CDC approves ACIP recommendations, acting director calls for MMR vaccine to be broken up into 3 shots

CDC on Monday officially approved a set of recommendations made by the Advisory Committee on Immunization Practices (ACIP), updating the adult and child immunization schedules. 

Specifically, CDC endorsed ACIP's recommendations that individuals aged six months to 64 years old discuss the risks and benefits of COVID-19 vaccination before being vaccinated, and that the availability of a combined shot for measles, mumps, rubella, and varicella — the virus that causes chickenpox — should be limited by giving toddlers separate vaccinations for MMR and varicella.

Acting CDC Director Jim O'Neill said the new recommendations emphasized personal choice in a distinctly different way from previous broad recommendations for COVID-19 booster shots.

"Informed consent is back," O'Neill said in a statement. "CDC's 2022 blanket recommendation for perpetual COVID-19 boosters deterred healthcare providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today."

Separately, O'Neill also called on drug manufacturers to break up the MMR vaccine into three separate shots.

"I call on vaccine manufacturers to develop safe monovalent vaccines to replace the combined MMR and 'break up the MMR shot into three totally separate shots,'" O'Neill said in a post on X. The post didn't provide a reason for breaking up the MMR vaccine but linked to a message from President Donald Trump that called for separating the vaccine into three different shots and giving it at different medical appointments.

Some experts have said in the past that the idea of breaking up the MMR vaccine into separate shots could leave children more vulnerable to infections and isn't feasible, as monovalent vaccines for measles, mumps, and rubella are no longer available in the United States.

A 2017 study found that 69% of U.S. children who received a combination vaccine completed the recommended series of shots compared to 50% of children whose parents opted for single antigen vaccines.

"We have 1,544 measles cases this year, 92% in unvaccinated people, and three deaths. The problem isn't the vaccine — it's that people aren't getting it," said Jake Scott, an infectious disease physician at Stanford University. "O'Neill hasn't offered a single scientific rationale for breaking up MMR. Not one study, not one safety concern, not one piece of data."

(Bettelheim, Axios, 10/6; Oza/Cirruzzo, STAT, 10/6; Oza, STAT, 10/6)

Groups sue Trump administration over $100K H-1B visa fees

A coalition of labor unions, religious organizations, and others, led by healthcare-staffing firm Global Nurse Force filed a lawsuit in the Northern District of California on Friday suing the Trump administration for its executive order implementing a $100,000 fee for any new H-1B petitions. The administration argues that the fee is designed to help combat "systemic abuse" in the H-1B program.

In the lawsuit, the plaintiffs argue that the administration doesn't have the authority to demand $100,000 for every new visa application and asks the court to block the government from proceeding with the fees. The groups argue that President Trump implemented the visa fees without the approval of Congress and that the administration violated the Administrative Procedure Act by acting unreasonably and skipping the usual process for considering regulatory changes.

"The Constitution assigns the 'power of the purse' to Congress, as one of its most fundamental premises," the lawsuit says. "Here, the President disregarded those limitations, asserted power he does not have, and displaced a complex, Congressionally specified system for evaluating petitions and granting H-1B visas."

According to Becker's Hospital Review, healthcare employers often use H-1B visas to sponsor medical residents and physicians. Currently, immigrants account for 27% of physicians and surgeons, 22% of nursing assistants, and 16% of RNs in the United States.

(Radnofsky/Cutter, Wall Street Journal, 10/3; Ngo/Aleaziz, New York Times, 10/3)

Experts said that even if consumers have high copays or deductibles, their out-of-pocket share with their health insurer will still likely be cheaper than paying the full cost for prescription medications, even at a substantial discount.

"There are not a lot of people in the market who have the ability or desire to pay full price for these drugs out-of-pocket," said Craig Garthwaite, a professor at Northwestern University's Kellogg School of Management, who studies healthcare markets. "For most patients, they're certainly better off buying from insurance."

Garthwaite added that, while the Trump administration said the program is focused on helping Medicaid patients, Medicaid beneficiaries already pay nothing out-of-pocket for drugs in many states and in others, they pay between $3 and $5.

Stacie Dusetzina, a health policy professor at Vanderbilt University who studies drug pricing, said the administration's announcement was "a really good way to say you're doing something about drug prices, and not actually do anything to change the underlying profits of the industry."

Dusetzina added that she doesn't believe TrumpRx is "going to help many people."

"There is a specific consumer who could benefit — it's a person who has health insurance that does not cover the drug that they need, and they really need this specific branded drug."

(Whyte, et al., Wall Street Journal, 10/2; Robbins, New York Times, 10/1; Lovelace Jr., NBC News, 9/30; Walker/Loftus, Wall Street Journal, 10/1; Gardner, BioPharmaDive, 9/30)

FDA approves generic version of abortion pill

FDA last week approved a generic version of the abortion pill mifepristone, allowing three American companies to produce the drug.

Mifepristone, which was approved by FDA in 2000, was the subject of a lawsuit that made its way to the Supreme Court last year in which plaintiffs argued that FDA didn't adequately review scientific evidence or follow proper protocols when it initially approved the drug.

Ultimately, the Supreme Court unanimously ruled that the plaintiffs in the case lacked legal standing to challenge FDA's decision, meaning the lawsuit would be dismissed, and mifepristone would continue to be widely available.

In June, FDA Commissioner Marty Makary wrote in a letter to Sen. Josh Hawley (R-Mo.) that he planned to review the drug, saying that as FDA commissioner, he is "committed to conducting a review of mifepristone and working with professional career scientists at [FDA] who review this data."

In a post on X, Hawley called Tuesday's approval of a generic version of mifepristone "shocking."

"FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they've just greenlighted new versions of it for distribution," Hawley said. "I have lost confidence in the leadership at FDA."

In a statement, HHS spokesperson Andrew Nixon said the agency "has very limited discretion in deciding whether to approve a generic drug," and that by law the department must approve a generic drug application if the manufacturer demonstrates it's identical to the branded product.

Nixon added that HHS is studying reported adverse events from mifepristone to make sure FDA's risk-mitigation program for the drug "is sufficient to protect women from unstated risks. The FDA does not endorse any drug product and directs prescribers to follow all labeling."

(Gardner, POLITICO, 10/2; Belluck, New York Times, 10/2)

6 surgeons general warn against RFK Jr.

In an opinion piece for the Washington Post, six former surgeons general warned against HHS Secretary Robert F. Kennedy Jr., saying that his actions "are endangering the health of the nation."

The former surgeons general who authored the piece include:

• Jerome Adams, appointed by President Donald Trump
• Richard Carmona, appointed by President George W. Bush
• Jocelyn Elders, appointed by President Bill Clinton
• Vivek Murthy, appointed by President Barack Obama and again by President Joe Biden
• Antonia Novello, appointed by President George H.W. Bush
• David Satcher, appointed by President Bill Clinton

"Never before have we issued a joint public warning like this," the former surgeons general wrote. "But the profound, immediate, and unprecedented threat that Kennedy's policies and positions pose to the nation's health cannot be ignored."

Specifically, they called out Kennedy's views on vaccines, noting that he has "promoted misinformation about the HPV vaccine … and he has repeatedly misrepresented the risks of mRNA technology and coronavirus vaccines, despite their lifesaving impact during the pandemic."

They also called out Kennedy's removal of every member of ACIP, filling the committee with "individuals who often lacked basic qualifications, some of whom are vaccine conspiracy theorists," and HHS' proposal to place new warning labels on products containing acetaminophen, citing a supposed link between prenatal use of the drug and autism, a move that "has been widely condemned by the scientific and medical communities."

"Secretary Kennedy is entitled to his views. But he is not entitled to put people's health at risk," the former surgeons general wrote. "He has rejected science, misled the public and compromised the health of Americans. The nation deserves a health and human services secretary who is committed to scientific integrity and can restore morale and trust in our public health agencies."

(Adams et al., Washington Post, 10/7)