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In health news, Pfizer wants the FDA to authorize the omicron booster shot for kids ages 5 to 11.
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.
Pfizer asks FDA to authorize new booster for children
Pfizer on Monday announced it has submitted an application to the Food and Drug Administration (FDA) seeking authorization of its bivalent COVID-19 booster shot for children between the ages of 5 and 11.
In a press release, Pfizer said it has requested authorization of a 10-microgram dose of its omicron-specific booster for that age group.
- Pfizer’s bivalent boosters are currently only authorized for use in those 12 and older.
- The dosage that Pfizer is asking to be authorized for children is one-third of the 30 microgram dose that was authorized for adults in August.
Pfizer said its decision to request authorization was supported by “safety and immunogenicity data” as well as “non-clinical” and “pre-clinical” data.
Unlike previously authorized doses, the FDA did not wait for full human clinical trials to be completed on the bivalent boosters before giving them the green light, instead going off animal data, as is the case with annual flu shots.
Pfizer’s request for authorization of a bivalent booster for children comes just days after Moderna also requested FDA authorization to administer its updated dose to children as young as 6. Moderna’s booster shots are currently authorized for adults only.
Canada ending COVID restrictions at border Oct. 1
Canada is lifting its testing, quarantine and vaccination requirements at the border,
a step in rolling back pandemic restrictions designed to stave off the spread of COVID-19, the government announced Monday.
What changes:
- Starting Saturday, international travelers will be able to enter Canada without providing proof of vaccination, taking a pre-arrival test or undergoing quarantine, according to a government release.
- Compulsory masking on domestic planes and trains will also end, as will a longstanding requirement to share health information with the Canadian government via its ArriveCAN application prior to entry.
The move comes as many countries attempt to ease out of the strict restrictions put in place during the COVID-19 pandemic, even as the virus continues to circulate.
“Thanks largely to Canadians who have rolled up their sleeves to get vaccinated, we have reached the point where we can safely lift the sanitary measures at the border,” Canadian Health Minister Jean-Yves Duclos said in a statement.
The government cited high vaccination rates, low hospitalization and death rates and the availability of booster vaccinations, including the new bivalent booster targeted at the omicron variant, as reasons for the eased restrictions.
YOUNG PEOPLE STRUGGLE TO ACCESS BIRTH CONTROL: STUDY
Young people are particularly struggling to access birth control pills, a critically important medication that can help prevent unplanned pregnancies, ease symptoms of Endometriosis and Polycystic Ovarian Syndrome, and regulate periods, among other benefits.
That’s according to a new survey from Advocates for Youth, which found that an overwhelming majority of young people, 88 percent, in most states struggled to access birth control. Fifty-five percent experienced so many barriers they were unable to start taking the drug on their preferred timeline.
Demographic barriers: The results also revealed that young people — especially low-income, people of color, trans, queer and other marginalized youth — found accessing birth control to be unnecessarily difficult, with challenges to filling prescriptions and picking up the medication far from school campuses.
That’s partially because birth control currently requires a doctor’s prescription in the U.S., though pharmaceutical company Perrigo has applied for the first over-the-counter (OTC) daily birth control pill. The Food and Drug Administration (FDA) is scheduled to discuss the new pill next month.
SUCCESS OF EGG FREEZING DEPENDS ON TWO FACTORS, STUDY FINDS
Most women who tried to become pregnant through the process of egg freezing did not end up having a baby, according to a study of more than 500 such women over a 15-year span.
The fertility team at New York University Langone Center found that about
1 in 3 patients who chose to freeze their eggs had a baby after in vitro fertilization, and the success rate depended largely on two factors: age and the number of eggs frozen.
Results from NYU’s study suggest that the process is not a guarantee for a future baby. Overall, the final live birth rate for all 543 patients was 39 percent. For patients who froze their eggs before they were 38 years old or who thawed 20 or more eggs, this birth rate was about 50 percent.
Egg freezing — a method where a patient’s eggs are extracted, frozen and stored — has become an increasingly popular decision among women, especially during the COVID-19 pandemic. To freeze their eggs, patients take synthetic hormones to stimulate egg growth in their ovaries and undergo an egg retrieval process under anesthesia.
CDC rolls back universal masking in health facilities
The Centers for Disease Control and Prevention no longer recommends universal masking in health care settings, unless the facilities are in areas of high COVID-19 transmission.
The agency quietly issued the updates as part of an overhaul to its infection control guidance for health workers published late Friday afternoon.
It marks a major departure from the agency's previous recommendation for universal masking.
"Updates were made to reflect the high levels of vaccine-and infection-induced immunity and the availability of effective treatments and prevention tools," the CDC's new guidance says.
Now, the CDC says facilities in regions without high transmission can "choose not to require" all doctors, patients, and visitors to mask. Transmission is different from the community levels CDC uses to guide non-health care settings.
- Even if masking is not universally required, if a provider works in a part of the facility experiencing a COVID-19 outbreak, or if they care for immunocompromised patients, they should wear a mask.
- When transmission levels are high, masking is recommended for everyone when they are in areas of the health care facility where they could encounter patients.
WHAT WE'RE READING
- How a hospital chain used a poor neighborhood to turn huge profits (New York Times)
- Seniors are stuck home alone as health aides flee for higher-paying jobs (Washington Post)
- Searching for a nursing home? Biden administration takes 'unprecedented step' to release ownership data (USA Today)
STATE BY STATE
- Twin Cities mental health workers plan 3-day strike (WCCO)
- State legislators approve nearly $6 million for water emergencies in rural Oregon (Oregon Capital Chronicle)
- Telemedicine abortions just got more complicated for health providers (Alabama Public Radio)
That's it for today, thanks for reading. Check out The Hill's Health Care page for the latest news and coverage. See you tomorrow.
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