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Today brought some long-awaited news on the COVID-19 vaccine front, from both Moderna and Novavax.
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Let’s get started.
FDA fully approves Modern vaccine
The Food and Drug Administration (FDA) on Monday granted full approval to Moderna’s COVID-19 vaccine, giving an additional vote of confidence in its safety and effectiveness.
The full approval for people ages 18 and older was based on follow-up data showing “high efficiency and favorable safety approximately six months after the second dose.”
The vaccine had already been available since December 2020 under an emergency use authorization, but full approval provides an extra emphasis.
Acting FDA Commissioner Janet Woodcock said she hoped the move gives some people additional confidence in the vaccine.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” she said in a statement. 19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated. ”
Latest numbers: About 74 percent of adults are now fully vaccinated, according to Centers for Disease Control and Prevention data. The numbers are much lower for boosters, which are crucial for achieving higher protection against the omicron variant, with 44 percent of fully vaccinated adults having received a booster, according to the public health agency.
Read more here.
Novavax asks the FDA to authorize its vaccine
In the other big COVID-19 vaccine news, Maryland-based Novavax finally applied for emergency use authorization for its vaccine in adults.
The request was based in part on results from two large clinical trials of approximately 30,000 participants in the US and Mexico. The company said two doses of the vaccine given three weeks apart demonstrated an overall efficacy of approximately 90 percent, though the trials took place before the omicron variant became dominant.
Novavax was one of the six companies the US invested in as part of Operation Warp Speed. The company originally wanted to ask the FDA for authorization by May 2021, but had to delay the request multiple times due to numerous development and manufacturing setbacks.
The protein-based vaccine could provide an alternative to the mRNA shots available from Pfizer and Moderna, as there is a small risk the mRNA vaccines cause heart inflammation in certain adults.
The authorization process from the FDA could take several months, though the vaccine is available during emergency use from the European Commission, and the World Health Organization.
The Novavax vaccine is given in two doses spaced 21 days apart; the company recently announced plans to test a booster shot.
Read more here.
DRUG PRICING PRESSURE RISES
A group of 40 House Democrats is pressuring party leadership to act quickly on measures to lower prescription drug prices, highlighting the importance of the issue to the party, especially in an election year.
Lowering drug prices is a long-held policy goal for Democrats and a crucial aspect of their campaign messaging.
But the proposal is stalled in Congress along with a slew of other measures included in President BidenJoe BidenCongress in jeopardy of missing shutdown deadline Senate to get Ukraine, Russia briefing on Thursday As Social Security field offices reopen, it’s time to expand and revitalize them MORE‘s Build Back Better agenda, given concerns from Sen. Joe ManchinJoe ManchinCongress in jeopardy of missing shutdown deadline A strategic pivot to healthcare reform could save the midterms for Democrats Carville says he’d help fundraise for potential Gallego Senate bid MORE (DW.Va.) about other parts of the package.
The group of Democrats, led by Rep. Susan WildSusan WildTo boost economy and midterm outlook, Democrats must pass clean energy bill The Hill’s Morning Report – Presented by Altria – Marking the Jan. 6 ‘chaos and carnage’ Overnight Defense & National Security – Nation marks 1 year since Capitol riot MORE (Pa.), Is pushing to jumpstart action.
“We write today urging you to take legislative action as swiftly as possible to lower drug prices,” the Democrats, many of whom represent competitive seats, wrote to Speaker Nancy PelosiNancy PelosiSenate to get Ukraine, Russia briefing on Thursday The Super Bowl of hypocrisy comes to California as the homeless get hidden The promise of the House Select Committee on the Modernization of Congress MORE (D-Calif.) And Senate Majority Leader Charles SchumerChuck SchumerBiden’s ‘New Political Order’ The Hill’s Morning Report – Democrats sense opportunity with SCOTUS vacancy Schumer finds unity moment in Supreme Court fight MORE (DN.Y.). “For years, people have sent us to Washington on the promise that we end Big Pharma’s monopoly control over prices and provide patients with much needed relief. We must make good on that promise – and we have the ability to do so. ”
Unclear path forward: But the proposal is facing a murky path forward, given the obstacles for the larger Build Back Better package of which it is a part. Manchin supports action to lower drug prices, but he has concerns about other parts of the package related to spending and the possibility of causing more inflation.
Read more here.
WARREN SECURES ETHICS PLEDGE FROM FDA PICK
President Biden’s nominee to lead the Food and Drug Administration (FDA) made significant ethics concessions to Sen. Elizabeth WarrenElizabeth WarrenDemocrats press cryptomining companies on energy consumption Ocasio-Cortez: Supporting Sinema challenge by someone like Gallego would be easy decision Over 80 lawmakers urge Biden to release memo outlining his authority on student debt cancellation MORE (D-Mass.) In an effort to secure Democratic votes ahead of his confirmation.
In a letter to Warren, Robert Califf committed not to seek employment or compensation from any drug or medical device companies he interacts with as commissioner for four years following his tenure if confirmed.
Califf also committed to recuse himself from matters involving his former employers and clients for four years, two years longer than what is required in the Biden-Harris administration’s ethics pledge.
A spokesperson for Warren said the senator plans to support Califf if his nomination comes to a vote.
In 2016, Califf was easily confirmed by a vote of 89-4, but it’s not clear he has enough support among the necessary 50 senators this time around.
Read more here.
Hutchinson asks for path to endemic status
“And so that’s an important element that we as governors, in a bipartisan way, hope that the CDC can be helpful to define that more clearly,” added Hutchinson, who chairs the association. “We want to go from today to more normal.”
Context: Hutchinson’s call for a clear set of guidelines to help Americans ease back into normal life comes as recent polls have shown much of the public is fatigued and frustrated by the pandemic two years after the first cases were detected in the United States.
Still, President Biden cannot control a virus, and many areas of the country have already decided they are “done” with COVID, with no requirements for masks or vaccines anywhere.
Read more here.
WHAT WE’RE READING
- Millions of Americans have quit their jobs. Is Obamacare helping them? (CNBC)
- Protest against COVID mandates roils Ottawa despite officials’ plea for it to end (NPR)
- America’s split-screen pandemic: Many families resume their lives even as hospitals are overwhelmed (Washington Post)
- States were sharing covid test kits. Then omicron hit (Kaiser Health News)
STATE BY STATE
- In California nursing homes, omicron is bad, but so is the isolation (Kaiser Health News)
- Texas students, frustrated by limited COVID-19 protocols, turn to petition drives and walkouts (Texas Tribune)
- As Connecticut’s COVID-19 numbers improve, what’s next? Experts are optimistic – with some important caveats (Hartford Courant)
- UC is split over return to in-person classes (LA Times)
That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Tuesday.