With Susannah Luthi and Emily Martin
— AstraZeneca strives for confidence after European countries panicked about its vaccine, but an independent safety board is raising new questions.
— Will J&J miss its vaccine goal? Officials grow worried about production.
— Drugmakers prepare for the rare: pricing reform as Democrats ready to include drug pricing legislation in the next Covid package.
It’s Tuesday, welcome back to Prescription Pulse. Your authors await the day they become eligible for a daily free donut. As always, send tips to Sarah Owermohle ([email protected] or @owermohle) and David Lim ([email protected] or @davidalim).
THE RISE AND FALL AND MAYBE RISE AGAIN OF ASTRAZENECA’S VACCINE: The company’s shot could be the key to vaccinating billions of people worldwide — if AstraZeneca can overcome a series of public relations missteps that have clouded the vaccine’s reputation and left governments wary.
The latest twist: The National Institute of Allergy and Infectious Diseases early Tuesday morning issued an alert that the Data and Safety Monitoring Board warned AstraZeneca and health agencies that it “was concerned by information” released by the vaccine maker on its Covid-19 vaccine clinical trial.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” NIAID said in a statement. “We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
The data in question: AstraZeneca had reported Monday that its two-dose vaccine provided strong protection against the virus without serious side effects in its largest trial yet: a 32,000-person U.S. study. The company said the shot was 79 percent effective at preventing symptomatic disease and completely effective at preventing hospitalization and death, Sarah reports.
The good news: The study found an 80-percent efficacy rate among participants 65 years and older — a notable result given early doubts around lack of data for older patients in Europe.
The trial’s independent data safety monitoring board analyzed the results for any signs of blood clots and found no increased risk, and there were no instances of rare cerebral venous sinus thrombosis, which had previously worried Germany’s Paul-Ehrlich-Institut, POLITICO EU’s Carlo Martuscelli reports.
The bad news: Concerns about possible blood clot linkage are still rampant in Europe, as a new poll found more than half of people surveyed in France, Germany and Spain now believe the AstraZeneca coronavirus vaccine is unsafe, POLITICO EU’s Mark Scott reports.
The drastic decline in confidence comes after several EU governments briefly paused or limited the vaccine’s use over thrombosis concerns. Many countries, including Ireland, resumed administering it after the European Medicines Agency last week confirmed the shot’s safety and urged people to take the drug.
The bottom line: American officials and health experts are increasingly worried that AstraZeneca’s shot, once billed as the world’s coronavirus vaccine for its low price and ease of storage, could be dragged down by anti-vaccine rhetoric.
Crumbling confidence in the AstraZeneca shot in particular could have devastating results among hard to reach, underserved U.S. populations already skeptical of the government’s inoculation campaign — not to mention people in developing countries who may feel like they are getting the third- or fourth-best option.
“You have a company that very likely has a very good vaccine, that has done everything possible to mess up appreciating whether it’s a good vaccine or not,” said a person with knowledge of the company’s vaccine trials and data who pointed to the U.K. dosing mistake and the company’s attempts to cobble together trial data from multiple dosing regimens. “Their entire approach … could be described, kindly, as sloppy.”
WILL J&J MISS ITS VACCINE GOAL? — The Biden administration is increasingly concerned Johnson & Johnson may not deliver the 20 million doses of coronavirus vaccine it promised would be available by the end of this month, according to three senior administration officials.
The full tranche of vaccine Johnson & Johnson committed in February to delivering may not be ready to ship until the second or third week of April, the officials said, potentially complicating preparations for states expecting millions of J&J shots, Erin Banco, Sarah and Rachel Roubein report.
What’s at hand: J&J is shipping components from Europe to a U.S. “fill and finish” facility before sending the doses to the federal government, officials said. The company is also waiting for the Food and Drug Administration to authorize two key American partners, Emergent BioSolutions and Catalent, who’d send out “tens of millions” of usable shots, according to a person familiar with the process.
That authorization is expected to materialize in the coming days, one individual with knowledge of the matter said, adding that it’s believed the number of doses released would be in the “millions.”
The situation has frustrated administration officials as they look to deliver on President Joe Biden’s directive to offer vaccines to all U.S. adults by May.
“There is a slowness to J&J getting stuff done,” said the person familiar with the process. “They are slow to address some of this stuff. No one thinks they move fast.”
DRUGMAKERS PREPARE FOR A RARE DEFEAT — The pharmaceutical industry is preparing to take a hit in Democrats’ next major legislative package — and the long-untouchable powerhouse is racing to contain the damage.
Democratic lawmakers are weighing whether to include drug pricing measures that could extract tens of billions of dollars from the industry, or potentially more, to help pay for a massive infrastructure bill they could try to pass along party lines this summer, Susannah Luthi and Sarah report.
A renewed debate over whether to allow the government to negotiate drug prices, which is strongly opposed by pharma and Republican lawmakers, could become a watershed moment for an industry that’s unaccustomed to losing — and survived the Trump era largely unscathed.
But those with knowledge of initial discussions told POLITICO that Democratic lawmakers appear intent on using their razor-thin congressional majorities to finally push through a drug pricing overhaul for at least one simple reason: It’s one of the few issues under consideration that would save money in a sprawling package expected to cost trillions.
FDA AUTHORIZES DEVICE THAT MAY DETECT COVID BIOMARKERS — FDA on Friday authorized a medical device that can be used to screen for biomarkers that are associated with Covid-19. The armband device made by Tiger Techis not intended for diagnosis. It uses light sensors and machine learning to determine if a person has signs of conditions like hypercoagulation.
“Combining use of this new screening device, that can indicate the presence of certain biomarkers, with temperature checks could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums and airports,” FDA medical device director Jeff Shuren said in a statement.
Tuesday: FDA holds an advisory committee meeting to examine the risks and benefits of dermal fillers.
The Senate HELP Primary Health and Retirement Security Subcommittee holds a hearing on U.S. drug prices.
Thursday: The full Senate HELP Committee holds a hearing on the Covid-19 pandemic focusing on how to improve health equity by examining health disparities.
U.K.-EU FRICTION GROWS OVER VACCINE DOSES — Amid rising tensions between the U.K. and EU sparked over the U.K.’s vaccine export numbers, European Commission President Ursula von der Leyen said AstraZeneca could face a ban on exports of vaccine doses it produces in the EU if it did not meet its delivery obligations.
Von der Leyen had already said that the EU was prepared to use the mechanisms it had in place to stop exports of vaccines from the bloc destined to countries that were producing their own doses and not exporting them in turn — a slight towards the U.K.
In response, U.K. Defense Secretary Ben Wallace said such attempts to block exports would be “counterproductive” and the “grown-up thing” would be to work with the U.K. to maximize production. Wallace warned that “the world is watching” the Commission’s decision, which will come at a meeting Thursday.
Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.
— The FDA last week expressed concern with specific, unnamed generic drugs with modified-release characteristics. The agency said it had identified several topics for which testing on approved generic drugs could be necessary, including “whether formulation complexity” may warrant additional testing for modified-release drug products. FDA has previously indicated concern with similar modified release generics, including generics of the antidepressant Wellbutrin XL that were removed from the market in 2012 for not being sufficiently generic.
— FDA data show a steady decline in generic drug submissions to the agency, according to a review by AgencyIQ. The average number of annual submissions has declined every year since 2017. In 2017, the FDA received an average of 94 submissions per month compared to 65 per month in 2020. January 2021 was also the second-lowest month for submissions since October 2015 with just 36 submissions. The decline could hamstring efforts to use generic drugs to lower drug pricing in the future.
Oravax announced its plans to begin the first phase of human clinical trials for a “second-generation” coronavirus vaccine in pill form by June, Business Insider reports.
Major drugmakers continue to lobby against any erosion of their monopolies on coronavirus vaccines, and to defend the industry’s traditional business model of patents as developing nations call on them to share their formulas, The Washington Post reports.
Gilead and Novo Nordisk announced a larger mid-stage study to test a combination of Nordisk’s diabetes drug and two experimental Gilead drugs to treat nonalcoholic steatohepatitis, MedCity News reports.
Advocates are hoping that the combined pressure from the pandemic and the Black Lives Matter movement will push Congress to finally ban menthol cigarettes, which have been aggressively marketed towards Black Americans, The New York Times reports.
HHS announced it is postponing the effective date of the Securing Updated and Necessary Statutory Evaluations Timely final rule, pending judicial review, in addition to correcting errors in the final rule.
A study published this month in Cancer found that Black patients continue to be underrepresented in cancer clinical trials, a trend that may be exacerbated by the globalization of cancer studies.
The European Medicines Agency issued a warning against the use of Merck’s anti-parasite drug ivermectin for the treatment or prevention of Covid-19 outside clinical trials, following similar warnings from FDA in February.
FDA diagnostics director Tim Stenzel and Shuren took to Health Affairs Monday to discuss Covid-19 test development, FDA’s regulatory oversight of diagnostics and lessons for the future.