The United States said Thursday that only adults who “have personal concerns” about messenger RNA vaccines, access issues or medical reasons for refusing them can now receive the COVID-19 vaccine from Johnson & Johnsonrelated to unusual and potentially dangerous coagulation.
The vaccine, which is a single dose, protects less than those developed by Pfizer Y modernand in December the Centers for Disease Control and Prevention (CDC) advised the public to refrain from using it.
This Thursday’s decision of the Food and Drug Administration The FDA is building on that recommendation by limiting the emergency use authorization of the J&J vaccine.
Today’s action demonstrates the strength of our safety surveillance systems and our commitment to ensuring science and data guide our decisions,” FDA scientist Peter Marks said in a statement.
On March 18, had reported 60 cases, and 9 deathsdue to thrombosis with thrombocytopenia syndrome (TTS), which produces unusual and life-threatening blood clots with low levels of platelets in the blood.
Symptoms begin about one to two weeks after the needle stick and occur more often in premenopausal women.
Concerns about the vaccine have meant that only 18.7 million doses have been administered in the United States, about 3.2% of the national total of 577 million.
However, the FDA did not completely disavow it, and Marks acknowledged the impact a ban could have on global use of the vaccine.
Although rare cases of inflammation of the heart in adolescent males and young men are generally transient with most affected recovering completely, more general objections have also been raised against mRNA vaccines by anti-vaccine groups and linked to conspiracy theories.
Although such reservations are not based on evidence, the exemption to use the J&J injection does extend to those who “have personal concerns about receiving mRNA vaccines and who would not otherwise receive the Covid-19 vaccine“says the FDA statement.