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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:
- October 20, 2021: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
- October 19, 2021: COVID-19 Update including approval of an abbreviated new drug application for propofol injectable emulsion, single patient-use vials. This drug is an intravenous general anesthetic and sedation drug listed in the FDA Drug Shortage Database. Side effects of propofol emulsion injection include hypotension (low blood pressure), bradycardia (low heart rate), and apnea (temporary stopping of breathing).
- October 15, 2021: COVID-19 Update including posting information about an assessment of the EUA process the FDA’s Center for Devices and Radiological Health (CDRH) implemented to help authorize COVID-19 tests during the public health emergency
- October 14, 2021: Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results
- October 14, 2021: FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
- October 14, 2021: FDA Encourages Food and Agriculture Workers to Get Vaccinated Against Flu and COVID-19
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
Today, the FDA took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the Emergency Use Authorizations (EUAs) for COVID-19 vaccines to allow for the use of a single booster dose as follows:
Listen to a media call today, October 20, 2021, 6:15 p.m. ET
Acting FDA Commissioner Dr. Janet Woodcock and FDA's Center for Biologics Evaluation and Research Director Dr. Peter Marks discuss the FDA’s authorization of booster doses for eligible populations of Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine recipients and Janssen COVID-19 Vaccine recipients 18 and older, as well as the FDA’s authorization of the use of heterologous (“mix and match”) boosters.
Food and agriculture workers: Get vaccinated against flu and COVID-19
FDA encourages food and agricultural workers to protect themselves by getting an annual flu vaccination and a COVID-19 vaccination. Throughout the pandemic, millions of workers on the front lines of processing, preparing, selling, and delivering food for humans and animals have remained steadfast and on the job. Right now, the best protection for you, your family, your workplace, and your community, is to get vaccinated against both the seasonal flu AND COVID-19.
ICYMI - Multilingual COVID-19 vaccines myths social media toolkit
FDA has created a new toolkit with Twitter, Facebook, and Instagram messages and images to help address common myths about the COVID-19 vaccines, and share the facts with your community. Messages are available for download in English, Spanish, Simplified Chinese, Korean, Tagalog, and Vietnamese.
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Emergency Use Authorization (EUA) updates
In vitro diagnostic (test) EUAs
As of October 19, 2021, 418 tests and sample collection devices are authorized by FDA under EUAs. These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests, and 37 antigen tests. There are 66 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, 7 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 16 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 654 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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October 26, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet in open session to discuss Pfizer Inc.’s request to amend its EUA to allow for the use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age.
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New! November 16, 2021: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA) (virtual) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to system attributes necessary to enable secure tracing of product at the package level.
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New! November 30, 2021: Antimicrobial Drugs Advisory Committee (AMDAC) meeting (webcast) - To discuss Merck and Ridgeback’s request for an EUA for molnupiravir, an investigational antiviral drug to treat COVID-19. The committee will discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
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New! December 7-8, 2021: Clinical Investigator Training Course (CITC) Update (virtual), including a review of the development and emergency use authorization of medical products for the prevention and treatment of COVID-19, and investigator responsibilities during the pandemic.
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Information for industry and health care providers
Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for potential false positive SARS-CoV-2 test results
Abbott Molecular, Inc. is recalling Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits because they have the potential to give false positive results when used to detect SARS-CoV-2. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. The recall described in this notice is due to the same issue that was announced in the September 17, 2021 Letter to Health Care Providers: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. (October 14, 2021)
On October 15, 2021, FDA updated this recall classification notice to clarify that the potential for false positive results is due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits, and the associated recall is to correct the software. The kits can continue to be used following the implementation of the software correction. If used before the software correction, positive results should be treated as presumptive.
Advanced and continuous manufacturing updates
FDA’s advanced manufacturing initiatives helping to provide quality human drugs for patients
FDA has long recognized the importance of advanced manufacturing. The FDA has received significant funding from Congress for advanced manufacturing-related projects, and we continue to work with manufacturers looking to implement these new technologies to benefit even more patients. To do so, the Center for Drug Evaluation and Research (CDER) has established numerous initiatives, including the development of a research program to better understand the science of advanced manufacturing. To date, this program has fueled nearly 60 research projects, including many collaborations with experts in the field. Read more in FDA Voices, and learn more about FDA's work in this area on our Advanced Manufacturing web page (October 13, 2021)
Draft guidance on continuous manufacturing
FDA announced the availability of a draft ICH guidance for industry titled Q13 Continuous Manufacturing of Drug Substances and Drug Products. The guidance, which was prepared under the support of the International Council for Harmonisation (ICH), describes scientific and regulatory considerations for the development, implementation, and operation of continuous manufacturing. Submit comments by December 13, 2021. (October 13, 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
It's a good time to get your flu vaccine Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.
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Why you should not use ivermectin to treat or prevent COVID-19 Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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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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Learn more about COVID-19 vaccines Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you. Learn about the evidence supporting FDA approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines.
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