The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.
An updated U.S. FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts, was published on September 4, 2020.
The FDA’s ongoing response includes increasing the availability of tests, therapeutics, and devices, such as personal protective equipment, and many other important items necessary to reduce the spreading of the SARS-CoV-2 coronavirus and reduce the impact of COVID-19 disease.
The first commercial test for fully automated high-throughput systems to detect and differentiate SARS-CoV-2 and influenza viruses, with a single sample from patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19 disease, was authorized by the U.S. FDA on September 4, 2020.
Switzerland based Roche's cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription-polymerase chain reaction (RT-PCR) assay that can provide up to 96 test results in about 3 hours.
The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control, and internal control. Multiplexing will increase lab efficiency and save resources in the labs. Negative results do not preclude infection from SARS-CoV-2 or Influenza virus and should not be used as the sole basis of treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
This announcement is the 4th flu-coronavirus combination test authorized by the FDA during the COVID-19 pandemic of 2020.
Based on death certificate data, the percentage of fatalities attributed to pneumonia, influenza, or COVID-19 (PIC) for week #35 was reported by the U.S. CDC's COVIDView to be 6.6%. This is currently lower than the percentage reported during week #34 (10.7%).
However, the percentage will likely increase as more death certificates are processed, said the CDC on August 4, 2020.
Across the USA, the percentage of respiratory specimens testing positive for SARS-CoV-2 increased slightly to reach 5.5% during week #35. As the coronavirus outbreak progresses, it is possible that different types of laboratories will take on different roles, and the data interpretation may need to change.
Since March 2020, there have been 44,203,187 completed lab tests by commercial labs in the USA.
The newly identified COVID-19 disease was initially classified as respiratory disease, but scientists now appreciate that it also affects other organs in the body, including the heart. Even patients who experience mild COVID-19 symptoms exhibit signs of cardiac dysfunction several months after recovery, said scientists from Gladstone Institutes on August 25, 2020.
A new study by these scientists helps explain how SARS-CoV-2, the coronavirus that causes COVID-19, inflicts damage on heart cells. The team’s non-peer-reviewed findings, shared publicly on bioRxiv, show the virus’s unexpected effects on the structure of heart cells in the lab, as well as in heart tissue from COVID-19 patients.
This study found 'infection of human iPSC-derived cardiomyocytes with SARS-CoV-2 revealed robust transcriptomic and morphological signatures of damage in cardiomyocytes. These morphological signatures include a distinct pattern of sarcomere fragmentation, with specific cleavage of thick filaments, and numerous iPSC-cardiomyocytes that lacked nuclear DNA.'
The U.S. FDA updated its guidance on the use of convalescent plasma on September 2, 2020, to provide additional information related to the use in the treatment of severe COVID-19 disease patients. Previously, on August 23rd, the FDA issued an Emergency Use Authorization for convalescent plasma collected from individuals who have recovered from COVID-19, which contains antibodies to SARS-CoV-2.
Convalescent plasma treatments have been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009 H1N1 influenza virus (Swine Flu) pandemic, and the 2012 MERS-CoV epidemic.
This new FDA guidance provides recommendations to healthcare providers and investigators, also provides recommendations to blood establishments on collection.
The chief of Russia's sovereign wealth fund, which is backing the new Sputnik V vaccine, said to CNBC on September 4, 2020, the country was “on track” to provide exports of the new coronavirus preventive vaccine by November 2020.
This positive announcement is related to the Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation's publication of a scientific article in The Lancet on the results of Phase I-II clinical trials of the world's first registered coronavirus vaccine, Sputnik V.
“We are now witnessing a change in the global approach towards the registration of vaccines with the USA, UK, China, and other countries following Russia's path in fast-tracking registration," stated Kirill Dmitriev, CEO of the Russian Direct Investment Fund, in a related press statement.
The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration, announced on September 1, 2020, the 28,000 assisted living facilities (ALFs) located in the USA may now apply for funding under the Provider Relief Fund Phase 2 General Distribution allocation. HHS is now encouraging ALFs to apply for funding to help minimize the financial hardships of these increased expenses caused by COVID-19.
To combat the risks and better protect their residents from the SARS-CoV2 virus, and COVID-19 disease, many ALFs have implemented recommendations that have resulted in increased healthcare-related costs to their facilities.
“HHS is committed to ensuring America’s healthcare providers have what they need to protect their patients and continue providing care through the pandemic,“ said HHS Secretary Alex Azar. “By expanding the Provider Relief Fund to assisted living facilities, we are supporting more frontline providers and helping to protect the nearly 1 million vulnerable older Americans in their care.”
The U.S. FDA said on August 28, 2020, 'We hope that you find these translations useful. While the agency has attempted to obtain translations that are as faithful as possible to the English version, we recognize that the translated versions may not be as precise, clear, or complete as the English version. The official version of these FDA translations is the English version, which was the last update don September 3, 2020.
France's Education Minister Jean-Michel Blanquer told Europe 1 radio on September 4, 2020, that 12 mainland schools had so far been closed across France, after some 60,000 schools opened and 12 million students returned to school during the past week.
Minister Blanquer added authorities were investigating around 250 incidents related to COVID-19 disease in schools each day, which are mainly linked to "factors outside school, concerning people who could have been contaminated over the summer. If a school reports more than 3 coronavirus cases, it is temporarily shut, reported France 24.
Across France, the number of COVID-19 disease-related fatalities has reached 30,706 during 2020. According to the latest reports of the Agence régionale de Santé, as of September 4th, the Ile-de-France region has reported 7,746 related-fatalities in total.
'Among the many longer-term health problems that have been associated with COVID-19 disease are shortness of breath, fatigue, cognitive issues, erratic heartbeat, gastrointestinal issues, low-grade fever, intolerance to physical or mental activity, and muscle and joint pains,' wrote Dr. Francis S. Collins, the 16th director of the US National Institutes of Health, on September 3, 2020.
'COVID-19 survivors report that these symptoms flare-up unpredictably, often in different combinations, and can be debilitating for days and weeks at a time. Because COVID-19 is such a new disease, little is known about what causes the persistence of symptoms, what is impeding full recovery, or how to help the long-haulers.'
New information is now emerging from the first detailed patient survey of the post-COVID syndrome, also known as Long COVID.
What’s unique about the survey is that it has been issued by a group of individuals who are struggling with the syndrome themselves. These citizen scientists, who belong to the online Body Politic COVID-19 Support Group, decided to take matters into their own hands. They already had a pretty good grip on what sort of questions to ask, as well as online access to hundreds of long-haulers to whom they could pose the questions.
This group opted to cast a wide investigative net, concluding that limiting its data to only people who tested positive for COVID-19 might lead to the loss of essential information on long-haulers. It turns out that half of the respondents hadn’t been tested for SARS-CoV-2, the coronavirus that causes COVID-19. The other half was divided almost equally between those who tested positive and those who tested negative.
Some highlights of the survey’s findings are posted at this link.
September 3, 2020, the U.S. FDA has authorized 240 coronavirus diagnostic tests, which include 193 molecular tests, 43 antibody tests, and 4 antigen tests during the COVID-19 pandemic of 2020.
Antibodies that people make to fight the new SARS-CoV-2 coronavirus last for at least 4-months after diagnosis and do not fade quickly as some earlier reports suggested, scientists reported in a study published in NEJM on September 1, 2020. This finding that natural antibodies don’t quickly disappear “will be encouraging those working on preventive vaccines" said these researchers.
Furthermore, this study estimated that the risk of death from coronavirus infection was just 0.3%. Although previous studies have been reporting COVID-19 disease fatality rates based on specific groups, such as hospitalized patients, the rate of death among all infected with the coronavirus has been unknown.
The governor of New York announced that the state was expanding its COVID-19 testing pilot program to include both JFK and Laguardia airports. Previously, on August 20, 2020, a new XpresCheck COVID-19 testing facility opened at Terminal B at Newark Liberty International Airport. and during June, the Port Authority had launched a pilot testing center for airport workers at JFK.
“The Port Authority has taken proactive measures to provide a safe environment for both employees and customers, including piloting a partnership with XpresCheck to bring testing right into our airport terminals,” said Rick Cotton, Port Authority Executive Director, in a press statement.
Does remdesivir (Veklury) provide a benefit on clinical status for patients hospitalized with moderate COVID-19 pneumonia? That question was the focus of a study published by JAMA on August 21, 2020. This study found 'patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.'
These researchers identified several factors that may account for the lack of difference in clinical status observed in the 10-day remdesivir group, although the median length of treatment was 6 days in this group.
The majority of these patients were enrolled within 2-days of hospitalization, yet 15% received supplemental oxygen on day 1. 'This is a relevant observation for future trials as the ordinal clinical status scales used to date do not take into account oxygen saturation values or oxygen supplies and patterns of use in different health systems,' concluded these researchers.
In an open letter to the biopharma industry on September 3, 2020, Dr. Jeremy M. Levin stated 'The biopharmaceutical industry is at the center of the world’s fight against Covid-19 disease, leading the effort to develop new vaccines, therapeutic medicines, and diagnostics. Over time, we expect these efforts to be successful, resulting in a range of new healthcare products for the benefit of the entire world.'
'As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value.'
'We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge.'
Dr. Levein's letter contained various recommendations, which can be found at this link.
As of September 3rd, there are various SARS-CoV-2 preventive vaccines in late-stage clinical study, which are listed on this CoronavirusToday webpage.
