Johnson & Johnson Just Said This About the Risks of Its Vaccine
Amid an investigation on blood clots, a top member of the Johnson & Johnson team gave this update.
Johnson & Johnson's COVID vaccine has faced controversy this month after reports of rare blood clots emerged among a handful recipients of the single-dose vaccine. This resulted in both the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) jointly recommending that providers pause use of the Johnson & Johnson vaccine on April 13 until more research is done. Now, a week into the pause, a top member of the Johnson & Johnson team has given an update on what the pharmaceutical company thinks about the risks of its vaccine. Read on to find out what the company's chief scientific officer said, and for more on blood clots from the Johnson & Johnson vaccine, check out Dr. Fauci Just Said This Medication Could Make Blood Clots Worse.
Johnson & Johnson's chief scientific officer said the positive benefits of the vaccine outweigh the risks.
During an earnings call on April 20, Johnson & Johnson's Chief Scientific Officer Paul Stoffels, MD, said that the company believes that the benefits of its COVID vaccine far outweigh the potential risks. "We continue to believe in the positive benefit/risk profile of our vaccine," Stoffels said, according to CNN. "In view of the raging pandemic that continues to devastate communities around the world, [we] continue to collaborate with medical experts and global health authorities—including the CDC, FDA, EMA, the WHO and the South African Health Products Regulatory Authority, SAHPRA—as we work towards continuing vaccination to end the global pandemic."
Stoffels added that the company's top priority is "the safety and well-being of the people who use [their] product."
"We strongly support awareness of the signs and symptoms of this extremely rare event to ensure the correct diagnosis, appropriate treatment and expedited report by health care professionals," he added. And for more on a side effect that's much more common, Moderna Caused This Reaction in 82 Percent of People, New Study Says.
Eight people in the U.S. have reportedly developed blood clots after getting the Johnson & Johnson vaccine.
In a joint statement from the CDC and FDA on April 13, the agencies said they are "reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals" after receiving the Johnson & Johnson vaccine. "In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia)," the statement read.
All six of the initial reported blood clots occurred in women who were 18 to 48 years old and all symptoms occurred six to 13 days after receiving the vaccination. One woman died and a second was hospitalized and is in critical condition, per The New York Times. The Times also reported on two more cases: a man who received the Johnson & Johnson vaccine during a clinical trial and a seventh woman who received the vaccine after it was given emergency use authorization by the FDA in February.
According to the CDC, more than 17.6 million people in the U.S. have received the Johnson & Johnson vaccine, as of April 20. All in all, that means 8 in 17.6 million Johnson & Johnson recipients have experienced the adverse effect, which is an extremely low 0.000045 percent rate.
According to the CDC, if you experience a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after getting the Johnson & Johnson vaccine, you should contact your healthcare provider. And for more signs of blood clots, check out If You Have 1 of These 8 Side Effects, the CDC Says "Seek Medical Care Urgently."
European public health officials said they also discovered a possible link between the Johnson & Johnson vaccine and blood clots.
The European Medicines Agency (EMA) announced on April 20 that it had found a possible link between rare blood clots and Johnson & Johnson's COVID vaccine. However, like Stoffels, the agency still said that the benefits of the vaccine outweighed the potential risks. Though Johnson & Johnson had made the decision to "proactively delay the rollout" of its vaccine in Europe, the EMA ruled that it can now be administered throughout the continent, but it must include a warning.
"EMA's safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen," the agency said in a statement. "PRAC also concluded that these events should be listed as very rare side effects of the vaccine." And for more up-to-date COVID vaccine news, sign up for our daily newsletter.
The CDC and FDA should have a decision about the future of the Johnson & Johnson vaccine in the U.S. on Friday.
The CDC's Advisory Committee on Immunization Practices (ACIP) met last week on April 14 to discuss the potential risks of the Johnson & Johnson vaccine, but did not make any decisions to lift the pause. Instead, the organization is reconvening on Friday, April 23 to discuss the risk further after gathering and reviewing more data.
Anthony Fauci, MD, chief White House medical adviser, said he doesn't believe an extension on the Johnson & Johnson vaccine pause will extend past Friday. "We should have an answer as to where we're going with it. … There will very likely be a decision," Fauci said on ABC's This Week on Apr. 18.
While he doesn't believe the CDC will advise a cancellation of the Johnson & Johnson vaccine, he imagines it will either come with a warning, like the EMA recommended, or it will be restricted for use among certain people, considering most cases were seen in women under 50.
"I do think that there will likely be some sort of warning or restriction or risk assessment. … Not sure what that will be, whether they'll be age or sex," Fauci said on Meet the Press on Apr. 18. "I don't think it's just going to go back and say, 'OK, everything's fine, go right back.' I think it'll likely say, 'OK, we're going to use it. But be careful under these certain circumstances.'" And for more on factors that can you put you at risk of a blood clot in general, If You Have This Blood Type, You're More Likely to Get Blood Clots.