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Coronavirus Disease 2019 (COVID-19) updates
Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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 COVID-19 vaccine updates
Update on ongoing evaluation of adverse event reports of myocarditis & pericarditis following vaccination with Moderna and Pfizer-BioNTech COVID-19 vaccines
On June 25, 2021, FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.
For each vaccine, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about myocarditis and pericarditis and the Fact Sheet for Recipients and Caregivers has been revised to include information about myocarditis and pericarditis.
This update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on June 23, 2021. The data presented at this meeting reinforced the FDA’s decision to revise the fact sheets and further informed the specific revisions.
The warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with onset of symptoms within a few days after vaccination. Additionally, the Fact Sheets for Recipients and Caregivers for these vaccines note that vaccine recipients should seek medical attention right away if they have chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination.
The FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.
FDA authorizes drug for treatment of COVID-19
On June 24, 2021, FDA issued an EUA (PDF) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19.
FDA warns that vapors from alcohol-based hand sanitizers can have side effects
Consumers should use hand sanitizer in a well-ventilated area
FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger. FDA reviewed case reports submitted to FDA and cases from calls to U.S. poison control centers of adverse events after applying alcohol-based hand sanitizers to the skin. While the majority of cases resulted in minor or minimal effects, some cases resulted in treatment by a health care professional. These reports have occurred after the start of the COVID-19 pandemic. |
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Listen to the FDA Drug Safety Podcast and view the transcript. (June 16, 2021)
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Emergency Use Authorization (EUA) updates
Pause in the distribution of bamlanivimab/etesevimab
The Assistant Secretary for Preparedness and Response (ASPR) is immediately pausing all distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) on a national basis until further notice. In addition, FDA recommends that health care providers nationwide use alternative authorized monoclonal antibody therapies, as described in this June 25, 2021 update, and not use bamlanivimab and etesevimab administered together at this time. Read more
Update: COVID-19 Pooling and Serial Testing Amendment Exhibit 1
On June 28, 2021, FDA updated Exhibit 1 of the Pooling and Serial Testing Amendment to include:
- Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard-CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3)
- Biomeme Inc. SARS-CoV-2 Real Time RT-PCR Test
- Viracor Eurofins Clinical Diagnostics SARS-CoV-2 assay
Tests authorized for SARS-CoV-2 that can be used for pooling, as part of a serial testing program under this amendment, are added to Exhibit 1 after the FDA confirms that the required documentation has been submitted by the test developer.
Diagnostic test EUAs
As of June 29, 2021, 389 tests and sample collection devices are authorized by FDA under EUAs. These include 278 molecular tests and sample collection devices, 83 antibody and other immune response tests, and 28 antigen tests. There are 52 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 5 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 11 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 553 revisions to EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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Today! June 30, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host additional webinars in this series on July 14 and 28.
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New! July 8, 2021: FDA Grand Rounds webcast - SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern, 12:00 - 1:00 p.m. ET
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July 19-23, 2021: Regulatory Education for Industry (REdI) Annual Conference 2021 - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements. The keynote speaker, Acting Commissioner Janet Woodcock, MD, will reflect on FDA’s use of EUAs and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.
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Save the date! August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
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Information for industry
Drug Shortages Report
- FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2020 (PDF), which includes a section on the agency’s drug shortages efforts in response to COVID-19. These actions include reminding manufacturers to notify FDA of permanent discontinuances or interruptions in manufacturing and asking them to evaluate their supply chain. In addition, FDA has leveraged various tools, such as expediting reviews, exercising enforcement discretion, and publishing guidances, with the goal of increasing patient access to medications in shortage or preventing potential shortages. FDA is also working to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, and Economic Security Act. (June 28, 2021)
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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In case you missed it
Find a COVID-19 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. Learn more at vaccines.gov.
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Your EUA questions answered
In a new episode of FDA's Health Equity Forum podcast, Associate Commissioner for Minority Health RADM Richardae Araojo discusses FDA’s EUA process with FDA Chief Scientist RADM Denise Hinton.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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