Coronavirus Roundup: The NIH Releases a New Pandemic Preparedness Plan 

The National Institute of Allergy and Infectious Diseases published a new pandemic preparedness plan as the third year of the coronavirus pandemic starts. NIAD, a division of the National Institutes of Health, will focus on two fronts. 

“First, researchers will identify ‘prototype pathogens’—viruses within viral families with the potential to cause significant human disease. Knowledge gained from studying prototype pathogens will also build a framework for a rapid research and product development response for other viruses within that virus family should an outbreak occur,” said a press release from the agency on Wednesday. “The plan’s second key research focus is on priority pathogens—viruses already known to be capable of causing significant human illness or death, such as Zika virus.” NIAD hosted a workshop in November 2021 with members of the scientific community, which helped inform this new plan. Here are some of the other recent headlines you might have missed. 

The Food and Drug Administration on Monday granted full approval to the Moderna vaccine for individuals 18 years and older. Pfizer/BioNTech’s vaccine previously received full approval in August. “While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” said acting FDA Commissioner Dr. Janet Woodcock, in a press release. 

On Tuesday, Pfizer-BioNTech announced that, at the request of the FDA due to the surging number of COVID-19 cases in young kids, they have started submitting data to the FDA on a two dose regimen of their vaccine for kids 6 months through 4 years old. They will submit further data on the three-dose regime in the coming months, which the companies believe would be most effective. This is part of a rolling submission process to seek emergency use authorization for this age group. The agency’s advisory committee will meet on February 15 to discuss the request. 

“In a highly unusual move, federal regulators pressed the companies to submit the request even though two doses failed to produce the hoped-for immune response among children 2 to 4 years old in a clinical trial,” The New York Times reported. “Only children between 6 months and 2 years old demonstrated an immune response comparable to that of older teenagers and young adults, the standard for a successful trial.” 

This “prompted the companies to test a third low dose of the shot in that age group. But rather than wait until the end of March for the results, federal regulators decided to encourage Pfizer to apply for authorization of a two-dose regimen now in hopes of getting a head start on the vaccination effort,” the report continued. 

The biotechnology company Novavax submitted an application to the FDA for emergency use authorization for its protein-based vaccine for individuals 18 and up. “We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," said Stanley Erck, president and CEO of Novavax in a press release on Monday. “I'd like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today's milestone of EUA request submission.”

During the briefing on Tuesday, White House Press Secretary Jen Psaki was asked if the president still has confidence in Health and Human Services Department Secretary Xavier Becerra and if he’s discussed any leadership changes at HHS following the recent federal watchdog report that identified HHS leadership as a major challenge along with other issues related the federal pandemic response and news reports that allege White House officials are frustrated with Becerra. “I would just reiterate that the president remains confident in the role of Secretary Becerra,” said Psaki. “He is somebody who is an important partner. He has been leading a range of efforts from…the Department of Health and Human Services. And we have strong partnerships from the very top down with HHS.” She added they aren’t focused on “palace intrigue, as much as we are on vaccinating more Americans, fighting the Omicron surge, expanding testing capacity, and getting more therapeutics out to the American people,” which is “how we believe we and the leadership of the Cabinet will be judged.” 

A new watchdog report identified issues in the use and handling of 57 grants totaling $366 million from the CARES Act awarded as of August 2020 for employment and training services for workers displaced by the pandemic. The Labor Department’s Employment and Training Administration generally administered the program following the appropriate federal regulations and guidelines, there were “significant delays in grantees providing disaster relief employment and training services,” said a report by The Lopez Group LLP, a public accounting firm the Labor Department inspector general contracted with. 

“This occurred in part because [the administration] relied on existing [Disaster National Dislocated Worker Grants] guidance and measures and did not establish additional metrics or guidance to assist grantees with the timely delivery of services to quickly assist dislocated workers with disaster relief activities,” the report continued. “Further, one state indicated the reason it had not spent any of the funds allocated through the grant early on was due to confusion over how the grant funds should be properly spent per provisions in the grant.” 

Upcoming:

• White House Press Secretary Jen Psaki will give a briefing at 12:30 p.m.
• The White House COVID-19 response team and public health officials will give a briefing at 3 p.m.

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