FDA Experts Are Still Puzzled Over Who Should Get Which Covid Shots and When

At a meeting to simplify the nation’s covid vaccination policy, the FDA’s panel of experts could agree on only one thing: Information is woefully lacking about how often different groups of Americans need to be vaccinated. That data gap has contributed to widespread skepticism, undervaccination, and ultimately unnecessary deaths from covid-19.

The committee voted unanimously Thursday to support the FDA’s proposal for all vaccine-makers to adopt the same strain of the virus when making changes in their vaccines, and suggested they might meet in May or June to select a strain for the vaccines that would be rolled out this fall.

However, the panel members disagreed with the FDA’s proposal that everyone get at least one shot a year, saying more information was needed to make such a declaration. Several panelists noted that in recent studies, only about a third of people hospitalized with a positive covid test actually were there because of covid illness. That’s because everyone entering a hospital is tested for covid, so deaths of patients with incidental infections are counted as covid deaths even when it isn’t the cause.

The experts questioned the rationale for annual shots for everyone, given that current vaccines do not seem to protect against infection for more than a few months. Yet even a single booster seems to prevent death and hospitalization in most people, except for the very old and people with certain medical conditions.

“We need the CDC to tell us exactly who is getting hospitalized and dying of this virus — the ages, vulnerability, the type of immune compromise, and whether they were treated with antivirals. And we need immunological data to indicate who’s at risk,” said Dr. Paul Offit, director of the Vaccine Education Center and a pediatrician at Children’s Hospital of Philadelphia. “Only then can we decide who gets vaccinated with what and when.”

Offit and others have expressed frustration over the lack of clear government messaging on what the public can expect from covid vaccines. While regular boosters might be important for keeping the elderly and medically frail out of the hospital, he said, the annual boosters suggested by the FDA and the drug companies may not be necessary for everyone.

Read the full article from KHN.

Want a Clue on Health Care Costs in Advance? New Tools Take a Crack at It

Need medical treatment this year and want to nail down your out-of-pocket costs before you walk into the doctor’s office? There’s a new tool for that, at least for insured patients.

As of Jan. 1, health insurers and employers that offer health plans must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs.

It’s the latest effort in an ongoing movement to make prices and upfront cost comparisons possible in a business known for its opaqueness.

Insurers must make the cost information available for 500 nonemergency services considered “shoppable,” meaning patients generally have time to consider their options. The federal requirement stems from the Transparency in Coverage rule finalized in 2020.

So how will it work?

Patients, knowing they need a specific treatment, drug, or medical service, first log on to the cost estimator on a website offered through their insurer or, for some, their employer. Next, they can search for the care they need by billing code, which many patients may not have; or by a general description, like “repair of knee joint,” or “MRI of abdomen.” They can also enter a hospital’s or physician’s name or the dosage amount of a drug for which they are seeking price information.

Not all drugs or services will be available in the first year of the tools’ rollout, but the required 500-item list covers a wide swath of medical services, from acne surgery to X-rays.

Once the information is entered, the calculators are supposed to produce real-time estimates of a patient’s out-of-pocket cost.

Starting in 2024, the requirement on insurers expands to include all drugs and services.

These estimator-tool requirements come on top of other price information disclosures that became effective during the past two years, which require hospitals and insurers to publicly post their prices, including those negotiated between them, along with the cost for cash-paying or uninsured patients.

Still, some hospitals have not fully complied with this 2021 disclosure directive and the insurer data released in July is so voluminous that even researchers are finding it cumbersome to download and analyze.

The price estimator tools may help fill that gap.

The new estimates are personalized, computing how much of an annual deductible patients still owe and the out-of-pocket limit that applies to their coverage. The amount the insurer would pay if the service were out of network must also be shown. Patients can request to have the information delivered on paper, if they prefer that to online.

Read the full article from KHN.

Omicron-targeted COVID-19 boosters now authorized for children ages 6 months and older

OLYMPIA  – The Washington State Department of Health (DOH) and other healthcare providers will soon begin offering omicron variant-targeted bivalent booster doses of COVID-19 vaccines to children ages 6 months and older. This follows guidance and recommendations from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

  • Children 6 months through 5 years of age who received the original (monovalent) two-dose Moderna COVID-19 vaccine series are now eligible to receive a booster of the updated (bivalent) Moderna COVID-19 vaccine two months after their last dose.
  • Children 6 months through 4 years of age who have not started or completed their three-dose Pfizer-BioNTech COVID-19 vaccine series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 vaccine.
  • Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 vaccine are not eligible for an updated (bivalent) booster dose at this time.

DOH urges all parents and guardians of children ages 6 months and older to prioritize vaccinating their children with the updated booster if eligible, or starting the COVID-19 vaccine primary series if they are yet to begin. Washington state is currently seeing record pediatric hospitalizations from respiratory viruses and vaccines add an extra level of protection from severe illness. Additionally, flu vaccines are available to everyone 6 months and older at provider offices and pharmacies across the state. Flu and COVID-19 vaccines can be safely given at the same time.

“This is great news that infants and young children can now get the updated bivalent booster, which offers better protection against Omicron subvariants,” said Tao Sheng Kwan-Gett, MD, MPH, Chief Science Officer. “We encourage everyone 6 months and older to get up to date on your COVID-19 vaccines and boosters as well as the seasonal flu shot in order to keep yourself and those around you safe, and to reduce the pressure on our severely stressed hospital system.”

Pediatric-focused COVID-19 boosters are expected to start arriving in provider offices the week of December 12. To make a vaccine or booster appointment, visit VaccinateWA.org, or call the COVID-19 Information Hotline at 833-VAX-HELP. Language assistance is available. If you have questions, visit DOH’s COVID-19 Vaccine Frequently Asked Questions webpage or talk to a trusted healthcare provider.

Public health experts recommend the flu and COVID-19 vaccines for everyone age 6 months and older

The Washington State Department of Health (DOH) is urging the public to get an influenza (flu) vaccine in addition to a COVID-19 booster this fall to keep themselves and others safe and out of the hospital.

In recent years flu activity was low due to the preventive benefits of social distancing, masking, and other COVID-19 precautions. Now that guidance and recommendations have relaxed, people are more active, mobile, and have returned to traditional gatherings. At the tail of the last flu season, Washington experienced an unusual late spring wave of flu.

With the start of fall, many adults have returned to in-person work and most children are back in school. These conditions could lead to an increase in flu or COVID-19 cases this fall or winter.

“Flu can be unpredictable and sometimes severe,” said Tao Sheng Kwan-Gett, MD, MPH, Chief Science Officer. “To protect your family’s health, getting vaccinated against influenza with a flu shot or nasal spray vaccine should be part of the fall routine for everyone 6 months and older. It’s also the perfect time to get up to date on COVID-19 vaccines and boosters too.”

Young children, pregnant people, those with underlying health conditions, and people aged 65 and older are at high risk for flu-related complications. The flu is a highly contagious disease that can cause severe illness and lead to hospitalization and death – even in healthy, young people. Getting a flu vaccine reduces the chance of flu illness and protects individuals from serious flu symptoms. The flu shot can be safely given at the same time as a COVID-19 vaccine or booster.

Flu illness is more dangerous than the common cold for children, especially for children under 5 years old. Flu can be deadly in young children. About 80% of flu-related deaths in children are in those who were not vaccinated. Across Washington, the flu vaccine, and all recommended childhood vaccines, are available at no cost for everyone age 18 years and younger.

For weekly flu activity reports, educational materials, vaccine information, and other flu prevention resources, visit www.KnockOutFlu.org. For more information on COVID-19 vaccines, visit the COVID-19 website.

What You Need to Know About Monkeypox

The World Health Organization said June 25 that monkeypox wasn’t yet a public health emergency of international concern. More than 4,500 cases have been reported worldwide, with more than 300 in the U.S. And with public health officials unable to follow all chains of transmission, they’re likely undercounting cases. Everyone should be aware of its symptoms, how it spreads, and the risks of it getting worse.

Q: Should I be worried about monkeypox?

The American public is currently at low risk for monkeypox. It is spreading among men who have sex with men, but it is only a matter of time before it spreads to others. As of June 27, the European Centre for Disease Prevention and Control had reported 10 cases among women. Monkeypox is generally a mild disease but can be serious or even deadly for people who are immunocompromisedpregnant womena fetus or newbornwomen who are breastfeedingyoung children, and people with severe skin diseases such as eczema.

But monkeypox could become endemic in the U.S. and around the world if it continues to spread unchecked.

Read the full article from KHN.

Should You Worry About Data From Your Period-Tracking App Being Used Against You?

It’s estimated that millions of people in the U.S. use period-tracking apps to plan ahead, track when they are ovulating, and monitor other health effects. The apps can help signal when a period is late.

After Politico published on May 2 a draft opinion from the Supreme Court indicating that Roe v. Wade, the landmark decision that guarantees the constitutional right to an abortion, would be overturned, people turned to social media. They were expressing concerns about the privacy of this information — especially for people who live in states with strict limits on abortion — and how it might be used against them.

Many users recommended immediately deleting all personal data from period-tracking apps.

“If you are using an online period tracker or tracking your cycles through your phone, get off it and delete your data,” activist and attorney Elizabeth McLaughlin said in a viral tweet. “Now.”

Similarly, Eva Galperin, a cybersecurity expert, said the data could “be used to prosecute you if you ever choose to have an abortion.”

That got us wondering — are these concerns warranted, and should people who use period-tracking apps delete the data or the app completely from their phones? We asked the experts.

Read the full article from KHN.

Childhood immunization rates decline during the pandemic

A new report shows routine childhood immunization rates decreased during the pandemic, dropping by 13% in 2021 when compared to pre-pandemic levels. The drop was most noticeable in young children.

In response, the Washington State Department of Health (DOH), health care providers and other agencies are working with families to catch up and stay current on routine immunizations. “The pandemic has been difficult for everyone. Disruptions to schooling, childcare and in-person health care made it hard for some families to stay up to date on their shots,” said Tao Sheng Kwan-Gett, MD, MPH, Chief Science Officer. “We encourage parents and caregivers to schedule their well-child visits as soon as possible, to make sure their kids are happy, healthy, meeting developmental milestones, and ready for school.”

The new report, compiled by DOH, compares routine childhood vaccination rates in Washington from 2021 to averages from 2015-2019. Rates were found to have declined the most in younger children, however rates in teens increased. Key findings include:

  • Vaccinations decreased 9.6% in the 19–35-month age group.
  • Vaccinations decreased 3.9% in the 4–6-year age group.
  • Vaccinations decreased 3.6% in the 11–12-year age group.
  • Vaccinations increased 1.8% in the 13–17-year age group.

Children need to be up to date on immunizations to attend pre-school, kindergarten, school, or childcare this fall. Scheduling well-child visits early ensure children can attend educational programs on time and can reduce the stress of finding a last-minute appointment. DOH has online tools to help you determine if your child is up to date on state immunization requirements. Vaccine requirement charts for parents and caregivers are available in a variety of languages here. Washington state provides all recommended childhood vaccines at no cost to children through the age of 18.

The Department of Health has implemented a variety of efforts to boost childhood immunization rates to pre-pandemic levels. Some of these efforts include direct messaging through the Watch Me Grow Washington program for parents with young children, improving equitable vaccine access and support for tribes, and collaboration with local public health. “Vaccines are the best tools we have to protect kids from getting sick from preventable diseases,” added Dr. Kwan-Gett.

EPA unveils strategy to regulate toxic ‘forever chemicals’

The Biden administration said Monday it is launching a broad strategy to regulate toxic industrial compounds associated with serious health conditions that are used in products ranging from cookware to carpets and firefighting foams.

Michael Regan, the head of the Environmental Protection Agency, said his agency is taking a series of actions to limit pollution from a cluster of long-lasting chemicals known as PFAS that are increasingly turning up in public drinking water systems, private wells and even food.

The Defense Department said it is moving to assess and clean up PFAS-contaminated sites throughout the country, while the Food and Drug Administration will expand testing of the food supply to estimate Americans’ exposure to PFAS from food. And the Agriculture Department will boost efforts to prevent and address PFAS contamination in food.

Read the full article from AP.

Supreme Court Declines to Overturn ACA — Again

The Supreme Court on Thursday turned back its third chance to upend the Affordable Care Act, rejecting a lawsuit filed by a group of Republican state attorneys general claiming that a change made by Congress in 2017 had rendered the entire law unconstitutional.

By a vote of 7-2, however, the justices did not even reach the merits of the case, ruling instead that the suing states and the individual plaintiffs, two self-employed Texans, lacked “standing” to bring the case to court.

“We proceed no further than standing,” wrote Justice Stephen Breyer for the majority. “Neither the individual nor the state plaintiffs have shown that the injury they will suffer or have suffered is ‘fairly traceable’ to the ‘allegedly unlawful conduct’ of which they complain.”

The two dissenters in the case, Justices Samuel Alito and Neil Gorsuch, disagreed. “The States have clearly shown that they suffer concrete and particularized financial injuries that are traceable to conduct of the Federal Government,” Alito wrote. “The ACA saddles them with expensive and burdensome obligations, and those obligations are enforced by the Federal Government. That is sufficient to establish standing.”

The ruling represented a win not only for backers of the health law in general, but also for Health and Human Services Secretary Xavier Becerra. As California attorney general, Becerra led the Democratic states defending the ACA after the Trump administration sided with the Republican states’ suit.

Read the full article from KHN.