What is the real Warp Speed timeline?

With help from Zachary Brennan, David Lim, Brianna Ehley and Lauraine Genota. — What is

With help from Zachary Brennan, David Lim, Brianna Ehley and Lauraine Genota.

— What is the real Warp Speed timeline? A new Pentagon website raises questions.

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AstraZeneca leads vaccine trial enrollment, but companies are a far cry from 30,000 apiece.

FDA says HCQ came from a questionable manufacturer in new memo.

It’s Friday, welcome back to Prescription Pulse. Did you get your Anthony Fauci bobblehead before they sold out? Never fear, they’re introducing a new line: Facepalm Fauci. Send weird pandemic souvenirs, pharma tips and news to [email protected] or @owermohle. Loop in David Lim ([email protected] or @davidalim) and Zachary Brennan (zbrennan[email protected] or @ZacharyBrennan)!

WHAT IS THE REAL WARP SPEED TIMELINE? The Department of Defense unveiled an Operation Warp Speed website on Thursday, including a vaccine development timeline that raises new questions about whether the initiative will meet its goals. The timeline says the coronavirus vaccine development process has been sped up from a standard 73 months to 14 months. But coronavirus vaccine development didn’t begin until January, 12 months before Warp Speed’s January 2021 goal to deliver 300 million safe and effective vaccine doses.

Warp Speed officials seemed surprised. “I have not seen that graphic but I can tell you and reiterate that we are on track to deliver hundreds of millions of doses by January 2021,” Paul Mango, HHS deputy chief of staff for policy, said on a call with reporters Thursday afternoon. “I’m not sure of the math of that graphic; maybe that’s a mistake if it says 14 months.”

HHS officials discussed the graphic for a moment on the call, with one saying “it looks like a draft.” Mango left the briefing shortly after for another meeting.

NIH Director Francis Collins said that it was not a discrepancy, but rather three months built in to distribute a vaccine.

“That is the process of getting a dose to every American, which we didn’t expect we could do on the first of January. That’s going to take months to do … with the expectation of FDA giving an emergency use authorization,” he said. FDA left a window for emergency use in recent guidance, but vaccine experts have balked at the idea of that authority before full data for any shot.

Remember: “We’re on pace to have a vaccine available this year, maybe far in advance of the end of the year,” Trump said during a White House press briefing last week.

The expedited timeline reduces “the typical 12-month [FDA] approval process to three months,” the website says. But FDA’s typical approval process takes 10 months, expedited reviews are done in six months, and some accelerated approvals have come even faster.

FIRST IN Rx PULSE: ASTRAZENECA LEADS THE FIELD OF LATE-STAGE VACCINE TRIALS — AstraZeneca and Oxford University have now enrolled more than 11,000 people in three late-stage clinical trials testing their vaccine candidate in the U.K., South Africa and Brazil, a spokesperson for Oxford University told Prescription Pulse’s Zachary Brennan. That total includes more than 3,000 people vaccinated in Brazil, almost 1,000 in South Africa, and more than 7,500 in the UK.

The companies expect the three Phase II/III trials will enroll a total of about 17,000 participants, who will each receive two doses of the vaccine. Oxford and AstraZeneca also plan to run a U.S.-based Phase III trial with 30,000 participants, beginning later this month. HHS previously said the first AstraZeneca coronavirus vaccine doses could be available in October.

The overseas AstraZeneca trials, which began in June, are on pace to finish before two late-stage U.S. trials of Pfizer’s and Moderna’s vaccines. Those began in late July and have enrolled fewer than 5,000 participants so far, according to CNN.

Pfizer expects to complete enrollment in its trial — enrolling at least 25,000 more people — in the first half of September, a company spokesperson said. Pfizer CEO Albert Bourla told the Washington Post last week that his company aims to seek FDA approval in October. Moderna expects to complete enrollment of its late-stage trial in September, a spokesperson told Prescription Pulse.

Elsewhere, China-based Sinopharm has now injected one of two vaccine doses into 15,000 participants in a late-stage trial in the United Arab Emirates.

RESEARCHERS: DO BETTER ON COVID TRIAL DIVERSITY — We already know there have been disproportionately high rates of coronavirus infections, hospitalizations and deaths in racial and ethnic minorities. But clinical trials haven’t caught up to the need in those populations yet, writes a group of scientists in a New England Journal of Medicine perspective this week.

Case in point: There was no race or ethnicity data for patients treated with Gilead’s remdesivir under the compassionate use pathway. In two randomized trials for the therapy, Black Americans accounted for just 20 percent and 11 percent of volunteers. Latinx and Native American populations had similarly small enrollment, despite all three groups being overrepresented in Covid-19 cases and deaths in the areas around the trial sites, the researchers write.

“Lack of diversity in these clinical trials may stem from long-standing medical distrust on the part of minority communities, but the problem may be compounded by cost … poor health literacy, lack of information, language barriers, limited accessibility, and implicit biases against minorities,” they note.

VACCINE MANUFACTURING: THE NEXT HURDLE — The U.S. government has now signed six deals with vaccine-makers to produce coronavirus shots, even before it’s clear any are effective — and with a risk the companies won’t be able to ramp up production in time to deliver hundreds of millions of doses.

Some of the experimental vaccines use technology that has never before reached the market, so there is no precedent for producing hundreds of millions of doses. Other potential bottlenecks include a global sand shortage that could throttle the production of glass vials, and limited supplies of chemicals called adjuvants that are sometimes used to boost a vaccine’s ability to provoke an immune response.

“The challenge is no different than putting a man on the moon,” said Sean Kirk, executive vice president of manufacturing and technical operations at Emergent Biosolutions.

What are the major ways to implement vaccination strategies and which makes most sense now? Our Pro DataPoint colleague Cristina Rivero lays it out in a handy graphic. Here’s a teaser:

HHS INVESTS $6.5M INTO LAB CAPACITY — Testing czar Brett Giroir announced Thursday the government is working to boost Covid-19 testing capacity by 1 million per week by early October by investing $6.5 million into labs run by Aegis Sciences and Sonic Healthcare.

HHS will provide lab equipment from Beckman Coulter Life Sciences and Thermo Fisher Scientific to the facilities. Other funds will be used to help increase staffing and other infrastructure.

“We expect by September, we will have the capacity to do almost 90 million tests,” Giroir told reporters. “We do expect point of care tests that are low cost, cheap and and high volume that are going to have good sensitivity, potentially coming on the market within the next couple of months and know that they’re in process with the FDA,” he added.

FDA MEMO: HCQ CAME FROM QUESTIONABLE MANUFACTURER More information on the lead-up to the FDA authorizing the emergency use of hydroxychloroquine and chloroquine emerged this week, with the release of a memo the agency issued in March to allow imports of the drugs from a dubious source.

The memo notes that the agency allowed India-based IPCA Laboratories to send supplies of both unproven drugs to the U.S. as coronavirus treatments, despite not being allowed to ship other drugs and as the agency uncovered numerous issues in a 2014 inspection of the company. In particular, FDA inspectors questioned the firm’s data handling practices after finding some raw data files were manipulated or deleted.

The memo was sent a few weeks before FDA issued an emergency use authorization for HCQ and chloroquine. That EUA was later retracted as the drugs failed to show any benefit in treating Covid-19. Ousted BARDA Director Rick Bright also previously warned in his whistleblower complaint of HCQ supplies coming from factories in Pakistan and India that had not been inspected by the FDA.

FDA SEEKS CONTRACTOR TO TEST CBD PRODUCTSThe FDA is seeking a third party to help it sample and test consumer CBD products across the U.S. in a solicitation posted Thursday.

What is the agency looking for? A team to sample a variety of CBD products and test them for cannabinoid content and contaminants, starting this September. The study will involve sampling 1,000 to 3,000 products, with the contractor responsible for having the necessary lab equipment, POLITICO cannabis reporter Mona Zhang writes.

“These studies and the analytical information they obtain will not only be reported to Congress, but will also be used to guide the development of future policy,” the request said.

LUNG CANCER DEATHS SHARPLY FALL WITH NEW MEDS — Mortality rates from the most common lung cancer have dropped significantly in the U.S. due to new treatments, the National Cancer Institute said in a study published this week.

Lung cancer rates had been decreasing steadily for years as tobacco use fell, but this is the first clear evidence that medical advances also had a hand, said NCI Deputy Director Douglas Lowy, who co-authored the study. In the past decade there have been several new drugs targeting genetic mutations in non-small cell lung cancer, which accounts for roughly three-quarters of U.S. cases. Those gene-targeting drugs include EGFR and ALK inhibitors.

The numbers: In recent years, non-small cell lung cancer deaths decreased faster than new-case trends, and survival rates improved. Researchers also said that two-year survival improvements happened across race and ethnicities, “despite concerns that the newer cancer treatments, many of which are expensive, might increase disparities.”

Worth noting: Newer gene-targeting therapies like Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, leaders of a new wave of checkpoint blockers, were not widely available during this timeframe — so we could see sharper trends in the future.

STATES SLOW TO EMBRACE MAT IN CORRECTIONAL FACILITIES — A new analysis from Georgetown University’s O’Neal Institute says many states have been slow to expand medication assisted treatment to incarcerated populations, despite the high prevalence of opioid use disorder among this cohort.

Background: Rhode Island became the first state to use all three FDA-approved forms of MAT in a correctional facility setting in 2016. Since then, Colorado, New Hampshire, Oklahoma and Wisconsin have passed and enacted similar measures requiring the availability of these treatments in prisons, though New Hampshire is the only other state that requires all three medications to be made available.

The federal government in recent years has had a number of programs to expand access to MAT to these populations. But the coronavirus pandemic has delayed research on the issue, as many researchers aren’t allowed inside jails or prisons amid lockdown orders, NIDA Director Nora Volkow told POLITICO in a previous interview.

TRUMP ADMIN LOOKS TO ENROLL GLOBAL VAX TRIALS — Operation Warp Speed is enlisting scientists in South Africa and Latin America to help test experimental vaccines funded by the U.S., Reuters reported.

In exchange, the administration is pledging to ease those countries’ access to approved versions of the vaccines. Warp Speed chief Moncef Slaoui made that commitment late last month, two people familiar told Reuters.

Except: NIH Director Francis Collins seemed to push back on the need for global trials. “We thought when we were first setting up the vaccine trials that that might be necessary if the presence of a lot of illness in the U.S. had faded. As we all know, that did not happen,” he said in a call with reporters Thursday. “So at the present time, we find no need really, to activate those sites outside of the U.S. There’s plenty of illness in our own country to be able to assess whether the vaccine works.”

EU TO BUY J&J VAX — The European Commission will sign a deal with Johnson & Johnson to purchase 200 million doses of its coronavirus vaccine candidate, Politico Europe’s Jillian Deutsch reports. The deal has not yet been signed but the “envisaged contract” would let the Commission buy 200 million more doses if the vaccine is proven safe and effective.

QIAGEN SHAREHOLDERS SPIKE THERMO FISHER OFFER — Diagnostics manufacturer Qiagen will remain an independent company after its shareholders rejected a voluntary public takeover by Thermo Fisher Scientific. “The magnitude and duration of the global coronavirus pandemic have proven the increasingly critical importance of molecular testing to society. Qiagen’s business prospects have improved significantly,” Qiagen CEO Thierry Bernard said in a statement.

Thermo Fisher is set to receive $95 million from Qiagen as a result of the deal falling apart.

WHAT ROLE WILL ANTIBODY DRUGS PLAY IN PANDEMIC? — Scientists are close to getting important data that may indicate whether monoclonal antibodies could be a safe and effective treatment for Covid-19. But debate continues about what role the antibodies might play in changing the course of the pandemic — especially since the U.S. has done far less to shore up antibody treatments than to support vaccine development. Former FDA Commissioner Scott Gottlieb tells STAT that “we may have missed a window to scale the manufacturing of antibody drugs that could have been an important bridge to a vaccine, and a hedge in the event vaccines are delayed or don’t work.”

OPIOID SCANDAL HAUNTING DRUG COMPANIES Even as pharmaceutical companies race to become key players in the fight against the coronavirus, the industry continues to face civil lawsuits from its role in the opioid epidemic, NPR reports. Thousands of cases that were put on pause are moving forward again as courts reopen. Some companies have already paid millions of dollars to settle claims, while others have filed for bankruptcy. Because many firms lack the cash to compensate Americans, there is pressure to reach a national settlement of opioid-related cases. The goal would be to cap the industry’s total liability and end financial instability for firms while accelerating payouts to cash-strapped communities.

John Lepore is now SVP for government engagement at Moderna. He previously was general counsel for policy and advocacy at Mastercard.

Paul Diaz is being tapped as the next president and CEO of Myriad Genetics. He previously was a partner at private equity firm Cressey & Co., and formerly served as CEO of Kindred Healthcare.

The FDA’s Oncology Center of Excellence and data company Syapse are expanding an existing multiyear research collaboration agreement on the use of real-world data to support clinical and regulatory decision-making.

Pfizer and BioNTech published the preliminary, peer-reviewed data from the Phase I/II study of their mRNA-based vaccine candidate for Covid-19 in the journal Nature.

CMS issued a proposed national coverage determination for artificial hearts and ventricular assist devices Wednesday.

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