The J&J Vaccine Is Coming Again

vials of the J&J vaccine

Photograph: JORGE GUERRERO/AFP (Getty Photographs)

The pause in administration of the Johnson & Johnson/Janssen COVID-19 vaccine seems to be at its finish. The CDC’s impartial advisory panel, ACIP, voted right this moment to as soon as once more suggest the vaccine for everybody aged 18 and over, regardless that there’s a very small threat of blood clots in girls beneath age 50. Vaccinations are anticipated to renew early subsequent week.

What’s the brand new suggestion?

The brand new suggestion is identical because the outdated one: the J&J vaccine is really useful for all adults 18 and over. The FDA will embrace a warning about the opportunity of blood clots within the vaccine data leaflet.

For those who fall into the group that has been extra more likely to get the clots—girls beneath age 50—you could favor to get a special vaccine as an alternative of the J&J, however that’s as much as you. All three vaccines are nonetheless approved and really useful for all adults, no matter intercourse.

What do we all know in regards to the blood clots?

The pause, begun last week, was triggered by six instances of a uncommon sort of blood clot. This situation that regulators are calling TTS for “thrombosis with thrombocytopenia syndrome” is an uncommon mixture of blood clots which will happen within the mind alongside a low platelet rely. (The clots within the mind are often called cerebral venous sinus thrombosis, or CVST, however in line with right this moment’s replace they will additionally happen in different components of the physique.) The situation is vanishingly uncommon within the inhabitants normally, however has occurred in a small quantity of people that received the J&J shot. The situation will not be related to the Pfizer or Moderna vaccines.

The signs of TTS start six or extra days after the vaccine, and embrace extreme headache, leg ache, belly ache, and shortness of breath. (A headache within the few days following the vaccine is frequent as a part of the vaccine response and is not an indication of TTS.) For those who expertise these signs and had the J&J vaccine previously few weeks, go to the emergency room and ensure to allow them to know while you had your vaccine.

In an update given today, the variety of recognized instances was introduced as much as 15, with 13 of these occurring in girls age 18-49 and two in girls aged 50 and over. That brings the chance, which initially seemed to be one in one million, to seven per million girls in that age group. (One man had TTS within the scientific trial earlier than the vaccine was approved, and it’s potential that as extra instances come to mild, a number of could change into in males.)

Outdoors of this case, blood clots are extra frequent in girls, and contraception capsules and being pregnant are each threat elements for the extra frequent varieties of clots. However amongst these individuals with TTS, solely two used oral contraceptives and none had a latest being pregnant. The chance of TTS after the J&J vaccine is smaller than the chance of blood clots on contraception, and it’s additionally smaller than the chance of blood clots from COVID-19 itself.

One factor that’s uncommon about these clots is that the same old remedy for blood clots, heparin, could also be harmful to sufferers, and so suppliers ought to be looking out for the situation and bear in mind to not use that remedy. Within the replace, we discovered that six of the sufferers had been handled with heparin, however all had been hospitalized earlier than the CDC’s alert final week. After the alert, none had been handled with heparin. This implies that the trouble to get the phrase out about TTS helped suppliers to make the best calls.

Why did they make this resolution?

The panel spent a lot of the afternoon debating the professionals and cons of fixing suggestions. One concern was that the J&J vaccine is most well-liked for outreach to homeless, homebound, and migrant populations (because it’s straightforward to retailer at fridge temperature and since individuals don’t must return for a second appointment). If the panel had been to suggest the J&J vaccine just for males, that may imply that these outreach efforts wouldn’t have the ability to vaccinate households or {couples} until they started stocking two totally different vaccines with totally different storage necessities. Here are screenshots of the professionals and cons of a number of choices that the panel mentioned:

A pc mannequin of the implications of recommending the vaccine (or not) calculated that over the subsequent six months, resuming vaccination would seemingly end in 9.eight million J&J vaccinations, inflicting 26 instances of TTS however stopping 1,435 deaths and a couple of,236 ICU admissions. That mannequin assumed that individuals who can’t get J&J wouldn’t get any vaccine in any respect, which might be not the case, but it surely provides an thought of the dangers and advantages of the choice.

Finally, the panel confronted a troublesome resolution, however the resolution for people is a little bit bit simpler: All three vaccines are efficient, and all three are comparatively protected. TTS continues to be a uncommon situation, and we settle for bigger dangers than seven per million for different vaccines, medicines, and dangers of on a regular basis life. Nonetheless, if that’s a much bigger threat than you’d wish to take, search out a vaccine from Pfizer or Moderna.


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