It was a week of welcome news and encouraging milestones in the COVID-19 response, especially in the U.S., where the federal government passed a $1.9 trillion COVID-19 relief package and President Biden announced a goal to make vaccines available to all U.S. adults by May 1.
CDC Published Guidelines for the Vaccinated
The Centers for Disease Control and Prevention (CDC) on Monday released the highly anticipated guidelines on what those who have been fully vaccinated can do. Socializing indoors, without a mask or distancing is now possible when two fully vaccinated individuals are in contact. Considering only a fraction of the population is vaccinated, those unvaccinated from a single household can meet a vaccinated individual indoors. If a vaccinated individual has been exposed but does not develop symptoms, he or she does not have to quarantine or get tested. Preventative public health measures are still encouraged as more Americans get vaccinated. The CDC guidelines did not issue new guidance on travel, a decision that was criticized this week, but the agency said recommendations will come when more people are vaccinated.
President Wants All Adults To Be Eligible for Vaccination by May
President Biden Thursday night announced his goal for all adults to be eligible for vaccination by May 1. If all distribution strategies are utilized — increasing Federal Emergency Management Agency (FEMA)-run mass vaccination sites, leveraging community health centers, authorizing more types of providers to be able to vaccinate, and establishing a federal website and call center to book an appointment — he believes it can be done. President Biden aims to be back to near-normal life by Independence Day, July 4.
$1.9 Trillion COVID Relief Package Signed Into Law
Yesterday, President Biden received his first legislative victory, as he signed the $1.9 trillion American Rescue Plan into law. The legislation was narrowly approved by the House on Wednesday after it passed the Senate last weekend via party lines. The American Rescue plan provides $1,400 direct payments to individuals, $360 million in state and local aid, and will ensure that COVID-19 vaccines and treatments are covered at no cost to individuals up to one year after the public health emergency.
Novavax’s Promising Vaccine Results
On Thursday, Novavax announced final data from the U.K. Phase 3 trial and South Africa Phase 2b trial of their COVID-19 vaccine candidate. Final analysis of the U.K. trial confirmed 96% efficacy against the original strain of COVID-19. Both trials demonstrated 100% protection against severe disease, including all hospitalization and death. Both studies achieved their statistical success criteria. Novavax has completed enrollment of PREVENT-19, the U.S. Phase 3 clinical trial.
NIH Study Aims to Understand Who and Why Would Develop Long COVID-19
The lingering illness experienced by a large proportion of COVID-19 patients who had recovered from the initial acute phase now has an official name — Post Acute Sequelae of SARS-CoV-2 infection (PASC) — and a focused National Institutes of Health (NIH) effort to understand its causes and eventually treatments. The NIH study will start with the prospective tracking of tens of thousands COVID-19 patients long term. As a parallel effort, NIH will host a database of biospecimens from PASC patients, which may inform future studies. Another investigation will examine the results of autopsies in detail to characterize organ injuries. The NIH initiative reflects the growing broader consensus that this underappreciated and poorly understood condition, which in the past may have been brushed off as imaginary or rare, deserves close attention and serious study. For example, the U.K. National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI) are funding studies into PASC. In addition, Lancet recently published a call to update clinical guidelines to address longer-term effects of COVID-19.
CDC Is Watching Multisystem Inflammatory Syndrome in Children
As the total number of COVID-19 cases keeps rising, more children get infected or exposed to the virus, and in some of the pediatric patients, the body’s reaction leads to a multisystem inflammatory response, which can include severe cardiological and neurological complications and death. MIS-C has been observed even in newborns due to their pre-birth exposure to the mother’s SARS-CoV-2 infection and the ensuing inflammatory response. Clinical guidelines for recognizing and treating MIS-C are evolving. CDC keeps watch over cases in the U.S. and is researching causes of MIS-C, the World Health Organization (WHO) collects data on MIS-C globally.
‘Last Mile’ in Vaccines Delivery Is the Next Frontier To Be Conquered
“Vaccines don’t help if they are not given to people” is a common refrain of many public health experts these days. The good news is that vaccines are produced in larger and larger quantities, and the flow of vaccines to health centers is getting steadier and steadier. Nevertheless, the overall system of getting vaccines into as many people as possible, given all the applicable guidelines and available infrastructure, is still far from operating smoothly even though CDC had issued general guidelines for “mass vaccination sites” as early as July 2020. The sooner this last major challenge is addressed, the sooner life could become “normal.” In addition, the fastest possible complete vaccination of the widest possible segments of population would help curb the spread of mutated virus variants, which otherwise would continue to evolve to evade current vaccines. Worldwide, the pace of vaccinations varies, with some countries ahead of the U.S. and many more still falling behind. Fortunately, there are examples of thoughtful, coordinated approaches that have been implemented and described in some detail so that they could be emulated elsewhere, and there innovative approaches based on best medical practices, which could be considered by those setting up mass-vaccination sites.
Dining Out and Masking Are Correlated With COVID-19 Cases Growing or Declining
The CDC analysis of U.S. data from March through December 2020 showed that counties with masking mandates and restrictions on restaurant dining saw a slower growth in COVID-19 cases and deaths compared with counties that did not have such mandates and restrictions.
Masks Do Not Impede Children’s Breathing
With school reopenings, safety measures are being reassessed for their suitability and effectiveness in student populations. Many previous studies have demonstrated the effectiveness of masks in slowing the spread of SARS-CoV-2. Now researchers have shown that even in young children masks could be worn safely without affecting blood oxygen saturation.
People With Antibodies to SARS-CoV-2 Are at a Lower Risk of Reinfection
A longitudinal study of over three million U.S. patients showed that those with antibodies to SARS-CoV-2 in one’s blood (meaning the person had been infected with the virus at some point) have a small (but non-zero) risk of being re-infected. For this study, data for individuals tested and retested January through August 2020 were analyzed. Clinical observations prior to January 2020 were also included to account for cases with symptoms that may have been caused by COVID-19 but were not diagnosed as such at the time.
A New Scientific Discipline of ‘Infodemics’ Explores Tangible Consequences of Intangible Information
The January-February 2021 issue of Health Security takes a close look at the new science of infodemics, which can be defined as a study of how information — both false and accurate — affects public decisions and public health. Better understanding of these phenomena should help ensure more effective implementation of various countermeasures to the current pandemic around the world. The problems caused by misinformation are not entirely new, but the stakes now are higher than ever.
Global COVID-19-Related Patent Office Status and Deadline Extension Updates
Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.
Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.
Tracking Fraud Related to the COVID-19 Pandemic
Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.
Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.