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 this week's Report: U.S. authorizes Pfizer vaccine in pediatric population, NIH launches Independent Test Assessment Program, FDA authorizes more tests and offers advice on labeling updates, and we analyze whether European employers may demand proof of vaccination.

Wednesday, 3 November 2021 

  • An expert panel advising the U.S. Centers for Disease Control and Prevention (CDC) recommended Tuesday that Pfizer’s pediatric vaccine should be used in children ages 5 to 11. The recommendation now goes to CDC Director Rochelle Walensky for final approval. Last week, the U.S. Food and Drug Administration (FDA) had authorized two shots of the Pfizer-BioNTech vaccine, but with just one-third of the active ingredient, for children five through 11 years old. The two shots are to be administered three weeks apart, just like in adults. Over the past week, the U.S. Department of Health and Human Services (HHS) has also announced several measures to accelerate access to COVID-19 testing:

    • The National Institutes of Health (NIH) is investing $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with FDA. NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing. The program is an extension of the NIH Rapid Acceleration of Diagnostics (RADx) initiative.

    • FDA is further streamlining the regulatory pathway for manufacturers developing over-the-counter (OTC) at-home tests. FDA is providing recommendations for labeling updates to facilitate OTC single-use testing for symptomatic individuals for tests currently authorized only for serial testing. The developers of those tests will now be able to request authorization to add single-use testing for symptomatic individuals without submitting additional data.

    • FDA announced it has authorized another OTC rapid antigen test. FDA has granted an emergency use authorization to Celltrion Diatrust for its COVID-19 Home Ag Test for over-the-counter single-use testing for symptomatic adults and over-the-counter serial testing for all adults.

    • FDA also issued an emergency use authorization (EUA) for the Detect Covid-19 Test, an OTC COVID-19 diagnostic molecular test. The test requires the use of a compatible smartphone and a downloadable app to provide testing instructions and delivers results in about one hour.

    • FDA reissued the EUA for the OraSure Technologies InteliSwab to authorize its use as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms and as a single use test with a prescription for symptomatic people who are suspected of COVID-19 by their health care provider.

    • The CDC released its “ACIP Evidence to Recommendations for Use of COVID-19 Vaccine Booster Doses” document, along with its information on additional dose for immunocompromised people.

    • In addition, the U.S. government has purchased 614,000 additional doses of the Eli Lilly COVID-19 antibody therapy for $1.29 billion. (Authored by Randy Prebula)

  • Online here we have analyzed whether European employers may ask employees to work from home if they cannot show a valid QR code demonstrating proof of vaccination. In sectors in which a coronavirus access card have been compulsory for visitors and customers since 25 September 2021, there is explicitly no legal obligation for employees to show a valid QR code. Incidentally, European regulators are currently exploring legislation that would allow the exception for certain categories of employees to lapse under certain conditions. (Authored by Anita de Jong)