Revisiting vaccine safety

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Feb 16, 2024 View in browser   By Lauren Gardner Programming note: We’ll be off this Monday for Presidents Day but will be back in your inboxes on Wednesday. Driving The Day Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research (shown here at a 2021 hearing), testified Thursday in front of a House panel investigating the systems that track adverse events from vaccines. | Susan Walsh/AP Photo COVID VACCINE MESSAGE WARS — A House oversight hearing Thursday on vaccine safety offered a platform for some members to accuse others of continuing to spread misinformation about the safety and effectiveness of Covid-19 vaccines. And others took a shot at relitigating pandemic-era communications and policy decisions. Officials from the FDA, the CDC and the federal government’s vaccine injury compensation program appeared before the Select Subcommittee on the Coronavirus Pandemic to testify about the systems that track adverse events from vaccines. The databases have shown that, despite the rare instances of serious side effects caused by the vaccines, their benefits far outweighed their risks. Some lawmakers complained the FDA and the CDC didn’t do enough to communicate clearly to the public how they investigated reports of possible adverse events from Covid shots. Anyone can report reactions to the Vaccine Adverse Event Reporting System, but federal agencies must conduct further investigation to determine whether a vaccine caused them. Separately, a federal program to compensate people injured by pandemic-era products like the Covid vaccines has received nearly 13,000 claims for alleged injuries from the shots and other treatments. So far, 40 claims have been deemed eligible for compensation. Meanwhile, others continued to insist children were at “zero risk” of serious outcomes from Covid. While children tend to fare better with Covid compared with older and high-risk adults, kids under 5 make up the greatest share of child deaths by age group, with 846 attributed to the disease through 2023. “I do need to apologize to the thousand or so parents of children who are under 4 years of age who have died from Covid-19 who were unvaccinated, because there were deaths and are continuing to be deaths in children, and that's the reason why you need to get vaccinated,” Dr. Peter Marks, the FDA’s top vaccine regulator, said during the hearing. Changes along the way: Marks and Dr. Daniel Jernigan, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, noted that federal surveillance systems identified myocarditis, or inflammation of the heart muscle, as a rare but potentially serious side effect of the messenger RNA vaccines, particularly in males ages 12 to 39. The FDA added a warning about the condition to Moderna’s and Pfizer’s shots, and the CDC later advised a longer dosing interval for the vaccines’ primary series, in part to mitigate the myocarditis risk in younger males. Still, some lawmakers bemoaned federal officials’ statements in 2021 about the vaccines’ ability to prevent viral transmission and some entities’ decisions to implement vaccine mandates — signaling that the U.S. public health system’s messaging problems persist. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Anyone else out there getting over “the 100-day cough”? Send news, tips and cough drops to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).   CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here.     Eye on the FDA FDA Commissioner Robert Califf wants to team up with agencies like the NIH to conduct more postmarketing research. | Jim Watson/AFP via Getty Images WHERE DOES THE DATA GO? FDA Commissioner Robert Califf fielded a good question this week from the Pink Sheet’s (and RxP alum) Sarah Karlin-Smith: Can the agency ensure the data Biogen collected on its Alzheimer’s drug Aduhelm be released publicly despite the company’s decision to discontinue the drug? “We can’t force the research to get finished if they discontinue a product,” he said after a lunch address at the National Press Club. “We have no authority to make them.” Califf suggested during his remarks that he’d like to partner with other federal agencies, like the National Institutes of Health, to do more postmarketing research so regulators aren’t solely reliant on industry to conduct the required studies, which he said incentivizes companies to “protect their asset.” Related reading: Marks hinted this week that the FDA could soon explain how it plans to use new powers to pull accelerated-approved drugs that don’t meet expectations from the market, David reports. ICYMI: CALIFF’S  MENTHOL BAN PUSH — Califf is encouraging friends and public health experts to pressure the White House to green-light the agency’s proposed ban on menthol cigarettes, David and POLITICO’s Adam Cancryn report. The behind-the-scenes pressure campaign is an unconventional turn for the agency chief but underscores Califf’s conviction that the ban would be a landmark public health policy, possibly saving hundreds of thousands of lives. The FDA sent its final rule to the White House for review in October, but it’s been held up amid pushback from Black leaders who have voiced concerns that a ban could worsen overpolicing in minority communities and trigger widespread illegal cigarette sales. Some have argued that it could even dampen Black voter turnout for the November election. Menthol cigarettes are most popular among Black smokers. In Congress A ‘STICKY’ SITUATION — The top House Democrat on FDA spending said this week that several issues are gumming up negotiations on the chamber’s appropriations bill for the agency and the Department of Agriculture, increasing the likelihood that Hill leaders will get involved. “There are probably around three or four issues that are sticky that will have to be resolved,” Rep. Sanford Bishop (D-Ga.) told POLITICO’s Garrett Downs. Government funding for the FDA runs out on March 1. Congress is in recess next week. Industry Intel K STREET EYES 340B PLANS — Lobbying around the 340B drug discount program grew last year in a sign of what’s likely to come in 2024 as lawmakers consider reforms, POLITICO’s Megan R. Wilson reports. Advocacy around the program has swelled in recent years as Congress has mulled more transparency measures to rein it in. Overhauling the program could save drugmakers billions, while so-called safety-net hospitals that sell outpatient drugs could take a hit. Research Corner PREGNANCY COVID SHOTS — Women who receive an mRNA Covid vaccine during pregnancy can provide strong protection against virus infection to their infants through at least 6 months of age, according to a recently published study from the National Institute of Allergy and Infectious Diseases. Researchers found that infants whose mothers received a booster dose during pregnancy had higher levels of antibodies at birth than those born to mothers who’d gotten just two vaccine doses, though they also displayed “a robust antibody response at birth.” Pharma Moves Dr. Robyn Neblett Fanfair has been appointed permanent director of the CDC’s Division of HIV Prevention. She’s a captain in the U.S. Public Health Service who has led the division in an acting capacity since August 2022. WHAT WE'RE READING A hospital group claims that a number of major drugmakers vastly overcharged them and the federal government through the 340B safety-net program, according to STAT’s Ed Silverman. Document Drawer Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) wrote to Califf on Wednesday, asking for clarification on the FDA’s authority to regulate prescription drug promotion on social media — and whether the agency wants and needs more power to address the issue, which they worry has kicked into high gear on many platforms.   DON’T MISS POLITICO’S GOVERNORS SUMMIT: Join POLITICO on Feb. 22 to dive into how Governors are wielding immense power. While Washington remains gridlocked, governors are at the center of landmark decisions in AI and tech, economic development, infrastructure, housing, reproductive health and energy. How are they setting the stage for the future of American politics, policies and priorities? How are they confronting major challenges? Explore these questions and more at the 2024 Governors Summit. REGISTER HERE.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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