of J&J vaccine administered, nine additional cases of this type of blood clot were identified, all in women.
What did the CDC and FDA do on April 23?
The CDC and the FDA announced yes it is safe to restart the use of Johnson & Johnson’s COVID-19 vaccine because the benefits of COVID-19 protection far outweigh the risks. They did so after meeting twice with ACIP independent vaccine experts, who also recommended restarting.
Why did the CDC and the FDA restart the use of Johnson & Johnson’s COVID-19 vaccine?
First, the side effect is rare. According to the agencies, it has occurred at most in one in 100,000 young women receive the Johnson & Johnson vaccine. No man or woman over the age of 50 is believed to have had this side effect. Second, the J&J vaccine is highly effective in preventing COVID-19, which is a common and serious infection that has killed 1 in 500 Americans.
Third, the J&J vaccine has advantages over mRNA vaccines made by Pfizer and Moderna, as it requires only a single dose. It is also easier to transport and store, as it does not require very low temperatures, as do the Pfizer and Moderna vaccines.
Fourth and most importantly, now that the side effect is known, people can make informed decisions about the COVID-19 vaccine to receive. A young woman with oral contraceptives, who can also promote blood clots, could logically choose one of the mRNA vaccines, while a man could choose the J&J vaccine, as it is a single dose. Young women are the riskiest group.
Is this side effect seen with the other COVID-19 vaccines?
TTS is not a side effect of mRNA vaccines made by Moderna and Pfizer BioNTech. There has been no cases were identified in the 97.9 million doses of Pfizer BioNTech or in the 85 million doses of the Modern vaccine. Five recipients of the mRNA vaccines had thrombosis of the cerebral venous sinus, but not with thrombocytopenia, so it was not TTS. TTS appears to be a side effect of only two vaccines against COVID, which use a common cold virus called adenovirus as part of the vaccine: J&J vaccine in the USA and Oxford-Astrazeneca vaccine used in Europe but not in the US
How do I know if I have TTS?
ETS has only occurred in women and in the period six to 15 days after vaccination. Symptoms may include intense headache, nausea, vomiting, and abdominal pain followed by weakness on one side of the body, difficulty speaking, seizures and loss of consciousness.
How is TTS treated?
TTS clots are treated with what is called direct-acting anticoagulants, and not with heparin. This was part of the reason for the break, so this information could reach healthcare providers on how to properly treat this rare form of blood clots.
Should I get the J&J vaccine?
My recommendation if you are a woman under the age of 50 to have the Pfizer or Moderna vaccine vaccine and not the J&J vaccine. This is because this rare side effect has been observed only in young women; 13 of the 15 women who developed TTS is in this age group. For the rest, the J&J vaccine offers the comfort of needing one and not the two doses of the other vaccines.