- NIH Director Dr. Francis Collins released a blog post on new findings showing that people who survive a COVID-19 infection continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms.
- CDC updated information on protecting yourself when using public transit, rideshares and taxis, micro-mobility devices, and personal vehicles, as CDC Director Dr. Robert Redfield is warning that the U.S. is experiencing a “distressing trend” as infections are rising for three-quarters of the country.
- Dr. Moncef Slaoui, the head of the White House Operation Warp Speed vaccine development and distribution initiative, is optimistic that all Americans can have access to a COVID-19 vaccine by June 2021.
- Dr. Peter Marks, FDA’s Director of the Center for Biologics Evaluation and Research, returns for his third episode on FDA Insight podcast to provide an update on COVID-19 vaccines and to discuss the upcoming Vaccines and Related Biological Products Advisory Committee meeting.
Congress
Speaker of the House Nancy Pelosi (D-CA) and Treasury Secretary Stephen Mnuchin are continuing to make progress toward a comprehensive, bipartisan COVID-19 relief bill. Their goal is to vote on a bill before the November 3 election.
- If a deal is reached, it is highly unlikely the bill will be completed in time for a vote before the election.
- Despite this progress, Senate Majority Leader Mitch McConnell (R-KY) is warning negotiators that most Senate Republicans do not support a bill as large as the $2 trillion bill Pelosi and Mnuchin are negotiating.
- Leader McConnell introduced and held a Senate vote on a $500 billion bill but it was not passed due to opposition from Democrats.
White House and Federal Agencies
NIH Director Dr. Francis Collins released a blog post on new findings showing that people who survive a COVID-19 infection continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms.
The FDA issued a Consumer Update entitled, Advisory Committees Give FDA Critical Advice and the Public a Voice. It describes how the FDA relies on its many advisory committees to help it make sound decisions based on the best science available.
Centers for Disease Control and Prevention (CDC) Updates
CDC Director Dr. Robert Redfield is warning that the U.S. is experiencing a “distressing trend” as infections are rising for three-quarters of the country.
According to a report from the CDC, 300,000 more people died during the period of January-October of 2020 compared to the typical number of deaths observed during the same period in previous years. The higher death rate disproportionately impacted people of color. The report also suggests that public health officials have undercounted COVID-19 deaths.
CDC released a Morbidity and Mortality Weekly Report (MMWR) on Risk for In-Hospital Complications Associated with COVID-19 and Influenza in the Veterans Health Administration between October 1, 2018 and May 31, 2020. Hospitalized patients with COVID-19 in the Veterans Health Administration had a more than five times higher risk for in-hospital death and increased risk for 17 respiratory and non-respiratory complications than did hospitalized patients with influenza. The risks for sepsis and respiratory, neurologic, and renal complications of COVID-19 were higher among Black and Hispanic patients than among non-Hispanic White patients.
CDC issued updated guidance to clarify the amount of time it would take for someone to be considered a close contact exposed to a person with COVID-19. The updated guidance now defines a close contact as someone who has spent a cumulative total of 15 minutes or more, in a 24-hour period within six feet of an infected person. Previous guidance defined a close contact as someone who spent at least 15 consecutive minutes within 6 feet of a confirmed case.
CDC updated:
- Considerations for who should get tested for COVID-19.
- Guidance on the appropriate use of testing for SARS-CoV-2 in light of additional testing capacity throughout the country and does not address decisions regarding payment for or insurance coverage of such testing. CDC updated their COVID-19 testing overview with information on viral and antibody tests.
- Guidance to help college and university administrators protect students, faculty, and staff from COVID-19 infections and slow the spread of the virus. This document includes considerations for expanded and widespread testing; provides a tiered approach to testing in the context of an outbreak; gives examples of successful entry and periodic screening strategies; and discusses the likelihood of off-campus transmission.
- Information on protecting yourself when using public transit, rideshares and taxis, micro-mobility devices, and personal vehicles.
Economy, Vaccine, Testing and Treatment
On October 22, the FDA Vaccines and Related Biological Products Advisory Committee held a full day public meeting to discuss the COVID-19 vaccine and distribution plan.
Moncef Slaoui, the head of the White House Operation Warp Speed vaccine development and distribution initiative, is optimistic that AstraZeneca and Johnson & Johnson will soon resume the U.S. trials for their respective COVID-19 vaccine candidates. The two companies paused their trials after reported safety issues.
- Slaoui is also optimistic that all Americans can have access to a COVID-19 vaccine by June 2021.
An FDA study found that front-line healthcare workers and minorities – two groups that should be among the first in line to get access to COVID-19 vaccines upon their approval – are distrustful of the vaccine candidates under development.
Moderna announced that it has completed enrolling the 30,000 participants it needs for its Phase III COVID-19 vaccine trial. The company says that 37 percent of trial participants are people of color and that 42 percent of participants represent high-risk groups.
The FDA officially approved remdesivir as a treatment for COVID-19. The FDA previously had authorized the treatment under a temporary Emergency Use Authorization.
- A NIH study confirmed that remdesivir shortened recovery time for patients hospitalized with COVID-19. The NIH study contradicts a recent World Health Organization (WHO) study that found that remdesivir had no real effect on COVID-19 mortality or recovery.
A new report from several research institutions shows that the average turnaround time for COVID-19 test results has decreased from four days to three days.
HHS Secretary Alex Azar is cautiously optimistic that at least one vaccine candidate will be approved before the end of the year.
Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci expressed optimism for the vaccine candidates undergoing Phase III clinical trials.
A new study in the United Kingdom (UK) will be the first to intentionally infect young, healthy volunteers with the coronavirus, to study its effects on the human body.
Peter Marks, FDA’s Director of the Center for Biologics Evaluation and Research, returns for his third episode on FDA Insight podcast to provide an update on COVID-19 vaccines and to discuss the upcoming Vaccines and Related Biological Products Advisory Committee meeting.
