Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 22, 2021

Excerpt of U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 22, 2021 | site |



(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: January 22, 2021)

• The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simula

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National Institutes of Health article says Full-dose Blood Thinners decreased need for Life Support and improved Outcome in Hospitalized COVID-19 Patients | site |



Information contained in National Institutes of Health [NIH] press release dated: January 22 2021) In large clinical trial conducted worldwide, full dose anti-coagulation (blood thinner) treatments given to moderately ill patients hospitalized for COVID-19 reduced the requirement of vital organ support—such as the need for ventilation. A trend in possible reduction of mortality was also observed and is being further studied. With large numbers of COVID-19 patients requiring hospitalization, these outcomes could also help reduce the overload on intensive care units around the world. Early in the pandemic, physicians around the world observed increased rates of blood clots and inflammation among COVID-19 patients which affected multiple organs and led to complications such as lung failure, h...

National Institutes of Health Officials Highlight COVID-19 Vaccine Facts, Unknowns for Healthcare Providers | site |



(Information included in a National Institute of Allergy and Infectious Diseases (NIAID) news release dated: January 18, 2021)

Healthcare providers must be able to explain the latest data supporting the safety and efficacy of vaccines for coronavirus disease 2019 (COVID-19) so they can strongly encourage vaccination when appropriate while acknowledging that uncertainty and unknowns remain. This message comes from a new commentary co-authored by Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and other leading NIAID scientists in the journal Annals of Internal Medicine. The commentary provides an overview of the seven COVID-19 vaccines furthest along in development in the United States. For each vaccine candidate, the authors des...

U.S. Department of Veterans Affairs says VA plays Crucial Role in COVID-19 Treatment Study | site |



(Information contained in U.S. Department of Veterans Affairs press release dated: January 19, 2021)

Washington - - U.S. Department of Veterans Affairs (VA) researchers and Veteran volunteers from the Atlanta and San Antonio VA medical centers were part of a recently published study that yielded crucial insights into COVID-19 treatment.

The study published Dec. 11, 2020, by the New England Journal of Medicine, showed the drugs baricitinib and remdesivir combined were far better at improving and reducing recovery time of COVID-19 patients than treatment with remdesivir alone. “Safe and effective vaccines for COVID-19 are being rolled out in VA and other health care settings, but finding treatments remains crucial,” said VA Secretary Robert Wilkie. “VA researchers and all the Veterans who volunteer for studies are contributing to steady p...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 19, 2021 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: January 19, 2021)


The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, to help protect consumers from methanol poisoning, the FDA issued a new guidance, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs. Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects.
• To accelerate the adoption of advanced and smart manufacturing

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U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, the FDA issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.” This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency.
• On January 14, the FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement

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U.S. Department of Veterans Affairs begins administering COVID-19 Vaccines to Department of Homeland Security Mission-essential Personnel | site |


(Information contained in U.S. Department of Veterans Affairs press release: January 12, 2021)

Washington - - The U.S. Department of Veterans Affairs (VA) began administering COVID-19 vaccinations to Department of Homeland Security (DHS) employees Jan. 6, through an interagency agreement to support DHS’s COVID-19 vaccination program.

The agreement was initiated in response to President Donald Trump’s declaration of COVID-19 as a national emergency and falls under the Economy Act, which authorizes federal agencies to provide services or supplies to other federal agencies on a reimbursable basis. As part of the agreement, trained VA medical professionals at certain VA medical centers are vaccinating DHS employees using DHS’s Centers for Disease Control and Prevention vaccine allocations. “This is a ...

Centers for Disease Control and Prevention Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States | site |


(Information contained in Centers for Disease Control and Prevention [CDC] press release: January 12, 2021) The Centers for Disease Control and Prevention is expanding the requirement for a negative COVID-19 test to all air passengers entering the United States. Testing before and after travel is a critical layer to slow the introduction and spread of COVID-19. This strategy is consistent with the current phase of the pandemic and more efficiently protects the health of Americans. Variants of the SARS-CoV-2 virus continue to emerge in countries around the world, and there is evidence of increased transmissibility of some of these variants. With the US already in surge status, the testing requirement for air passengers will help slow the spread of the virus as we work to vaccinate the American public. Before departu...

U.S. Department of Veterans Affairs, Fitbit help support Veteran Health and Wellness during COVID-19 Pandemic | site |




(Information contained in U.S. Department of Veterans Affairs press release: January 11, 2021)

Washington - - The U.S. Department of Veterans Affairs (VA) announced today a new initiative with Fitbit that will provide eligible Veterans, caregivers and VA staff with access to Fitbit programs and services to help manage stress, improve sleep and increase physical activity during the COVID-19 pandemic. The initiative will be focused on participants who currently use Fitbit devices. VA has contracted with Fitbit to initially provide 10,000 eligible Veterans, caregivers and VA staff a one-year free membership to Fitbit Premium. This includes access to guided programs, hundreds of workouts, mindfulness content, a wellness report and a health metrics dashboard. Participants will also have access to Fitbit Health Coachi...

U.S. Department of Health and Human Services Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies | site |

• System helps doctors and patients find locations for COVID-19 outpatient treatment

• Use of monoclonal antibody treatments could help reduce need for hospitalization in high-risk patients

(Information contained in U.S. Department of Health and Human Services press release: January 11, 2021)

A web-based COVID-19 outpatient treatment locator maintained by the U.S. Department of Health and Human Services (HHS) is now available to assist healthcare providers and patients in finding potential locations for treatment with monoclonal antibody therapeutics. These medicines are authorized for emergency use in treating patients with mild or moderate COVID-19 who are at high risk of developing severe symptoms and requiring hospitalization. "We are focused intently on supporting healthcare providers in their efforts to save liv...

Walgreens Expects to Complete Administration of COVID-19 Vaccine First Doses in Skilled Nursing Facilities by January 25 | site |


Walgreens continues to accelerate access to COVID-19 vaccinations among additional vulnerable populations as part of state and local jurisdictions distribution plans


(Information contained in Walgreens press release dated: January 6, 2021)

Deerfield, Ill., January 06, 2021 - Walgreens expects to complete the administration of COVID-19 vaccine first doses in skilled nursing facilities by Monday, Jan. 25. The company is also rapidly expanding access to vaccinations among assisted living facilities and additional vulnerable populations outlined by states and local jurisdictions as part of expanded distribution plans. “Since receiving our first allotments of vaccines in late December, Walgreens has remained on track in vaccinating our most vulnerable populations, and we are steadfast in our comm...

U.S. Department of Veterans Affairs expands Access to Telehealth Services during COVID-19 Pandemic for Older, Rural and Homeless Veterans | site |


(Information contained in U.S. Department of Veterans Affairs press release dated: January 6, 2021)

Washington - - The U.S. Department of Veterans Affairs (VA) announced today its Digital Divide Consult has helped more than 12,000 Veterans obtain internet access or a video-capable device for their health care needs.

As part of the program, VA providers refer Veterans to a VA social worker, who determines eligibility for various programs to assist with getting the internet service or technology needed for VA telehealth — ensuring older Veterans, those living in rural areas and Veterans who are homeless or in temporary housing have the opportunity to participate.

According to the Journal of the American Medical Informatics Association, Veterans with lower incomes, more severe...

Coronavirus (COVID-19) Update: January 8, 2021 | site |



(The following is part of the information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021)


The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

• The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
  • Details on the effect of genetic variants on test performance.
  • Recommendations for clinical laboratory staff and health care providers.
  • Actions the FDA has taken.
  • Instructions for reporting problems with a test.
• This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently

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U.S. Department of Health and Human Services Continues Community Based Testing Sites for COVID-19 | site |


(Information contained in U.S. Department of Health and Human Services press release dated: January 7, 2021) Today, the Department of Health and Human Services (HHS) announced the extension of the Community Based Testing Site program for COVID-19 testing, through partnership with national pharmacy and retail chains CVS, Rite-Aid, Walgreens, Quest (through services at Walmart) and service provider eTrueNorth (through services at Health Mart and Topco locations). The partnership has resulted in establishing more than 3,300 COVID-19 testing locations in all 50 states, the District of Columbia, and Puerto Rico. To date, more than 5.6 million tests have been conducted as a result of this partnership. The Community Based Testing Site program began in the spring of 2020 and includes a large percentage - over 70% - of testing sites located in communities ...

U.S. Department of Veterans Affairs administers over 146,000 COVID-19 Vaccine Doses to date | site |



(Information contained in U.S. Department of Veterans Affairs press release dated: January 5, 2021)

Washington - - The U.S. Department of Veterans Affairs (VA) announced today it has administered initial COVID-19 vaccine doses to more than 14,000 Veterans at high risk of getting COVID-19 infection, and more than 132,000 health care employees as of Jan. 4.

In accordance with VA’s COVID-19 Vaccine Distribution Plan, the department started vaccination efforts at 37 initial VA medical centers, following the Food and Drug Administration’s Dec. 11 decision to issue an Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine. The 37 initial sites to first receive the vaccine were selected based on several factors, including having the capacity to store the vaccine at extremely cold temperatures and the ability to offer hi...