Coronavirus Files: Moderna files for child vax, White House to lower Paxlovid hurdles

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THE CORONAVIRUS FILES

By Amber Dance

Judge delays Biden plans to ease migrant entry

President Biden’s plans to end pandemic-era restrictions on U.S. entry by asylum seekers are in jeopardy after a federal judge said he would issue a two-week restraining order on any change to migrant entry.

The restrictions, known as Title 42 and in place since March 2020, have been used more than 1.8 million times by immigration officials since then to expel migrants seeking asylum, according to Miriam Jordan and Eileen Sullivan at The New York Times.

The Biden administration plans to let the restrictions expire on May 23, setting up an anticipated influx of up to 18,000 migrants per day via the southern border.

Republican states have filed a lawsuit over that expiration, arguing authorities haven’t followed the proper steps to end the measure.

After learning immigration authorities were already exerting a bit more leniency, a few of those states then filed for the immediate restraining order. Federal court papers indicate “relatively small” number of asylum-seekers has been allowed through, reports Suzanne Monyak at Roll Call.

The White House notes Title 42 was a public health measure, and that CDC has said the policy is no longer needed.

“We applauded the CDC decision to lift the order,” Robyn Barnard, counsel for the international nonprofit Human Rights First, told The New York Times. “All pretexts that this was a public health measure were just that.”

US situation is improved, but new status is fuzzy

Depending on where you consumed news last week, you might have heard that the United States is “out of the pandemic phase,” past the “full-blown explosive pandemic phase” or in a rather vague “different moment of the pandemic.”

All are quotes from Dr. Anthony Fauci of the National Institutes of Health, who clarified later in the week that no, the pandemic is not over. In fact, Fauci himself opted out of the annual White House Correspondents’ Association dinner over COVID concerns.

The nation is certainly in a better place than in either of the past two winters. There are now several antiviral medications (see below), and two-thirds of the population has been fully vaccinated.

And most people in the U.S. have some immunity because they already had COVID, according to recent CDC data. Nearly six in 10 adults and three in four children carry antibodies to the coronavirus, indicating past infection.

The European Union, where as many as four in five people may have had COVID, also said last week it was beyond the “emergency phase” of the pandemic.

But elsewhere, the situation is still bad. Beijing just shut down its schools, and Taiwan is having its worst outbreak yet.

South Africa appears to be headed for a possible fifth wave, based on omicron variants BA.4 and BA.5. Karen Weintraub at USA Today notes that U.S. cases exploded last fall soon after omicron was discovered in South Africa.

Those variants are present in the United States, in low numbers, but Weintraub writes, “It’s too early to know whether they will be any more dangerous or will evade vaccine protection.”

Moderna files to vaccinate youngest kids

A vaccine for kids younger than 5 may be weeks away, as Moderna officially filed last Thursday for emergency authorization for this youngest age group, the only population that still can’t get even their first shot.

Moderna’s full application won’t be complete until May 9. The main basis for the authorization is an antibody response in the kids that matched the one in vaccinated adults.

“Moderna’s announcement will intensify pressure on the Food and Drug Administration to move quickly, as parents, pediatricians, and politicians have become increasingly impatient about the lack of vaccines and treatments to protect young children,” writes Carolyn Y. Johnson at The Washington Post. (This newsletter’s editor, a father of two 4-year-olds, confirms this is true.)

That pressure grew more heated recently when Politico’s Adam Cancryn reported that the FDA might wait until they have a full application from Pfizer, too, to decide on the best course for young children. Regulators, Cancryn wrote, believed parents would be confused about their options if the agency were to greenlightt one vaccine shortly before the other.

New York Times opinion columnist Zeynep Tufekci captured some of the frustration with the FDA’s approach in a column last week, writing that the ongoing wait seems “due to officials making unjustified assumptions about the public and relying on overly narrow and even outdated measures of vaccine benefits.”

FDA vaccine head Dr. Peter Marks told a Senate committee that the agency can’t authorize either vaccine without a full application in hand.

“It’s critically important,” Marks added, “that we have the proper evaluation so that parents will have trust in any vaccine we authorize.”

Marks told reporters at The Washington Post that there will be no unnecessary delays.

The FDA has also promised to convene its panel of vaccine experts before any decision, and scheduled meetings for June 8, 21 and 22. If the data support authorization, Marks expects at least one vaccine will be available in June.

Regardless of the FDA timeline, parents may have to weigh differences between the vaccines. Pfizer’s two-dose course didn’t quite generate the hoped-for antibody response, so the company is now testing a booster dose, given at least two months after the second shot. That means those who go with Pfizer might not achieve full immunity until summer’s end. Moderna is proposing a two-dose series kids could complete more quickly.

For now, the overall risk of severe COVID-19 for children younger than 5 is low, but children with other health conditions may be more vulnerable, writes Tara Law at Time.

For kids who do get sick, the FDA just approved the antiviral drug remdesivir for children as young as four weeks. It can be prescribed to children who are sick enough to be in the hospital, or those who are at high risk for severe disease.

New effort aims to expand antiviral access

There are now a number of treatments to blunt a COVID infection — so many that some experts say no Americans should by dying from the virus, reports Arielle Mitropoulos at ABC News.

Yet more than 300 people, on average, are dying every day in the U.S.

Many of those haven’t taken advantage of the vaccines, but there’s another problem: Boxes of lifesaving pills are sitting unused on pharmacy shelves.

Last week the Biden administration said it’ll work harder to get the medications — such as Pfizer’s Paxlovid — into the hands of patients who could benefit.

The plan involves doubling the number of pharmacies that stock Paxlovid, to 40,000 sites.

The government will also expand the number of “test to treat” sites where people could go straight from positive COVID test to physician’s prescription to pharmacy checkout, all in one location.

“Officials acknowledged that the new moves do not address some of the criticisms levied against the Biden administration’s treatment effort,” reports Alexander Tin at CBS News.

For example, if a test-to-treat site isn’t nearby, patients (who are probably infectious and feeling lousy) must get tested, see a physician and fill the prescription, likely at different places, all within five days for the medication to be helpful.

Paxlovid was in short supply when it first came out, leading physicians to restrict their prescriptions to those at the very highest risk for severe disease. Though the drug is still only authorized for high-risk patients, that includes people as young as 12 with common conditions such as obesity and diabetes, and could apply to up to 60% of adults, reports Shannon Firth at MedPage Today.

And the pills are now plentiful, but many doctors still have a scarcity mindset, said White House coronavirus coordinator Dr. Ashish Jha.

Some providers are daunted by the possible interactions Paxlovid with other drugs people are taking, writes Jennifer Hudson at MedPage Today.

New awareness campaigns will target both physicians and the public.

Even with expanded pharmacy sites, it will still be difficult for people who don’t have health insurance or transportation to get the medicine, not to mention the time and know-how to rapidly manage a series of pit-stops in the health care system.

Across the nation, there are more pharmacies in wealthy neighborhoods catering to white residents than in poorer communities housing primarily people of color.

“Equitable access is a huge barrier at this point,” Dr. Colleen Kelly, of Emory University, told ABC.

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