FDA to tighten vaccine approval requirements; face shields alone don't reduce virus spread, study suggests — 8 COVID-19 updates

The U.S. has reported an average of 41,490 new COVID-19 cases daily in the past week, up 13 percent from the average seen two weeks ago, reports The New York Times.

At least 22 states are reporting an uptick in cases as of Sept. 23, compared to just nine states on Sept. 14, according to CNN's analysis of data from Baltimore-based Johns Hopkins University.

Eight updates:

1. The FDA is set to issue stricter emergency authorization requirements for a COVID-19 vaccine, reports The Washington Post. The new standards will make it more challenging to clear a vaccine before Election Day in an attempt to improve public confidence in the agency. Currently under review by the White House Office of Management and Budget, the proposed changes include manufacturers following participants in late-stage clinical trials for at least two months, two people familiar with the situation told the Post.  

2. Johnson & Johnson's single-shot COVID-19 vaccine has entered the final stage of testing, according to The Washington Post. The vaccine is the first single-dose vaccine to enter a large, phase 3 clinical trial in the U.S., and the fourth experimental vaccine total to enter said phase. 

3. The CDC has issued safety recommendations for the holiday season, including family and community gatherings. The guidelines are meant to supplement — not replace — any local safety regulations, and urge individuals to consider community levels of COVID-19; location of gathering; event duration; number of people; location attendees are traveling from; and behavior of attendees prior to and during the gathering. 

4. Four top health officials are testifying before the Senate Health, Education, Labor and Pensions Committee about the national COVID-19 response this morning. Health officials include Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases; CDC Director Robert Redfield, MD; FDA Commissioner Stephen Hahn, MD, and HHS Assistant Secretary Adm. Brett Giroir, MD. Dr. Fauci said federal scientists are starting to study COVID-19 "long-haulers," or patients who experience long-term side effects from the virus. He also said federal research shows "a disturbing number of individuals" who still have heart inflammation after recovering from COVID-19, reports The New York Times. When asked about a temporary change to CDC testing guidelines, which said people without symptoms do not always need to be tested, Dr. Redfield said the intent was never to limit testing of asymptomatic individuals. "It's clear the guidelines weren't interpreted in the manner we wanted them to be," he said, adding that the original guidance was produced with "full enegagement from individuals at CDC." To view a livestream of the hearing, which began at 10 a.m. ET, click here.

5. Thirty-four Senate Democrats introduced a bill Sept. 22 that would investigate any political interference in federal health agencies. The Science and Transparency Over Politics (STOP) Act would create a task force charged with investigating any political interference involving decisions made by scientific agencies within HHS. 

6. California's positivity rate fell below 3 percent for first time since the pandemic started, reports The Washington Post. As of Sept. 22, the state's seven-day average positivity rate was 2.8 percent. Wildfires have caused a drop in testing, which may affect this figure. However, the state is also reporting 2,632 hospitalizations as of Sept. 22 — the lowest figure seen since April.

7. COVID-19 hospitalizations hit a record high in Wisconsin on Sept. 22. The Wisconsin Hospital Association reported 474 hospitalizations, surpassing the previous record of 446 hospitalizations set April 9, according to Fox affiliate WLUK.

8. Face shields alone do little to reduce COVID-19's spread, suggests a Japanese study cited by The New York Times. Scientists at a research institute in Kobe, Japan, used the world's fastest supercomputer to simulate the diffusion of respiratory droplets from people wearing plastic face shields. While the shields may protect the wearer from other people's respiratory droplets, they do nearly nothing to capture and prevent the spread of droplets five microns or smaller that come from the wearer, the simulations showed. 

Snapshot of COVID-19 in the U.S.

Cases: 6,897,661
Deaths: 200,818
Recovered: 2,646,959

Counts reflect data available as of 8:25 a.m. CDT Sept. 23.

More articles on public health:
NIH staffer to depart after anonymous posts criticizing agency; vaccine for kids may not be ready by fall 2021 — 5 COVID-19 updates
COVID-19 hospitalizations by state: Sept. 23
28 states where COVID-19 is spreading fastest, slowest: Sept. 23


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