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Officials sound the alarm on vaccine supply- POLITICO

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Fourth Covid shots are here for many but could be difficult to supply to the broader population.

Moderna thinks it has the data for young kids’ vaccines, but their studies have split health researchers on what’s enough.

BA.2’s moment has arrived as the highly transmissible strain becomes dominant in the U.S.

WELCOME TO WEDNESDAY PULSE — The perfect gown accessory is a public health graph. Send your favorite Oscar looks (or graphs), news and tips to [email protected] and [email protected].

POLITICO will host its inaugural health care summit on Thursday, March 31, as the U.S. enters its third year of the Covid-19 pandemic. Through a series of interviews and panel discussions, summit participants — including providers, policymakers, regulators and patient representatives — will discuss the policies, political dynamics and tech trends shaping the sector. For details, or to attend in person or watch online, click here.

BROADER BOOSTING TURNS UP SUPPLY PRESSURES The Centers for Disease Control and Prevention’s Tuesday recommendation that people over 50 get another booster dose was expected. But what occurs next — like the possibility of another Covid-19 vaccine for all adults — could get dicey.

What happened: The CDC said people over 50 and immunocompromised adults should get an additional dose of Moderna’s or Pfizer and BioNTech’s vaccine. Immunocompromised teens can also get another Pfizer booster. It’s “especially important” for people over 65 and people with underlying conditions, Director Rochelle Walensky said.

The agency also recommended that people who received the Johnson & Johnson vaccine and booster get an mRNA shot.

Where it gets tricky: Biden officials say they have enough mRNA vaccines on hand for this wave of booster dosing, but they don’t have the funds for more supply.

“What worries us is … if a different variant comes up and we need a variant-specific boost in a few months,” Dawn O’Connell, the Department of Health and Human Services’ assistant secretary for preparedness and response, said during a press conference on Monday. “That would be quite a bit more expensive, and we don’t have those doses on hand nor do we currently have the funding to cover those doses.”

White House spokesperson Kate Bedingfield reiterated the point Tuesday, telling reporters that if “the full population requires a fourth shot, we’re going to need additional funding.”

Biden officials are publicly turning up the pressure on Congress, which dropped new Covid-19 funding from the omnibus package and hasn’t come up with a vehicle for new spending (as Republicans demand accounts of how earlier funds were spent).

“When it comes to funding, timing matters,” Surgeon General Vivek Murthy and Covid-19 Chief Science Officer David Kessler wrote in a New York Times op-ed Tuesday. “Manufacturers cannot turn the production of vaccines, treatments and tests on and off like a switch. Purchases have to be made months in advance if we want supplies to be available when we need them.”

WHAT’S THE KID VACCINE DELAY? Moderna says it has gathered sufficient data to support its Covid-19 vaccine for use in the youngest children. But it may not be enough for regulators to green-light the shot for kids.

Public health officials, pediatricians and infectious disease experts are split over whether the company’s trial results are sufficient for the Food and Drug Administration and its independent advisers or whether they’ll want to see data on a third dose as they did with Pfizer and BioNTech’s vaccine for children under 5, POLITICO’s Katherine Ellen Foley writes.

The backdrop: Children under 5 make up about 3 percent of U.S. Covid cases and 0.1 percent of deaths, according to CDC data, but during Omicron, this age group was more likely to be hospitalized than older kids.

Moderna said last week that two shots reduced symptomatic cases by 43.7 percent among children 6 months to 2 years old and by 35.7 percent in children 2 to 6. That’s below the 50 percent threshold the FDA set for adults, but Moderna officials said the regimen met a metric called immunobridging, meaning the pediatric doses produced the same immune response that’s been seen in young adults.

Not everyone agrees. Immunogenicity alone might not be enough because it doesn’t guarantee better protection. The FDA might need to demand a higher standard, Peter Hotez, a professor of pediatrics and molecular virology & microbiology at the Baylor College of Medicine, told POLITICO. “Given the other data that surrounds it, I don’t know that it’s a slam dunk that the FDA will move forward in terms of releasing it for emergency use.”

And the stakes are high. An FDA authorization that doesn’t show clear and strong benefits, especially for the youngest kids, could do more harm than good to vaccine confidence.

“We have to do our job extremely well to make sure that we ensure that there is a very good evaluation of the safety and effectiveness so that when we make our recommendation, people will trust that recommendation,” Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, told reporters Tuesday.

BA.2 TAKEOVER — New CDC data released on Tuesday indicates that the BA.2 Omicron subvariant is now the dominant Covid-19 strain in the U.S., Krista reports. The subvariant accounted for more than 54 percent of new cases in the U.S. as of last week, an increase from 39 percent the week before.

Why it matters: The BA.2 strain is more transmissible than Omicron, though nothing indicates it’s any more severe. It’s been driving the surge of cases in Europe, and though cases in the U.S. are still falling, along with deaths and hospitalizations rates, White House officials and public health experts agree that the government needs to be prepared if cases here reverse course.

What’s next: Those new numbers won’t be lost on administration officials who have been pushing Congress to get behind their $22.5 billion request for more Covid-19 aid to shore up vaccine, treatment and testing supplies should another wave wash ashore.

RACIAL DISPARITIES IN COVID-19 AMONG PATIENTS WITH CANCER — A new study published in JAMA Network Open found that Black patients with cancer who are infected with Covid-19 had worse outcomes with the disease than white patients with cancer.

“Higher rates of hospitalization, intensive care unit admission, and mechanical ventilation were observed among Black patients compared with White patients,” the researchers wrote. All-cause mortality rates were also higher among Black patients, at 19 percent versus 17 percent in white patients.

Black patients also experienced an increased prevalence of lung and heart and vascular complications and acute kidney injuries. They were less likely to be treated with remdesivir than white patients and more likely to be treated with hydroxychloroquine.

Separately, disparities in both Covid-19 and cancer outcomes in racial and ethnic minority groups are well documented. “These findings suggest that, within the framework of structural racism in the US, having cancer and COVID-19 is associated with worse outcomes among Black patients compared with White patients,” the researchers wrote.

BIPARTISAN RESOLUTION HIGHLIGHTS ENDOMETRIOSISSen. Tammy Duckworth (D-Ill.) and Sen. Shelley Moore Capito (R-W.Va.) introduced a resolution Tuesday to draw attention to the underrecognized but common chronic disease of endometriosis.

Endometriosis is an often painful gynecological condition that can lead to infertility and affects 6.5 million American women, who often are not diagnosed for years. The resolution would mark March 2022 as National Endometriosis month and calls on the Secretaries of Health and Human Services, Defense and Veterans Affairs “to provide information on the disease to women, patients and providers and to improve screening tools and treatment options.”

FLORIDA SUES BIDEN OVER MASK MANDATE — Florida and 20 other states are suing the Biden administration over its decision to keep a mask mandate in place for travel until April 18, POLITICO’s Arek Sarkissian writes.

Gov. Rick DeSantis, who has made his disapproval of masking well known, announced the lawsuit at a press conference Tuesday. State attorney general Ashley Moody, who joined DeSantis for the announcement, said the TSA order, which was extended earlier this month, is illegal.

The Florida governor said it wasn’t grounded in science. “If you have somebody sitting in a window seat, and they’re nibbling on peanuts for two and a half hours, they can have their masks down,” DeSantis told reporters. “Then you have the person in the middle seat, that is not eating, they just wanted to read a magazine without the mask, that somehow that would be a big problem.”

Kaiser Health News tells the story of a Tennessee pharmacy that courted opioid buyers by filling dodgy prescriptions. There’s a monkey involved.

The National Institutes of Health made its first foray into studying long Covid, and it’s not going well, reports STAT News.

While lead poisoning has plummeted since the 1970s, roughly 500,000 children under 6 still have risky levels, and it’s increasingly difficult to find legal recourse for health care costs, Ellen Gabler writes in The New York Times.



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