Overnight Health Care: CDC panel meets on vaccines and heart inflammation | Health officials emphasize vaccine is safe | Judge rules Missouri doesn't have to implement Medicaid expansion

Overnight Health Care: CDC panel meets on vaccines and heart inflammation | Health officials emphasize vaccine is safe | Judge rules Missouri doesn't have to implement Medicaid expansion
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Welcome to Wednesday’s Overnight Health Care. McDonald’s locations in California are the latest to get in on the vaccine incentives, giving away free menu items for people who get the shots. 

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Today: A CDC advisory panel met to examine heart inflammation and the vaccines, a judge gave a setback to Missouri Medicaid expansion, and Biogen opened the door to adjusting the price of its controversial Alzheimer’s drug. 

Let’s start with the CDC:

CDC panel finds 'likely' link between rare mild heart inflammation in adolescents and COVID-19 vaccine

A Centers for Disease Control and Prevention (CDC) safety panel said there is a "likely association" of mild heart inflammation in adolescents and young adults after they were vaccinated with an mRNA COVID-19 vaccine.

The initial cases of myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the membrane surrounding the heart, reported on the federal government's tracking system were generally mild, especially compared to traditional myocarditis, scientists said.

Most cases have been mild, with symptoms like fatigue, chest pain and disturbances in heart rhythm that quickly clear up within a day or so.

Rarity: Officials said they are tracking about 1,200 initial reports of the rare heart inflammation following doses of mRNA coronavirus vaccines have been filed with the federal government's Vaccine Adverse Event Reporting System (VAERS), though they have not yet been definitively linked to the vaccines.

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Most reports came from people in their late teens and early 20s, and many more occurred after the second dose than the first.

Read more here

 

Health officials emphasize vaccine is safe for adolescents

Top administration health officials joined with a host of groups representing physicians, hospitals, nurses and others to endorse the safety of COVID-19 vaccines for adolescents.

The joint statement from more than a dozen federal and professional groups on Wednesday followed a meeting of the Centers for Disease Control and Prevention's vaccine advisory panel regarding reports of heart inflammation in young adults after use of either the Moderna or Pfizer-BioNTech vaccine.

Their statement: "The facts are clear: This is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment," the groups said.

Officials are tracking about 1,200 initial reports of the rare heart inflammation following doses of mRNA coronavirus vaccines, including about 480 who were younger than age 30.

There have been more than 300 million vaccine doses administered to date.

Read more here

 

Judge rules Missouri doesn't have to implement Medicaid expansion

A Missouri judge on Wednesday ruled against a lawsuit seeking to force the state to implement Medicaid expansion under the Affordable Care Act, a setback for supporters of expansion.

The ruling will be appealed, though, meaning it is not the final word.

Missouri voters passed a ballot measure last year to expand Medicaid, but GOP Gov. Mike Parson said in May he would drop plans to expand the program after the Republican-controlled legislature declined to provide funding for it.

Supporters of Medicaid expansion sued, seeking to force the state to expand the program starting July 1, which would provide health insurance to about 275,000 low-income people.

Judge Jon Beetem ruled against the lawsuit on Wednesday, writing that the voter-approved ballot measure was actually unconstitutional, since it sought to spend state funds without identifying a funding source, infringing on the legislature's appropriations power.

National effort: The setback for expansion in Missouri comes as congressional Democrats are exploring ways to go around states and expand the program in the 12 states that have still not accepted expansion.

Read more here.

 

Biogen opens door to adjusting price of Alzheimer's drug amid outcry 

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The pharmaceutical company Biogen on Wednesday opened the door to adjusting the price of its new Alzheimer's treatment amid an outcry over the cost. 

The company said in a statement that if more people end up taking the drug than it expects, it could adjust the price, which is currently set at $56,000 per year. 

"We have determined the launch price of Aduhelm based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials," the company said. "In the event that our fundamental assumptions on population size and rate of adoption are significantly different than expected, we stand ready to work with public and private payers to address pricing in order to achieve both patient access and support budget sustainability."

But: The company did not provide details on how many more people than expected would need to take the drug for it to adjust the price, or by how much it would adjust it. 

The Kaiser Family Foundation has estimated that the cost of the drug to the Medicare program could be massive. If 1 million people take the drug, that would cost more than $57 billion, more than Medicare Part B spends on all other drugs combined. 

Read more here.

 

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Story’s not over for Emergent BioSolutions…..Lawmakers expand investigation of troubled Baltimore vaccine plant

Lawmakers are expanding their probe of the troubled Emergent BioSolutions vaccine plant in Baltimore and are now focusing attention on manufacturing contracts with AstraZeneca and Johnson & Johnson.

Democratic leaders on two House panels in letters dated Tuesday asked the CEOs of AstraZeneca and Johnson & Johnson to produce all communications related to efforts to supervise manufacturing, quality or compliance of their vaccines at the Emergent plant. 

The lawmakers also asked the companies to produce all records related to their decisions to hire Emergent as a subcontractor, as well as the specific numbers of doses that have either been destroyed, delayed or shipped.

The story so far: The company is facing scrutiny from Congress after it was awarded a $628 million contract last year to establish the primary U.S. facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca.

The Baltimore plant has been forced to destroy the equivalent of tens of millions of doses of Johnson & Johnson’s coronavirus vaccine because of suspected contamination with an ingredient for the AstraZeneca vaccine. Both vaccines were being manufactured by Emergent at its Baltimore facility. 

Read more here.

 

Warren renews push for $100 billion medical research funding boost

Sen. Elizabeth WarrenElizabeth WarrenCalifornia Democrats warn of low turnout in recall election Pelosi disputes Biden's power to forgive student loans Warren hits the airwaves for Newsom ahead of recall election MORE (D-Mass.) and Rep. Yvette ClarkeYvette Diane ClarkeHouse passes host of bills to strengthen cybersecurity in wake of attacks Haiti Caucus: Forging path out of crisis will not be quick, but necessary to avoid false 'democracy' US lawmakers express shock at Haitian president's assassination MORE (D-N.Y.) are reintroducing a bill to provide an infusion of $100 billion over 10 years for the National Institutes of Health and Food and Drug Administration. They say the funding boost would help fight a future outbreak after COVID-19. 

“Now more than ever, we need my bill with Congresswoman Clarke to ensure the federal government fully invests in the medical breakthroughs in disease prevention, diagnoses, and cures to help counter future outbreaks and to allow everyone to receive the best treatments available," Warren said. 

 

What we’re reading

Nearly every new Covid-19 death is now entirely preventable, CDC director says (CNN)

Key Democrats slam FDA for failing to crack down on Juul and other e-cigarette makers (Stat)

Nearly 900 Secret Service members were infected with the coronavirus. A watchdog blames Trump. (Washington Post

 

State by state

Spread of delta coronavirus variant exposes poorly vaccinated regions to renewed danger (Washington Post)

Missouri special session on Medicaid funding begins (Associated Press)  

California’s COVID-19 vaccinations rise as U.S. struggles. Does the lottery deserve credit? (LA Times)