The US’s Johnson & Johnson COVID-19 Vaccine will be resuming within a few days after another suspension. This comes as a surprise to many, especially after the shocking ingredient mix-up at one of the Emergent BioSolutions production plants as well as newfound deadly side-effects. However, there is now one slight change to the vaccine: a new label on the vaccine warns about a risk of a rare blood-clotting disorder that has occurred among young women, which the Food and Drug Administration announced last Friday.
A vaccine in Europe made by AstraZeneca has been warned to cause a similar clotting disorder, and many European countries have now imposed age and gender restrictions for those that are allowed to receive that particular vaccine. On the contrary, the F.D.A. has decided against implementing those same limitations on the Johnson & Johnson vaccine.
Federal health officials stated that information about the disorder will be provided at vaccination sights as well as vaccination websites. Dr. Peter Mark, the F.D.A.’s top vaccine regulator, predicted that the shots could be resumed on Saturday morning.
After the vaccine production was halted as a result of the ingredient mix-up, it has been suspended again 10 days after the original halt ended, when officials learned that six women who had taken the vaccine had developed a severe disorder, leading to blood-clotting in their brains within two weeks of receiving the vaccination. One of the six women died. The label notes that “most cases” of the disorder have occurred in women between the ages of 18 and 49.
The pause in the Johnson & Johnson vaccine distribution and usage was widely considered to be a huge blow to national and global vaccination efforts, specifically by removing an effective vaccine that numerous countries had counted on to be able to reach more remote places. The vaccine only requires one shot, in addition to being very easy to store and distribute because it does not require cold temperatures to do so, unlike the vaccines made by Pfizer-BioNTech and Moderna.
At an advisory panel meeting about the clotting disorder issue last Friday, the C.D.C. reported that there have been a total of 15 identified cases and three deaths. However, the risk is extremely small, as nearly eight million Americans have received the Johnson & Johnson vaccine. The panel came to the conclusion that the vaccine’s benefits and positive impacts far outweighed that of the negative and harmful risks, and that not using the vaccine entirely or imposing restrictions on who is allowed to receive it would cause more deaths in the long run than the risk of the blood-clotting disorder would.