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 Johnson & Johnson’s covid vaccine, linked to a rare and potentially dangerous coagulation.
The single-dose vaccine is less protective than those developed by Pfizer and Moderna, and in December the Centers for Disease Control and Prevention (CDC) advised the public to refrain from using it.
Thursday’s decision by the Food and Drug Administration (FDA) builds on that recommendation by limiting use authorization emergency J&J vaccine.
"Today’s action demonstrates the strength of our security surveillance systems and our commitment to ensuring science and data guide our decisions."FDA scientist Peter Marks said in a statement.
On March 18, it was reported 60 cases, and 9 deaths, due to thrombosis with thrombocytopenia syndrome (TTS), which causes 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 in the United Statesabout 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 the rare cases of heart inflammation in adolescent males and young men are generally transient and most affected recover completely, objections have also been raised more generally 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 would not otherwise receive the covid-19 vaccine"says the FDA statement.