“People have a hard time with probabilities,” Brown University professor Emily Oster told me. “We have a hard time parsing what is the risk of anything.”
One person out of every 1 million who got the Johnson & Johnson shot in the U.S. developed a blood-clotting condition.
A total of six people – all of them women under age 48 – developed a rare and severe type of blood clot. One of them died, while another is in critical condition.
In response, the Food and Drug Administration recommended yesterday that states temporarily halt the administration of the vaccine.
Officials said their decision was driven by “an abundance of caution.” And there is some evidence that both the Johnson & Johnson vaccine and the vaccine developed by AstraZeneca are, on extremely rare occasions, associated with some people developing antibodies that can lead to such blood clots. European health officials are investigating both vaccines.
“Covid-19 vaccine safety is a top priority for the federal government, and we take all reports of adverse events following vaccination very seriously,” acting FDA commissioner Janet Woodcock told reporters yesterday.
Yet even if all six cases are found to stem from the vaccine, getting sick from the coronavirus would still be far riskier.
Granted, the fatality rate from the coronavirus is extremely low for people in their 20s and 30s, who have about a 0.2 percent chance of dying of it. But even those low odds mean that for every million people in that age group who contract the virus, 2,000 people will die of it. The odds of dying increase somewhat for those in their 40s.
That’s clearly a higher fatality rate than what has been observed so far with the Johnson & Johnson vaccine. Of the six women who developed dangerous blood clots, one has died.
And that’s not the only comparison to be made. Many people yesterday noted that oral contraceptive pills carry a much greater risk of developing blood clots — about 1 in every 2,500 women who take such pills — yet most women don’t think twice about using them. Others noted that even the risk of being struck by lightening is one in half a million.
Angela Rasmussen, a virologist at Georgetown University:
Brown University professor Ashish Jha:
Phil Galewitz, reporter for Kaiser Health News:
“The decision to pause the use of the vaccine in the United States ignited a debate on social media, with some arguing that the risk of covid-19, the disease the virus causes, remained higher than the rare risk of an adverse effect from vaccination,” my colleagues write.
New York Times writer Ezra Klein:
FiveThirtyEight’s Nate Silver:
Some medical experts also criticized the Biden administration’s decision.
Bruce Gellin, president of global immunization at the Sabin Vaccine Institute, questioned whether an “outright pause” was the right way to go. “It’s hard to unscramble the egg,” he told Laurie McGinley, Lena H. Sun and Frances Stead Sellers.
Gellin suggested the public could have been sufficiently alerted without a full pause, which might have a harmful longer term impact, pointing to a scare around the HPV vaccine in Japan that proved to be unwarranted but meant the program was never able to be reinstated.
Ezekiel Emanuel, an oncologist at the University of Pennsylvania, also expressed concerns to my colleagues. “Let’s hope it doesn’t induce [vaccine] hesitancy,” he said. “We’re in a critical race with variants, and people are dying.”
Biden officials made their decision during a Zoom meeting on Monday night.
On that call, they debated the tricky balancing act they faced.
“Given that people in the United States have access to alternative vaccines — the Moderna and Pfizer-BioNTech shots — that have not been linked to the clotting problem, the officials opted to be extremely cautious, said one individual who was not authorized to discuss the decision,” my colleagues write.
Another official said the discussion was amiable and eventually they all agreed that “there is a tremendous need for vaccines but also a tremendous need for trust in the vaccine.”
Centers for Disease Control officials grew concerned over the weekend.
Initial information about the clotting case was detected by a vaccine-monitoring system jointly run by the CDC and the Food and Drug Administration. By the weekend, the number of unusual cases, along with additional clinical information, raised “many, many concerns,” one CDC official told my colleagues.
“On Monday afternoon, the vaccine safety subcommittee of the CDC’s vaccine advisory committee, which has been meeting weekly since last year, gathered for about two hours,” they report.
Based on that review, “the information was consolidated, and CDC and FDA convened to discuss the findings,” Anne Schuchat, the CDC’s principal deputy director, said in an interview.
Ahh, oof and ouch
AHH: The FDA will allow women to get abortion pills via telemedicine during the pandemic.
The FDA said in a letter to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine that it will temporarily stop enforcing a rule requiring women to obtain abortion medication in person, the Hill’s Justine Coleman reports.
The agency said it had determined that allowing women to receive the pills via mail and over telemedicine would not increase safety concerns, but that in-person clinic visits could present coronavirus-related risks.
The new decision is a departure from the Trump administration, which continued to enforce the in-person mandate during the pandemic and successfully defended it before the Supreme Court.
The Biden administration may face pressure from abortion rights groups to permanently lift the in-person requirement for abortion medication.
OOF: A federal court lifted a hold on an Ohio law prohibiting abortions based on a Down syndrome diagnosis.
The court ruled that the 2017 law, which imposes criminal penalties on doctors who perform abortions if they are aware of that a Down syndrome diagnosis is the reason for seeking an abortion, does not constitute an undue burden on women’s right to seek an abortion, the Cincinnati Enquirer reports.
The divided 9-to-7 ruling from the U.S. Court of Appeals for the 6th Circuit reverses an injunction put in place by lower courts preventing the law from going into effect.
Abortion rights groups argue the law will infringe on the relationship between patients and their doctors. An abortion can still proceed if a woman does not disclose a reason for obtaining it.
One judge compared selective abortions to the Holocaust.
“Many think that eugenics ended with the horrors of the Holocaust. Unfortunately, it did not,” wrote Judge Richard Allen Griffin, who was nominated by President George W. Bush. “Eugenics was the root of the Holocaust and is a motivation for many of the selective abortions that occur today.”
OUCH: National cases of sexually transmitted diseases were at an all-time high in 2019.
New data from the Centers for Disease Control and Prevention’s 2019 STD surveillance report finds that there were 2.5 million reported cases of chlamydia, gonorrhea, and syphilis — representing the sixth year in a row that STDs have reached record levels and a nearly 30 percent increase since 2015. The biggest increase came in cases of syphilis among newborns, which nearly quadrupled between 2012 and 2019, KQED’s April Dembosky reports.
“Less than 20 years ago, gonorrhea rates in the U.S. were at historic lows, syphilis was close to elimination, and advances in chlamydia diagnostics made it easier to detect infections,” Raul Romaguera, the acting director for the CDC’s Division of STD Prevention, said in a statement.
About half of syphilis cases are in men who have sex with other men. Among women, methamphetamine use is associated with higher rates of syphilis, April reports.
Syphilis can cause blindness, deafness and brain damage, but it’s usually easy to treat with a simple shot of penicillin, if it’s diagnosed. The problem is that the disease can go undiagnosed, especially because specialized STD clinics have been shutting down across the country.
There’s no single cause for the rise of STDs, although some experts have pointed to use of online dating apps that may encourage casual hookups and make contact tracing harder. The use of highly effective medication to prevent contracting HIV could also cause more men to ditch condoms, putting them at risk for other infections.
Coronavirus latest
The White House is resisting pressure to space out doses of coronavirus vaccines.
Several former Biden advisers have called for the United States to prioritize administering as many first doses of the two-dose coronavirus vaccines as possible, even if it means spreading out the interval between first and second shots beyond the three- or four-week interval studied in clinical trials, Roll Call’s Emily Kopp reports.
University of Minnesota epidemiologist Michael Osterholm points out that the recommended three- to four-week interval is mostly arbitrary and was selected to speed along clinical trials. He recommends opting for a 12-week delay.
“You can protect two people at 80 percent effectiveness, or you can protect one person with 90 percent effectiveness,” Osterholm said. “It’s simple math.”
Former Biden adviser Zeke Emanuel:
In March, a working group with the CDC’s Advisory Committee on Immunization Practices argued against changing vaccine practices, citing a lack of evidence. But supporters of stretching out dose intervals point to more data that has emerged since then. The CDC has released a study showing that first shots are 80 percent effective. And the United Kingdom, which is spacing doses 12 weeks apart, has seen average daily deaths plummet.
Still, White House chief medical adviser Anthony Fauci said that he thinks the United States should stay the course, especially given the rapid pace of vaccinations. Other experts have raised concerns that delaying second shots could cause confusion and that some people might not return to get the second dose.
Elsewhere in health care
The United States had far higher mortality rates than Europe even before the coronavirus.
Far fewer Americans would die each year if the United States had similar mortality rates to Europe, according to an analysis published in the journal Proceedings of the National Academy of Sciences. The researchers estimated how many fewer deaths the country would have experienced if it had the same death rates by age and sex of an average peer European country.
“In the latest analysis, the authors found mortality conditions in the US have worsened significantly since 2000 — and resulted in more than 400,000 excess deaths in 2017 alone. That year, Americans aged 30 to 34 were three times more likely to die than their European counterparts, which the researchers suggested was probably driven by drug overdoses — in particular opioids — as well as gun violence,” the Guardian’s Natalie Grover reports.
The United States does better in one respect, however. It has significantly lower death rates in people over 85, perhaps because it tends to spend more on aggressive end-of-life care.
The House passed a bill to avert cuts to Medicare.
A strong bipartisan majority of lawmakers voted 384 to 38 in favor of the bill, which would put off cuts to Medicare until the end of the year.
“The automatic cuts were originally put into place by the 2011 Budget Control Act, which set up an annual 2 percent reduction in Medicare payments as one of its mechanisms for reducing the debt. Congress has never allowed the cuts to take place, however, voting to overturn them regularly over the past decade,” the Hill’s Niv Elis reports.
