|
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:
- January 18, 2022: FDA Roundup including COVID-19 testing updates
- January 14, 2022: FDA Roundup including an FDA Voices entitled, Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues, which highlights the wide variety of safe and effective new drug therapies approved in 2021 despite challenges brought on by the ongoing COVID-19 pandemic
- January 13, 2022: FDA 2021 Year in Review (PDF) - This year-end report highlights key FDA actions in 2021 to protect and improve public health, including a COVID-19 vaccine approval and authorizations of COVID-19 tests and treatments.
Bookmark www.fda.gov/coronavirus for the latest.
|
|
|
COVID-19 vaccine updates
 Video frequently asked questions
Visit FDA's COVID-19 Vaccines page to see video FAQs with responses to questions including:
- What are the ingredients in the COVID-19 vaccines?
- Do you need a booster if you've already had COVID-19?
- What if someone has not been vaccinated?
Janssen COVID-19 Vaccine fact sheet updates
FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (PDF) and the Fact Sheet for Recipients and Caregivers (PDF). These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.
Specifically, the Fact Sheet for Health Care Providers includes information about reports of adverse events following use of the vaccine which suggest an increased risk of ITP during the 42 days following vaccination, and that individuals with a history of ITP should discuss the risk and the potential need for platelet monitoring following vaccination with their health care provider.
The Fact Sheet for Recipients and Caregivers includes additional information under the questions, “What should you mention to your vaccination provider before you get the Janssen COVID-19 Vaccine?” and “What are the risks of the Janssen COVID-19 Vaccine?” regarding ITP, as well as what to look for and when to seek medical attention.
FDA and CDC continue to monitor the level of potential excess risk. Individuals should speak to their health care provider to determine which COVID-19 vaccine is most appropriate for their own situation.(January 11, 2022)
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.
|
|
Emergency Use Authorization (EUA) updates
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 January 18, 2022, 420 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 44 antigen tests. There are 69 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, 13 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 24 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 766 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
|
|
|
Events
-
January 26, 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 February 9 and 23, 2022.
-
January 26, 2022: 2022 Filovirus Vaccine Development Workshop (virtual) - HHS/ASPR will convene a USG workshop focused on development of medical countermeasures against Marburg virus (MARV) and Sudan ebolavirus (SUDV). Companies, USG interagency partners, and others interested in the topic area are encouraged to attend this workshop. The event is open to the public, but space is limited. Register by January 21, 2022.
-
February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
-
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: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
|
|
Information for industry and health care providers
Updated information for blood establishments regarding the COVID-19 pandemic and blood donation
FDA continues to work closely with CDC and other federal and international agencies to monitor the coronavirus disease 2019 (COVID-19) pandemic caused by the virus, SARS-CoV-2. Respiratory viruses, in general, are not known to be transmitted by blood transfusion. There have been no reported cases of transfusion-transmitted coronavirus, including SARS-CoV-2, worldwide.
FDA provided on its website Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation. (January 11, 2022)
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.
|
|
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.
|
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.
|
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.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
