Coronavirus Breaking News

The U.S. Food and Drug Administration (FDA) issued new guidance on November 25, 2020, regarding the use of dry heat to support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, when there is a limited supply of respirators during the COVID-19 public health emergency.

This announcement stated the 'immediately-in-effect guidance provides the FDA’s thinking and recommendations regarding the use of bioburden reduction systems that use dry heat to reduce the bioburden, or amount of microorganisms present, on certain respirators for reuse by a single user. Bioburden reduction systems are intended to achieve a certain level of microbial reduction on a device; these are not decontamination systems.'

“There exists sufficient evidence demonstrating that there is a reduction of microbial load on certain respirators when exposed to certain dry heat parameters. Bioburden reduction systems can play an important role in the ongoing efforts to help address shortages of FFRs,” said Dr. Binita Ashar, Director of the Division of Surgical Devices in FDA’s Center for Devices and Radiological Health, in a press release.

According to new data reported by the US Transporation Services Administration on November 25, 2020, airport security screened 1,070,967 travelers in the USA. This data indicates a record number of travelers since the COVID-19 pandemic began in early 2020.

CureVac N.V. and Wacker Chemie AG announced on November 23, 2020, that they had signed a contract for the manufacturing of the mRNA drug substance for CVnCoV vaccine candidate at a biotech site in Amsterdam in the first half of 2021. These companies plan to produce more than 100 million doses of the CVnCoV vaccine per year in the Netherlands.

The state of New York announced it is launching checkpoints at various entry points into the state. New York states 'these checkpoints are an educational tool designed to ensure travelers understand and comply with New York State’s travel restrictions.'

New York State law now requires anyone entering the State who has spent more than 24-hours in any state on New York’s Restricted State List to 1.) Register by completing the New York State Traveler Health Form; 2.) Quarantine upon arrival for 14-days from the last day of travel within a state on the restricted list; 3.) Essential workers coming to work in New York from a restricted state must follow the guidance of the State Department of Health.

And, New York City Mayor Bill de Blasio has said 'those who violate quarantine restrictions could face fines of up to $2,000,' reported The Hill.

Pentagon spokesman Jonathan Rath Hoffman said during a press conference on November 24, 2020, "We've seen a general uptake and COVID-19 positive cases as we head into the holiday season. We wanted to take this opportunity to re-emphasize the importance of taking preventive measures to mitigate the spread of coronavirus, particularly following CDC guidelines."

'The DOD's primary support to the U.S. government response has been providing military medical personnel to augment civilian medical facilities in areas experiencing high COVID-19 hospitalization rates. Today, there are more than 20,000 National Guardsmen deployed in 52 states and territories, providing COVID-19 support,' added Ken Rapuano, the assistant secretary of defense for homeland defense and global security.

As of November 23, 2020, the DoD reported 74,992 active-duty personnel were confirmed with SARS-CoV-2 coronavirus infections. However, only 11 fatalities related to COVID-19 have been reported during 2020.

Appili Therapeutics Inc. announced the initiation of its Phase 3 Post-Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan tablets (favipiravir) in the prevention of COVID-19. And, Health Canada has provided a ‘No Objection Letter’ for Appili’s proposed study.

In September 2020, the U.S. FDA previously accepted a submission of a protocol amendment to conduct the trial in the USA.

This is the second Phase 3 study Appili has announced to evaluate the utility of Avigan tablets against COVID-19 in the community setting. The other study also known as the PRESECO study is evaluating Avigan for the treatment of adults with mild-to-moderate symptoms of COVID-19.