On Friday, the US Department of Health and Human Services ended an 11-day moratorium on COVID-19 vaccines using Johnson & Johnson’s single-dose injection, after scientific advisors determined that the vaccine’s benefits outweighed the possibility of a blood clot.
Out of almost 8 million people who received the J&J vaccine, the government discovered 15 people who developed a rare type of blood clot. They were all women, the majority of whom were under the age of 50. Three people died, and seven people are still in the hospital.
But, in the end, federal health officials concluded that J&J’s one-shot vaccine is vital to combating the pandemic — and that the small clot risk could be mitigated with alerts to help younger women determine whether to use it or not.
According to the Centers for Disease Control and Prevention, the J&J vaccine has significant benefits for certain people who have been waiting for its return. The Food and Drug Administration also modified online vaccine awareness leaflets for potential recipients and health professionals, allowing shots to resume as soon as Saturday.
FDA Acting Commissioner Janet Woodcock told reporters late Friday, “This is not a decision the agencies took easily.”
The pause, according to CDC Director Dr. Rochelle Walensky, should boost vaccine safety by demonstrating that “we are taking every one of those needles in a haystack that we find seriously.”
The decision comes after CDC advisors discussed the severity of the risk in a daylong meeting, similar to how European regulators are implementing J&J’s shot. The panel voted 10-4 to resume vaccines without age limits but stipulated that the shots would include explicit alerts about blood clots.
Dr. Sarah Long of Drexel University College of Medicine, who voted against the initiative because she thought it did not go far enough in warning younger women, said, “I think we have a duty to make sure they know this.”
In an interview following the vote, panel chairman Dr. Jose Romero, Arkansas’ health secretary, said that the J&J vaccine “should be put back into circulation.” “What made the difference was how you communicated the danger… It does not absolve us from ensuring that people who receive this vaccine are informed if they are in the danger group.”
European regulators made a similar decision earlier this week, finding that the clot risk was low enough to allow J&J’s shot to be rolled out. However, how the United States handles J&J’s vaccine will have an effect on countries that don’t have as many vaccination choices.
J&J’s chief scientific officer, Dr. Paul Stoffels, promised that the organization would collaborate with US and international authorities “to insure this very unusual occurrence can be detected early and handled effectively.”
A strange type of blood clot that occurs in odd ways, such as veins draining blood from the brain, and in patients with abnormally low levels of platelets that form clots, is a problem. Extreme headaches, stomach pain, and nausea are among the symptoms of the rare clots, called “thrombosis with thrombocytopenia syndrome” a week or two after the J&J vaccine — not right away.
Six cases of the unusual clots were discovered by the government at first, with nine more cases discovered in the last week or so.
However, even the first few studies raised concerns because European authorities had previously discovered similar unusual clots in recipients of an AstraZeneca COVID-19 vaccine. Although the AstraZeneca and J&J shots are not similar, they are both manufactured using the same technology.
European researchers discovered evidence that an irregular platelet-harming immune response to AstraZeneca’s vaccine might be to blame — and if that’s the case, doctors can stop using the most popular clot drug, heparin.
This heightened the urgency in which US authorities halted J&J vaccinations so that doctors might learn how to identify and treat these unusual clots. Six patients were given heparin until it was discovered that it could do more damage than good.
Dr. Jesse Goodman of Georgetown University kept a close eye on Friday’s proceedings and said that while people should be aware of the clotting risk, it shouldn’t outweigh the benefits of COVID-19 security.
“We need to treat people as adults, teach them the facts, and give them these options,” said Goodman, a former FDA vaccine specialist.
The mainstay of the US vaccination effort is two-dose vaccines from Pfizer and Moderna, which are produced differently and haven’t been related to clot threats.
However, several states had hoped that the one-dose alternative, which is easier to store, would help protect hard-to-reach communities such as the homeless and disabled.
The CDC’s advisers had a hard time putting the unusual clot cases into context. COVID-19 can cause a variety of blood clots in its own right. Medications like birth control pills, for example, may have this effect.
The controversy about side effects isn’t J&J’s only issue. Separately, the FDA discovered manufacturing violations at a Baltimore factory that the company had employed to assist with the vaccine’s production.
J&J’s output has so far come from Europe, so no Emergent Biosciences shots have been used.
However, it’s unclear how the idled factory will affect J&J’s commitment to providing 100 million vaccine doses in the United States by the end of May and 1 billion doses worldwide this year.
- Janssen Vaccine: Cheryl Gerber/AP