Vial of the J&J vaccinePhoto: JORGE GUERRERO / AFP (Getty Images)

Johnson & Johnson / Janssen’s suspension of administration of COVID-19 vaccine appears to have come to an end. The CDC’s independent advisory body, ACIP, voted today to re-recommend the vaccine for everyone aged 18 and over, although women under 50 have a very low risk of blood clots. The vaccinations are expected to resume early next week.

What’s the new recommendation?

The new recommendation is the same as the old one: the J&J vaccine is recommended for all adults aged 18 and over. The FDA will include a potential blood clot warning in the vaccine information leaflet.

If you fall into the group where blood clots are more common – women under the age of 50 – you may prefer a vaccine other than J&J, but that’s up to you. All three vaccines are still approved and recommended for all adults, regardless of gender.

What do we know about the blood clots?

The break, started last weekwas caused by six cases of a rare type of blood clot. This condition, which regulators refer to as TTS for “thrombosis with thrombocytopenia syndrome,” is an unusual combination of blood clots that can appear in the brain alongside low platelet counts. (The blood clots in the brain are known as cerebral venous sinus thrombosis, or CVST, but can occur in other parts of the body as well, according to today’s update.) The condition is vanishingly rare in the general population, but has occurred in a small number of people who have the J. & J-Shot. The disease is not linked to the Pfizer or Moderna vaccines.

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Symptoms of TTS begin six or more days after the vaccine and include severe headache, leg pain, abdominal pain, and shortness of breath. (Headache in the few days after the vaccine is often part of the vaccine response and is not a sign of TTS.) If you have these symptoms and have had the J&J vaccine in the past few weeks, go to the emergency room and do let them know when you had your vaccine.

in the given an update todayThe number of known cases was increased to 15, with 13 cases occurring in women aged 18 to 49 years and two in women aged 50 and over. That brings the risk that originally appeared to be one in a million to seven per million women in that age group. (One man had TTS in the clinical trial before the vaccine was approved, and it is possible that some cases in men will emerge as more cases come to light.)

Outside of this situation, blood clots are more common in women, and birth control pills and pregnancy are both risk factors for the more common types of blood clots. But among these people with TTS, only two were using oral contraceptives and neither have recently had a pregnancy. The risk of TTS after the J&J vaccine is less than the risk of blood clots with contraception and also less than the risk of blood clots from COVID-19 itself.

One unusual thing about these clots is that the usual blood clot treatment, heparin, can be dangerous for patients. Therefore, providers should be on the lookout for the disease and be aware not to use this treatment. In the update, we learned that six of the patients had been treated with heparin, but all were hospitalized before the CDC alerted last week. After the alarm, none were treated with heparin. This suggests that efforts to get the word out about TTS helped providers make the right calls.

Why did you make this decision?

The panel spent much of the afternoon debating the pros and cons of changing the recommendations. One concern was that the J&J vaccine is preferred for outreach with the homeless, homeless, and migrants (as it is easy to store at refrigerator temperature and people don’t have to return for a second appointment). If the panel were to recommend the J&J vaccine only for men, it would mean that outreach would not be able to vaccinate families or couples unless they had two different vaccines with different storage requirements on hand. Here are screenshots of the pros and cons of various options that the panel discussed:

A computer model of the consequences of recommending the vaccine (or not) calculated that resuming vaccination would likely result in 9.8 million J&J vaccinations over the next six months, which would cause 26 cases of TTS, but 1,435 deaths and 2,236 recordings in the intensive care unit. This model assumed that people who couldn’t get J&J would not get a vaccine at all, which they probably wouldn’t, but it does give an idea of ​​the risks and benefits of choosing.

Ultimately, the panel faced a difficult decision, but the decision for individuals is a little easier: all three vaccines are effective and all three are relatively safe. TTS is still a rare disease, and we accept risks greater than seven per million for other vaccines, drugs, and everyday risks. However, if this poses a greater risk than you would like to take, seek a vaccine from Pfizer or Moderna.