COVID-19 tracker: Novartis’ Ilaris sputters in COVID trial; AstraZeneca to file ex-U.S. shot data for FDA nod

Novartis’ arthritis med Ilaris missed the mark in a phase 3 COVID-19 trial. The U.K.’s Recovery Trial added aspirin to the list of repurposed drugs it’s testing against the disease. 

AstraZeneca plans to present data from its non-U.S. vaccine trials to the FDA for an emergency authorization—even if those readouts come before its U.S. phase 3 wraps—a company exec told Reuters. Plus, Regeneron is optimistic that the FDA will authorize its antibody cocktail, but declined to lay out a timeline for the decision. 

Meanwhile, Amgen employees will continue to work from home until June of next year, SVP Julie Brown said in an email. 

The worldwide case count passed 48.8 million Friday morning, with more than 1.2 million reported deaths, according to Johns Hopkins University’s COVID-19 dashboard.

Please read below for the latest updates. Daily COVID-19 tracker entries from Aug. 11 to Oct. 30 can be found here. Entries from April 21 through Aug. 11 are here. Entries from Jan. 30 through April 20 are here.

UPDATED: Friday, Nov. 6 at 9:19 a.m. ET

Novartis’ arthritis med Ilaris, also known as canakinumab, failed to keep seriously ill patients off ventilators and didn’t beat standard of care at preventing deaths, phase 3 data showed. The trial tested the drug in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome. Novartis is also testing Jakafi against the disease and joined forces with Molecular Partners in October to develop two DARPin therapies as potential treatments. 

AstraZeneca plans to bring ex-U.S. vaccine data before the FDA once it obtains results from its British, South African or Brazilian trials—even if those data precede a readout from the drugmaker’s U.S. phase 3, EVP of biopharmaceuticals R&D Mene Pangalos told Reuters. The FDA has set expectations for safety and efficacy, but hasn’t said those data must come from U.S. studies, Pangalos said, adding that an approval would be unlikely to disrupt its ongoing stateside trial. 

The U.K.’s Recovery Trial on Friday started investigating aspirin to see whether the cheap and widely-available drug could reduce the risk of blood clots in hospitalized COVID patients. The trial expects to dose at least 2,000 patients with aspirin plus standard of care and will primarily assess mortality after 28 days. The researchers are also curious whether the drug can reduce the length of hospitalization and need for ventilation. 

Regeneron is optimistic the FDA will authorize its antibody cocktail but still doesn’t know the timeline for that decision, CEO Leonard Schleifer said on a Thursday earnings call. The company earlier this year said clinical data showed the drug reduced medical visits in patients with mild or moderate disease. Regeneron could make about 80,000 doses available by the end of this month and have 300,000 doses ready by the end of January, the company said. Story

Amgen staffers who have worked remotely since March will continue to work from home until the end of June 2021, Judy Brown, SVP and site head at Amgen’s global headquarters, said in an email obtained by Acorn. Brown reasoned that the Greater Los Angeles area, where the company is based, is unlikely to see a drop in cases before spring, adding that a vaccine probably wouldn’t become available during that timeframe, either. 

UPDATED: Thursday, Nov. 5 at 3:55 p.m. ET

Hologic’s revenue may have slipped last quarter, but its COVID-19 testing business has continued to soar, helping the company net more than $1.3 billion in sales in the final quarter of its 2020 fiscal year. The company’s molecular diagnostics division alone managed to pull $818.9 million for the period—almost as much as the $865.8 million in total revenues Hologic made during the last quarter of 2019. Story

Children with COVID-19 produce fewer, weaker antibodies than adults, a study published in Nature Immunology found. While both adults and children in the study produced COVID-19 antibodies, children mainly produced one kind, called IgG, which binds to the virus’ spike protein. Adults, meanwhile, made multiple types of antibodies—better than IgG at neutralizing the virus—that bound to the spike protein and other viral proteins, too. 

Contract research organization Parexel teamed up with bioanalytics firm Synexa Life Sciences and blood-drawing specialist Drawbridge Health to offer Synexa’s serology test, which can help identify whether a person has had a virus such as SARS-CoV-2, and Drawbridge’s OneDraw remote blood collection device to customers as part of the company’s myriad COVID-19 projects and trials. Parexel cited an “urgent need” for accurate serology testing that also limits risk of exposure to COVID-19—which it thinks its new pact can deliver on. Story

The time has come for the U.S. to develop a testing strategy to track asymptomatic spread of COVID-19, CDC director Robert Redfield said. The CDC in August issued a recommendation that people who had come into close contact with an infected person didn’t necessarily need to get tested unless they were at higher risk of infection or severe disease. The agency changed its tune in September, urging anyone who has been in close contact with an infected individual to get tested, even if they don’t display symptoms. 

An oversight panel called for changes at the World Health Organization, stressing that it was essential the agency maintain “neutrality and political independence.” The panel urged the U.N. agency to establish a graded system to “alert and engage the wider international community at an earlier stage in a health crisis,” and also said the WHO’s Emergency Program is in “a constant struggle to mobilize resources, with staff forced to juggle competing priorities simultaneously.”

UPDATED: Thursday, Nov. 5 at 9:30 a.m. ET

AstraZeneca is poised to supply “hundreds of millions” of vaccine doses on a rolling basis once its shot is authorized, CEO Pascal Soriot told Bloomberg, despite delays in early U.K. shipments. Soriot added that a recent resurgence in cases had enabled scientists to gather necessary clinical data. A day earlier, Kate Bingham, chair of the UK Vaccine Taskforce, had said just 4 million AZ doses would be ready by year-end in the U.K., rather than the 30 million doses the drugmaker had hoped to deliver by September. 

Chile’s drug regulator green lighted a clinical trial of AstraZeneca’s vaccine, the country’s President, Sebastian Pinera, said. The AZ study joins a Chilean trial of Johnson & Johnson’s shot, plus a separate test of Sinovac’s pandemic hopeful. The country has penned a deal for 10 million doses of Pfizer and BioNTech’s shot and is looking to ink similar agreements with AstraZeneca, J&J and Sinovac, Pinera said. Elsewhere, Peru said J&J and AZ would kick off vaccine trials in the country next week. 

And Bangladesh locked down 30 million AstraZeneca doses through Serum Institute of India (SII). The country will purchase 5 million doses from SII per month through Bangladeshi drugmaker Beximco, provided the shot is cleared by regulators, the country’s health minister said. 

The World Health Organization is going all-in on monoclonal antibodies, dexamethasone and repurposed meds—but not Gilead’s Veklury (remdesivir)—in its scheme to provide COVID-19 drugs to low-income countries, an internal document obtained by Reuters showed. Unitaid, a health partnership co-leading the effort, confirmed that the scheme would not include Veklury, though it didn’t comment on the reason for excluding the antiviral. A WHO trial reported in October found Gilead’s drug offered little benefit in COVID-19 patients; Gilead has disputed those findings.

The U.S. charted more than 107,800 new COVID-19 cases Wednesday, according to The New York Times, setting a grim record for daily infections. Meanwhile, Maine, Minnesota, Indiana, Nebraska and Colorado also hit single-day case records. 

Bharat Biotech could launch its shot as early as February, jumping ahead of its previously stated second-quarter rollout goal, a senior scientist at the Indian Council of Medical Research (ICMR) told Reuters. Bharat plans to kick off a late-stage study of its shot, Covaxin, this month. “It is expected that by the beginning of next year, February or March, something would be available,” he added. 

UPDATED: Wednesday, Nov. 4 at 3:00 p.m. ET

Britain will receive an estimated 4 million doses of AstraZeneca’s vaccine by year-end, rather than the 30 million doses AZ had hoped to supply by September, UK Vaccine Taskforce chief Kate Bingham told lawmakers Wednesday. Earlier in the day, the chief investigator of the University of Oxford’s vaccine trial said he was “optimistic” that AZ could deliver late-stage trial data before year-end, adding that doses were already in production. The U.K. in May penned a deal for 100 million doses of AZ’s shot, which should now be available in the first half of 2021, Bingham said. 

Russia aims to provide its citizens with tens of millions of doses of its Sputnik V vaccine by year-end, but production and quality control hurdles may deflate that number, The Bell reported. “We can’t stabilize the vaccine, no one yet can,” an unnamed exec at one of the Gamaleya Institute’s four Russian manufacturing partners told the news outlet. Meanwhile, vaccine batches frequently miss the institute’s quality control bar and attempts to launch bioreactors at scale have been “generally unsuccessful.” 

A COVID-19 breathalyzer test from Singapore’s Breathonix achieved at least 90% accuracy when screening participants on-site for 60 seconds, the company said. An ongoing pilot study in 180 people showed an overall sensitivity of 93% and a specificity of 95%. The test, which uses a one-way valve and disposable mouthpiece, could be used for mass screening in high-traffic areas, Breathonix figures. Story

BD inked a contract with the Dutch Ministry of Health to supply an initial 1.2 million units of its rapid antigen diagnostic, the hand-held Veritor Plus system, this month, with another 8 million slated for delivery to the Netherlands by June of next year. The portable, point-of-care system won an emergency coronavirus nod from the FDA in July and a CE mark in September. Story

The FDA on Tuesday warned healthcare professionals that antigen tests could deliver false positives if users fail to follow instructions. The regulator encouraged labs to perform follow-up testing with a molecular assay when appropriate and cautioned that improper storage, failure to read testing results at the correct time and cross-contamination could all lead to inaccurate readouts. The warning follows reports of false positives from antigen tests in nursing homes and other healthcare settings.

UPDATED: Wednesday, Nov. 4 at 9:12 a.m. ET

Australia locked down 40 million vaccine doses from Novavax, plus 10 million doses  from Pfizer and BioNTech, bringing the country’s total vaccine investment up to more than $3.2 billion. If the shots win approval, they’re expected to become available in Australia during the first half of 2021. The country earlier this year secured doses from AstraZeneca and the University of Queensland. 

China’s Fosun Pharma stopped development on BioNTech’s first COVID-19 vaccine and will instead seek Chinese approval for the German shot maker’s second candidate, currently in late-stage testing in the U.S. Fosun aims to run a bridging study that may enable it to use global data on the second candidate, BNT162b2. Pfizer and BioNTech chose that shot as their phase 2/3 candidate after it turned up a lower rate of side effects than their first prospect. Story

Speaking of Pfizer and BioNTech, the chair of the UK Vaccine Taskforce, Kate Bingham, is hopeful that strong interim data from the mRNA partners, plus AstraZeneca and the University of Oxford, will emerge in early December, potentially teeing up a vaccine rollout before year-end. 

For its part, the University of Oxford is “optimistic” that it could unveil late-stage results on its AstraZeneca-partnered shot this year, said chief investigator of the university’s vaccine trial, Andrew Pollard. As for whether the shot might be available before Christmas, “[there] is a small chance of that being possible but I just don’t know,” he said, adding that a shot would not be a panacea. “We will still have people getting this virus because it is just too good at transmitting.” Story

In people with symptomatic COVID-19, Quidel’s rapid Sofia test was able to detect more than 80% of cases found by the slower, gold-standard PCR test—but when Quidel’s test was used to randomly screen asymptomatic patients, it only picked up 32% of infections caught by the PCR method, a University of Arizona study found. It’s possible the rapid test missed asymptomatic cases ID’d by the lab test because those people were carrying too little of the virus to spread it to others, one study author said. 

The U.S. FDA ordered NovaBay Pharmaceuticals to stop claiming that its Avenova antimicrobial eyelid and eyelash spray can kill the SARS-CoV-2 virus. The company’s website asserts that “an independent third-party laboratory study” confirmed its spray can fully inactivate the virus and recommends using it to eliminate airborne respiratory droplets. In a warning letter, the FDA pointed out that the NovaBay spray has no human data to back it up.

UPDATED: Tuesday, Nov. 3 at 3:16 p.m. ET

While most vaccine makers will pass their shots off to McKesson for U.S. distribution, Pfizer is taking matters into its own hands, Tanya Alcorn, VP for biopharma global supply chain at the company, said. Pfizer has developed a GPS and temperature-tracked thermal cooler to help transport its vaccine, along with a control tower that provides real-time alerts if temperatures deviate or a shipment runs late. Still, some officials remain concerned that vaccination centers won’t have the cold-storage capabilities to house Pfizer’s shot. Story

T cell immunity to the coronavirus may outlast antibodies in patients who’ve recovered from COVID-19, a recent U.K. study showed. Analyzing the blood of 100 patients six months after they had asymptomatic or mild disease, researchers found that while antibody levels dropped in some patients, T cell response endured. T cell response was also higher in patients who displayed symptoms while infected. 

61,000 new coronavirus cases cropped up in children last week, more than any previous week in the pandemic, the American Academy of Pediatrics (AAP) reported. Severe illness due to COVID-19 in children is rare, but there is an “urgent need” to collect more data on the long-term impact of the disease in kids, AAP said. 

Colorado State University is using the fecal matter and pooled spit of undergraduates to catch COVID-19 cases early, Kaiser Health News reports. The school’s sewage review follows emerging research suggesting people shed the virus in feces early in their infections. The school is also conducting “paired” pooling of saliva samples, which allows testing of multiple samples at once without the need for much retesting if a pool of samples turns up positive. 

UPDATED: Tuesday, Nov. 3 at 9:30 a.m. ET

Advocacy group Public Citizen urged Gilead Sciences to give up the priority review voucher it earned alongside its FDA approval of Veklury, also known as remdesivir. The voucher can be used to speed up FDA review time for another drug or sold—and previous sales have netted hundreds of millions of dollars. Public Citizen called the incentive “unnecessary” and “inappropriate” given Gilead’s expected Veklury sales. Story 

The Coalition for Epidemic Preparedness Innovations (CEPI) will fund development of Clover Biopharmaceuticals’ protein-based S-Trimer vaccine through a global phase 2/3 trial, bringing its total investment in the program to upward of $328 million. Beyond the upcoming efficacy trial, pegged to start before year-end, CEPI’s investment will fund studies in people with autoimmune conditions, children, pregnant women and more. If the shot clears the clinic, Clover and CEPI aim to make hundreds of millions of doses available per year through the WHO’s Covax effort. Story

Israel dosed the first two patients in a phase 1 trial of its coronavirus vaccine, Brilife, developed by the Israel Institute for Biological Research. A phase 2 trial that seeks to enroll 960 healthy volunteers is expected to kick off in December, while a 30,000-person phase 3 is pegged to start in April or May 2021 if warranted. 

The pandemic is entering a new, “deadly phase,” White House coronavirus coordinator Deborah Birx said in a private memo to White House officials obtained by The Washington Post. Birx called for consistent messaging about masks, hand-washing and social distancing. It’s not about lockdowns, she wrote, but rather, “an aggressive balanced approach that is not being implemented.” Her comments put her at odds with President Donald Trump, who says the nation is “rounding the corner” on the pandemic. 

Scientists at the University of Washington School of Medicine developed a nanoparticle vaccine candidate that sparked neutralizing antibody levels in mice ten times higher than those seen in recovered patients—and at a much lower dose than required for vaccination with the SARS-CoV-2 spike protein. The University licensed its candidate to Icosavax for further study. Amgen agreed to manufacture a key intermediate for initial R&D while South Korea’s SK Bioscience advances its own studies on the shot. 

South Korea‘s new minister for food and drug safety, Kim Gang-lip, made his first goal to “mobilize our regulatory capacity as much as possible to help develop a Covid-19 treatment and vaccine that people can trust.” Kim also aims to boost the Korean drug regulator’s global competitiveness and is seeking “international regulatory harmonization.” 

UPDATED: Monday, Nov. 2 at 3:20 a.m. ET

CureVac aims to build an mRNA vaccine that generates a balanced immune response similar to the body’s natural reaction, and now it’s armed with interim phase 1 data supporting that goal. In the dose escalation study, CureVac’s highest 12-microgram dose—pegged to advance into a phase 2b/3—raised binding and neutralizing antibody levels to those seen in a set of 67 seriously ill COVID-19 patients, the company said. Story

Pfizer and Bristol Myers Squibb launched a new campaign to promote doctor visits amid the pandemic. “No Time to Wait,” which covers broadcast and streaming TV and radio, as well as digital and social media, focuses on three conditions: atrial fibrillation, deep vein thrombosis and pulmonary embolism, all treated by the partner’s anticoagulant Eliquis. Story

Johnson & Johnson’s weekly video series, “The Road to a Vaccine,” has racked up more than 100 million views since launching in April. Hosted by journalist Lisa Ling, the show features J&J researchers and execs, public health officials and advocates in conversation about vaccine development, mental health, racial disparities and more. “At the end of the day, science is about society, and society has to understand the processes of science,”J&J communications exec Seema Kumar said of the series during Fierce Pharma Marketing’s Digital Pharma Innovation Week. Story

Massachusetts-based biotech incubator LabCentral, together with lab facility provider BioLabs, launched the Cambridge Consortium for Rapid COVID-19 Tests (CCRCT) to assess and validate COVID-19 diagnostics that people can use at home. CCRCT last month started a trial of a 15-minute, self-administered antigen test made by LabCentral alum E25BioStory

Hologic snared a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, with the goal to provide 13 million COVID tests per month by January 2022. The company’s Panther Fusion and Aptima SARS-CoV-2 assays won emergency nods in March and May, respectively, and the FDA in September OK’d Hologic’s Panther Fusion test to screen asymptomatic patients. Story

Novavax inked a 15-year lease for about 122,000-square-feet of offices in Gaithersburg, Maryland, for manufacturing, office space and R&D, while an affiliate of the company bought 9.7 acres in Gaithersburg for future development. Novavax has scored up to $2 billion from the U.S. government and CEPI for its COVID-19 vaccine program; the company’s shot is currently in late-stage testing in the U.K. and a large phase 3 trial in the U.S. and Mexico is set to kick off later this month. Story

Fifty-nine percent of Russians say they wouldn’t get the country’s Sputnik V vaccine, an October poll from Russia’s Levada Center showed. That number rose from 54% of respondents unwilling to get the shot in August. Meanwhile, just 31% of people polled in October said they would get the shot, down nearly nine percentage points from August. Levada polled 1,601 Russians between Oct. 22 and Oct. 28. 

UPDATED: Monday, Nov. 2 at 9:15 a.m. ET

Johnson & Johnson hopes to start testing its vaccine in children ages 12 to 18 as soon as possible, said Jerry Sadoff, a vaccine research scientist at J&J’s Janssen unit. The company could eventually test its shot in even younger children, Sadoff said. The vaccine platform J&J’s using for its COVID-19 shot, AdVac, is also used in an Ebola vaccine that’s been given to infants, children and pregnant women. 

Africa’s biggest drugmaker, Aspen Pharmacare, struck a preliminary deal to produce Johnson & Johnson’s vaccine in South Africa. The company would carry out manufacturing and packaging work at its Port Elizabeth plant, which boasts capacity for 300 million doses a year, if the shot snares regulatory approval in the country.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) awarded £1.5 million ($1.9 million) to GenPactfor an artificial intelligence tool to process potential side effects and safety signals from an approved vaccine. Based on historical vaccination data, the MHRA expects to see between 50,000 and 100,000 side effect reports for every 100 million doses administered over a six to 12 month span. 

Bharat Biotech aims to launch its vaccine hopeful in the second quarter of 2021, pending an approval in India, the company’s executive director said. The shot, Covaxin, has a ways to go: Bharat expects to kick off recruitment for a phase 3 trial this month. 

At a rally early Monday morning, President Donald Trump floated the possibility of firing the nation’s top infectious disease expert, Anthony Fauci, after the election. During the event, Trump once again said the country has “turned the corner” on the pandemic. But in a Washington Post article published Saturday, Fauci said the U.S. “could not be positioned more poorly” ahead of the winter. Story

The U.S. needs to make an “abrupt change” in public health practices and behaviors to counter the pandemic, Anthony Fauci told The Washington Post. The coronavirus task force is meeting infrequently and has much less influence with the President now, Fauci said. And the NIAID chief said Scott Atlas, a neuroradiologist who has become Trump’s favored pandemic advisor is “a smart guy who’s talking about things that I believe he doesn’t have any real insight or knowledge or experience in.”

Meanwhile, Thanksgiving will be a COVID-19 “inflection point,” former FDA commissioner Scott Gottlieb said. “There are about 23 states that are accelerating the spread right now,” he added. It’s unlikely that the entire country would lock down again, as Europe is doing, though Gottlieb said he expects states to take local action as hospitals become overwhelmed. 

The U.K.’s Department for Business, Energy & Industrial Strategy came to the defense of Kate Bingham, chair of the country’s vaccine task force, after The Sunday Times published an article alleging she had disclosed “sensitive” information about U.K. investments in COVID vaccines and therapeutics. Her presentation, for a U.S. women’s conference, had been cleared by the government, the department said, and Bingham said little that experts at the conference couldn’t deduce themselves. 

Siberia-based drugmaker Pharmasyntez asked the Russian government for permission to produce a generic version of Gilead Sciences’ Veklury, or remdesivir, despite lacking a patent or license. The drugmaker wrote to Gilead in July but did not hear back, and it is now asking the Russian government for a compulsory license, which would allow it to make a remdesivir generic without Gilead’s OK. 


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