Decision day for Covid-19 boosters

From: POLITICO Pulse - Thursday Sep 23,2021 02:06 pm
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Quick Fix

— The Biden administration is on the verge of rolling out Covid-19 vaccine boosters, though not to as wide a crowd as it first anticipated.

— Pfizer CEO Albert Bourla is urging his employees to oppose the drug pricing plan at the center of President Joe Biden's health agenda.

— The current ban on government drug negotiations cost taxpayers billions of dollars in higher prices, a report from House Democrats found.

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Driving the Day

DECISION DAY FOR BOOSTERSCoronavirus vaccine booster shots are coming. The question now is who will be first in line to get them.

The answer is likely to emerge from today’s meeting of outside CDC advisers, who are slated to spend hours debating the specifics of the much-anticipated booster rollout.

The pivotal session comes shortly after the FDA authorized Pfizer and BioNTech’s Covid-19 booster shot, clearing the way for the administration to begin carrying out a plan it first telegraphed in mid-August.

The FDA authorization did establish some initial parameters, greenlighting the shots for three categories of Pfizer vaccine recipients six months after finishing their first series. Those categories are: people 65 and older, people 18 to 64 at high risk of severe Covid-19, and people 18 to 64 whose jobs could expose them to the virus enough to make severe Covid-19 a high risk.

But some specifics still need to be hashed out, especially in defining what types of occupations qualify people in that last group to get a booster as soon as possible. The CDC advisory panel laid some of that initial groundwork during its first day of meetings Wednesday, POLITICO's Lauren Gardner wrote.

The CDC is not bound to follow whatever its conclusion its advisers reach, but has so far reliably followed their advice over the past several months.

The upshot: The booster rollout could get officially underway by the end of the week, just under the wire for the deadline the White House initially set when it first announced plans for an additional shot.

That Aug. 18 pledge — which came before the FDA and CDC had weighed in on the science — spurred weeks of internal disputes and badly muddled the administration’s vaccine campaign to the point that Biden himself sought to reset the messaging two weeks ago.

But reaching a conclusion today won’t be a total victory for the White House, no matter how officials try to spin it. The original plan was to give boosters to all adults eight months out from their last vaccination — a blanket policy that appealed to Biden’s Covid team for its simplicity.

This rollout will instead be far narrower and more complicated, beginning first with just a slice of the population — and bringing with it all the challenges of convincing the rest of the nation to wait its turn.

BIDEN’S ‘GOOD FRIEND’ HATES HIS DRUG PLANWhen Biden kicked off Wednesday’s global Covid-19 summit, he went out of his way to laud one person: Pfizer CEO Albert Bourla, who he hailed as a “good friend” and a leader in the pandemic fight.

But while Biden piled on the praise, Bourla was busy trying to kill the president’s signature drug plan.

The Pfizer chief sent a video message to his employees urging them to oppose the Democrats’ plan to let the government directly negotiate drug prices, Sarah scooped, arguing that the provision would have “little positive impact” and expressing frustration with Congress.

Bourla also framed the fight against Biden’s core drug policy as a top priority, telling staff it was as “equally important” to educate themselves on the policy’s drawbacks as it was to speed the development of the Covid-19 vaccine.

The appeal comes as the pharmaceutical industry ramps up lobbying against the drug pricing effort at the center of the White House’s health agenda — and while companies like Pfizer work closely with the administration on Covid-19.

The major drug industry group PhRMA earlier this month warned that its companies’ ability to innovate was “under attack” from Democrats crafting the drug price reforms, and launched a seven-figure ad campaign to fight the proposal.

Three centrist Democrats — who have received significant campaign donations from the pharmaceutical industry — have since come out against the plan, putting Democrats’ entire social spending bill at risk.

On Wednesday, hours after praising Bourla, Biden met with various groups of congressional Democrats to try to personally salvage the package.

The White House did not respond to questions about Bourla’s video message — or the status of his friendship with Biden.

FIRST IN PULSE: DRUG NEGOTIATION BAN COST TAXPAYERS BILLIONS, DEMS PROJECT — A new House Oversight Committee report calculates that the current ban on negotiating drug prices Bourla and company are trying to preserve forced taxpayers to pay at least $25 billion more than they should have for just seven drugs over the past four years.

The projection is the latest data point that top Democrats are using to pressure centrist holdouts to support the party’s aggressive drug pricing plan, POLITICO’s Alice Miranda Ollstein reports.

The Oversight Committee has spent the past two years investigating pharmaceutical prices as part of an effort to build momentum for reining in the industry — and this is the eighth report it’s made public. But it comes as Democratic leaders are trying to salvage their drug price ambitions.

Other conclusions included in the report:

— Drug companies relied on Medicare — and its inability to negotiate prices — to boost profits. Internal documents obtained from manufacturers including Pfizer and Novartis show that Medicare Part D has driven financial growth faster than in the commercial market, the committee said.

— Drug companies have consistently raised prices in the U.S. to boost profits, since most other developed countries directly negotiate the cost of medicines.

— Giving the government the power to negotiate with just three insulin makers would have saved taxpayers $16.7 billion between 2011 and 2017.

 

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Vaping

FDA CRACKDOWN PLUNGES VAPE SHOPS INTO CRISIS — In the days since the FDA ordered more than 6 million flavored e-cigarettes off the market, small- and medium-sized vape shops have scrambled to plot their next move, POLITICO’s Katherine Ellen Foley reports.

The deliberations have split the industry into two camps: Those eager to defy the FDA’s decision and continue doing business as usual, and those who want to find legal ways of staying in business — either by exploiting a loophole or taking the government to court.

“I don’t think I’m doing anything wrong from an ethical or moral standpoint,” said one Arizona vape-shop owner who’s selling their products even after receiving formal orders to pull them off the shelves. “I never said it was healthy … in the grand scheme of vices, [vaping] is probably worse than coffee, but better than cigarettes.”

That attitude could eventually force the FDA and states to step up enforcement of flavored e-cig manufacturing and sale bans — and raises the prospect of a drawn-out fight between regulators and business owners.

But first, the FDA has to decide the fate of the industry’s largest manufacturers, including Juul, Vuse and NJOY. Those products are still being sold widely at gas stations, convenience stores and other retailers, and account for the bulk of the market share.

 

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Coronavirus

BIDEN ADMIN INKS MORE RAPID TEST CONTRACTS — The government is adding to its agreements with Covid-19 test manufacturers, signing a spate of contracts in recent days, POLITICO’s David Lim reports.

The Defense Department awarded a $109 million deal to OraSure Technologies to increase production of its rapid InteliSwab test from 8.3 million to 16.7 million units a month by March 2024, according to an administration official.

Cepheid, meanwhile, signed a $63.8 million contract to boost production of molded plastic cartridges for real-time PCR tests by 3.2 million units a month come September 2022.

Those follow Defense Departments award worth up to $626.4 million to Celltrion USA and up to $554.4 million to Abbott for rapid point-of-care tests. The order period for those one-year contracts ends Sept. 16, 2022.

ICYMI: US PARTNERS WITH EU ON VAX DISTRIBUTION — The United States struck a partnership with the European Union to coordinate Covid-19 vaccine distribution to the rest of the world, Biden announced Wednesday.

The administration is also sending an additional $370 million to aid delivery and administration of the shots globally, as well as $380 million to specifically bolster work done by the Gavi, the Vaccine Alliance, to get the vaccine to the neediest regions.

The moves came as part of a global summit to outline plans for fighting the pandemic around the world. Biden also proposed holding a follow-up summit early next year to measure countries’ progress.

But not everyone came away impressed. Oxfam America blasted the event as “full of speeches but tragically lacking in action,” calling the 1 billion doses the U.S. has committed to donate far below the amount needed to curb the virus.

Advocacy group Public Citizen also criticized the government for not pushing harder to waive patent rights and share the proprietary details needed to more widely manufacture vaccines.

 

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What We're Reading

Sen. Susan Collins, one of the few remaining Republican abortion-rights supporters, is opposed to a Democratic bill that would ban states like Texas from restricting abortions through fetal viability, The Los Angeles Times’ Jennifer Haberkorn reports.

A “simple and ugly” forum cataloging the deaths of anti-vaxxers from Covid-19 has become one of the fastest-growing subreddits on Reddit.com, Slate’s Lili Loofbourow writes.

The CEO of Sutter Health is retiring after two years of turmoil that included paying $575 million in damages to resolve an antitrust case, The Sacramento Bee’s Dale Kasler reports.

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