Coronavirus Disease 2019 (COVID-19) updates  Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: Bookmark www.fda.gov/coronavirus for the latest. | COVID-19 vaccine updates  FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in children 5 through 11 years of age On October 29, 2021, FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization (PDF) was based on the FDA's thorough and transparent evaluation of the vaccine that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. Key points for parents and caregivers: - Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In that study, the vaccine was 90.7% effective in preventing COVID-19 in children 5 through 11.
- Safety: The vaccine's safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
- The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices met November 2, 2021, to discuss further clinical recommendations.
Fact sheets are available at the following links (PDFs):
The Fact Sheets for Recipients and Caregivers in multiple additional languages will be posted as translations become available on the FDA web page Comirnaty and Pfizer-BioNTech COVID-19 Vaccine.
You can view a recording of Acting FDA Commissioner Janet Woodcock, MD, and FDA Center for Biologics Evaluation and Research Director Peter Marks, MD, PhD discussing this authorization in a press conference on FDA's YouTube channel. ICYMI - stakeholder call on vaccine booster doses You can also watch on YouTube a recording of an October 22, 2021, stakeholder call with Dr. Woodcock and Dr. Marks, where they answer questions about vaccine boosters. 'Chipping' away at personalized medicine FDA and other agencies are collaborating with NASA on a research project to extend the life of 3D tissue chips, which will allow longer-term studies to help scientists better understand disease models, and inform drug development and clinical trial design. FDA remains deeply engaged in identifying and fostering strategies that can bring alternative testing methods such as microphysiological systems to FDA for integration into the review process. Collaboration with our partners in the public and private sectors has been critical to advancing our efforts in this area, particularly with respect to medical countermeasures. | |  | Upcoming events -
November 8 - 9, 2021: 13th Annual Sentinel Initiative Public Workshop - This virtual public workshop will highlight milestones and strategic initiatives underway to enhance and build a more robust Sentinel Initiative. Stakeholders will discuss opportunities to utilize Sentinel's existing data, infrastructure, and technology. -
November 9, 2021: FDA CERSI Lecture on Long COVID: Risk factors, Symptomology and Patient Reported Outcomes Captured Through a Novel Digital Platform, presented by by Dr. Erica Spatz & Dr. Kelli O'Laughlin, 3:00 - 4:00 p.m. ET (virtual) - 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.
- November 17, 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 December 1 and December 15, 2021.
- 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.
- 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.
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. | |  | 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. | |  | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
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