Prior to now few weeks, a lot has modified in our data of the Johnson & Johnson vaccine. On April 13, the CDC and the Meals and Drug Administration issued a pause on administering this vaccine after six experiences of a really uncommon and severe blood clotting dysfunction, a blood clot within the mind referred to as cerebral venous sinus thrombosis (CVST), mixed with thrombocytopenia, or low platelets, the cells that assist blood clot. On April 14, the CDC advisory committee determined that it wanted extra data earlier than reinstating the vaccine. Particularly, it wished to see what number of extra circumstances of this clotting dysfunction would emerge after the general public grew to become conscious.
These had been prudent steps, essential to protect public confidence in vaccine security. The committee discovered that out of the almost eight million Johnson & Johnson vaccine doses administered in america, there have been solely 12 whole confirmed circumstances of this uncommon mixture of CVST and low platelets. Broadening the factors to incorporate all blood clots (not simply within the mind) and low platelets, a situation referred to as thrombosis with thrombocytopenia syndrome (TTS), there have been 15 circumstances.
The preliminary six circumstances all occurred in ladies between the ages of 18 and 49. The brand new experiences had been additionally all in ladies. Of the 15 TTS circumstances, 13 had been in ladies underneath the age of 50, with a median age of 37. Of observe, solely two ladies had been on oral contraceptives (a recognized danger issue for blood clots), and there have been no different causes recognized as to why these people had been more likely to develop this uncommon situation. The one commonalities recognized had been their age and gender — and lately receiving the Johnson & Johnson vaccine.
It’s essential to place the danger of TTS into perspective. Fifteen circumstances out of eight million is a danger of lower than two in one million. In ladies underneath 50, this danger rises to about 1 in 80,000. The CDC estimated that for each 1 million doses of this vaccine given within the under-50 feminine group, it will forestall 657 hospitalizations and 12 deaths. In ladies over 50, one million doses would forestall 4,794 hospitalizations and 593 deaths.
All of this greater than justifies the choice to permit the Johnson & Johnson vaccine to be administered as soon as once more. In recognition of the danger of TTS, the FDA says that it’ll add data to the vaccine’s label that alerts individuals to its indicators and signs. That is notably essential as a result of the usual remedy for blood clots, administering the blood thinner heparin, is harmful and may be deadly when there are low platelets.
However this isn’t sufficient for the highest-risk group of girls underneath age 50. We’re not speaking about run-of-the-mill blood clots right here. TTS is a extreme, life-threatening sickness afflicting in any other case wholesome, younger ladies. Of the 15 ladies with TTS after vaccination, seven stay hospitalized, 4 in crucial situation. Three have died.
If there have been no options, the advantages of the Johnson & Johnson vaccine would absolutely outweigh the dangers. However that’s not the case. There are two different very secure and efficient vaccines that don’t pose any danger of TTS. Why not subject a warning that advises ladies underneath 50 to obtain one among these two different vaccines as a substitute?
Within the CDC deliberations, these towards a focused warning pointed to precedent — different frequent vaccines even have uncommon unintended effects. Some additionally famous the benefit of a one-dose vaccine for many who wouldn’t return for a second shot.
I’m not saying that ladies underneath 50 shouldn’t be allowed to get the Johnson & Johnson vaccine if that’s their choice. There are many individuals who would select a one-dose vaccine as a result of they’ve needle-phobia or don’t need the inconvenience of a second shot. There are those that assume the messenger RNA know-how used for Pfizer and Moderna is just too “new.” Though there are many arguments to reassure them of security, some may nonetheless go for a extra “conventional” vaccine just like the viral vector know-how utilized by Johnson & Johnson. Clinicians involved that their affected person gained’t come again for a second vaccination may additionally suggest this one-dose inoculation. However the default place ought to be towards administering the Johnson & Johnson vaccine to ladies underneath 50.
In lots of components of america, vaccine provide already exceeds demand. Individuals ought to be empowered to determine which vaccine to get based mostly on the dangers, advantages and options. For young women, the CDC must be way more express to warn them towards the Johnson & Johnson vaccine based mostly on the very uncommon however very extreme danger related to it — and, critically, to direct them to options that don’t carry this danger in any respect. After all of the emphasis federal well being officers placed on prioritizing security, it’s what we must always count on from them.