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Leaders of the Biden administration's COVID-19 response announced new efforts on Monday to boost vaccine confidence, urged schools to return to in-person learning, and walked through new FDA guidance for drug manufacturers aiming to address variants.

The team also acknowledged the tragic toll of the pandemic, 500,000 Americans to date, which CDC Director Rochelle Walensky, MD, MPH, characterized as a "truly tragic reminder of the enormity of this pandemic, and the loss it has inflicted on our personal lives and our communities."

COVID-19 cases have continued to follow a downward trend over the last 5 weeks, and the 7-day average of cases has fallen 74% since its peak on Jan. 11, Walensky said.

The nation is averaging roughly 66,000 cases per day, which is close to the average number of cases during the virus's peak this past summer, Walensky said.

At 6,500 new COVID-19 hospital admissions per day, the 7-day average dropped 60% from its peak average on January 9, and the 7-day average of deaths fell by 38% to just north of 1,900 deaths, in comparison to the previous week, she noted.

Weather Delays, Vax Confidence Campaign

Andy Slavitt, senior advisor to the White House COVID-19 Response Team, acknowledged that extreme weather conditions delayed vaccine distributions last week. But shippers including McKesson, UPS, and the military are working to make up the shortfalls.

According to their plans, 7 million doses were expected for delivery on Monday alone and the backlog should be cleared by "mid-week." The week's regular shipments should proceed on schedule as well.

Slavitt also announced that over the next two weeks, the White House response team will hold listening sessions with underserved communities hit hardest by the pandemic with the goal of increasing vaccine confidence and reducing barriers to immunization through paid leave, transportation, and adjustments to scheduling.

The response team began meeting with members of the Black community on Monday and will also be speaking with representatives from the Latinx community, faith leaders and rural Americans later this week. In addition, the CDC will host a from Monday through Wednesday.

CDC Director Nudges Schools, Points to Data

Walensky also said more schools could reopen safely for in-person learning.

The percentage of counties with the highest level of COVID-19 transmission fell from 90% when agency's revised guidance on school operations was released 10 days ago, to 60% as of Sunday, she said.

Currently, 18% of counties have COVID-19 levels that are "low or moderate," she said, a level for which recommend "full in-person learning for all K-12 schools."

Another 22% of counties meet the criteria for a "substantial level" of community spread, a level for which the agency advises hybrid learning or reduced in-person attendance for all K-12 schools, Walensky noted.

Even in the "red zone" counties, K-5 students could "return to school in hybrid or reduced in-person attendance," she said.

Those schools already operating in-person should continue to do so "as long as cases are low and they strictly use mitigation measures to keep them low," Walensky added.

New Variants Demand New Therapeutics

The emergence of virus variants has raised questions about vaccine efficacy, but Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and President Biden's chief medical advisor, pointed out that treatments for acute infection shouldn't be neglected.

"The bottom line of what we need to do looking forward, and the clear need in this, is the development of potent antivirals directly acting on SARS-CoV-2," Fauci said, drawing parallels to the "highly successful drug development" for HIV and hepatitis C therapeutics.

This will involve locating vulnerable targets in the SARS-CoV-2 replication cycle and designing drugs to hit them.

To that end, new FDA guidance released Monday seeks to help drug and diagnostic companies design new products and for other manufacturers to modify previously authorized vaccines that can respond to new coronavirus variants, he said.

With respect to vaccines, Fauci reiterated the FDA's view that modified products should be judged through immunogenicity studies and not by large efficacy trials.

"The same holds true for COVID-19 tests, the updated guidelines describes the FDA's activities to better understand the public health impacts on the variants and the impact on the test performances and provide recommendations to the developers of these tests regarding the future genetic mutations and what they need to do when designing or modifying their existing tests," Fauci said.

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