The U.S. continues to see more than 100,000 cases reported per day, casting a long shadow over any short-term economic recovery even as positive vaccine and treatment news begins to emerge.
The U.S. Food and Drug Administration (FDA) authorized Eli Lilly’s (LLY) antibody therapy, bamlanivimab, for emergency use late Monday, marking the first antibody therapy to receive the designation.
The authorization adds another option for treatment in hospitalized patients, but also for patients who are not severe or on oxygen. Existing treatment options cater to more severe patients. The antibody treatment is also useful as a defensive treatment for individuals who can’t receive vaccines.
The emergency use authorization (EUA) didn’t come easy— the trial hit a speed bump last month, when the National Institutes of Health (NIH) paused its trial over safety concerns, and a manufacturing plant ran into issues. But that won’t slow it down, the company said.
“Lilly can confirm there has been no impact to (active pharmaceutical ingredient) supply from the Branchburg (N.J.) site...we anticipate manufacturing up to one million doses” by the end of 2020, a spokesperson told Yahoo Finance Tuesday.
Questions remain about the out-of-pocket costs to consumers for administering the drug in a hospital, but the U.S. has already purchased 300,000 doses with an option to buy more.
“Lilly will offer bamlanivimab monotherapy at $1,250 per vial to wealthy countries,” the company said.
The company acknowledged limitations in its statement, saying the treatment remains “an investigational drug and has not been approved under a Biologics License Application (BLA). Evaluation of its safety and efficacy is ongoing across a range of patient populations impacted by COVID-19.”
Regeneron (REGN), another antibody treatment, which was used by President Donald Trump when he contracted COVID-19, also hit a snag last month and it, too, applied for an EUA. But that remains pending.
In an analyst note, SVB Leerink said, “We had low expectations for this approval, and certainly didn’t expect it to occur before Regeneron’s REGN-CoV2 doublet antibody. Lilly’s antibody was approved despite only marginal efficacy at the interim analysis of its phase II trial in mild to moderate COVID patients.”
The note also anticipated less market share available for Regeneron.
Lilly noted in a statement to Yahoo Finance that despite it being first out of the gate with an authorization, “we know there will be significantly more demand than supply for Lilly’s— and all other— antibodies currently in development.”
Pfizer’s vaccine faces hurdles
Meanwhile, despite a surge of enthusiasm around the lead vaccine candidate in the U.S. Monday, experts cautioned the announcement of positive early results from Pfizer (PFE) and BioNTech (BNTX) lacked proof of data to back it up.
The duo announced Monday positive interim results after participants received the second of two doses of the vaccine candidate, showing the vaccine was 90% effective against the virus.
But experts warned that it is likely the effectiveness will wane over time, and that delivery of the vaccines, using technology never been commercialized, remains a significant hurdle.
For one, the companies are faced with delivering the initial, limited supply of doses through an ultra-cold chain system that has been slowly but surely ramping up, and focusing on being able to do so for a projected 1.3 billion doses by the end of 2021.
The U.S. agreed to purchase 100 million doses for $1.95 million in the summer, which amounts to enough doses for 50 million people at about $19.50 per dose. The federal government has also reserved the option to purchase up to 500 million additional doses. The companies are preparing to produce 20 million doses per month beginning as early as later this month.
The companies are the only ones to not officially be funded by Operation Warp Speed, though Pfizer CEO Albert Bourla previously indicated otherwise. U.S. Health Sec. Alex Azar said Tuesday that the relationship is still a strong one, since OWS pre-purchasing doses helped to de-risk development of the vaccine. In addition, the companies will have access to ancillary products like syringes and dry ice that are necessary to distribute and administer the vaccine.
SVB Leerink analysts noted Monday that the announcement seemed rushed.
“We view it as very sensible for the companies to wait and perform the first interim as there was nothing to gain scientifically to rush to reach an efficacy conclusion, while still waiting for the safety data,” they said.
The companies are likely to get emergency use authorization at earliest in December, with a full licensure likely to come next year — much quicker than is standard for vaccines.
The second major hurdle for the companies, and all vaccine companies looking at two-dose inoculations, is the idea of distributing the vaccines to major pharmacies — which the government is partnering to do with CVS (CVS) and Walgreens (WBA).
“I can’t see it happening ... in large-scale pharmacies,” vaccine expert Dr. Paul Offit told Yahoo Finance.
Biden announces COVID task force
President-elect Joe Biden announced a new task force with some of the country’s top health experts and scientists, including former Surgeon General Vivek Murthy— who served in President Barack Obama’s administration.
The Biden team is endorsing mask-wearing, signaling a significant shift for the country’s future pandemic response. It’s a move many health experts have been waiting for.
Dr. Mary Clifton, an internal medicine doctor in Manhattan, told Yahoo Finance that, “without a face mask mandate and recommendations for the use of proper face masks with three layers of tightly woven fabric, we will continue to see high rates of cases and ongoing high mortality throughout the winter months.”
The country continues to report more than 100,000 cases daily, leading to more 10 million total cases as the second wave engulfs the country. The global total surpassed 50 million, and more than 1.2 million deaths have been reported.
With no change in strategy from the White House, the remainder of the year promises escalated cases and deaths.
“Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts,” Biden said in a statement.
“The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.”
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