By Jeff Overley

Law360 (November 9, 2020, 11:01 PM EST) -- President-elect Joe Biden on Monday announced a blue-ribbon panel of pandemic advisers, Pfizer Inc. reported that its coronavirus vaccine candidate appears strikingly effective, and confirmed COVID-19 cases in the U.S. climbed to roughly 10 million amid signs that the crisis is rapidly intensifying.

Here are four key developments to know as the nation faces yet another sobering pandemic milestone.

Pandemic Enters 'Critical Phase'

The U.S. late Monday was poised to become the first country with coronavirus infections in eight-figure territory. Johns Hopkins University put the tally slightly above 10 million, while the COVID Tracking Project had an estimate just below 10 million. The roughly 10 million cases account for one-fifth of the 50 million positive tests recorded globally, according to Johns Hopkins.

The caseload partly reflects America being the world's third-most populous country and the global leader in coronavirus testing. But regardless of comparisons to other nations, there are clear signs of an increasingly dire situation. The seven-day average of new cases has more than doubled over the past month, far outpacing the rise in testing during that period. Average daily deaths and hospitalizations have also jumped significantly.

"We all realize our nation is in a critical phase of the pandemic," Brett Giroir, a U.S. Department of Health and Human Services assistant secretary and the Trump administration's coronavirus testing czar, told reporters on Monday afternoon.


Average daily fatalities are still less than half the peak levels experienced in April, but the pandemic appears likely to worsen before it improves.

"You have a much better chance of surviving COVID than you did even a few months ago," Giroir said, citing advances in treatment. "Nonetheless ... hospitalizations and deaths will continue to rise until we rigorously adhere to public health prevention measures."

Biden Outlines New Steps to Tackle Virus

During remarks in Delaware, Biden said that he and Vice President-elect Kamala Harris have formed a 13-member advisory board that will develop recommendations for swift implementation of new response measures after the Democrats take office on Jan. 20, assuming that President Donald Trump is unsuccessful in challenging the election results.

The board will have three co-chairs: Dr. David Kessler, who served as U.S. Food and Drug Administration commissioner during the Clinton administration; Dr. Vivek Murthy, who served as U.S. surgeon general during the Obama administration; and Dr. Marcella Nunez-Smith, a Yale School of Medicine associate dean.

Dr. Rick Bright, a pandemic and vaccine expert who led the Biomedical Advanced Research and Development Authority at HHS until April, when he claimed to have been demoted for opposing Trump's promotion of malaria drug hydroxychloroquine for COVID-19, will also sit on the advisory board. Bright recently resigned from HHS.

Biden on Monday described several goals, such as making rapid testing "much more widely available," building a "corps of contact tracers" to help extinguish outbreaks and ramping up production of personal protective equipment for health care workers who are seeing more COVID-19 patients in much of the country.

The president-elect also signaled that he will prioritize getting future vaccines to racial and ethnic minorities who have sustained disproportionate numbers of COVID-19 deaths. Those signals included a vow that vaccines will be "distributed equitably" and the appointment of Nunez-Smith, who studies health care among minorities and other "marginalized populations."

"We're going to address the health and economic disparities that mean this virus is hitting the Black, Latino, Asian-American, Pacific Islanders, Native American communities harder than white communities," Biden said.

Pfizer Sees 'Great Day' for Vaccine Efforts 

No coronavirus vaccines have won authorization yet, but Pfizer on Monday delivered some of the best evidence yet that an unprecedented effort to rapidly develop such inoculations is on the right track.

The New Jersey-based drugmaker said that an "interim analysis" shows "a vaccine efficacy rate above 90%" in its proposed vaccine. If further analysis validates that number, it would far exceed the FDA's requirement that vaccines prevent coronavirus infections or reduce COVID-19's severity in at least 50% of inoculated patients.

"Today is a great day for science and humanity," Dr. Albert Bourla, Pfizer's CEO, said in a statement. "We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen."

Pfizer said that it hopes to have enough safety data by the third week of November to seek emergency authorization from the FDA. As part of a vaccine development effort called Operation Warp Speed, the Trump administration has agreed to pay nearly $2 billion for 100 million doses of Pfizer's vaccine if it wins clearance.

Even in a best-case scenario, it will likely be several more months before a vaccine starts to become widely available. There have been nearly 240,000 coronavirus deaths in the U.S., and Biden on Monday cautioned that "we could lose 200,000 more lives" before large-scale vaccine distribution commences.

"We're still facing a very dark winter," Biden said during his remarks, which featured repeated and forceful entreaties for Americans to wear masks that became a political flashpoint during the presidential campaign.

"We can save tens of thousands of lives if everyone would just wear a mask for the next few months. Not Democrat or Republican lives — American lives," Biden said.

Trump, who was hospitalized last month with COVID-19, has largely eschewed mask wearing and has recently seemed to view pandemic prevention measures as futile. Mark Meadows, the White House chief of staff — who has also eschewed mask-wearing and reportedly tested positive recently for the coronavirus — said two weeks ago that the country was "not going to control the pandemic" and should focus on protecting its most vulnerable citizens while awaiting a vaccine.

Pfizer's vaccine requires two doses per person, and the administration has said it may purchase up to 500 million additional doses. Several other drugmakers have active clinical trials of vaccine candidates. One of the most advanced trials involves a Moderna Inc. product, which like Pfizer's product uses mRNA, or messenger RNA, to teach the immune system to recognize and defeat the novel coronavirus.

FDA Clears Eli Lilly Biologic for COVID-19

On the therapeutic front, the FDA on Monday granted an emergency authorization to an Eli Lilly & Co. biologic for treatment of mild-to-moderate COVID-19 in certain patients who "are at high risk for progressing to severe COVID-19 and/or hospitalization."

The product is a monoclonal antibody called bamlanivimab, and the FDA said there is preliminary evidence that it can reduce hospitalizations and emergency room visits in high-risk patients. Bamlanivimab's authorization doesn't cover treatment of patients who are already hospitalized.

Eli Lilly CEO David A. Ricks said in a Monday statement that the authorization adds "a valuable tool for doctors fighting the now-increasing burden of this global pandemic."

The FDA has granted only a few other emergency authorizations for COVID-19 therapeutics. They include so-called convalescent plasma, which is essentially filtered blood with coronavirus antibodies; the antiviral remdesivir, which last month won full approval; and hydroxychloroquine, which later had its authorization revoked amid doubts about its effectiveness.

--Editing by Jill Coffey.

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