Should covid shots become like annual flu shots? FDA advisers aren’t sure.
Getting the covid vaccine could become a once-a-year regimen
The coronavirus shot could become more like the annual flu vaccine.
The Food and Drug Administration is proposing a once-a-year regimen for coronavirus immunizations — a shift from the agency’s previous strategy of pressing for new boosters to fend off differing variants.
But the new blueprint, which the Biden administration telegraphed in September, is drawing mixed reaction from the public health community. Some argue there isn’t sufficient data to show the shots provide enough protection to last for a full year, while others contend it’s a reasonable step that would simplify the current vaccination guidance, our colleague Laurie McGinley reports.
Expect robust discussion on the topic this Thursday, when the change is going to be one of the key topics discussed at the FDA’s vaccine advisory committee meeting. The FDA will take into consideration the panel’s views when it decides on a plan, and two advisers told The Health 202 they had not yet fully formed an opinion on the shift.
- “We need to have a discussion as to what is going to provide and offer the best protection for Americans,” said Cody Meissner, a member of the advisory committee and a professor at Dartmouth Hitchcock Medical Center. “What’s the most effective way to sustain public health? And I don’t think the answer is clear.”
- “I’m open-minded,” Eric Rubin, an adviser and the editor in chief of the New England Journal of Medicine, wrote in a text message, adding: “In general, I’d like to see more data, which means more research, to back up the strategies we’re using now and propose in the future. Because of the pace of Covid, that might mean learning after we’ve made decisions. But we should have those research plans in place when making a new policy.”
Here’s how it would work: The idea is to determine in the spring which strain of the coronavirus will pose the biggest threat during the next winter. The annual formation of the vaccine could then be chosen every June, in time for it to be manufactured and administered by September. If there was an emergency, like the sudden appearance of a dangerous variant, the FDA indicated it could call a meeting of its vaccine advisers to select a new strain, Laurie notes.
“I really believe this is why God gave us two arms — one for the flu shot and the other one for the covid shot,” Ashish Jha, the White House coronavirus coordinator, said last September.
But some are questioning whether such a model is the best approach. Eric Topol, a professor of molecular medicine at Scripps Research, called the idea “a flawed approach,” telling Laurie that no data exists to support the idea that the vaccine provides protection beyond four to six months.
In a briefing document, the FDA wrote that evidence suggests “moving forward, most individuals may only need to receive one dose” of the coronavirus vaccine “to restore protective immunity for a period of time.” Most people would get an annual shot, but those who are older or very young, immunocompromised or have serious health problems may need two doses, the FDA added.
In late August, the FDA authorized reformulated coronavirus booster shots aimed at also targeting omicron.
But the uptake of the shots has been minimal. Only 16 percent of people 5 and older have gotten the new booster, while just 40 percent of people 65 and over — a population particularly vulnerable to the coronavirus — have received the updated shot.
“Communicating about the benefits of getting multiple boosters in addition to the standard COVID-19 primary series of shots, has been challenging at best,” Lori Tremmel Freeman, the CEO of the National Association of County and City Health Officials, wrote in an email. “People have vaccine fatigue.”
Will shifting to an annual campaign increase vaccination rates? The answer isn’t clear, but federal health officials appear to think it might.
- “FDA expects that simplification of COVID-19 vaccine composition and annual immunization schedules may contribute to more facile vaccine deployment, fewer vaccine administration errors, and less complex communication, all potentially leading to improved vaccine coverage rates,” the FDA’s briefing document states.
Marcus Plescia, the chief medical officer at Association of State and Territorial Health Officials, said he thinks an annual vaccine is more likely to be accepted by the public than frequent shots. But he noted that the uptake of the influenza vaccine isn’t as high as he wants it to be, either. Among adults, nearly 46 percent have received the flu shot this season, compared with 40 percent at this time last season.
Democrats introduce legislation to ban providers from sharing abortion information with investigators
First in The Health 202: Reps. Sara Jacobs (D-Calif.) and Anna Eshoo (D-Calif.) are introducing legislation today that would prohibit medical providers from disclosing personal health information related to abortion or pregnancy loss without patient consent.
Currently, the Health Insurance Portability and Accountability Act allows reproductive health information to be used for legal investigations and court cases without patient authorization. If passed, the Secure Access for Essential Reproductive (SAFER) Health Act would restrict HIPAA-covered entities from disclosing information about pregnancy termination or loss in federal, state or tribal proceedings without the patient’s greenlight.
The background: The Supreme Court’s decision to overturn Roe v. Wade last year raised concerns from abortion rights advocates that patients’ medical records could be used to prosecute patients who terminate their pregnancy. Mainstream antiabortion leaders have publicly opposed the notion of prosecuting the woman.
Reality check: The legislation isn’t likely to get a vote in the Republican-controlled House, but the move underscores Democratic efforts to attempt to shore up abortion protections in the post-Roe era.
Florida’s 15-week abortion ban is heading to the state Supreme Court
Florida’s high court will take up a case challenging the state’s ban on most abortions after 15 weeks of pregnancy, and the justices turned down a motion yesterday to temporarily block enforcement of the law while the legal battle plays out.
The case centers on a lawsuit filed by Planned Parenthood, the American Civil Liberties Union and several abortion providers who argue that the law is unconstitutional.
The major question in the case will be whether the state Supreme Court reaffirms or reverses its decades of legal precedent that a privacy clause in the Florida Constitution protects the right to abortion. The latter option has become an increasingly realistic outcome in recent years because of Republican Florida Gov. Ron DeSantis’s conservative remake of the high court.
The bigger picture: If the court moves to overturn its precedent and allow the 15-week ban to stand, the move would likely pave the way for Republican lawmakers to enact more restrictions on the procedure during this legislative session. DeSantis previously signaled his willingness to sign additional antiabortion legislation, but hasn’t specified what further restrictions he supports, per the Orlando Sentinel.
Rep. Kathy Castor (D-Fla.):
Even with a strong and broad right to privacy in the Florida Constitution AND long-standing legal precedent, the Florida Supreme Court and GOP politicians want to control our lives and restrict the freedom to make personal decisions – radical and extreme https://t.co/2Fier3mzoz
— US Rep Kathy Castor (@USRepKCastor) January 24, 2023
In other abortion news from across the country …
In New Mexico: Democratic Attorney General Raúl Torrez is petitioning the state Supreme Court to invalidate ordinances that local elected officials have passed in recent months restricting abortion access in their communities, the Associated Press reports.
In Oregon: The state’s Justice Department is partnering with local law firms to launch a new abortion hotline, which anonymous callers from any state can contact for free legal advice and receive a response from a lawyer within 48 hours, Oregon Attorney General Ellen Rosenblum (D) announced yesterday.
Supreme Court upholds firm deadline in veterans’ benefits case
The Supreme Court returned to the bench yesterday to issue opinions in person for the first time since the start of the coronavirus pandemic, handing down a unanimous ruling that went against a veteran who was seeking expanded disability benefits for a trauma he said he suffered decades ago, The Post’s Robert Barnes writes.
The details: Navy veteran Adolfo Arellano says he suffered a severe mental health condition as a result of his service before he was discharged in 1981 — but he didn’t file a disability claim with the Veterans Affairs’ Department until 2011.
While Arellano received benefits moving forward, he ran up against a law that says to receive retroactive benefits, a claim must be filed within one year of discharge. Arellano appealed the decision, arguing that the one-year time frame should be subject to equitable tolling because his injuries prevented him from filing for retroactive benefits.
In the unanimous ruling, Justice Amy Coney Barrett wrote that Arellano and others in his situation might be deserving, but that Congress was clear on the deadline. “Congress could have designed a scheme that allowed adjudicators to maximize fairness in every case,” she wrote. But Congress opted for rules that “prioritize efficiency and predictability.”
- On the move: John Bowman has been appointed executive vice president for U.S. programs at the Campaign for Tobacco-Free Kids. Bowman most recently served as managing director of government affairs for the Natural Resources Defense Council.
- The pharmaceutical industry lobbying group PhRMA has cut ties with Jeff Ricchetti, a lobbyist and the brother of a high-level counselor to the president in the White House who was a central figure in the Biden administration’s prescription drug pricing reform effort, Stat’s Rachel Cohrs reports.
- The Department of Health and Human Services is appealing a ruling by a federal judge in Texas that invalidated a federal rule issued by the Biden administration in 2021 prohibiting doctors from denying certain medical care based on a patient’s sexual orientation and gender identity, Mary Anne Pazanowski reports for Bloomberg Law.
Every medical show, at least once:
Doctor: “There’s nothing we can do.”
Patient’s parent: “Nothing at all?”
Doctor: “Well, there is this experimental procedure but it’s very risky-“
Parent: “We’ll do that.”
Doctor: “I don’t know-“
Parent: “WE WILL DO THAT.”
— Dave Jorgenson 📈 (@davejorgenson) January 24, 2023
Thanks for reading! See y’all tomorrow.