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COVID-19 Related News
COVID-19 Related News
04
May
Key insights
Nonfederal entities that have expended federal funds of $750,000 or more during the fiscal year are required to have a single audit performed on those funds.
If funds are not used in accordance with the intended purpose and within the laws and regulations of the federal agency, the federal government could require the funds to be paid back.
If your organization meets the threshold for a single audit, be aware of which documentation and support to prepare...
28
Apr
The Commission is today proposing a set of actions to manage the current phase of the COVID-19 pandemic and prepare for the next one. By working together, the EU has so far saved hundreds of thousands of lives thanks to COVID-19 vaccines, kept its single market operational, minimised travel restrictions and mobilised manufacturing capacity of critical products when supply chains were disrupted. In the new phase of the pandemic, where preparedness and response need to be sustained, coordination will...
27
Jan
The EU Council today adopted a recommendation on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. This recommendation responds to the significant increase in vaccine uptake and the rapid roll-out of the EU digital COVID certificate, and replaces the previously existing recommendation. It will enter into force on 1 February 2022, on the same day as a delegated act amending the digital COVID-19 certificate regulation and providing for an acceptance period of 270 days for...
24
Jan
If we’ve learned one thing over the past 2 years, it’s that the only predictable thing is that this pandemic is unpredictable. Viruses mutate in nature constantly. Most mutations do not amount to anything significant, but given time and endless probabilities, an occasional mutation will make a virus different enough that it might escape a body’s natural immunity or the immunity conferred by vaccinations. The virus might be more easily transmissible or more virulent or both.
The Omicron variant was...
04
Jan
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the FDA’s Enforcement Policies during the Coronavirus Disease 2019 (COVID-19) public health emergency (COVID-19 PHE). The draft guidance for EUAs can be located here, and the draft guidance for devices commercialized under the FDA’s COVID-19 Enforcement Policies can be located here.
This alert provides an overview of the draft guidance(s).
Overview
The...
04
Jan
Today, the Commission adopted rules relating to the EU Digital COVID Certificate, establishing a binding acceptance period of 9 months (precisely 270 days) of vaccination certificates for the purposes of intra-EU travel. A clear and uniform acceptance period for vaccination certificates will guarantee that travel measures continue to be coordinated, as called for by the European Council following its latest meeting of 16 December 2021. The new rules will ensure restrictions are based on the best available scientific evidence as well...
10
Nov
Today, the European Commission approved the eighth contract with a pharmaceutical company with a view to purchasing its potential vaccine against COVID-19. The contract with Valneva provides for the possibility for all EU Member States to purchase almost 27 million doses in 2022. It also includes the possibility to adapt the vaccine to new variant strains, and for Member States to make a further order of up to 33 million additional vaccines in 2023.
The contract with Valneva comes in...
20
Sep
On September 9, 2021, President Biden announced an executive order (EO) that expands upon the administration’s goals of requiring both federal employees and contractors and subcontractors working in connection with federal contracts to receive a vaccine against COVID-19. The new requirements are much more aggressive than the administration’s safety protocols previously issued on July 29, which only required verification of vaccination status or testing for government employees and onsite contractors. The new EO eliminates the testing option and expands...
