More options enter the vaccine game, but new variants loom large — European leaders balk as AstraZeneca lags — HHS confident in syringe supply

By Sarah Owermohle

Presented by The AIDS Institute

With David Lim, Brianna Ehley and Emily Martin

— More options enter the vaccine game, but new variants loom large.

— European leaders balk as AstraZeneca lags while Sanofi chips in for others.

— HHS confident in syringe supply as providers scramble for needed vaccine tools.

It’s Friday, welcome back to Prescription Pulse. Here for this headline, not for this rollout. As always, send tips to Sarah Owermohle at sowermohle@politico.com or @owermohle. Loop in David Lim (dlim@politico.com or @davidalim) and Brianna Ehley (behley@politico.com or @briannaehley).

A message from The AIDS Institute:

People with HIV can’t afford another health crisis. In the midst of a global pandemic, there’s another public health crisis looming for people with HIV. A new Trump Administration rule threatens to drastically increase out-of-pocket costs for life-saving HIV medicines. Help fight this rule. Call the White House and demand they leave copay assistance alone. TheAidsInstitute.org/action

MORE OPTIONS ENTERING THE VACCINE GAME, BUT VARIANTS LOOM LARGE — Maryland biotech Novavax released welcome news Thursday that its Covid-19 vaccine is 89 percent effective in a late-stage trial. The catch: The shot is significantly less effective against the strain first found in South Africa. South Carolina on Thursday reported the first known cases of that strain in the U.S.

It’s a notable gap. Moderna said earlier this week that its own vaccine, using messenger RNA technology, is slightly weaker against that variant but still protective. But Novavax reports that its shot is just 49.4 percent effective after a phase IIb study in South Africa. Company executives told investors they are in conversations with FDA about whether the data from the U.K. and South African trials will enable Novavax to apply for emergency use authorization.

Officials have been worried about this. Top infectious disease expert Anthony Fauci told POLITICO this week that the South African variant is “problematic” and it is “prudent” for companies like Moderna to get to work on a booster shot. Pfizer, maker of the other authorized Covid-19 vaccine along with BioNTech, also says it is exploring the data to understand its shot’s efficacy against the emerging variant.

In the meantime, the Centers for Disease Control and Prevention is recommending against travel right now, while the White House is banning visits from South Africa and much of Europe and requiring negative tests from Americans returning from those countries.

Don’t forget: Johnson & Johnson, maker of the single-dose candidate, should release data for its single-dose shot today.

WHAT IS GOING ON WITH THE ASTRAZENECA VACCINE? European leaders are increasingly frustrated with the British drugmaker after a shortfall in vaccine doses. Some regional officials are calling on AstraZeneca to publish its production contracts while others say it could be time to invoke emergency provisions that steamroll patents.

The anger comes after a production lag and comments by AstraZeneca CEO Pascal Soriot in the Italian newspaper La Repubblica — noting caveats to the agreement and saying the company is making its “best efforts” to supply 100 million vaccines.

Remember: The United Kingdom and a handful of other countries have authorized the AstraZeneca and Oxford shot; the European Union is expected to approve its use today. While U.S. regulators have not weighed in on the vaccine yet, the government did order 300 million shots from the manufacturer.

European Union officials are struggling to close up the gap on vaccine supplies, our POLITICO Europe colleagues report. Authorities have threatened to get their money back — a €336 million down payment — if AstraZeneca doesn’t deliver all its promised doses for the first quarter, writes Jillian Deustch.

And European Council President Charles Michel on Thursday also said the EU could invoke emergency provisions in the region’s treaties to meet the shortfall. Those could include forcing vaccine makers to share their patents and other licenses to ramp up production, David Herszenhorn writes.

MEANWHILE: ANOTHER MANUFACTURER LENDS A HAND — French drugmaker Sanofi announced this week that it will help Pfizer and its German partner BioNTech with bottling Covid-19 vaccines destined for Europe.

Production won’t start until July, but Sanofi CEO Paul Hudson told Le Figaro that the company should be able to chip in 100 million doses by the end of the year. They will churn out of Sanofi’s Frankfurt facility, which isn’t far from BioNTech’s headquarters.

The news comes after Sanofi’s own Covid-19 vaccine attempt, developed with GSK, failed to show sufficient immune response in older adults in early trials, delaying its production until late 2021.

A message from The AIDS Institute:

HHS CONFIDENT IN SPECIALTY SYRINGE SUPPLY — The federal health department does “not anticipate an immediate shortage” of low dead-volume syringes needed to help extract a sixth dose from Pfizer and its German partner BioNTech’s Covid-19 vaccine vials based on “current contracts,” an HHS spokesperson tells POLITICO. Demand for the ultra-efficient syringes has increased since Pfizer said it would deliver fewer vials to the U.S. when the speciality syringes are able to garner a sixth dose.

Pharmaceutical and medical supply distributor McKesson, which is helping the government provide vaccination supplies, began to ship “larger supply kits to support ... six doses per vial” of Pfizer’s vaccine early last week, company spokesperson David Matthews said in an email.

CVS spokesperson Mike DeAngelis told POLITICO the pharmacy chain was previously using its “existing stock” of low dead-volume syringes augmented by “a supply of them that we were able to procure” prior to the McKesson change. Walgreens, the other major retail pharmacy already administering Covid-19 vaccinations, declined an interview on its supply of low-dead space syringes.

More supplies are on the way. The U.S signed a contract for 286 million syringes with BD in 2020 — of which a little more than 40 million are low dead-volume syringes slated to be delivered to the government between now and March, according to a company spokesperson.

But Biden officials are worried. The administration’s 200-page national pandemic strategy calls out the specialty syringes as one of 12 products needed for pandemic response that face an “immediate supply shortfall.” Biden health advisers have raised the possibility of using the Defense Production Act if necessary.

“Everything is on the table across the whole supply chain, from the [specialized] syringes, to other pharmaceutical companies, to anything we can do to increase the vaccine supply and the timing of the delivery,” White House Covid-19 coordinator Jeff Zients said Wednesday.

HOUSE OVERSIGHT DEMOCRAT WANTS ANSWERS ON TRUMP ADMINISTRATION CONTRACT FOR VENTILATORS — Rep. Raja Krishnamoorthi, (D-Ill.), a member of the House Oversight and Reform Committee, is requesting information about a $70 million U.S. contract for ventilators that may not be appropriate to treat coronavirus patients.

Krishnamoorthi has reached out to Safeguard Medical and AutoMedx, Inc. regarding the purchase of SAVe II and SAVe II+ ventilators following a Washington Post report that the machines are intended to treat wounded soldiers and not the kind of respiratory problems caused by the coronavirus.

TRACK THE FIRST 100 DAYS OF THE BIDEN ADMINISTRATION: A new president occupies the White House and he is already making changes. What are some of the key moments from Biden's first week in office? Find out in Transition Playbook, our scoop-filled newsletter tracking the appointments, people, and emerging power centers of the first 100 days of the new administration. Subscribe today.

OPIOID ADVOCATES RAISE WOODCOCK CONCERNS — Janet Woodcock, frontrunner to lead Biden’s FDA, is facing growing scrutiny over her decades-long track record at the agency, including several years overseeing its drug division during the opioid crisis.

Democratic Sens. Maggie Hassan of New Hampshire and Ed Markey of Massachusetts warned Wednesday that the agency hasn’t “fully reckoned” with drug approvals and labelling decisions that allowed dozens of opioids onto the market, contributing to the opioid abuse epidemic.

“It’s important that the next FDA commissioner is someone who has demonstrated that they have learned from the FDA’s past mistakes – not someone who has been involved in repeating them,” they said, just hours after more than two dozen consumer health groups declared their opposition to Woodcock over similar issues.

Hassan sits on the Senate health committee that would hold confirmation hearings on Biden’s FDA nominee.

— The opioid issue has long plagued the FDA. Agency critics argue it needs to take public health issues into account when approving opioids. FDA officials have said that could open a Pandora’s box for regulators because each drug needs to be reviewed independently on its safety and effectiveness, not necessarily stacked up against predecessors.

Former FDA Commissioner Scott Gottlieb even weighed in after the agency approved a controversial, super-potent fentanyl pill in 2018. He defended the decision but said FDA “should consider whether we should be doing more” to assess opioids in the broader health crisis.

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FDA RESUMING MORE INSPECTIONS ABROAD — FDA CDER acting director Patrizia Cavazzoni tweeted Tuesday the agency has resumed priority inspections in China and plans to restart them in India “shortly.”

Melissa von Stauffenberg will become the Biotechnology Innovation Organization’s first chief marketing officer on Feb. 1.

A message from The AIDS Institute:

In the midst of a global pandemic, there’s another public health crisis looming for people living with HIV. A recently imposed Trump administration rule threatens to take away much-needed copay assistance for patients relying on HIV medicines. And that would mean drastic increases in out-of-pocket costs. For too many, these life-saving medicines could become too expensive to afford. And let’s face it — HIV is treatable only if the medicines patients rely on are affordable. Putting them out of reach financially is cruel, unsafe and unnecessary. Please help us right this wrong. Call the White House and demand they leave copay assistance for HIV medicines alone. TheAidsInstitute.org/action

— The Washington Post’s Eli Saslow spoke to Stanley Plotkin, 88, a world-renowned vaccinologist, about his involvement in developing the Covid-19 vaccine and the subsequent chaotic distribution. Even he, part of the priority group, is struggling to get a dose.

— U.S. pharmaceutical distributors are looking to increase the number of companies shipping coronavirus vaccines as part of the Biden administration’s push to speed up inoculations, Reuters reported.

— Some governments are wrestling with how to prioritize vaccine doses — whether that is getting as many first shots out as possible or reserving an already limited supply to deliver second doses at the optimal time. Scientists are warning untested timelines could cause even more problems, Fortune Magazine reported.

The National Institutes of Health launched a new database of information from clinicians about Covid-19-related neurological symptoms, complications and outcomes as well as effects on pre-existing neurological conditions.

Science Magazine published a study that found a cancer drug from manufacturer PharmaMar was almost 30 times more potent than remdesivir in treating Covid-19.

FDA released final guidance aimed at making certain coagulation systems more available during the Covid-19 public health emergency.

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