Overnight Health Care: AstraZeneca may have included outdated data on vaccine trial, officials say | Pelosi says drug pricing measure under discussion for infrastructure package | Biden administration extends special ObamaCare enrollment until August
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Today: It was a bad day for AstraZeneca. A powerful teachers union is not happy with the CDC’s new distancing guidelines, more states are expanding vaccine eligibility and HHS is extending ObamaCare’s open enrollment.
We’ll start with AstraZeneca:
AstraZeneca may have included outdated data on vaccine trial, officials say
Federal authorities are raising concerns that AstraZeneca may have included “outdated information” on its COVID-19 vaccine trial in reporting its efficacy, making the drug appear to be more effective than the data actually show.
The National Institute of Allergy and Infectious Diseases (NIAID), which is led by Anthony Fauci, said in a statement on Tuesday that the Data and Safety Monitoring Board (DSMB), an independent panel of experts, notified federal officials and the company that “it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”
According to Fauci, the DSMB “wrote a rather harsh note to them and with a copy to me, saying that they in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit and wanted them to straighten it out.”
The unusual press release, which was sent after midnight, came just hours after AstraZeneca announced its vaccine is 79 percent effective, seemingly paving the way for the Food and Drug Administration’s authorization.
In a statement on Tuesday, AstraZeneca noted that the data released the day prior was based on “pre-specified interim analysis with a data cut-off” of Feb. 17.
Pattern of behavior: It was a pretty big own-goal by AstraZeneca, which has scored a few of them throughout its long saga towards U.S. authorization of its coronavirus vaccine. The company initially had to pause its trials in the U.S. and U.K. because of safety concerns, and it took two months to restart.
Then just a couple months later, it messed up its dosing and mistakenly gave trial participants just half the intended level of first dose, which actually performed better than the full dose.
Getting their act together: The company vowed to fix the issue in the next 48 hours and send correct data to regulators. “We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data,” AstraZeneca said. “We intend to issue results of the primary analysis within 48 hours.”
Watch out pharma! Pelosi says drug pricing measure under discussion for infrastructure package
Speaker Nancy Pelosi (D-Calif.) said Tuesday that lawmakers are discussing including legislation to lower prescription drug prices as part of the next major legislative package, centered on infrastructure.
“One of the considerations that members are discussing is whether we have aspects of HR 3, the Elijah Cummings Lower Drug Costs Now legislation,” Pelosi said during an event hosted by the Democratic group Protect Our Care, when asked about including health care priorities in the coming infrastructure package.
The move is attractive as Democrats draft their next major package not only because it is a long-held Democratic priority, but because it saves significant amounts of money, about $450 billion according to the Congressional Budget Office, that could be spent on other priorities.
“If we were able to do that we could save almost a half a trillion dollars,” Pelosi said.
Public option, maybe not so much: On another health care front, Pelosi downplayed the chances that a public option to compete alongside private insurers would be included in the coming package.
“Obviously it is something that we want to do,” she said when asked about one flavor of that idea, lowering the eligibility age for Medicare. “I want a public option, I don’t know that we get that in this bill, but this is an ongoing conversation.”
Biden administration extends special ObamaCare enrollment until August
The Biden administration announced Tuesday it is expanding the special pandemic enrollment period for ObamaCare plans for three additional months, until Aug. 15.
The move means signups on the Healthcare.gov website will remain open for the majority of 2021, and comes on the 11th anniversary of the Affordable Care Act being signed into law.
New and current enrollees will have an additional three months to enroll in coverage or change their plans, and to have access to additional subsidies from the American Rescue Plan that could make coverage cheaper.
Subsidies available soon: The additional financial assistance will become available starting April 1. As a result of the law, premiums will be capped at the maximum of 8.5 percent of income, down from about 10 percent. According to the Department of Health and Human Services, costs will drop by an average of $50 per person per month, and $85 per policy per month. About 80 percent of people will be able to find plans for $10 or less after subsidies.
Teachers union ‘not convinced’ on CDC guidance to reduce classroom spacing
The nation’s second-largest teachers union on Tuesday questioned the Biden administration’s decision to reduce the recommended distance between students in a classroom during the coronavirus pandemic from 6 feet to 3 feet.
In a letter to Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky and Secretary of Education Miguel Cardona, the American Federation of Teachers (AFT) pressed for additional recommendations on mitigation measures such as ventilation, testing and effective cleaning.
“We are not convinced that the evidence supports changing physical distancing requirements at this time. Our concern is that the cited studies do not identify the baseline mitigation strategies needed to support 3 feet of physical distancing,” AFT President Randi Weingarten wrote.
What they want: Specifically, Weingarten said any shift from 6 feet to 3 feet must be accompanied by universal and correct masking; effective ventilation; thorough cleaning of buildings; regular COVID-19 testing of teachers, staff and students; effective contact tracing and quarantine/isolation protocols; and the availability of vaccines to all people in schools who are eligible.
Flashback: Last week, the CDC updated its guidance on schools to suggest students can maintain a distance of 3 feet or more in classroom settings, so long as there is universal masking. The agency based its recommendation on a growing body of research that showed in-person learning could be done safely for all K-12 students, regardless of community transmission levels.
Two other states opening up vaccinations to all adults: Texas and Georgia
Texas and Georgia officials announced Tuesday the states will open up COVID-19 vaccine availability to all adults starting Thursday for Georgia residents and next Monday for Texans, as states across the country aim to expand eligibility to the vaccine.
The Texas Department of State Health Services (DSHS) declared that all adults are eligible to get the vaccine on Monday, per a recommendation from the state’s Expert Vaccine Allocation Panel.
The panel said inoculations should be open to all people whom the Food and Drug Administration’s emergency use authorizations have approved to get the shot in order “to protect as many Texans as possible.”
“We are closing in on 10 million doses administered in Texas, and we want to keep up the momentum as the vaccine supply increases,” said DSHS Associate Commissioner Imelda Garcia, who is also the chair of the expert panel.
West Virginia, Alaska and Mississippi are currently the only states where all adults are eligible to receive shots.
What we’re reading
Germany imposes Easter lockdown to curb new surge (BBC)
Inside the scramble to bring Covid-19 vaccines to homebound Americans (Stat)
As U.S. parties, Europe fights third coronavirus wave (Washington Post)
Vaccination sign-ups prove daunting for speakers of other languages (Kaiser Health News)
State by state
Colorado COVID hospitalizations stall as state prepares to loosen restrictions (Denver Post)
DeSantis says contract tracing didn’t work. So why is Florida paying for this app? (Tampa Bay Times)
Weeks into spring break, adults under 50 spur COVID rise in Florida tourism hubs (Miami Herald)
In America, Covid vaccine eligibility is a ‘crazy quilt’ of state rules (Kaiser Health News)
The Hill op-eds
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