Addressing new variants, coordinating vaccine shipments and the continued progress of a third vaccine highlighted this week in the COVID-19 response.
Vaccine Manufacturers Tackle New Variant
Manufacturers of COVID-19 vaccines currently available in the US look to a third dose to provide additional protection against the virus and its variants as both have been found to generate a weaker immune response to the South Africa variant. One such newly developed COVID-19 vaccine will begin human trials and another is being given to existing phase I clinical trial participants a third dose of the current vaccine to see if it can help. Earlier this week, the Food & Drug Administration (FDA) released guidance suggesting manufacturers could skip massive phase 3 trials for modified coronavirus vaccines targeting certain strains.
Vaccine Shipment Coordination
Governors earlier this week were told by White House Coronavirus Coordinator Jeff Zentis that they can expect to know how many vaccine shipments they will be getting months ahead of time — rather than on a week-to-week basis. This will hopefully help states to plan vaccination distribution and set appointments at clinics appropriately. In the past month, vaccine weekly shipments have ramped up from 8.6 million a week to 14.5 million. This new forecasting approach from the administration comes just a week after governors raised concerns that the new federal strategy to directly send vaccines to pharmacies will exclude their input and cause redundancy and inefficiencies. States hope this forecasting will help in bringing them clarity.
Third Vaccine Approaches EUA
A single-dose vaccine is on track for FDA emergency use authorization (EUA). If approved, it will be the third vaccine to be circulated in the country. Today, FDA's Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) will decide to recommend FDA to issue an EUA for the vaccine.
Study Explores Vitamin D3 Benefits
Vitamin D3, which has been suggested to positively impact immunity, has been a focus as a potential therapeutic intervention for COVID-19. A recent study found that single high doses of Vitamin D3 did not significantly reduce length of hospital stay for patients with moderate to severe COVID-19. The randomized, placebo-controlled study included 240 hospitalized individuals. Some limitations of the study include the relatively small number of patients and thus may lack the statistical power to exclude small, clinically meaningful differences among the study groups; and co-morbidities and consequent intake of other medications among the patients.
Pigmentation Differences Creating Disparities in Pulse Oximeter Accuracy?
The FDA recently released a safety communication explaining that pulse oximeters may be inaccurate when applied to people with dark skin pigmentation. The announcement references the December 2020 communication from researchers who compared the accuracy of pulse oximeters on two large cohorts of Black and white patients and found that Black patients had nearly three times the frequency of lowered arterial oxygen saturation not detected by pulse oximetry compared to white patients. The paper notes the criticality of understanding and correcting racial bias in this and other medical technologies.
COVID-19 Relief Legislation Update
The United States House of Representatives is expected to pass President Biden’s requested $1.9 trillion COVID-19 relief legislative package Friday night along party lines. Despite the Senate parliamentarian’s determination late Thursday that the inclusion of a mandated $15 federal minimum wage violates budget rules dictating the legislative process, House Democrats are leaving the policy in the package. That policy will likely be stripped in the Senate, requiring the package to be sent back to the House for passage at least one more time.
Additional ResourcesGlobal 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.Government Actions: COVID-19
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.