The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
In Tuesday's Report: Germany clarifies restrictions on dispensing in-vitro diagnostic kits, UK partners with Valneva on vaccine production, U.S. CDC reverts to older guidance, HHS bars health agencies from signing new rules, and other Congressional updates.
Tuesday, 22 September 2020
For months now there has been ongoing controversial debate about whether or not specimen-collecting kits for the detection of a SARS-CoV-2 infection or related antibodies may be furnished to members of the general public. The background to this discussion is that section 3(4) of the German Medical Devices Dispensing Ordinance (MDDO) prohibits the dispensing of in-vitro diagnostic kits to persons who do not belong to any specifically named specialist groups such as doctors or healthcare institutions. The German Federal Ministry of Health (MoH) has now made it clear, both towards representatives of the specialist press as well as the authors themselves, that such sets are not subject to the prohibition on dispensing under section 3(4). Read more here. (Authored by Joerg Schickert)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The Centers for Disease Control and Prevention (CDC) suddenly reverted back to an old guidance after posting an updated version Sept. 18 on the aerosol transmission of COVID-19. The CDC reports that it was “a mistake” to post this draft and will update the recommendations soon. President Trump said Monday that a coronavirus vaccine would become available “within a matter of weeks.” According to a 15 September memorandum from Health and Human Services (HHS) Secretary Alex Azar, all government health agencies are barred from signing any new rule regarding food, medicines, medical devices, and other products, including vaccines. Emails from President Donald Trump's top HHS spokesman, Michael Caputo, and Caputo's top aide Paul Alexander, show how they routinely worked to revise and delay the CDC's closely guarded and internationally admired health bulletins. Read about these and other updates online here. (Authored by Ivan Zapien)
Hogan Lovells has advised Valneva, a specialty vaccine company focused on prevention against diseases with major unmet needs, on its partnership with the UK Government for its inactivated adjuvanted COVID-19 vaccine, VLA2001. As part of the agreement, should the vaccine be successful, Valneva will supply 60 million doses of the vaccine to the UK Government in the second half of 2021, at a cost of around €470 million. David Lawrence, Chief Financial Officer of Valneva, said "In the face of the pandemic, moving at speed to put our partnership with the UK Government in place has been a priority for Valneva. The Hogan Lovells team have been invaluable to us in achieving that." Read more here.
The U.S. Food and Drug Administration (FDA) announced that it released an eight-page update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot Program, which ran in 2019 with 9 company participants. The Pre-Cert program is meant to fast-track digital health products by reducing regulatory hurdles for developers of Software as a Medical Device (SaMD), i.e., software-only products that meet the Federal Food, Drug, and Cosmetic Act definition of a medical device through up-front evaluation of the company’s processes and capabilities. The update highlights what the agency learned from activities conducted to test the program as presently envisioned, and how it will use this information for the next iteration of building and testing. FDA’s update indicated that “more work is needed” to understand how information collected to address the product’s total life cycle namely during Excellence Appraisals, Review Determination and Real-World Performance monitoring can be leveraged to support the Streamlined Review for introduction of new devices to market. Read more here. (Authored by Jodi Scott, Lina Kontos, and Meredith Manning)