COVID-19 Weekly Newsletter: A Trio of Potential EUAs
In the coming weeks, the Food and Drug Administration (FDA) will be contemplating three noteworthy emergency use authorizations (EUA). Meanwhile, public health authorities continue to work to assuage public skepticism toward the vaccines and other evidence-based medicine.
2021 COVID-19 Death Toll Exceeds 2020 Numbers
Last week, the U.S. topped 700,000 COVID-19 deaths, making it the deadliest pandemic in American history, costing more lives than the Spanish flu of 1918. Fortunately, the number of patients hospitalized has decreased in the past few weeks with an increase in vaccine uptick, partially due to government and corporate mandates. However, as of this week, more lives have been lost to COVID-19 in 2021 than the 352,000 deaths reported in 2020.
First COVID-19 Prophylactic Treatment Seeks FDA EUA
On Tuesday, a biopharmaceutical company submitted a request for an FDA EUA for its long-acting antibody combination as a prophylactic treatment for COVID-19. If authorized, the drug would likely be used, not as a substitute, but as a supplement for those with compromised immune systems who don't get sufficient protection from vaccination. It is said to boost immunity for up to one year. FDA has authorized three antibody drugs so far that offer a month or two of protection.
COVID-19 Vaccine Manufacturer Seeks FDA EUA for Its Booster Shot
On Tuesday, the one-dose vaccine manufacturer asked FDA to authorize a booster dose of its COVID-19 vaccine for people 18 and older. The manufacturer has left it up to the FDA and the Centers for Disease Control and Prevention (CDC) to decide who should get their boosters and when. The FDA’s Vaccines and Related Biological Products Advisory Board (VRBPAC) is meeting next week to evaluate the EUA.
WHO Announces Strategy to Achieve Goal COVID-19 Vaccination by Mid-2022
On Thursday, the World Health Organization (WHO) released its strategy to end the pandemic by vaccinating 40% of the population of every country by the end of this year and 70% by mid-2022. To meet these targets, 11 billion vaccine doses are needed, currently 1.5 billion doses are produced every month. With sufficient supply, the target can be achieved if distribution is done equitably.
FDA EUA for COVID-19 Vaccine for Children
On Thursday, one of the two-dose mRNA vaccine manufacturer announced it will seek FDA EUA on its COVID-19 vaccine for children ages 5 to 11, opening a pathway for nearly 28 million children in the U.S. to be vaccinated — perhaps within a few weeks. On October 26, FDA VRBPAC is meeting to evaluate the EUA.
Vaccine Maintains High Efficacy Against Hospitalizations After Six Months
One of the mRNA-based COVID-19 vaccines remains roughly 90% effective against hospitalization for all COVID-19 variants for at least six months, according to a study published Monday.
Safety of COVID-19 Vaccines in Pregnancy
The safety and efficacy of COVID-19 vaccines during pregnancy was indirectly studied in the original clinical trials for the eventually authorized COVID-19 vaccines, since some of the enrolled subjects became pregnant during the course of those clinical trials. Subsequently, the observation of COVID-19 cases, as well as reactions to COVID-19 vaccinations among pregnant individuals, showed that vaccines are safe for pregnant women. COVID-19 disease, however, leads to complications for pregnant women. Moreover, the benefits of vaccination extend to the newborns. Now CDC has established a voluntary registry to monitor effects of vaccination in expecting mothers in a systematic manner.
COVID-19 Triples VTE Risk
In a large study that followed a diverse population of hospitalized adults for 30 days, the risk of blood clots in deep veins (known as venous thromboembolism, or VTE) is three times higher in patients with COVID-19 compared to those without COVID-19. VTE is a serious and sometimes fatal condition.
Indoor Exercising Safer With HEPA
An editorial in the scientific journal CHEST introduces two studies that have a bearing on the individual and organizational decision-making regarding exercising indoors. The first study documented the exponential increase in aerosol particles in a closed room during high-intensity aerobic cycling on a stationary bike. Furthermore, smaller-sized particles, which are particularly apt to get inhaled deeply into the lungs and potentially cause direct infection, were generated at an increased rate. The other study showed that portable high-efficiency particulate air (HEPA) filters cut down the amount of particles in the air by 94%, making the exercising indoors safer for all involved. Aerosols generated by heavy breathing, such as during intense exercise, may carry SARS-CoV-2 and other respiratory viruses. The publication of these studies is timely, considering that cooler temperatures and inclement weather are now coming to the Northern Hemisphere, and options for outdoor workouts may become limited.
Call To Strengthen Evidence-Based Medicine
A retrospective review of clinical practices during the COVID-19 pandemic noted that in the midst of a public health crisis, clinicians may have reached for treatments with no proven benefit, and researchers may have pursued candidate drugs without a reasonable justification. The authors call on the clinical and research communities to collaborate more closely so that practical clinical insights would inform research plans, and research findings, in turn, would lead more directly to patient care.
Health Problems After COVID-19 More Numerous and Serious Than After Flu
A study of over a quarter-million electronic health records found that a third of COVID-19 survivors had one or more symptoms of long COVID three to six months after diagnosis. This translates into longer-lasting and wider-spread chronic conditions, requiring more health care resources, than after a flu infection.
Addressing Fear Is Key To Finding Solutions
An essay published in MedPageToday suggests that fear might be fueling the remaining resistance to vaccinations, masking, and other measures that support and strengthen public health. The safety profile, clinical efficacy and cost-effectiveness of vaccinations have been demonstrated in numerous studies in many countries over the past year and a half. To win over those who have access to vaccines and to high-quality information yet refuse to follow public health recommendations, it could be helpful for physicians and authority figures to engage in active listening and to provide compassionate reassurance. At the same time, the article reminds us that physicians are also humans, and might also experience fear in the face of the double crisis on the medical and social fronts. To support our physicians, all of us and especially those involved in the public discourse should reaffirm our medics and help reinstill public trust in the medical profession.
Additional Resources
Global COVID-19-Related Patent Office Status and Deadline Extension UpdatesInformation regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.
Government Actions: COVID-19Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.
Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.
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