The Biden administration unveiled a new vaccine allocation strategy designed to address vaccine hesitancy and access issues. This new strategy coincides with a number of studies on COVID-19 variants that underscore the need for — and efficacy of — widespread vaccination and continued mitigation efforts.
Biden Unveils New Strategy for Vaccine Distribution
This week President Biden announced a new method for states to obtain vaccines that will enable them to order supply from other states that are not using them. The administration is optimistic that, in prioritizing need over population size to determine allocation, this new strategy will help to address the downturn in vaccination progress. The administration’s initial strategy of establishing mass vaccination sites in order to vaccinate as fast as possible succeeded in getting at least one vaccine dose into more than half of the country’s population. To address vaccine hesitancy and access issues in certain pockets of the country, the administration has asked for retail pharmacies to allow walk-in appointments and shift Federal Emergency Management Agency (FEMA) support to rural, underserved communities. These efforts are part of a broader effort to allow Americans to return to normalcy by July 4, by which time President Biden hopes that 70% of Americans will be vaccinated.
Vaccine Manufacturers Seek Full FDA Approval
Two COVID-19 vaccine manufacturers announced they will be seeking full Food and Drug Administration (FDA) approval after operating under an emergency use authorization (EUA) for the past six months. In addition, one manufacturer is seeking to expand its current EUA to allow adolescents (aged 12-15) to be eligible to receive its vaccine.
New Analysis Suggests COVID-19-Related Deaths Much Higher Than Reported
The Institute of Health Metrics and Evaluation (IHME) reported this week the results of its analysis of COVID-19 deaths worldwide. The analysis compared deaths from all causes during the pandemic to pre-pandemic data, taking into account factors such as excess mortality (e.g., avoidable deaths from individuals not seeking care due to fear of catching COVID-19 from health care facilities) as well as decreases in mortality due to changes in habits (e.g., decreased traffic deaths due to less traffic or fewer influenza related deaths) in order to produce estimates of deaths directly attributed to the SARS-CoV2 virus. From the study, the global number of COVID-19 deaths is estimated at 6.9 million, double what official numbers report. Official counts on a per-country basis are also believed to be underestimated; for example, the analysis estimates that there have been over 900,000 deaths in the U.S. — compared to the official count of 574,043 from March 2020 to May 3, 2021. The discrepancies between official counts and these new estimates are attributed to various factors such as differences in COVID-19 testing capacity, timing and policies among countries — as well as unrecorded deaths. If these estimates are accurate, it demonstrates that the global pandemic was much worse than anyone realized.
Studies of Variants Highlight Need for Widespread Vaccination, Continued Mitigation and Genomic Surveillance Efforts
Recent studies have reported that some vaccines have reduced efficacy toward the B.1.351 (South African) variant , while others demonstrate similar to slightly less efficacy to this variant than to the original SARS CoV2 form. Another study has looked at the possibility of “breakthrough” infections of vaccinated individuals exposed to the B.1.1.7 variant (U.K.) and the B.1.351 variant. This study showed that such infections related to the B.1.1.7 can occur after one dose but not two, and that slightly more frequent infection with respect to B.1.351 was found after two doses (as compared to the unvaccinated population), which suggests slightly less efficacy toward this variant.
These studies suggest that although variants may impact vaccine efficacy, vaccines may still prevent onset of severe COVID-19 symptoms — although more studies on this subject are warranted.
Additionally, the studies are reminders of the importance of widespread vaccination to reduce the risk of creating or propagating variants, and the importance of rigorous genomic surveillance. The importance of such surveillance was underscored in a recent study where researchers characterized the specific mutations on the P.1 variant (Brazil), finding that three spike protein mutations allow for easier binding of this variant to human cells, and estimating that the variant is roughly twice as transmissible as earlier variants.
Although the current administration is prioritizing genomic surveillance, the U.S. is still striving to increase and improve coordination on national genomic surveillance efforts.
Understanding of SARS-CoV-2 Variants Is Expanding
The relatively rapid and continuous evolution in SARS-CoV-2 — see here for a regularly updated database of SARS-CoV-2 variants and their spread by country — and similar microorganisms occurs because viruses make errors in their genetic code with every replication. Unlike in more complex organisms, viruses lack robust mechanisms for correcting those errors. As a result, a viral population at any given time is actually a mixture of slightly different genetic variants. Given permissive conditions, some of these variants replicate further, multiply and establish themselves within a host, then transmit from host to host, eventually spreading within a host population. For SARS-CoV-2, several studies have been published demonstrating the virus’ evolution within a single patient. Such evolution is especially likely in immunocompromised individuals with persistent or chronic COVID-19, although some of them may remain asymptomatic. Even those considered immunocompetent may go on to develop new variants over the course of a single acute infection. A recent review connected the emergence of variants in individual patients with the wider spread of new variants of concern.
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.
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.