FDA authorizes first two oral antivirals for treatment of COVID-19 | EUA updates for COVID-19 treatments and tests

U.S. Food and Drug Administration sent this bulletin at 12/30/2021 08:05 AM EST

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Coronavirus Disease 2019 (COVID-19) updates

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:

December 29, 2021: Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S. Market Quickly (HHS press release)
December 28, 2021: COVID-19 Update including an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information regarding the impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests
December 23, 2021: COVID-19 Update including authorization of two oral antivirals for the treatment of COVID-19 in certain patients and a joint statement with ASPR on the circulating SARS-CoV-2 viral variants, including omicron
December 23, 2021: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19
December 22, 2021: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Bookmark www.fda.gov/coronavirus for the latest.

FDA authorizes two oral antivirals for treatment of COVID-19

Last week, FDA authorized two oral antivirals for the treatment of COVID-19 in certain patients. Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Also see: Frequently Asked Questions on the EUA for Paxlovid for Treatment of COVID-19 (PDF)

Merck’s molnupiravir is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Also see: Frequently Asked Questions on the EUA for Molnupiravir for Treatment of COVID-19 (PDF)

Both treatments are available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. (December 28, 2021)

Learn more about Paxlovid

Learn more about molnupiravir

COVID-19 vaccine updates

Find a vaccine near you

Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.

Learn more about COVID-19 vaccines

Emergency Use Authorization (EUA) updates

ASPR pauses allocation of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV

The HHS Assistant Secretary for Preparedness and Response (ASPR) and FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including omicron, and how the variants may be associated with resistance to monoclonal antibodies. Data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the omicron variant. FDA updated the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered together (PDF), REGEN-COV (PDF), and sotrovimab (PDF) with specific information regarding expected activity against the omicron variant (B.1.1.529/BA.1).

Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun. An additional 300,000 doses of sotrovimab will be available for distribution in January. As additional data become available, FDA and ASPR will provide updates and further recommendations and consider if additional actions are warranted. (December 23, 2021)

COVID-19 convalescent plasma EUA update

FDA updated the EUA (PDF) for COVID-19 convalescent plasma. The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti -SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment. These patients may be treated in outpatient or inpatient settings. Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA revise acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies. (December 28, 2021)

FDA authorizes two COVID-19 OTC tests based on data from NIH

On December 24, 2021, FDA authorized (PDF) an over-the-counter (OTC) COVID-19 antigen test, the first test where validation data were gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The SD Biosensor, Inc COVID-19 At-Home Test will be distributed by Roche Diagnostics and is an OTC COVID-19 antigen diagnostic test that delivers results in 20 minutes.

On December 29, 2021, FDA authorized (PDF) an additional OTC COVID-19 antigen test, Siemens' CLINITEST Rapid COVID-19 Antigen Self-Test, where validation data were gathered through FDA's collaboration with the NIH ITAP. The CLINITEST Rapid COVID-19 Antigen Self-Test is an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes.

These EUAs are another example of the FDA’s commitment to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating access to these tests for all Americans.

Both tests can be used as:

A single test for people with COVID-19 symptoms.
A serial test for people without symptoms, meaning the test is done two times over three days.

Both tests can be used for people:

Age 14 years or older with a self-collected nasal swab sample.
Age 2 years or older when an adult collects the nasal swab sample.

For more information, see the HHS press release: Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S. Market Quickly.

SARS-CoV-2 viral mutations: Impact on COVID-19 tests

Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.

In vitro diagnostic (test) EUAs

As of December 28, 2021, 419 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 42 antigen tests. There are 67 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 12 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 23 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 747 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics

Events

January 12, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series on January 26 and February 9 and 23, 2022.
February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
New! March 7-9, 2022: FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual)
April 25-29, 2022: Save the date! Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022

Information for industry and health care providers

FDA issues draft guidances on transition plans for COVID-19 related medical devices

FDA issued two draft guidances on December 21, 2021. These draft guidances will be open for public comments for 90 days at www.regulations.gov until March 23, 2022, under the docket numbers listed below. The FDA encourages all stakeholders to comment on the specific topics listed in the notices of availability and on the draft guidance web pages:

Docket number FDA-2021-D-1149 for Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance (FR notice)
Docket number FDA-2021-D-1118 for Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance (FR notice)

On February 22, 2022, the FDA will host a webinar for industry and others interested in learning more about the draft guidances. Read more about the intent of these guidances, background information, and recommendations for manufacturers

FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.

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