Pfizer makes a case for more boosters among older adults- POLITICO

With Alice Miranda Ollstein, David Lim and Erin Banco

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Pfizer and BioNTech say older people need another Covid-19 booster, citing data from Israel that may not convince regulators.

Hospitals are worried about a shortage of fluids for IV bags after a perfect storm of pandemic struggles and transportation problems.

Senators seek to jump-start drug pricing talks but without a clear agenda to revive long-circulating measures.

WELCOME TO WEDNESDAY PULSEDaylight savings forever? We can think of a few things we’d rather see the Senate get united behind, but we’ll take it. Send your own Senate wishlist, news, and tips to [email protected] and [email protected].

A message from PhRMA:

ICYMI: A majority of Americans reject so-called government “negotiation” once they learn it could restrict access and choice and chill the innovation of new treatments and cures. The survey also shows a majority find health care coverage costs unreasonable and a top priority health care issue for policymakers to address today.

PFIZER WANTS TO ADD BOOSTERS FOR OLDER ADULTS — Pfizer and BioNTech have asked the FDA to grant emergency use authorization for a fourth Covid-19 vaccine dose for people 65 and older amid fears of waning immunity ahead of a possible late-spring wave of infections, the companies said Tuesday.

The backstory: Their request is based on real-world data from Israel that suggests another vaccine dose boosts protection against the Omicron variant while maintaining its safety profile. But it’s unclear whether that’s enough data for the FDA to consider amending the existing EUA, which allows one booster dose, POLITICO’s Lauren Gardner writes.

State of play: Moderately to severely immunocompromised people are permitted to seek out fourth doses of messenger RNA vaccines. Currently, anyone 12 and older can receive a Pfizer-BioNTech booster dose at least five months after completing their primary series.

Pfizer CEO Albert Bourla said Sunday that a fourth shot would be needed based on data the company had collected, continuing a pattern of getting ahead of the government’s decision-making process on vaccine schedules. Case in point: When Pfizer last recommended a booster, FDA officials initially disagreed but then ultimately changed course and recommended the shot.

SALINE, DEXTROSE SHORTAGES WORRY HOSPITALS — Hospitals and supply-chain experts are raising concerns that shortages of dextrose and saline solutions — basic IV fluids needed for routine care and drug delivery — will affect patient care if logistical logjams for the products don’t resolve in the coming weeks, David reports.

Why it’s happening: Transportation delays at U.S. ports, Covid-19 infections among manufacturing facility staff and increased demand for raw materials are all partially to blame, according to manufacturers. While Covid-19 infections have declined significantly since the peak of the Omicron wave in January, hospitals fear that if shortages of dextrose and saline solutions persist, they’d need to push off elective surgeries to save supplies.

SENATE TRIES TO RESTART DRUG PRICE REFORMThe Senate Finance Committee is holding a hearing this morning on drug price reform as Democrats attempt to revive their plan to allow direct government negotiation with pharmaceutical companies.

Yet, the hearing won’t feature new proposals or focus on the policies package the House passed last year, Alice reports. Those measures would penalize drugmakers who raise prices faster than inflation and limit out-of-pocket costs for insulin, among other provisions.

Instead, the committee will focus more broadly on the effects of high drug prices and allow people to float ideas to address them.

“This has been the longest-running battle since the Trojan War,” Finance Chair Sen. Ron Wyden (D-Ore.) told reporters Tuesday. “We’ve been debating and debating, but now’s the time to get relief to the millions of people who are trying to figure out how to afford insulin, arthritis medicine and the like.”

FIRST IN PULSE: DEM WOMEN ON OVERSIGHT ASK BECERRA FOR MEETING ON ABORTION PILLS — All the women members of the House Oversight Committee wrote to HHS Secretary Xavier Becerra on Wednesday, asking for agency action to make abortion pills more affordable and accessible and demanding a meeting on the issue, Alice reports.

The letter, led by committee chair Rep. Carolyn Maloney (D-N.Y.) and Reps. Ayanna Pressley (D-Mass.) and Cori Bush (D-Mo.), praises the Biden administration for lifting the decades-old restriction that required a doctor to personally hand the pills to a patient. Now, for the first time, the pills can be legally prescribed via telemedicine and mailed to patients’ homes or local pharmacies.

But given the national crackdown on access to abortion, including a tsunami of new laws in red states to make the pills harder to obtain, the women on the committee are asking HHS’ new Reproductive Healthcare Access Task Force to go further.

“The federal government must continue to use every tool at its disposal to ensure that medication abortion is accessible, affordable, and convenient for patients who seek it,” they wrote.

LAWMAKERS GO ON OFFENSE OVER TRANSIT MASKINGSome Democratic lawmakers have joined Republicans in pushing back against the White House’s extension last week of the federal mask mandate on planes and other public transportation, POLITICO’s Oriana Pawlyk and Alex Daugherty write.

On Tuesday, the Senate adopted a mostly symbolic resolution that would nullify the CDC’s rule requiring mask mandates on public transportation, with eight Democrats joining all Republicans present except Sen. Mitt Romney (R-Utah), who voted no. It’s not expected to pass the House and faces a likely veto from the White House if it does.

Earlier in the day, Sen. Roger Wicker (R-Miss.), ranking member of the Senate Commerce Committee, said the mask mandate, now in place until April 18, is inconsistent with other CDC guidelines that suggest most Americans no longer need to wear masks in other settings. On Monday, a group of House lawmakers filed a lawsuit against the CDC to end the travel mask mandate. (Never mind that it was the TSA that issued the order.)

OMICRON HIT THE LITTLEST KIDS HARD — A new CDC study released Tuesday found that children ages 0 to 4 were five times as likely to be hospitalized because of an Omicron infection than a Delta variant, reaching the highest level of the pandemic in January 2022. Hospitalization rates for infants and children have declined since Omicron’s Jan. 8 peak.

ICU admission rates for the age group were also 3.5 times higher during the Omicron wave than during Delta, the study found. The most affected group were infants under 6 months, which has seen the highest hospitalization rates in children throughout the pandemic.

A message from PhRMA:

CALIFORNIA REBUFFS EFFORT TO END EMERGENCYCalifornia senators on Tuesday rejected a Republican effort to halt Gov. Gavin Newsom’s emergency powers nearly two years after he first invoked them to respond to the pandemic.

State Republicans argue that receding infection and death rates show the crisis has passed — pointing to Newsom’s declaration that California is entering a new phase of living with the virus — and that it was time to restore a constitutional balance of power, POLITICO California’s Jeremy B. White writes.

Democrats stymied the measure on a largely party-line vote, embracing the argument that first responders and healthcare providers need the ability to respond nimbly and swiftly to new variants. The GOP measure also drew opposition from firefighter, hospital and labor groups plus big-city mayors, with each highlighting provisions or support the emergency gave them.

US INCREASES AID TO UKRAINE, CITING WORSENING HEALTH CONDITIONS — As Russian bombardment intensifies in Ukraine, the Biden administration is increasing its humanitarian assistance to those both trapped in the country and seeking refuge in countries such as Poland, Moldova and Romania.

The administration announced Tuesday that it’s sending an additional $186 million in assistance to help internally displaced persons inside Ukraine. The U.S. is also working with international partners, such as the World Food Programme and the International Organization for Migration, to distribute aid, including food, blankets and medical supplies, inside the country.

Senior administration officials told reporters that the situation is growing increasingly desperate as Russia ramps up its attacks on major roads and rail lines, cutting off aid routes. Kyiv and Moscow have in recent days tried and failed to broker ceasefires and establish clear humanitarian corridors.

“We’re hearing distressing reports from our partners in cities like Mariupol where people remain in dire conditions and lack safe drinking water, food, fuel and electricity,” a senior administration official told reporters Tuesday. “The extensive damage we are seeing all day means that shelter may be inadequate at a time when people face cold weather.”

The National Institute for Health Care Management shortlisted Joanne Kenen, Darius Tahir and Allan James Vestal’s probing POLITICO series on the pandemic’s devastating toll on Veterans Affairs nursing homes for its annual journalism awards.

Eli Lilly, Novartis and AbbVie join other drugmakers in scaling back business in Russia after the Ukraine invasion, Reuters reports.

First Gentleman Douglas Emhoff tested positive for Covid-19 on Tuesday after seeing his wife, Vice President Kamala Harris, in the morning. Harris and others continue to test negative, Los Angeles Times’ Noah Bierman reports.

Jeff Younger’s public custody battle fueled a Texas movement against transgender health care and, now, his run for state legislature. The Texas Tribune’s Karen Brooks Harper takes us inside the tense fight.

A message from PhRMA:

According to a new poll, voters overwhelmingly support policies that would lower out-of-pocket costs and bring greater transparency and accountability to the health insurance system.

 We need to make the cost of medicine more predictable and affordable. Government price setting is the wrong way. The right way means covering more medicines from day one, making out-of-pocket costs more predictable and sharing negotiated savings with patients at the pharmacy counter.

Learn more.


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