By Amber Dance

Omicron boosters for kids 5 and over arrive this week

The FDA and CDC have authorized the new omicron-specific COVID booster shots for elementary-aged kids.

Moderna’s booster will now be available for children 6 and up; Pfizer’s for ages 5 and older.

The FDA based its decision on studies in adults of an earlier bivalent booster that targeted omicron lineage BA.1, as well as data from children who received a booster of the original, monovalent mRNA vaccines, according to an agency statement.

On Friday, Pfizer released the first human study data related to the current, BA.4/BA.5 bivalent booster in a company press release. In adults, the updated shots exhibited a similar safety profile as the earlier version, and caused a “substantial increase” in the level of antibodies targeting the BA.4/BA.5 strains.

“These findings, however, still don’t address the question of how well the shots perform in the real world,” writes Berkeley Lovelace Jr. at NBC News. “That is, is it effective against infection or illness?”

The new boosters should be a boon for families, pediatrician Dr. James Campbell of the University of Maryland told The Washington Post’s Laurie McGinley.

“It is a mistake to believe that children do not get sick, or severely sick, from COVID,” said Campbell, who called the authorization “very good news.”

But it seems unlikely that many families will be lining up outside the pharmacy. Just under half of parents say they’ve already gotten at least one dose of the COVID-19 vaccine for their 5-to-11-year-olds, according to a recent Kaiser Family Foundation poll.

Among adults and teens, who became eligible for updated boosters six weeks ago, only 14.8 million have received the shot.

Pandemic stimulus funds miss many vulnerable Americans

As many as 10 million Americans may not have received their due from the COVID stimulus funds and child tax credit, and time is running out to claim it, says the U.S. Government Accountability Office.

That figure includes members of many marginalized groups, such as people experiencing homelessness, families with mixed immigration status, and people who lack internet access or bank accounts.

People who don’t make enough money to have to file taxes, or who had never filed before, were also left out.

A big part of the problem was that the IRS, which administered the stimulus funds, only had data on people who had previously filed taxes. The GAO said in June that it recommended the Treasury and IRS reach out to those populations.

“Many in the tax world have come to the defense of the IRS over the course of the pandemic, saying it was beyond the call of duty for a tax collection agency to become the primary administrator of emergency economic stimulus payments,” writes Tobias Burns at The Hill. “The extra pressure may also have resulted in the stimulus delivery shortage for up to 10 million Americans.”

People who didn’t have to file taxes have until Nov. 15 to fill out a simplified return and get their payments.

COVID created pregnancy complications

Coronavirus infection during pregnancy has been linked to stillbirth and the dangerous maternal condition preeclampsia, reports Ariana Eunjun Cha at The Washington Post.

The CDC has documented an increased risk of stillbirth among women who had COVID-19, and one study found a significantly increased risk of preeclampsia among women who had COVID, especially if it was their first pregnancy.

The reasons for these complications aren’t clear, but the virus may cause changes to a pregnant person’s immune and circulatory system, as well as to the placenta that supports the growing fetus.

Pathologists have described scarred, discolored placentas associated with stillbirths following COVID infection, often in unvaccinated or partially vaccinated women, Cha reports.

“Pregnancy can be both magical and brutal as it transforms a person’s body to support another life,” writes Cha. “Much of the stress is on the heart and circulatory system … The coronavirus, it turns out, can have a profound impact on that same system.”

For example, physicians have documented tiny blood clots in the blood vessels of people infected with the coronavirus, which could be particularly damaging to a pregnant person that needs to pump extra blood to support the fetus.

The CDC says COVID vaccination during pregnancy is safe and effective.

WHO urges ‘immediate’ action against long COVID

The head of the World Health Organization warned last week in The Guardian that long COVID is a “very serious” crisis that nations should address with ongoing programs to diagnose, support and treat affected individuals.

The WHO estimates that 10% to 20% of people have mid- or long-term symptoms after a coronavirus infection.

“It’s very clear that the condition is devastating people’s lives and livelihoods,” wrote WHO Director-General Tedros Adhanom Ghebreyesus. “It’s added a significant burden to health workers and the health system”

A new study from Scotland underscores the impact of long COVID. Researchers analyzed nearly 100,000 people, about one-third of whom had contracted COVID. Nearly half of those infected reported they weren’t fully recovered when surveyed six to 18 months after infection.

The study did offer some good news, writes Benjamin Mueller at The New York Times: long COVID was rarer in people whose initial infection was asymptomatic or mild, as well as in those who’d been vaccinated.

“We’re now heavily reliant on vaccination, which does confer some protection, but it’s not absolute,” said study author Jill Pell of the University of Glasgow.

Earlier this month, the National Institutes of Health posted an update on its long COVID efforts on an agency blog.

“This is a public health issue that is in desperate need of answers,” wrote Dr. Walter J. Koroshetz, director of the National Institute of Neurological Disorders and Stroke. He described the NIH’s research program as “unprecedented” in scope and promised clinical trials would be announced soon.

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By Amber Dance

Omicron-specific boosters expected after Labor Day

Both Moderna and Pfizer have applied for emergency authorization of their new vaccine formulas targeting both the original strain and the omicron BA.4/5 variant.

These are expected to sail through the regulatory process, with the FDA likely foregoing any consultation with outside experts and the CDC convening its advisory committee Sep. 1–2.

This would set up the next round of boosters — likely the last government freebies — to start soon after Labor Day, report Sharon LaFraniere and Noah Weiland at The New York Times.

Moderna’s booster is a 50-microgram dose, the same used in their previous boosters (which is half the dose of the primary series). They’ve requested authorization for ages 18 and up.

Pfizer’s formulation is 30 micrograms, matching their original vaccine series. The company is currently aiming for authorization in people ages 12 and older. It is reportedly also working on a booster for children as young as 6 months.

The new boosters will amplify antibodies, making people less likely to acquire the virus or pass it on for some unknown number of months following vaccination, writes epidemiologist Katelyn Jetelina on her blog. Moderna’s research with a different booster formulation, targeting the original strain plus the beta variant, suggested the one-two punch could lead to protection for at least six months.

But those seeking more reliable data will have to wait until human studies on the latest formulations are completed.

Results may vary from person to person, too, depending on an individual’s history with the coronavirus. At The Washington Post, Carolyn Y. Johnson explains how what scientists call “original antigenic sin” influences future immune responses.

“The version of virus to which we’re first exposed can dictate how we respond to later variants and, maybe, how well vaccines work,” writes Johnson. “People’s immune systems are on slightly different learning curves, depending in when they were infected or vaccinated, and with what variants or vaccines.”

Since the first exposure to a virus dominates any ongoing immune response, it could be difficult for the current or future variant-specific vaccines to retool that response for novel variants.

Dr. Barney Graham, who was part of the NIH effort that led to the Moderna vaccine and now works at the Morehouse School of Medicine, noted that the vaccines can still perform their most important task of keeping people from getting so sick that they require hospital care.

Racial disparities recur with monkeypox outbreak

The racial disparities in infection rates that have characterized the coronavirus pandemic are recurring with the monkeypox outbreak, writes Peter Sullivan at The Hill.

A new report from the Kaiser Family Foundation indicates that Black people make up 26% of monkeypox cases, though they only represent 12% of the general population.

Similarly, 28% of monkeypox cases are occurring in Hispanic people, much greater than the 19% of the overall population that is Hispanic.

And additional wrinkle to monkeypox is that most cases are occurring among men, particularly those who have sex with other men.

Disparities are also recurring in vaccination rates, though few states have reported the necessary data to track this so far. For example, in the D.C. area, Black people make up 36% of monkeypox cases but only 22% of those getting vaccinated.

With endemicity on the horizon, Fauci to leave office

The U.S. daily case rate has dropped below 100,000, suggesting the summer wave is on the wane at last, writes Carolyn Smith-Schoenwalder at US News & World Report. 

Wastewater data, after weeks of declining, now indicate a plateau in viral presence, writes Arielle Mitropoulos at ABC News. Testing levels have also dropped — which could contribute to the declining case rate — while wastewater is a less biased indicator.

Dr. Anthony Fauci’s announcement that he’ll depart his position at the end of the year is also a sign the COVID situation is improving, though not coming to an end, writes Sarah Owermohle at STAT.

“I think we’re in a good place now,” Fauci told her. “I believe, even though we are still dealing with COVID, that if we succeed in getting more people vaccinated, and enough people get infected, that there’ll be enough background immunity that we’ll be able to live with a low, low level of infection.”

Ingrid Hein at MedPage Today describes this new goal as “herd safety.” She reports how the state of Massachusetts, where 80% of the population is fully vaccinated, weathered the omicron wave with barely a blip in excess death rates.

“We are finally in a phase now where highly immune populations can start to shoulder COVID-19 waves without the guarantee of excess mortality,” said MedPage Today’s editor-in-chief, Dr. Jeremy Faust of Brigham and Women’s Hospital in Boston, who studied the phenomenon.

But COVID is unlikely to be the last viral outbreak with global impact, reports Youri Benadjaoud at ABC News. “Scientists are increasingly warning that global infectious outbreaks could become the new normal,” she writes.

Frequent international travel over the past few decades is one contributing factor. A warming climate is also making it easier for infectious agents to jump into humans.

“I think it’s very clear that we’re living in a new age of pandemics,” said Dr. Jay Varma of Weill Cornell Medicine.

Paxlovid’s benefits limited to seniors

Pfizer’s antiviral drug Paxlovid staves off serious illness from SARS-CoV-2 in people ages 65 and older, but provides little benefit to younger adults, according to a new study published in the New England Journal of Medicine.

The research, conducted in Israel, analyzed data from 109,000 COVID patients, of whom nearly 4,000 took Paxlovid, during the omicron surge. Seniors who took the drug had a 73% lower chance of hospitalization and 79% lower chance of dying, compared to those who didn’t take Paxlovid, but it made no difference to patients in the 40–64 age range.

“The findings throw into question whether taking the drug is worth it for people under 65,” writes Alice Park at Time. The meds come with a range of unpleasant possible side effects, including diarrhea and a garbage-like taste in the mouth.

Park notes that younger adults who have cancer or other conditions that alter immunity might still benefit from Paxlovid, but the study did not analyze this group separately.

Another issue: after a five-day course of Paxlovid, people sometimes test negative but then positive again. First Lady Jill Biden is the latest high-profile case of Paxlovid rebound, which also affected President Joe Biden and his chief medical advisor Dr. Anthony Fauci.

According to Reuters, the FDA has requested Pfizer test an additional course of Paxlovid in people who experience rebound.

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