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Pfizer reports promising RSV vaccine findings

🎃 In case you were wondering how the "One Percent" live: Supermodel Heidi Klum dressed as a worm for Halloween.

Today in health, Pfizer said its RSV vaccine was found to be effective at preventing symptoms in infants when the shot was administered to their mothers while pregnant.

Welcome to Overnight Health Care, where we're following the latest moves on policy and news affecting your health. For The Hill, we're Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Subscribe here.

RSV vaccine helps prevent severe illness: Pfizer

An experimental maternal vaccine for RSV from Pfizer, administered during pregnancy, was effective at preventing infants from developing severe symptoms from birth through their first six months, the company said.

Unlike some other RSV vaccine candidates, Pfizer's shot is administered during pregnancy, with the aim of transferring antibodies from mothers to infants.
Other maternal vaccines include the flu shot, as well as one for tetanus, diphtheria and pertussis.

The company said that it plans to file the data on the vaccine with regulators by the end of the year, with the hope of having it available by next winter.

There are currently no vaccines available for RSV, and the only treatment is monoclonal antibodies, usually reserved for extremely high-risk cases, including infants born prematurely or those with chronic diseases related to the heart and lungs.

According to Pfizer's news release, the vaccine reduced the rate of severe illness in infants that required medical attention by about 82 percent through the first 90 days of life.
That efficacy dropped to 69 percent over a baby's first six months, meaning protection likely wanes as children get older.

RSV season usually occurs during colder weather, though it's been hitting unusually hard and early this year, contributing to a wave of respiratory infections that is overwhelming children's hospitals nationwide.

Read more here.

A MESSAGE FROM PHRMA

Data show the 340B program may be driving up costs for some patients. 340B hospitals prescribe patients more expensive medicines than non-340B hospitals on average. It's time to fix the 340B program.

Online requests for abortion pills spiked after Dobbs

Telemedicine requests for abortion pills spiked dramatically after the Supreme Court overturned Roe v. Wade in June, according to new research released Tuesday.

The analysis, led by researchers at the University of Texas at Austin and published in the medical journal JAMA, analyzed requests made through Aid Access, a nonprofit telemedicine organization based in Austria that provides abortion pills for home use in states where the practice is restricted.

During the initial period of the study from September 2021 to May 2022, when abortion was legal in every state, the organization received an average of about 83 requests a day. After the opinion draft was leaked, between May and June 23, daily requests increased to about 137.
After the Supreme Court released its opinion on June 24 and some states immediately enacted abortion bans, the average daily requests jumped to nearly 214.
The study looked at requests for medications to the service starting in September 2021, before the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization, through August 2022.

Alternative avenues: The findings show that putting limits on abortion within the formal health care setting did not eliminate it. People instead went outside the system, and self-managed abortions increased.

"The increases indicate that while abortion bans create access barriers that lead to more people self-managing their abortions, self-managed abortion is also a method of choice for some," said Abigail Aiken, lead author and an assistant professor at the University of Texas Austin's LBJ School of Public Affairs.

Read more here.

THREE EXPERIMENTAL EBOLA VACCINES HEAD TO UGANDA

Three experimental Ebola vaccine candidates are being shipped to Uganda to aid in combatting the ongoing outbreak in the country, which has so far seen 129 confirmed cases and 37 deaths, according to the Ministry of Health of Uganda.

The outbreak, caused by a version of the virus that originated in Sudan, has reached Uganda's capital, Kampala, and is affecting six other districts, according to the Centers for Disease Control and Prevention (CDC).

A different virus: There is an approved and available vaccine for a different type of Ebola virus, the species named "Zaire ebolavirus." However, the species named "Sudan ebolavirus" does not have an approved vaccine available.

The three experimental vaccine candidates being sent to Uganda are currently in development to protect against that species. As they help fight the current outbreak, their use in the country will also supply additional data for clinical trials.

The shipment of the vaccine candidates is part of a large-scale coordinated effort between health agencies, including the World Health Organization (WHO) and the CDC, and the Ugandan government to fight the outbreak.

Read more here.

TELEMEDICINE MAY HAVE HELPED WITH RISING BLOOD PRESSURE DURING PANDEMIC: STUDY

The availability of telemedicine may have helped mitigate the rise in blood pressure levels that was observed during the early months of the COVID-19 pandemic, according to a new study published on Tuesday.

Researchers analyzed the electronic health records of 137,593 patients and found that blood pressure levels noticeably increased in the eight months after stay-at-home orders were issued in comparison to the roughly 18-month period before the pandemic.
The amount of people with controlled blood pressure — levels that are below what is considered to be high blood pressure — also dropped by about
3.4 percentage points in this same time frame.

Even though a worsening in blood pressure was observed, the NIH noted that the results of the study were not as bad as would be expected. The agency attributed this to the "rapid adoption of telemedicine and home blood pressure monitoring."

"We expected blood pressure control to be worse due to decreased physical activity, stress, poor sleep, and other cardiovascular disease risk factors that worsened during the pandemic," study leader Hiroshi Gotanda said. "But the results were better than we expected, probably because the use of telemedicine and home monitoring of blood pressure."

Read more here.

FDA reports shortages of amoxicillin

A type of amoxicillin used by children is in short supply in the U.S., according to the Food and Drug Administration (FDA).

Amoxicillin comes as a capsule, a tablet, a chewable tablet and as a liquid to be taken by mouth, depending on the age of the patient. The FDA listed the liquid form of the drug, which is used by young children, in its drug shortage database.

Hikma Pharmaceuticals, Teva Pharmaceutical Industries and Sandoz, the generics division of Novartis, have all reported shortages of various doses of amoxicillin, which is most commonly used to treat bacterial infections in children.

The FDA's website lists increased demand as the reason for shortages at Hikma, Teva, Aurobindo and Rising.

A shortage at a fifth company, Sandoz, was listed as "other."

The FDA only lists drugs on its website once it has confirmed that "overall market demand is not being met by the manufacturers of the product."

An agency spokesperson told The Hill on Oct. 26 it did not consider amoxicillin to be in shortage because at least one manufacturer was able to fully supply market demand.

Read more here.

A MESSAGE FROM PHRMA

Data show the 340B program may be driving up costs for some patients. 340B hospitals prescribe patients more expensive medicines than non-340B hospitals on average. It's time to fix the 340B program.

WHAT WE'RE READING

With Republicans on the verge of congressional control, science is on the line (Stat)
Mehmet Oz's medical research was rejected in 2003, resulting in 2-year ban (Washington Post)
CDC warns of bacteria in dental waterlines after children are infected (NBC News)
FDA panel to examine evidence that pulse oximeters may not work as well on dark skin (CNN)

STATE BY STATE

Hospital investigated for allegedly denying an emergency abortion after patient's water broke (Kaiser Health News)
Kentucky health cabinet reports discrepancy in recent CDC COVID transmission levels map (WTVQ)
How South Dakota voters could help save the lives of uninsured moms (PBS NewsHour)

THE HILL OP-ED