Your coronavirus update for August 24; stay up to date with Elite.
More than 23 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including 809,000 deaths. Healthcare officials in the United States have reported nearly 5.8 million positive COVID-19 cases and at least 179,000 deaths. Source: Johns Hopkins University & Medicine
CDC Removes Quarantine Restrictions For Travelers
Travel recommendations from the Centers for Disease Control and Prevention (CDC) do not currently suggest that travelers self-quarantine for 14 days upon returning home from domestic or international trips.
As of Aug. 21, CDC officials had updated their travel requirements, advising travelers to “follow state, territorial, tribal, and local recommendations or requirements after travel.” There is no longer a specific guideline for a 14-day quarantine for those people returning from international destinations or areas with a high concentration of coronavirus cases.
Recommendations related to social distancing, mask-wearing, and hand washing are still posted for all travelers.
The CDC also advises that travel increases the chances of acquiring and spreading COVID-19 and to not travel when feeing ill or after being around someone with COVID-19 in the past 14 days. There are also specific suggestions for travel type, such as air, bus or train, car, and RV. Tips for best practices after travel occurs are also provided.1
FDA Releases Recommendations For Investigational Plasma
Officials with the U.S. Food & Drug Administration (FDA) have issued guidance to healthcare providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.2
The guidance provides recommendations on pathways for use of investigational COVID-19 convalescent plasma in patients, patient eligibility, collection of COVID-19 convalescent plasma, donor eligibility and donor qualifications, labeling, and record keeping.
As it’s being regulated as an investigational product, healthcare providers must participate in certain pathways for utilization: clinical trials, expanded access through an investigational new drug (IND) application, or emergency IND application for individual patients. Healthcare providers and facilities must obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.
Specifically, convalescent plasma that contains antibodies to the virus that causes COVID-19 is being studied for administration to patients. Use of convalescent plasma has also been studied in outbreaks of other respiratory infections, including the 2003 severe acute respiratory syndrome epidemic, the 2009-10 swine flu virus pandemic, and the 2012 Middle East respiratory syndrome coronavirus epidemic.
Although the FDA considers the treatment promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19, officials said. There are also reports that claim some officials and scientists are questioning the data behind the decision to move forward with plasma as an option.3
Eligibility criteria for patients used for the National Expanded Access Treatment Protocol include laboratory confirmed COVID-19, severe or immediately life-threatening COVID-19 (severe disease is defined as one or more of shortness of breath, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, or lung infiltrates > 50% within 24 to 48 hours; life-threatening disease is defined as one or more of respiratory failure, septic shock, or multiple organ dysfunction or failure), and informed consent provided by the patient or healthcare proxy.
According to the FDA, COVID-19 convalescent plasma must only be collected from individuals who meet donor eligibility requirements,2 including:
- Evidence of COVID-19 documented by a laboratory test either by diagnostic test at the time of illness or a positive serological test for SARS-CoV-2 antibodies after recovery, if prior diagnostic testing was not performed at the time COVID-19 was suspected.
- Complete resolution of symptoms at least 14 days before donation.
- Male donors, or female donors who have not been pregnant, or female donors who have been tested since their most recent pregnancy and results interpreted as negative for human leukocyte antigen antibodies.
Related to recordkeeping, providers who are participating in an IND, must maintain records for the COVID-19 convalescent plasma unit(s) administered to COVID-19 patients, officials said. Such records should include the unique identification number(s) of the unit(s).
WHO & CDC: No Evidence of Virus Spread By Food
After reports out of China citing that frozen chicken imported from Brazil was found to have COVID-19 RNA on it and that an outbreak in New Zealand is feared to be linked to COVID-19, officials from the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) have announced that no known cases of virus spread through food exist. “There is currently no evidence that people can catch COVID-19 from food, including fruits and vegetables.” Coronaviruses cannot multiply in food; they need an animal or human host to multiply,” the WHO has posted online.4
While the CDC and WHO acknowledge that it’s possible for someone to contract COVID-19 from touching infected food or packaging, experts say the risk of this actually happening is extremely low, according to a report by Yahoo Life.5 “Epidemiologically, there isn’t any compelling evidence,” said Benjamin Chapman, a professor and food safety specialist at North Carolina State University, in the report.5 “The general consensus in the food safety world is that consuming food that has SARS-CoV-2 on it is not likely to get you sick.”
- Travel during the COVID-19 pandemic. CDC. 2020. Accessed online: www.cdc.gov/coronavirus/2019-ncov/travelers/travel-during-covid19.html
- Recommendations for investigational COVID-19 convalescent plasma. FDA. 2020. Accessed online: www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma
- Thomas K, Fink S. F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say. New York Times. 2020. Accessed online: www.nytimes.com/2020/08/24/health/fda-blood-plasma.html
- COVID-19 and food safety: guidance for food businesses. WHO & FAOUN. 2020. Accessed online: https://bit.ly/32q9V8n
- Miller K. Amid new fears around COVID-19 food transmission, experts say there is ‘no compelling evidence.’ YahooLife. 2020. Accessed online: www.yahoo.com/lifestyle/amid-new-fears-around-around-covid-19-food-transmission-experts-say-theres-no-compelling-evidence-143043012.html