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The Health 202: Don't expect another vaccine 'pause' over the myocarditis cases

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with Alexandra Ellerbeck

The Centers for Disease Control and Prevention took a highly cautious approach to the coronavirus vaccines when it temporarily paused the Johnson & Johnson shots earlier this year.

But now, as the agency considers hundreds of reports of heart inflammation among young adults, there’s more will to push forward without modifying the official vaccine recommendations. 

There’s a “likely association” between the heart condition and shots of the mRNA vaccines.

That was the conclusion reached by members of a CDC advisory panel, who spent part of yesterday reviewing reports of rare cases of myocarditis — inflammation of the heart muscle — predominantly in males ages 12 to 39. The cases chiefly occurred within five days of receiving a shot of the Pfizer or Moderna vaccine.

“Most cases have been mild and have taken place several days to a week after the second shot,” The Post’s Lena H. Sun reports. “Chest pain is the most common symptom. Patients generally recover from symptoms and do well.”

The cases of myocarditis are extremely rare: There were 1,226 reports of the condition out of about 300 million mRNA doses administered in the United States as of June 11. Of those, 267 were reported after the first dose and 827 after the second; 132 reports didn’t indicate which dose.

  • In males 12 to 39, the risk of myocarditis after the second dose of any mRNA vaccine was 32 cases per million, or about 1 in 31,000, according to a CDC analysis of data from one of several vaccine safety monitoring systems. 
  • For females in that age group, there were 4.7 cases per million, or about 1 in 212,000.
  • By comparison, the estimated incidence of the rare inflammatory syndrome in children is about 1 in every 3,200 covid-19 infections — with 36 percent of cases reported in those ages 12 to 20.
The CDC and 15 leading medical associations concluded the benefits of the vaccine still outweigh the risks for teens and young adults.

The groups — which included the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association and the American Nurses Association — issued a joint statement after the meeting saying they “strongly encourage everyone 12 and older” to get the shots.

“Especially with the troubling Delta variant increasingly circulating, and more readily impacting younger people, the risks of being unvaccinated are far greater than any rare side effects from the vaccines,” the statement said.

“The CDC and the Food and Drug Administration plan to do a three-month follow-up of these cases,” Lena writes. “Both agencies are also updating their fact sheets for providers and patients to reflect the additional data about the condition.”

“The choice to avoid an mRNA vaccine in order to avoid myocarditis ignores the fact that both covid and MIS-C [a rare inflammatory condition diagnosed in some children after covid infections] cause myocarditis, and far more commonly,” said Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia. “There are no risk-free choices.”

Baylor University professor Peter Hotez made the same point:

But some experts questioned whether administering a second dose is necessary or wise.

Most of the myocarditis events occurred after receiving a second shot, they noted.

A new study from Israeli researchers suggests the Pfizer vaccine provides full protection to kids between 12 and 15 after a single dose. Ben-Gurion University's Nadav Davidovitch, who led the research, told The Jerusalem Post that a single dose could be considered for young teengers “both because the second dose adds relatively little, if any, immunogenicity and we know that for some young people there can be complications like myocarditis.”

While Israel has been vaccinating teenagers for weeks, several other developed countries are holding back. Germany is offering just one vaccine dose to young people. In the U.K., vaccine experts aren't likely to recommend anytime soon that those ages 12-15 get the shots.

Johns Hopkins professor Marty Makary:

Venkatesh Murthy, a cardiologist at University of Michigan:

Monica Gandhi, an infectious disease doctor at University of California:

The World Health Organization isn't recommending that those under age 18 get the shots. 

In new guidance issued this week, WHO wrote that “more evidence is needed on the use of the different COVID-19 vaccines in children to be able to make general recommendations on vaccinating children against COVID-19.”

WHO's Strategic Advisory Group of Experts did conclude the Pfizer vaccine is suitable for use by people aged 12 years and above, but the agency is still recommending it only for those in high-risk categories. 

“Children aged between 12 and 15 who are at high risk may be offered this vaccine alongside other priority groups for vaccination,” says guidance on the agency's website. “Vaccine trials for children are ongoing and WHO will update its recommendations when the evidence or epidemiological situation warrants a change in policy.”

The evolving data make it harder for experts to answer questions from anxious parents.

We worry a little bit about, are we going to make the community nervous, or have them be more hesitant to vaccinate?” Patricia Stinchfield, director of infectious-disease control at Children’s Minnesota, a liaison from the National Association of Pediatric Nurse Practitioners, told Lena.

But, she added, the discussion “allows us to have conversations. … And the parents that I have talked to, which are numerous about this, are very appreciative of that. And [they] do go ahead and vaccinate and are very, very happy that we’re doing this kind of deep analysis, even on rare events.”

Ahh, oof and ouch

AHH: The spread of the delta variant is posing renewed danger to poorly vaccinated regions.

The United States is making progress against the coronavirus. Deaths are down to an average of 273 each day from a peak of nearly 3,300 deaths a day in January.

“But the delta variant, which is much more transmissible and causes more severe illness than previous versions of the virus, is taking over the United States with stunning speed, as it did in India, where it was first identified, and later the United Kingdom,” The Post’s Ariana Eunjung Cha, Karla Adam, Ben Guarino and Lenny Bernstein report. “Officials expect it to soon become the dominant strain in the United States.”

Top infectious-disease expert Anthony S. Fauci on June 22 warned that the delta coronavirus variant was associated with "increased disease severity." (Video: The Washington Post)

Health officials warned this week that the spread of the delta strain could lead to an uptick in hospitalizations in areas where vaccine uptake is low. The new strain is already taxing hospitals in rural Missouri, and caseloads and hospitalizations are on the rise in states such as Arkansas, Nevada and Utah, where less than half of the eligible population has received a vaccine.

A model produced by the Institute for Health Metrics and Evaluation at the University of Washington predicts a modest overall surge in cases, hospitalizations and deaths this fall. 

OOF: Democrats pressured the FDA to crack down on flavored e-cigarettes.

Congressional Democrats slammed the Food and Drug Administration for inaction on flavored e-cigarettes during a House Oversight subcommittee hearing. The hearing comes as the agency is in the process of deciding which e-cigarette manufacturers can stay on the market, Stat News’s Nicholas Florko reports.

“Who is the cop on the beat to whom we entrust our children? It’s the Food and Drug Administration. And this agency has been timid and reluctant for way too long,” said Sen. Richard J. Durbin (D-Ill.), who testified before the committee as a witness. 

The hearing put acting FDA commissioner Janet Woodcock in the hot seat, as some lawmakers urged her to make a public commitment to banning flavored e-cigarettes. Woodcock gave no indication of upcoming actions that the agency might take.

Woodcock is a leading contender to be nominated for the permanent position of FDA chief, but she has faced opposition from some influential lawmakers. Durbin told Stat News's Rachel Cohrs that he would not commit to supporting Woodcock for the top agency role given the FDA’s inaction.

Durbin’s comments come a week after Sen. Joe Manchin III (D-W.Va.) sent a letter urging Biden not to nominate Woodcock, citing the agency’s approval of a controversial Alzheimer’s drug and its past approvals of addictive opioids.

OUCH: A Seattle scientist dug up deleted coronavirus genetic data.

The discovery has added fuel to debates over the origin of the pandemic, The Post’s Joel Achenbach, Ben Guarino and Yasmeen Abutaleb report.

Jesse Bloom, a computational biologist at the Fred Hutchinson Cancer Research Center in Seattle, does not claim that the data advances either the theory that the coronavirus emerged naturally or that it leaked from a lab, but he says it bolsters evidence the coronavirus was circulating before a December outbreak in Wuhan, China.

In a long tweet thread about the paper, Bloom said he saw it as evidence that additional data on coronavirus origins could still come to light.

“What is not in dispute is that the data was deleted from a database at NIH. The data was included in a preprint paper posted in March 2020 and published that June in the journal Small,” our colleagues write.

NIH on Wednesday said a researcher who originally published the genetic sequences requested they be removed from the NIH database so they could be included in a different database.

Bloom, who retrieved the data from Google Cloud and posted his findings on the preprint server bioRxiv, says he is not accusing NIH of wrongdoing but suggests the deletion of the data violates scientific norms.

Other scientists are not so sure. Robert F. Garry, a Tulane University virologist, called the Bloom paper “inflammatory” and said it added little information that was not already known.

More in coronavirus news

  • Some U.S. lawmakers are calling for an investigation into whether the novel coronavirus was already spreading in October 2019 when Wuhan, China, hosted the Military World Games, an event like the Olympics for military athletes, Washington Post columnist Josh Rogin writes
     
  • Airlines have called for a crackdown on unruly passengers, some of whom have shouted or attacked flight attendants trying to enforce mask mandates. A coalition of airline industry groups has asked the Justice Department to fully prosecute acts of violence on planes, The Post’s Hannah Sampson reports.
     
  • Nearly 900 Secret Service members have tested positive for the coronavirus since March 2020, according to a report from the nonprofit Citizens for Responsibility and Ethics in Washington, a watchdog group. The report placed much of the blame on President Donald Trump, who held public rallies and violated public health orders even as the pandemic was raging, The Post’s Timothy Bella reports.
  • Colleges are divided on whether to require students to get the coronavirus shots. Data from the Chronicle of Higher Education shows that more than 500 colleges and universities intend to mandate vaccination for at least some of their students and employees. But some public universities in red states are shying away from requiring the shots, The Post’s Nick Anderson, Susan Svrluga, Isaac Stanley-Becker, Lauren Lumpkin and Maria Aguilar report.
     
  • The United States has shipped only a fraction of the doses it promised to donate globally by the end of the month. The administration has already conceded that it will not meet its target of delivering 80 million doses by the end of June, Politico’s Erin Banco reports.

Elsewhere in health care

FDA officials are weighing in on why they approved a controversial Alzheimer’s treatment.

Executives at the FDA’s Center for Drug Evaluation and Research defended their decision to approve Biogen’s new Alzheimer’s drug in an op-ed in The Post.

It’s a decision that has sparked controversy. At least three members of the FDA advisory committee that reviewed the drug, known as Aduhelm, and recommended against approval have resigned. Documents also show internal objections to the approval within the agency itself.

But FDA officials Patrizia Cavazzoni, Billy Dunn and Peter Stein argue that there was sufficient data to support a limited approval under the agency’s pathway for accelerated drugs, which will require a follow-up study on the drug to determine its clinical benefit.

“The accelerated pathway was created to give earlier access to potentially valuable drugs for patients who have a serious disease, such as Alzheimer’s, with limited or no treatment options. These patients are often willing to accept some degree of uncertainty of clinical benefit,” the FDA officials argue.

Some of the controversy has centered on the high price tag of the drug and its potential to drive up Medicare costs, all for a drug that may or may not help patients. But the FDA officials say that has no bearing on their decision. “[T]he FDA has no legal authority to investigate or control the prices set by manufacturers, distributors and retailers,” they write.

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