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States are moving quickly to vaccinate teens with Pfizer’s Covid-19 shot before the summer, with one moving ahead of a key advisory panel.
Health officials across the country say they are rolling out in-school vaccination clinics as soon as tomorrow to take advantage of the recent clearance of Pfizer’s Covid-19 vaccine for children as young as 12. They’re hoping to reach adolescents before the end of the school year to help boost their state vaccination rates.
“States are ready and able to vaccinate adolescents,” Marcus Plescia, chief medical officer at the Association of State and Territorial Officials, told reporters yesterday.
Plans for inoculating the new cohort differ from state to state as officials grapple with consent requirements for teens 12 to 15 years of age. Some states like Georgia say they’re vaccinating kids 12 and older already, one state health department spokeswoman said. Providers in Texas are holding off until the CDC’s vaccine advisory meeting set for today. The head of California’s pharmacist association also advised pharmacists to wait.
These different plans by states came under 12 hours after the Food and Drug Administration announced an expansion of the emergency use authorization for Pfizer-BioNTech vaccine to include children 12 years and older. FDA leaders said adolescents in that age group can start getting inoculated as early as tomorrow, following the CDC’s advisory meeting.
“This is a big step for our country as vaccinating a younger population can bring us closer to a sense of normalcy and to ending this pandemic,” said Peter Marks, head of the FDA’s division that regulates vaccines, at a Senate Health, Education, Labor and Pensions Committee hearing yesterday. Alex Ruoff, Jacquie Lee, and Jeannie Baumann have more.
Happening on the Hill
Hearings on the Hill:
- HHS Budget: The House Energy and Commerce Committee will meet with Health and Human Services Secretary Xavier Becerra to discuss the department’s fiscal year 2022 budget request.
- Mental Health: The Senate Finance Subcommittee on Health plans a hearing to examine mental health and addiction services amid of the Covid-19 pandemic.
- Covid-19 Response: The Senate Foreign Relations Committee scheduled a hearing on the U.S.’s international response to the Covid-19 pandemic.
Senate Floor: The Senate today will resume consideration of a motion to discharge the nomination of Chiquita Brooks-LaSure to be administrator of the Centers for Medicare and Medicaid Services. The Senate will vote at noon on whether to discharge the nomination, Nancy Ognanovich reports.
- The Biden administration’s pick to be the second in command at the Health and Human Services Department, Andrea Palm, was confirmed by the Senate in a 61-37 vote yesterday. Read more from Shira Stein.
Once Bipartisan Bill Languishes on House Floor: A bill on drug market exclusivity that previously had wide bipartisan support was rejected by the House last night, the latest sign of how divided lawmakers remain over the Jan. 6 vote to certify the electoral college, Emily Wilkins reports.
The legislation (H.R. 1629) would prevent drug makers from obtaining market exclusivity for certain drugs used to treat rare diseases. In 2019, the bill was sponsored by Rep. Madeleine Dean (D-Penn.) with Rep. Buddy Carter (R-Ga.) as a co-lead. It was passed easily by voice vote.
But this year, Dean refused to let Carter be a co-lead after Carter was one of 138 House Republicans to object to Pennsylvania’s’ electoral college votes. As a result, 168 Republicans voted against the bill. The final vote of 250-168 was insufficient for passage because the bill was moving under suspension of the rules—something reserved for bills that the vast majority of members support—which requires two-thirds of members to support for passage.
Dean said she offered Carter the chance to be a co-sponsor, rather than a co-lead, something she said Carter initially agreed to before changing his mind. It is “tragic that the ones who will face the repercussions of this ‘protest vote’ are the people seeking medical help for opioid addiction that would have been helped by the passage of this legislation,” Dean said in a statement.
Carter said Dean was the one to blame for playing politics rather than focusing on legislation. “I won’t sit silent as Washington Democrats attempt to bring cancel culture to the House,” he said in a statement.
House Majority Leader Steny Hoyer (D-Md.) said in a statement the bill will return to the floor next week via a process that will only require a simple majority for passage.
Democrats Want FDA Oversight of Covid-19 Tests: Top House Energy and Commerce Democrats pressed Becerra to reinstate the FDA’s ability to oversee Covid-19 tests made in a laboratory, a move that would reverse a Trump administration decision. The HHS issued a policy last summer saying the Food and Drug Administration doesn’t have to review laboratory-developed tests before they hit the market due to the public health emergency. Reps. Diana DeGette (D-Colo.), Frank Pallone, Jr. (D-N.J.) and Anna Eshoo (D-Calif.) wrote in a letter to Becerra that the reversal would ensure tests are accurate. “Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliability of diagnostic tests,” they said, Jeannie Baumann reports.
Lawmakers Press HHS on Medicare Advantage: An advocacy group is praising a bipartisan letter to Beccera to strengthen Medicare Advantage, which provides Medicare benefits to seniors and Americans with disabilities through private health-care insurers. Reps. Val Demings (D-Fla.), Mike Gallagher (R-Wis.), and 68 other lawmakers of districts where more than 50% of seniors are enrolled in Medicare Advantage signed onto the letter, which was shared with Bloomberg Government by the advocacy group Better Medicare Alliance. Read the bipartisan letter here.
Marshall Seeks Wuhan Outbreak Probe: Sen. Roger Marshall (R-Kan.) introduced a resolution yesterday seeking a 12 member bipartisan committee to investigate the Covid-19 outbreak in China that began in Wuhan, The Washington Post reports. The committee would conduct a full probe and study about the initial source of the novel coronavirus and research practices done at the Wuhan Institute of Virology. Read more from the Post.
More on the Pandemic
Uber, Lyft Will Give Free Rides to Vaccine Sites: The White House announced new efforts to vaccinate Americans, including an expansion of free rides from Uber and Lyft to get shots and a partnership with community colleges to administer vaccines. The ride-sharing platforms will offer rides through July 4, the White House said yesterday. It’s an expansion of programs they were already offering some low-income users in cooperation with pharmacies and nonprofits.
“Americans from every walk of life are getting their vaccines,” President Joe Biden said during an online meeting with governors from Massachusetts, Utah, Ohio, New Mexico, Maine, Minnesota and others. “We’ve got to do more, though.” He said the U.S. is in a new phase of its vaccination campaign as domestic demand weakens, with the U.S. administering about 2.1 million shots a day, down from 3.4 million a month ago.
“We always expected we’d be in a different phase,” White House Press Secretary Jen Psaki said yesterday. “And it means we have to work extra hard to get into communities, to have partnerships with local doctors, with primary care physicians, to expand access, to expand mobile units that are going into communities to get that supply out to people.”Read more from Josh Wingrove and Justin Sink.
Covid Panel Wants WHO Overhaul: The World Health Organization should be overhauled and given more authority to investigate global disease threats, according to a review of the international Covid-19 response that found a myriad of failures, gaps, and delays allowed the coronavirus to mushroom into a pandemic. While stopping short of assigning blame to any particular factor, the report released today by an independent panel co-chaired by former New Zealand Prime Minister Helen Clark linked the severity of the global outbreak to deficiencies across governments, the WHO and other multilateral organizations, and regulations that guide official actions. Read more from Jason Gale.
Airlines Press Buttigieg to Weigh U.S.-U.K. Flights: American Airlines, Delta, and four other airlines asked the U.S. and U.K. in a letter yesterday to set a meeting to consider how to open up transatlantic flights again. The letters were sent to Transportation Secretary Pete Buttigieg and U.K. Secretary of State for Transport Grant Shapps, Brody Ford reports.
- The letter comes as England reported no deaths from Covid-19 in its latest daily update, a milestone that highlights the effectiveness of the U.K.’s vaccine program in stopping the spread of the coronavirus. Sunday was the first day without any recorded deaths in England since the pandemic took hold in March of 2020. Read more from Neil Callanan.
- Related: Pfizer Seeks U.K.’s Vaccine Approval for Ages 12-15: Telegraph
- Doctors Watch Warily as Severe Covid-19 Infections Strike Kids
- Nursing Homes Must Educate, Offer Covid-19 Shots, HHS Says
- New Variant From India Triggers WHO Fears Over Fast Spread
- AMLO Says He Asked U.S. VP to Send Mexico More AstraZeneca
- Brazil Halts AstraZeneca in Pregnant Women After One Death
What Else to Know Today
Bid to Tie Social Needs to Patient Data: A proposal to use electronic health records to track housing, nutrition and other nonmedical needs may be a good step toward improving overall patient outcomes, but advocates say its impact could be limited if it stops short of addressing how social service providers get paid. HHS’s proposal is part of a broad push to make health-care spending more efficient by targeting the most important influences on health outcomes, many of which lie beyond the reach of medical care. Christopher Brown has more.
Rescission of Trump Insulin Rule Moves Ahead: The HHS is proposing to a rescind a Trump administration drug rule that required community health centers to pass on their insulin and epinephrine discount savings to patients. The proposal to pull that rule is under review at the Office of Management and Budget. The Health and Human Services Department can publish it after it’s cleared. Read more from Jacquie Lee.
SCOTUS Told Not to Dump Gag Rule Case: The U.S. Supreme Court should decide the fate of a Trump administration rule that prohibits family planning providers that get federal money from referring patients for abortion, because the case hasn’t been made moot despite the new administration, 19 states and Christian medical providers said. They want the justices to deny a motion to dismiss the suit filed jointly by HHS, states and providers. Mary Anne Pazanowski has more.
Eli Lilly Urges Judge to Allow Drug Discount Lawsuit to Proceed: An HHS “advisory opinion” requiring drugmakers to continue offering their products to contract pharmacies at steep discounts must be reviewed as a final agency action and invalidated because it is contrary to law, Eli Lilly & Co. told a federal court. Read more from Mary Anne Pazanowski.
- LGBT Group’s Bias Rule Lawsuit Against Trump Rule Proceeds
- DOL Looking for Red Flags on Mental Health Law Compliance
- Sanofi Accused of Wiping Emails Amid Heartburn Drug Recall
- Multilateral Pharmaceutical Merger Task Force Seeking Input
- Pfizer Files IPR Challenge to UniQure Hemophilia Patents
With assistance from Jeannie Baumann and Nancy Ognanovich
To contact the reporter on this story: Brandon Lee in Washington at firstname.lastname@example.org