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Sunday, February 28, 2021

States Need Vaccination Results, Not Headlines

 On the day that New York governor Andrew Cuomo won his Emmy, the governor of West Virginia announced a plan to vaccinate his state. Since then, Governor Jim Justice’s state has boasted one of the nation’s highest vaccination rates, striking a critical blow to Covid-19 and displaying a distinct heartland model of leadership. While leaders in coastal hubs drew headlines for their press conferences and top-down leadership styles, a number of heartland governors paired efficient government with trust in their communities and people—both to vaccinate and to educate.

Gretchen Garofoli, a local pharmacist in Morgantown, West Virginia, administered one of her state’s first Covid-19 vaccinations—a jab in the arm of a nursing-home patient— on December 15, weeks before any other state could do the same. “It was a beacon of hope,” Garofoli later told NPR. West Virginia is the only state in the country to use independent pharmacies to deliver shots; pharmacists in these communities often know their patients by name. “The more the state collaborates with those at the local, community level, the greater the vaccine uptake,” concluded Christopher Martin, a professor at the West Virginia University School of Public Health. As of mid-February, West Virginians have received more than 400,000 doses of the coronavirus vaccine, and some 8 percent of the population has received at least two jabs (a rate second only to Alaska’s 9 percent).

Smaller, redder states have been more successful than media coverage would suggest. Look at the rankings for Covid-19 vaccine doses given and you’ll see West Virginia, Alaska, North and South Dakota, and Utah ranking high. These states benefit from having fewer people to vaccinate—and only a few large health systems operate in North and South Dakota, allowing for easier logistics and nimbler vaccination plans— but they aren’t without geographical difficulties. Yet many of their governors have been pilloried in the press. South Dakota governor Kristi Noem, a common target, began planning her state’s vaccine rollout in mid-summer, well before the federal government gave its own guidance. Noem’s team held daily coordination meetings with local partners, who, in turn, led the distribution and shared lessons learned along the way.

The success of heartland states compares favorably with the performance of New York and California. A large hospital system or pharmacy network is by itself no guarantee of success in public health, as NYC Health + Hospitals likely knows. Meantime, California—whose governor, Gavin Newsom, was celebrated as “#PresidentNewsom” on Twitter last April—has consistently lagged the nation in vaccinations, at one point ranking dead last. In early January, Newsom promised 1 million doses in ten days; two weeks later, the governor acknowledged that he had no idea if the state had met its goal. “High-tech California can’t seem to efficiently administer the vaccine at scale,” summarized NPR. The Golden State had prided itself on stringent lockdowns and mask mandates, yet it experienced a winter surge on the way to becoming the first state to surpass 3 million cases. Things got so bad in January that Southern California’s air regulator suspended cremation limits to deal with the backlog of bodies from Covid-19.

Blue states and counties also have failed to reopen their public schools. As of December, according to one survey, some 42 percent of school-age children nationwide were still learning entirely remotely, while 17 percent were learning in-person only part-time. Data from the Centers for Disease Control found little evidence that schools contribute meaningfully to viral outbreaks. Yet school reopenings are driven more by politics than by science: the likelihood of in-person teaching falls dramatically in counties that voted for Hillary Clinton in 2016 or have strong teachers’ unions. The California Teachers Association refused to let its members return to the classroom until they were vaccinated. What the science does tell us is that closing school buildings has substantially harmed academic performance among children. In Montgomery County, Maryland, where schools remain shuttered, failure rates for African-American and Latino children from low-income families are more than six times higher than they were a year ago; white students have seen minimal declines. This week, the county’s teachers’ union voted to keep classrooms closed.

Other states have taken a different tack. “You can’t say ‘follow the science’ and keep schools closed,” Tennessee governor Bill Lee said last month. “You can’t say ‘I believe in public education’ and keep schools closed.” Lee had called a special session of the state’s General Assembly to help students and to give teachers the resources they need to reopen classrooms. Some cities resisted at first: in Memphis, the Shelby County Schools superintendent said that state lawmakers were “hurting my children,” while metro Nashville’s school district claimed that it needed more resources before committing to reopening. Lee’s office responded by asking what had happened to Nashville’s $110 million in unspent federal education grants. Ultimately, the state approved $160 million in aid and enacted a phonics-based program to boost literacy, among other measures.

Now that the pandemic has dealt severely with every state in the country, it’s fair to evaluate individual states’ performance—and it’s clearer than ever which ones are responding effectively. “West Virginia has been the diamond in the rough that a lot of people have missed,” said Governor Justice. He’s right. Justice and other leaders in heartland states are vaccinating and educating like their residents’ lives depend on it, which they do.

Advantages of the J&J vaccine

 Chalk up another victory for America’s innovative pharmaceutical sector in the battle against Covid-19. An FDA analysis has found that Johnson and Johnson’s vaccine is both safe and effective, setting up a likely emergency-use authorization for the product. This would add a third vaccine to the American market, following the introduction of vaccines from Pfizer and Moderna in December. The J&J vaccine will not only add much needed supply but also offer some significant advantages over the other two shots.

The top-line number for the J&J vaccine—67 percent effectiveness in decreasing moderate to severe Covid-19 illness—might seem to suggest that it is inferior to the Pfizer and Moderna vaccines, which boast more than 90 percent effectiveness. But the vaccine trials are not directly comparable. The Pfizer and Moderna trials were conducted earlier, when fewer and probably less dangerous virus variants were extant. More importantly, J&J’s vaccine is very effective at preventing severe illness: 77 percent effective in reducing cases occurring 14 days after vaccination and 85 percent for cases 28 days after vaccination. Notably, no deaths or hospitalizations occurred among the trial’s vaccine recipients. As with the Pfizer and Moderna vaccines, side effects were mostly minor and brief.

The J&J vaccine also offers important advantages. First, it is a single dose rather than the currently required two doses for Pfizer and Moderna. This makes it far more likely people will sign up for it, since a single dose is less of a time commitment and inconvenience than a two-dose regimen. A single dose also eliminates the logistical difficulties of scheduling second doses and ensuring that they are given.

The J&J vaccine can also be transported and stored for up to three months using regular refrigeration, unlike the freezers needed for the other two vaccines. This will make it much easier to get doses to rural areas and countries with less well-developed distribution systems.

Finally, the J&J vaccine is significantly less expensive than its competitors. Based on U.S. government purchases, it will cost $10 per dose, while Pfizer comes in at $19.50 per dose and Moderna at $25 to $37 per dose. And since the latter two require two doses, the relative product cost of vaccination is $10 for J&J, $39 for Pfizer, and $50–$74 for Moderna, plus the added labor costs of administering second doses.

J&J’s vaccine uses a relatively new technology: an adenovirus vector, which cannot replicate or cause illness, inserts genetic material (DNA) into patients’ cells, instructing them to manufacture the coronavirus spike protein, which then elicits an immune response. This differs from the Pfizer and Moderna vaccines, which both rely on a new mRNA technology. That all three could be developed, tested, and made available in hundreds of millions of doses within a year of the pandemic’s onset is a testament to the power of the free market to find innovative solutions to pressing human problems.

Biotech week ahead, March 1

 Biotech stocks extended their losses in the week ended Feb. 26 amid continued weakness in the broader market. Earnings came in thick and fast, with a skew of small and midcap companies releasing their quarterly results.

Sarepta Therapeutics Inc SRPT 2.12% won a regulatory nod for its Amondys 45 drug for treating certain types of Duchenne muscular dystrophy. This is the company's third product in a portfolio of related drugs to have received approval.

Merck & Co., Inc. MRK 2.68% announced a deal to buy Pandion Therapeutics Inc PAND 0.65%, a company that focuses on therapies for autoimmune disorders, for $1.85 billion.

Moderna Inc 

MRNA 4.33% and the duo of Pfizer Inc. PFE 0.83%-BioNTech SE – ADR BNTX 2.94% revealed their strategies for emerging coronavirus variants. The companies said they would test additional booster doses as well as variant-specific vaccines.

The week also witnessed multiple clinical readouts, while it was a relatively quiet week on the IPO front.

Here are the key events for the unfolding week:

Conferences

ESMO Targeted Anticancer Therapies Virtual Conference 2021: Feb. 28- March 2
Cowen 41st Annual Virtual Healthcare Conference: March 1-4
38th Annual Miami Breast Cancer Conference: March 4-7

PDUFA Dates

The Food and Drug Administration is scheduled to issue its verdict on KemPharm Inc's KMPH 8.84% new drug application for KP415, which is being evaluated for the treatment of attention deficit hyperactivity disorder. The decision is due Tuesday, March 2. KemPharm is collaborating with Aquestive Therapeutics Inc AQST 9.13% for an oral film dosage of KP415.

Gilead Sciences, Inc. GILD 2.21% has a PDUFA date of Friday, March 5, by which the FDA will decide on Yescarta, or axicabtagene ciloleucel. It is being evaluated for the treatment of certain types of lymphoma. Yescarta is a CAR T-cell therapy that came into Gilead's stable through its acquisition of Kite.

Clinical Readouts

At the ESMO meeting, Spectrum Pharmaceuticals, Inc. SPPI 4.72% will present safety, tolerability and preliminary efficacy of poziotinib, a lung cancer drug. The presentation is scheduled for Tuesday, March 2, at 11:25 a.m.


Earnings

Monday

Reata Pharmaceuticals Inc RETA 0.75% (before the market open)
Axsome Therapeutics Inc AXSM 1.49% (before the market open)
Amicus Therapeutics, Inc. FOLD 3.02% (before the market open)
Biohaven Pharmaceutical Holding Co Ltd BHVN 1.99% (before the market open)
Athenex Inc ATNX 1.94% (before the market open)
Agile Therapeutics Inc AGRX 5.59% (after the close)
Atara Biotherapeutics Inc ATRA 1.02% (after the close)
Arcturus Therapeutics Holdings Inc ARCT 2.41% (after the close)
Adverum Biotechnologies Inc ADVM 2.48% (after the close)
Omeros Corporation OMER 3.64% (after the close)
ChemoCentryx Inc CCXI 2.99% (after the close)
FibroGen Inc FGEN 0.34% (after the close)
Inovio Pharmaceuticals Inc INO 3.39% (after the close)
Precigen Inc PGEN 1.81% (after the close)
Turning Point Therapeutics Inc TPTX 0.86% (after the close)
OraSure Technologies, Inc. OSUR 0.84% (after the close)
Regenxbio Inc RGNX 2.33% (after the close)
Xenon Pharmaceuticals Inc XENE 3.09% (after the close)
Sarepta Therapeutics Inc SRPT 2.12% (after the close)
Silk Road Medical Inc SILK 0.33% (after the close)
Novavax, Inc. NVAX 4.39% (after the close)

Tuesday

Antares Pharma Inc ATRS 4.92% (before the market open)
Eagle Pharmaceuticals Inc EGRX 2.8% (before the market open)
GlycoMimetics Inc GLYC 2.92% (before the market open)
Seres Therapeutics Inc MCRB 1.33% (before the market open)
TherapeuticsMD Inc TXMD 1.3% (before the market open)
Rigel Pharmaceuticals, Inc. RIGL 0.24% (after the close)
Neuronetics Inc STIM 1.08% (after the close)

Wednesday

Strongbridge Biopharma plc SBBP 2.18% (before the market open)
OptiNose Inc OPTN 3.48% (before the market open)
Passage Bio Inc PASG 2.33% (before the market open)

Thursday

Arbutus Biopharma Corp ABUS 1.57% (before the market open)
Eyepoint Pharmaceuticals Inc EYPT 1.99% (before the market open)
X4 Pharmaceuticals Inc XFOR (before the market open)
Syros Pharmaceuticals Inc SYRS 5.41% (before the market open)
Opiant Pharmaceuticals Inc OPNT 2.84% (after the close)
Acorda Therapeutics Inc ACOR 3.8% (after the close)
Anika Therapeutics Inc ANIK 1.85% (after the close)
INmune Bio Inc INMB 0.18% (after the close)
Synthetic Biologics Inc SYN 3.04% (after the close)
T2 Biosystems Inc TTOO 1.72% (after the close)
Evofem Biosciences Inc EVFM 3.49% (after the close)
DermTech Inc DMTK 6.23% (after the close)
Chiasma Inc CHMA 1.04% (after the close)
Fulgent Genetics Inc FLGT 1.45% (after the close)
Clearpoint Neuro Inc CLPT 8.23% (after the close)

IPO Quiet Period Expiries

Sana Biotechnology Inc SANA 4.09%
Sensei Biotherapeutics Inc SNSE 1.29%
Landos Biopharma Inc LABP 3.77%
Angion Biomedica Corp ANGN 18.93%
Bolt Biotherapeutics Inc BOLT 4.78%
Immunocore Holdings PLC – ADR IMCR 1.31%
Lucira Health Inc LHDX 2.23%
Evaxion Biotech A/S – ADR EVAX 6.07%
Terns Pharmaceuticals Inc TERN 0.13%
Pharvaris BV PHVS 5.29%
Vor Biopharma Inc VOR 16.86%
Adagene Inc ADAG 1.45%

Other Events

Avenue Therapeutics Inc (NASDAQ: ATXI), a Avenue Fortress Biotech FBIO 0.27% portfolio company, is due to resubmit its drug application for intravenous tramadol in February. The company received a complete response letter for the original application in mid-October.

https://www.benzinga.com/general/biotech/21/02/19887970/the-week-ahead-in-biotech-feb-28-march-6-kempharm-gilead-fda-decisions-and-more-earnings