FDA authorizes Moderna COVID-19 vaccine; McKesson, US Army to help roll out millions of doses to augment national supply.

Dispersal of Moderna Inc.’s (Cambridge MA) COVID-19 vaccine to more than 3,700 locations in the US began Saturday, massively widening the rollout started the prior week by Pfizer Inc. (NYC), US Army General Gustave Perna said. The move followed the Food and Drug Administration’s Friday authorization of the Moderna’s vaccine for emergency use, allowing the shipment of millions more doses across the nation and escalating the debate over who will be next in line to get the jab.

The approval will make Moderna’s vaccine the second to reach the American public, after the jab developed by Pfizer and German partner BioNTech SE (Mainz) was cleared Dec. 11. Moderna has already moved vaccines from its manufacturing plants to warehouses operated by distributor McKesson Corp. (Irving TX) where they were being packed into containers and loaded on to trucks on Saturday, Perna said during a news conference. Trucks set out on Sunday and shipments will start reaching healthcare providers as soon as Monday, he said.

Workers in pharmaceutical services provider Catalent Inc.’s facility in Bloomington, IN, are filling and packaging vials with Moderna vaccine and handing them to McKesson, which will ship doses from facilities including Louisville and Memphis. Those locations are close to air hubs for United Parcel Service Inc. and FedEx Corp., according to Reuters. The start of delivery for the Moderna vaccine will significantly widen availability of COVID-19 vaccines as US deaths related to the respiratory virus set records. Perna apologized to US governors for confusion on the vaccine’s availability after the US government last week reduced allocation figures it had given to states to help them plan this coming week’s rollout. States including Oregon and Washington said their allocation had dropped by as much as 40%.

Perna said he made an error estimating the number of doses that would actually be cleared by regulators for shipment, which was fewer than the number of doses that had been produced. He said there are no problems with Pfizer’s or Moderna’s manufacturing processes. A spokeswoman for the US Department of Health and Human Services said it still expects to deliver 7.9 million doses of Pfizer and Moderna vaccines nationally this week. Moderna’s vaccine is available in quantities as small as 100 doses and can be stored for 30 days in standard-temperature refrigerators, while the inoculations from Pfizer come in boxes of 975 doses, must be shipped and stored at -70 Celsius (-94 F), and can be held for only 5 days at standard refrigerator temperatures. Initial doses were given to health professionals.

Perna said the US is on track to have enough doses available of Pfizer’s and Moderna’s vaccines by the end of the year to inoculate 20 million people, but deliveries of those doses may continue into the first week of January. Both vaccines were about 95% effective at preventing illness in clinical trials that found no serious safety issues. US officials said Pfizer is preparing to distribute two million additional doses of its vaccine to locations around the country this week, with preparations beginning over the weekend. (Ref: Reuters)

According to Johns Hopkins Medical, as of Saturday, December 19, there were nearly over 76 million global COVID-19 cases confirmed, and some 1.7 million deaths. Confirmed cases in the US totaled 17.6 million with nearly 315,000 deaths. The US figures comprise 23% and 19% respectively of the global totals. The US population comprises 4% of the global total.

COVID-19 Addendum: The United States is monitoring the new strain of COVID-19 emerging in the United Kingdom, multiple US officials said on Sunday, adding that it was unclear whether the mutated variant had made its way to America.

“We don’t know yet. We are, of course…looking very carefully into this,” US COVID-19 vaccine program head Dr. Moncef Slaoui told CNN’s “State of the Union” program.

Slaoui, chief scientific adviser for the Trump administration’s Operation Warp Speed, added that the UK mutation was “very unlikely” to be resistant to current vaccines, saying: “We can’t exclude it, but it’s not there now.” Other health officials from the outgoing Trump administration and the incoming Biden administration also said they were watching the strain rapidly spreading in Great Britain. The new UK variant appears 70% more transmissible, forcing new lockdown measures in Britain and travel restrictions from its European neighbors.

US President Donald Trump’s Surgeon General Jerome Adams said while mutating viruses were not unusual, any new COVID-19 strain means Americans must be more vigilant about washing hands, wearing masks, keeping distance and avoiding crowds.

“Right now, we have no indication that it is going to hurt our ability to continue to vaccinate people or that it is any more dangerous or deadly than the strains that are currently out there that we know about it,” Adams told CBS News’s “Face the Nation” program. Asked about the potential impact on US-UK travel, Assistant US Health Secretary Admiral Brett Giroir told ABC News’s “This Week” program: “I don’t think there should be any reason for alarm right now. We continue to watch.” Giroir, a White House Coronavirus Task Force member, added, “We don’t know that it’s more dangerous. Right now, it looks like the vaccine should cover everything that we see.”

Pfizer denies claims its COVID-19 vaccine hit with production distribution troubles.

In a statement issued Thursday, Pfizer Inc. (NYC) countered claims that the rollout of its COVID-19 vaccine BNT162b2 has been hampered by production and distribution problems. The BioNTech SE-partnered vaccine started shipping around the US last week after securing an FDA emergency-use authorization on December 11, with distribution having begun in other countries such as the UK and Canada prior to that, says FirstWord Pharma. Pfizer said it is “not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed.”

The company added it “successfully shipped all 2.9 million doses that we were asked to ship by the US government to the locations specified by them,” and has “millions more doses sitting in our warehouse,” although it has so far “not received any shipment instructions for additional doses.” Earlier last week, Trump administration officials and Pfizer confirmed that the two sides are negotiating for the government to purchase another 100 million doses of BNT162b2 for distribution between April and June 2021, on top of the initial order for 100 million agreed to this past July.

Stirring the pot, Health and Human Services Secretary Alex Azar indicated that Pfizer is having some supply chain issues that will make it more challenging for it to produce the extra doses in the spring. “We will ensure that, by whatever mechanism, we provide them full support to ensure that they can produce for the American people,” Azar said, with one option being to invoke the Defense Production Act to accelerate manufacturing of some raw materials needed to make the vaccine. Meanwhile, Gov. Ron DeSantis of Florida said the next two weeks’ worth of Pfizer vaccine shipments to his state “are on hold right now” as a result of purported production issues.

“We don’t know whether we will get any or not, and we’re just going to have to wait,” he said.

Washington Gov. Jay Inslee said he was told by the US Centers for Disease Control and Prevention that his state’s allocation would be cut by 40% this week, calling it “disruptive and frustrating.”

However, two senior Trump administration officials who spoke on condition of anonymity said states will receive their full allocations, but misunderstandings about vaccine supply and changes to the delivery schedule may be causing confusion. In another matter, US officials said some doses of the vaccine delivered in California needed to be replaced because they had been stored at excessively cold temperatures. In its statement on Thursday, Pfizer said both the production and distribution of BNT162b2 has been “working well.” On Thursday, Pfizer said “we remain confident in our ability to deliver up to 50 million doses globally this year and up to 1.3 billion next year.”

Biden introduces picks for top health team staff.

President-elect Joe Biden has formally announced several members of his healthcare team, calling them “a team of world-class experts at the top of their field.” At a press conference in Wilmington, DE, Biden said, “They’re going to be ready on Day One to spare not a single effort to get the pandemic under control, so we can get back to work, get back to our lives, and get back to our loved ones. He added, “They’ll lead the COVID-19 response across the government to accelerate testing, fix our supply chain, and distribute the vaccine.” Biden then introduced the members of his healthcare team, which included:

1) Xavier Becerra as secretary of the Department of Health and Human Services. Becerra is currently California’s attorney general. Before that, he was elected to the US House of Representatives in 1993 and stayed for over two decades. As California’s attorney general, in April 2018, Becerra and leaders in more than a dozen states and the District of Columbia filed the California v. Texas lawsuit that aimed to protect the Affordable Care Act, in response to the suit brought by Texas and 16 other states that sought to torpedo the landmark bill. Becerra was also among 23 state attorneys general who filed an amicus brief last year in a case seeking to overturn a Mississippi law that would ban abortions after 15 weeks.

2) Vivek Murthy, MD, MBA, as surgeon general. Murthy, 43, held the post under President Obama from December 2014 to April 2017. Biden has also chosen him to co-chair a coronavirus advisory board. In his second rotation as surgeon general, Murthy’s previous efforts in promoting vaccine acceptance will come in handy. Achieving adequate protection for the public would require three-fourths of the population to be vaccinated, which Murthy told NPR is “not going to be easy.” Yet he described the goal of herd immunity as “ambitious but achievable”– reaching it will largely depend on the vaccine supply and gaining the public’s trust, he said.

3) Rochelle Walensky, MD, MPH, as director of the CDC. Walensky is chief of infectious diseases at Massachusetts General Hospital and a professor of medicine at Harvard Medical School. She has been heavily involved in the state’s COVID-19 response. As a researcher, Walensky has focused on the cost-effectiveness of HIV testing, care and prevention, according to her Harvard biography. She also “has been influential in advancing international health policy towards the promotion of HIV treatment as prevention and the adoption of other effective and efficient strategies of HIV care.” She also chairs the advisory council for the NIH’s Office of AIDS Research.

4) Marcella Nunez-Smith, MD, MHS, as COVID-19 Equity Task Force chair. Nunez-Smith is an associate professor of medicine, public health, and management at the Yale University School of Medicine, and is founding director of Yale’s Equity Research and Innovation Center. Nunez-Smith’s research focuses on promoting health and healthcare equity for marginalized populations, according to her Yale biography. She has worked to support healthcare workforce diversity and develop patient-reported healthcare quality measures. Nunez-Smith’s areas of interest include the effects of social and structural determinants of health and systemic influences contributing to health disparities.

5) Anthony Fauci, MD, as chief medical adviser on COVID-19 and director of the National Institute of Allergy and Infectious Diseases (NIAID). Fauci, who is currently a member of the Trump administration’s coronavirus task force, has been outspoken during the pandemic, at one time earning President Trump’s wrath by disagreeing with Trump’s remark that 99% of coronavirus cases were “totally harmless.” Biden said, “Dr. Fauci has been of the most trusted figures in the country throughout the pandemic and for decades prior, and will remain an essential voice both in informing the public about health risks and safety measures and in helping the scientific community, the Biden-Harris administration, and local officials overcome the COVID-19 pandemic.” Biden added, “Dr. Fauci has the experience needed to get things done.”

Biden has yet to announce his pick for several important healthcare positions, including FDA commissioner and administrator of the Centers for Medicare & Medicaid Services.

Medical Stock Spotlight

Arvinas Inc. (NASDAQ:ARVN) led advancing issues last week, rocketing 130% to $68.95. The jump came after the New Haven, CT-based company announced positive developments for two of its potential cancer treatments. Interim data from the Phase 1 trial for ARV-471 in heavily pretreated patients with locally advanced or metastatic ER positive / HER2 negative breast cancer, displayed evidence of anti-tumor activity and signs of strong efficacy. The data showed three PRs (partial responses), of which one was confirmed, and a 42% clinical benefit rate.

Oppenheimer analyst Mark Breidenbach calls the data “highly encouraging.” The analyst added, “Estrogen receptor (ER) degradation approached 90% in some patients and responses were observed in patients with prior SERD (selective estrogen receptor degrader) exposure […] While early, we think these results point to best-in-class potential for ‘471 relative to competing, orally available SERDs…” A Phase 1b combination trial of ARV-471 and Ibrance, should kick off later this month and a Phase 2 expansion group for ARV-471 is mooted for 1H21.

Elsewhere, Mereo BioPharma Inc. (NASDAQ:MREO) soared 80% to $3.60 after announcing a license and collaboration agreement with Ultragenyx Pharmaceutical Inc. for setrusumab, a monoclonal antibody, for osteogenesis imperfecta (OI), a rare genetic disorder characterized by fragile bones and reduced bone mass resulting in bones that break easily, loose joints, and weakened teeth. The companies will expand and initially prioritize the development of setrusumab for pediatric patients with OI, with a pediatric Phase 2/3 study expected to start in 2021. Ultragenyx will lead future global development of setrusumab in both pediatric and adult patients and it has exclusive license to setrusumab in the US and rest of the world, excluding Europe where Mereo retains commercial rights. Redwood City, CA-based Mereo will receive an upfront payment of $50 million, and is entitled to milestone payment of up to $254 million, as well as tiered double digit percentage royalties. Mereo will pay a fixed double digit percentage royalty to Ultragenyx on net sales in Europe.

And Humanigen Inc. (NASDAQ:HGEN) surged 64% to $15.51. The clinical stage biopharmaceutical company developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases announced completing enrollment in its Phase 1 bioimaging study of ifabotuzumab in patients with recurrent glioblastoma multiforme (GBM). Ifabotuzumab, or ifab, is the South San Francisco-based company’s proprietary anti-EphA3 monoclonal antibody. This trial is supported by funding from the Cure Brain Cancer Foundation. Results from the study, being conducted in Heidelberg, Germany, and Victoria, Australia, are expected in the first half of 2021. GBM is the most frequent and lethal type of primary brain cancer, with only 10% of patients surviving five years, and preclinical research has shown that EphA3 is responsible for maintaining less differentiated, tumor-initiating cells. Ifabotuzumab is a non-fucosylated IgG1K antibody designed to bind to EphA3, which is expressed in 38-40% of GBM and 100% of the tumor vasculature and is widely expressed in the tumor stroma and tumor vasculature of other solid tumors.

But biotech company Mesoblast Ltd. (NASDAQ:MESO)  plummeted 45% to $9.27 after the company released discouraging news regarding the clinical trials of its COVID-19 treatment. Remestemcel-L is Melbourne-based Mesoblast’s solution to severe acute respiratory distress syndrome (ARDS), a potentially deadly outcome from the coronavirus. Mesoblast had previously partnered with Novartis AG to bring remestemcel-L to market. However, in last week’s announcement, the Data Safety Monitoring Board said, while there aren’t any safety concerns with the therapy, it’s not on pace to hit its primary endpoint (the desired success rate). While Mesoblast and Novartis can complete the trial with the 223 patients already enrolled to collect more data, it won’t expand trials to 300 as originally planned. It was the second time last week a Mesoblast trial failed to reach its primary endpoint, causing the stock to fall 20% on Tuesday. Revascor (rexlemestrocel-L), another cell therapy developed by Mesoblast, also failed late-stage clinical trials. On the brighter side, the company has more than doubled revenue in 2020, which is encouraging.