WASHINGTON — In yet another setback for Johnson & Johnson’s coronavirus vaccine, the Food and Drug Administration Thursday restricted its use to adults who cannot or refuse to receive the Pfizer-BioNTech or Moderna vaccines, citing safety concerns.
The agency said 60 cases of a rare but serious blood clotting disorder have been identified, including nine deaths, of the approximately 18 million doses administered. The move comes about five months after the Centers for Disease Control and Prevention recommended Moderna and Pfizer’s vaccines over Johnson & Johnson’s for booster shots.
The FDA said that by weighing the risks of the Johnson & Johnson vaccine against its benefits, it had decided to limit its use to adults who do not have access to Pfizer’s or Moderna’s vaccines, or who do not receive those injections. be “clinically appropriate”. An example would be people who have experienced an extreme allergic reaction to the other two vaccines, the agency said.
It said the vaccine could also be given to adults who “would not otherwise receive a Covid-19 vaccine.”
Johnson & Johnson was long overshadowed by Pfizer and Moderna in the country’s vaccination campaign; federal officials have said the mRNA vaccines produced by those companies are both safer and more effective. In a statement, Johnson & Johnson said the FDA’s action reflected the already known risk of the side effect, not new data on how quickly it occurs. But in sign of the company’s own waning interest in its vaccine, it has stopped providing pre-shot sales prospects to investors.
Reports that the vaccine can cause a condition known as thrombosis with thrombocytopenia syndrome ruined it from an early age. In April 2021, not long after it was approved for emergency use, federal authorities paused distribution of the vaccine for a safety review. Regulators lifted the pause 10 days later, but added a warning to the instructions for its use.
Then, in December, the CDC recommended that adults seeking a booster shot choose Moderna or Pfizer over Johnson & Johnson, citing greater benefits and lower risks. Coupled with a host of manufacturing problems in the United States, some experts said, the agency’s judgment illustrated that the federal government had nearly written off Johnson & Johnson’s vaccine.
According to Thursday’s FDA announcement, federal authorities now have 60 reports of the blood clotting disorder — or four times as many as were reported when the distribution interruption was lifted last year. In the meantime, the number of Johnson & Johnson doses administered has just more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.
The number of deaths attributed to the condition caused by Johnson & Johnson’s vaccine does not appear to have increased much, if at all. But there are far fewer, if any, suspected deaths from side effects of the mRNA vaccines, federal health officials have said.
In its announcement, the FDA cited more than six cases and nearly one death attributed to the blood clotting disorder for every two million injections of Johnson & Johnson vaccine administered in the United States.
About 17 million Americans have now received one dose of Johnson & Johnson’s vaccine, and another 1.5 million have received a booster dose, according to data from the CDC. By comparison, more than 200 million Americans have received at least two doses of the vaccine from Moderna or Pfizer.
In an effort to portray the tight new restrictions in a positive light, Johnson & Johnson said, “Data continues to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, compared to no vaccine.”