FDA authorizes additional booster for people 65+

The FDA authorized additional COVID-19 boosters for people who are over 65+ or immunocompromised, while House Energy and Commerce hearings looked at PBMs and issues at the FDA. (653 words, 3 minutes, 15 seconds)

FDA authorizes additional bivalent booster for people over 65

People who are 65 and over or immunocompromised are authorized to receive an additional bivalent COVID-19 booster, the U.S. Food and Drug Administration (FDA) announced yesterday.

The decision: FDA updated the Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to allow a second bivalent booster for people 65+ after four months and for the immunocompromised after two months. The decision followed a January advisory meeting.

The bivalent boosters protect against the original strain of COVID-19 and the Omicron BA.4/BA.5 variants. An updated version is anticipated by fall.

“Data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” said FDA’s Dr. Peter Marks, adding that up-to-date vaccination gives the best protection against COVID-19.

Reminder: COVID is still a threat. Although almost everyone in the U.S. 5 and over has antibodies from vaccination or infection, 1,300 die from the disease weekly, and only 16.7% of the population has received a bivalent booster, according to the Centers for Disease Control and Prevention (CDC).

What’s next: FDA’s decision is expected to become recommended medical practice when the CDC’s Advisory Committee on Immunization Practices meets today.

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PBMs, FDA approval come up in Energy & Commerce hearings

Concerns over drug market distortions by pharmacy benefit managers (PBMs) and Food and Drug Administration (FDA) approvals came up in House Energy & Commerce Committee hearings yesterday.

Calling PBMs “gangsters,” Rep. Buddy Carter (R-GA) said three PBMs use their 80% market share to inflate drug prices, during the Innovation, Data, and Commerce Subcommittee hearing on the Federal Trade Commission (FTC) 2024 budget.

FTC’s investigation of PBMs to “scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs” was discussed by Rep. Carter and Rep. Diana Harshbarger (R-TN). FTC Chair Lina Khan promised results soon.

What about the Ohio lawsuit? Rep. Carter asked if the FTC is assisting the Ohio attorney general’s suit charging Express Scripts with conspiring to “illegally drive up drug prices.” Kahn said FTC is aware, but some information about the litigation is not public.

Catch up: What are PBMs, anyway?  I am BIO podcast explains.

On mifepristone: In a Subcommittee on Oversight and Investigations hearing, Rep. Frank Pallone (D-CA) said the Texas mifepristone ruling undermines FDA’s approval process.

On approval time: FDA approval for new cancer treatments takes too long, especially for pediatric drugs, said Rep. Dan Crenshaw (R-TX), urging FDA approvals accelerate to match the pace of research.

President Biden’s Wednesday: Delivering a speech contrasting his economic vision with that of House Republicans, as both sides tussle over the spending limit.

What’s Happening on Capitol Hill: Yesterday, global trade and intellectual property came up in two hearings. In the Senate Judiciary Committee’s Subcommittee on Intellectual Property, Chair Chris Coons (D-DE) and Ranking Member Thom Tillis (R-NC) called for stronger U.S. IP protection, and lawmakers agreed with witnesses that a WTO waiver for COVID diagnostics and therapeutics would further damage the global IP system and weaken U.S. leadership in biotechnology. Meanwhile, in a House Ways and Means Subcommittee on Trade hearing, Chair Adrian Smith (R-NE) said the expansion of the waiver would undermine U.S. credibility in enforcing IP protections.

Today, HHS' Assistant Secretary for Preparedness and Response Dawn O'Connell, CDC Director Dr. Rochelle Walensky and acting NIH Director Dr. Lawrence Tabak discuss their agencies’ 2024 budgets before the House Appropriations Labor-HHS-Education Subcommittee. Elton John testifies for the Senate Foreign Relations Committee hearing on the President’s Emergency Plan for AIDS Relief (PEPFAR). A Senate Agriculture, Nutrition & Forestry Committee subcommittee will hold a hearing on SNAP and other nutrition assistance in the Farm Bill.