Overnight Health Care — Presented by Rare Access Action Project — Supply woes expected for anti-COVID drug

Welcome to Friday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: digital-stage.thehill.com/newsletter-signup.

The Jonas Brothers were at the White House today, filming a vaccine PSA. It was aimed squarely at the TikTok Generation. 

Pfizer’s antiviral COVID-19 treatment could be an important development in the fight against the disease, but supply is going to be a major concern.

For The Hill, we’re Peter Sullivan (psullivan@digital-stage.thehill.com), Nathaniel Weixel (nweixel@digital-stage.thehill.com) and Justine Coleman (jcoleman@digital-stage.thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let’s get started.

Omicron fight blunted by supply shortage 

A new pill from Pfizer to treat COVID-19 has been hailed as a game-changer that can drastically cut down the number of hospitalizations and deaths from the disease. 

But demand for the treatment, known as Paxlovid, is expected to far outrun supply, blunting its ability to help fight what medical professionals say is an oncoming wave of infections from the omicron variant. 

Experts are calling on the Biden administration to take action to help increase manufacturing capacity by enlisting additional companies to help Pfizer make the doses. 

“I think we should be doing everything we can,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center. “This requires a full court press.”

He noted that Merck is helping make the Johnson & Johnson vaccine, a model that could be applied to therapeutics like the Pfizer pill as well. 

But so far, he said. “I have not seen any aggressive push or attempt to access existing manufacturing capacity in the U.S. or globally to date around therapeutics.”

The numbers: Pfizer says it expects to have 180,000 courses of the treatment available by the end of 2021, with 30 million available globally in the first half of 2022, rising to 80 million by the end of next year. 

But with about 120,000 new COVID-19 cases every day and rising just in the United States, the demand for the anti-viral product is spiking sharply. 

Read more here.

CDC pushes ‘test-to-stay’ policy in schools 

The Biden administration is advocating for a “test-to-stay” policy in schools, aiming to reduce the number of absences and quarantines among students exposed to COVID-19.

The strategy, announced by the Centers for Disease Control and Prevention (CDC) on Friday, will permit close contacts of those with confirmed COVID-19 to stay in classrooms if they test negative at least twice in the week after interacting with an infected person.

The strategy is being employed by some school districts across the country, but it is not widely used. In many cases, any student who was in the same classroom with someone who tested positive is deemed a close contact and sent home to quarantine—sometimes even without any remote option. 

As cases rise in children, there have been an increasing number of disruptive quarantines. Almost 7.2 million children have tested positive for COVID-19 since the beginning of the pandemic, with children making up 17.2 percent of all cases as of Monday, according to the American Academy of Pediatrics.

“If exposed children meet a certain criteria and continue to test negative, they can stay in school, instead of quarantining at home,” CDC Director Rochelle Walensky said during a briefing.

The CDC cited two studies showing decreased absences in schools that implemented test-to-stay policies. Research involving 90 Lake County, Ill., schools predicted that the strategy eliminated more than 8,000 missed school days. In Los Angeles County schools, test-to-stay protocol prevented about 92,000 absences. 

“These studies demonstrate that test-to-stay works to keep unvaccinated children in school safely,” Walensky said.

Read more here.

 

A MESSAGE FROM RAAP

Tell Congress to protect rare disease patients

Right now, politicians need a win, and rare disease patients are going to lose. Congress is putting huge cost increases on the development of treatments for rare diseases – from 400-800%. Learn more.

DEMS URGE $17 BILLION TO FIGHT COVID-19

A group of over 80 Democratic lawmakers is calling for at least $17 billion in a coming government funding package to go towards helping vaccinate the world and fighting the pandemic abroad. 

The lawmakers say that the U.S. needs to do more to get shots in arms around the world, as well as boost testing and treatments, saying that stopping the pandemic everywhere is the only way to end the cycle of new and more dangerous variants developing. 

“Now, the world faces yet another variant, Omicron, which may be even more transmissible than the Delta variant,” states the letter, which was signed by lawmakers including Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), as well as Reps. Pramila Jayapal (D-Wash.) and Tom Malinowski (D-N.J.).

“We must end this cycle by prioritizing getting shots in arms around the world as soon as possible, especially in low- and lower-middle-income countries, which do not have the resources to vaccinate their populations.”

Many of the same lawmakers called for $34 billion in funding toward global vaccination to be included in President Biden’s Build Back Better package, but they note that the House-passed measure includes “a mere $1.3 billion.”

The Biden administration last month announced an effort to ramp up vaccine manufacturing to create a billion doses per year. 

But the lawmakers said the administration needs to do more. “The pace and scale of these efforts remain out of sync with the magnitude of the threat that an unvaccinated world poses to American lives, the American economy, and America’s global leadership,” they wrote. 

Read more here.

Vax for under 5 expected in first half of 2022 

Parents of young children are going to need to wait a little longer for an effective COVID-19 vaccine. 

Pfizer and BioNTech said Friday they expect to submit an application for the use of their COVID-19 vaccine in children under 5 years old in the “first half of 2022” as they test a third dose for the age group. 

Pfizer said it is studying a third small dose of its vaccine for children under 5, given that the testing so far showed that the immune response with two small doses was not as high as desired in children 2 to 4 years old. 

The company added that no safety concerns have been identified so far. Children under 5 are currently the only age group where vaccines are not available, and many families eagerly await their introduction. That moment, however, might not come until sometime toward the middle of next year. 

The companies have been testing two shots of a 3-microgram dose in children under 5. The decision to try a third dose “reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile,” Pfizer and BioNTech said. “If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.”

But the third dose trials are not expected to delay the filing substantially. White House medical adviser Anthony Fauci said last month that he had hoped the vaccine for children under 5 would be available “likely the beginning of next year in 2022, in the first quarter of 2022,” though he noted the timeline depended on results of the clinical trial. 

Read more here.

SOUTHWEST CEO TESTS POSITIVE FOR COVID

Southwest Airlines CEO Gary Kelly tested positive for COVID-19 following Wednesday’s Senate Commerce Committee hearing on airline oversight, the company told Reuters on Friday. 

Kelly testified before the committee alongside the president of the nation’s largest flight attendant union and executives at United Airlines, American Airlines and Delta Air Lines. They did not wear masks during the hearing, which examined the impact of $54 billion in pandemic aid Congress gave to airlines. 

During the hearing, Kelly said that masks don’t provide much additional protection to air travelers, pointing to airplanes’ advanced air filtering systems, which capture airborne pathogens. 

“I think the case is very strong that masks don’t add much if anything in the air cabin environment,” Kelly told senators Wednesday. “It’s very safe, very high quality compared to any other indoor setting.”

A Southwest Airlines spokesperson said Kelly “is doing well and currently resting at home, he has been fully vaccinated and received the booster earlier this year.”

Read more here.

 

A MESSAGE FROM RAAP

Tell Congress to protect rare disease patients

Right now, politicians need a win, and rare disease patients are going to lose. Congress is putting huge cost increases on the development of treatments for rare diseases – from 400-800%. Learn more.

 

WHAT WE’RE READING

• Doctors and nurses are ‘living in a constant crisis’ as Covid fills hospitals (The New York Times)
• The tragedy of Johnson & Johnson’s Covid vaccine (Stat) 
• Surging COVID-19 cases bring a 2020 feel to the end of 2021 (The Associated Press)
• A poorly matched flu shot could mean a bad flu season on top of a Covid surge (NBC News)

 

STATE BY STATE

• As hospitals fill up in Colorado, paramedics spend more time moving patients, less on emergencies (Kaiser Health News)
• Pennsylvania’s capacity to track coronavirus variants is lagging (Pittsburgh Post-Gazette)
• Indiana lawmakers take up vaccine limites amid COVID-19 surge (Chicago Tribune)

That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you next week.
{mosads}