Health Care — FDA panel to look into annual COVID vaccine shots

The FDA’s vaccine committee is set to consider a recommendation for an annual COVID-19 immunization plan, similar to the one employed for flu shots. We’ll dive into the details.

Plus: President Biden issues a memorandum to further protect access to medication abortion.

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Panel to consider annual COVID vaccines

The Food and Drug Administration’s (FDA) advisory panel on vaccines is set to consider an annual schedule for the coronavirus vaccine, akin to how flu vaccines are administered, when it meets this week.

  • The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Thursday to discuss how to simplify and streamline the COVID-19 vaccination process, including the composition of coronavirus vaccines and the recommended scheduling for these shots. 

  • The rapid evolution of the SARS-CoV-2 virus, resulting in variants with an improved ability to escape immune protection, means that “periodically updating the composition of COVID-19 vaccines as needed” — as was done with the updated bivalent booster — requires consideration, according to panel documents posted Monday.

Potential plans: The panel said it anticipates evaluating the composition of the COVID-19 vaccine annually in June and making a recommendation for the following year — though it acknowledged the difficulties of mounting a globally coordinated vaccine recommendation.

  • “FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to engage VRBPAC in about early June of each year regarding strain selection for the fall season,” the documents stated.

  • While acknowledging that COVID-19 and the flu are not identical, panel said the deployment of the bivalent COVID-19 boosters, created to target both the ancestral strain of the virus as well as the BA.4 and BA.5 omicron subvariants, was “analogous” to annual flu vaccinations.

Read more here.

Biden issues memo to protect access to abortion pills

President Biden on Sunday issued a presidential memorandum to further protect access to medication abortion by ensuring doctors can prescribe and dispense it across the United States.

Vice President Harris announced the memorandum on Sunday in remarks in Florida marking 50 years since the Supreme Court’s Roe v. Wade decision.

  • The memorandum directs the secretary of Health and Human Services, along with the attorney general and the secretary of Homeland Security, to consider new guidance to support patients, providers and pharmacies that want to access, prescribe or provide mifepristone legally.  

  • The memorandum will also ensure patients know their right to access reproductive health care, including medication abortion from a pharmacy

Mifepristone, which is a Food and Drug Administration (FDA)-approved drug used in medication abortion, has become an increasingly common method for ending pregnancies, especially in the wake of the Supreme Court overturning Roe v. Wade. It accounts for more than half of all abortions in the country.

Earlier this month, the FDA said it will allow U.S. retail pharmacies to offer abortion pills directly to patients with a prescription in states where abortion is legal.

Medication abortion has been available in the U.S. since 2000, when the FDA approved the use of mifepristone, but many states with strict abortion bans also limit the availability of mifepristone, either through restrictions on who can prescribe and dispense the pill or outright bans.

Read more here.

WISCONSIN BLOCKS BAN ON CONVERSION THERAPY OPPONENTS

Wisconsin LGBTQ advocates and lawmakers are recalibrating after state GOP legislators last week voted for a second time to block a ban on conversion therapy from taking effect.

  • “I’m very concerned about young people in Wisconsin who live in communities where it is once again allowed, being subjected to this really cruel and unscientific form of therapy,” state Rep. Greta Neubauer (D), one of six openly LGBTQ members of Wisconsin’s Republican-controlled legislature, told The Hill. 

  • “Conversion” or “reparative therapy” is a blanket term that refers to a host of interventions designed to change a person’s sexual orientation or gender identity. It’s been denounced by major medical organizations, including the American Medical Association (AMA) and the American Psychological Association, in part because such practices are underpinned by a belief that LGBTQ identities are pathologies that need to be cured.

Twenty-one states and the District of Columbia have laws or policies in place that ban conversion therapy for minors, according to the Movement Advancement Project, a think tank that tracks state legislation impacting the LGBTQ community. Five states, including Wisconsin through a 2021 executive order issued by Gov. Tony Evers (D), have partial bans.

Three states — Alabama, Georgia and Florida — are unable to enforce bans on conversion therapy because of an injunction in the 11th Circuit that prevents them from doing so.

Read more here.

57% SUPPORT GOVERNMENT ENSURING UNIVERSAL HEALTH CARE

A majority of adults in a new survey said that they believe it is the job of the federal government to ensure health care coverage for all Americans, but most also prefer a private health care system over a government-run option.

The 57 percent of respondents supporting the idea that ensuring health care coverage is the job of the federal government is the highest mark in Gallup’s polling since 2018. An overwhelming majority of Democrats share this view in the new survey, with 59 percent of independents concurring. Just 28 percent of Republicans support the idea.

  • While the poll showed that a majority of people said the federal government should ensure health coverage, it also found that a majority of respondents favored a private health care system over a government-run one. This is driven by a government-run system garnering just 13 percent support from Republicans and 46 percent support from independents. 

  • More than 7 in 10 Democrats — 72 percent — support the idea of a government-run health care system.

The survey results show the complex position most people in the U.S. hold on the country’s health care system. Balancing the responsibilities of the government in health care coverage while also maintaining a private coverage system has been a juggling act faced by lawmakers and successive presidential administrations for decades.

Read more here.

Health experts still learning about omicron subvariant

More than 80 percent of coronavirus cases in the Northeast are now due to XBB.1.5.

According to health authorities, XBB.1.5 appears to be the most transmissible subvariant of omicron that has been detected yet, though it is still unclear whether it causes more severe illness.

Physicians from across the Northeast who spoke with The Hill said they have not noticed a marked difference in disease severity among their recent COVID-19 patients.

Bernard Camins, medical director for infection prevention at the Mount Sinai Health System in New York, said the proportion of patients with illness severe enough to require an intensive care unit stay is the same as with previous variants.

Ulysses Wu, chief epidemiologist for Hartford Healthcare in Connecticut, said XBB.1.5 does not appear to be more lethal and noted that any time more cases of COVID-19 are seen, morbidity and mortality will increase in turn.

“The presentation is for the most part the same. Maybe they’re not presenting as ill, but we are still seeing plenty of ill patients and we are still certainly seeing patients that die,” said Wu.

  • Shira Doron, chief infection control officer for Tufts Medicine in Boston, said the new dominant strain was “not really such a big deal” in her area. According to Doron, her hospital has seen a “modest” increase in new admissions, though she noted that most of the patients who test positive for coronavirus are not being admitted due to a COVID-19 infection but because of another ailment.

  • “I do feel like we’re in a really good place. I want to make sure that we don’t lose access to testing, we don’t lose access to treatment,” Doron said, adding that there is still work to be done when it comes to ensuring access to effective medications to treat COVID-19.

Read more here.

HAT WE’RE READING

  • Three years on, the pandemic — and our response — have been jolting. Here’s what even the experts didn’t see coming (Stat)

  • Justice Department investigating troubled infant formula plant (The New York Times)

  • An ‘unprecedented pandemic of avian flu’ is wreaking havoc on the U.S. poultry industry (Fortune)


STATE BY STATE

  • Kindergarten vaccination rates drop in all but 3 WA counties (The Seattle Times)

  • Transgender people in rural America struggle to find doctors willing or able to provide care (Kaiser Health News)

  • Tennessee says it’s cutting federal HIV funding. Will other states follow? (NBC News)


THE HILL OP-EDS

A Roe requiem and a road to a brighter future

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