J&J Vaccine Pause Q&A

The FDA and CDC are reviewing data involving cases of a low level of platelets in combination with a rare and severe type of blood clot – cerebral venous sinus thrombosis (CVST)

• Out of an abundance of caution, the FDA and CDC are recommending a pause in J&J vaccines
• The agencies are investigating all reports to determine a causal relationship
• The agencies are ensuring health care providers for proper symptom recognition and management due to the unique treatment required for this condition
• For more information, visit this CDC page

Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

FDA’s inspections review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality

• During an inspection of Emergent BioSolutions, production site for J&J vaccine, a number of concerning observations (Form 483)
• Pause new vaccine production while issues are resolved
• For vaccines already manufactured, additional testing before distribution

Emergent Form 483

#VaccineReady campaign

FDA’s Office of Minority Health and Health Equity has joined the U.S. DHHS #VaccineReady campaign to address vaccine disparities

• Developed social medial messages to encourage vaccination of diverse communities
• Twitter and Facebook messages with a variety of graphics and videos on topics such as vaccine development, vaccine authorization, and the benefits of getting vaccinated against COVID-19

    TOOLKIT download and share

    Twitter Graphics: Download and Share    

   Facebook Graphics: Download and Share

2020 CDRH innovation to combat pandemic

High volume of EUAs including those for novel devices

Remarkable ability of the device ecosystem and the FDA to adapt and respond to emerging public health needs

• First sample pooling in diagnostic testing for COVID-19
• First Test for Screening of People Without Known or Suspected COVID-19 Infection
• First Combination Diagnostic Test for detection and differentiation of the viruses that cause flu and COVID-19 
• First diagnostic test where results can be read directly from testing card
• First point-of-care (POC) tests:
  • First point-of-care diagnostic test for COVID-19 
  • First point-of-care antibody test for COVID-19
• Home use tests:
  • First over-the-counter, at-home, rapid diagnostic test for COVID-19
  • First test for patient at-home sample collection for COVID-19 
  • First COVID-19 test for self-testing at home

Bamlanivimab EUA revoked

Revoked EUA for bamlanivimab, when administered alone, for treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients 

• Ongoing analysis of emerging scientific data, specifically the sustained increase of variants resistant to bamlanivimab alone
• Other monoclonal antibody therapies authorized for EUA remain appropriate treatment choices

READ

Streamlining Pooling and Serial Testing for Certain Molecular Diagnostic Tests

Amendment to allow certain authorized molecular diagnostic tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals

• Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment

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Remote Interactive Inspections of Drug Manufacturing and Bioresearch Monitoring Facilities

Use of various interactive and virtual tools for remote interactive evaluation of manufacturing facilities

• Will use existing risk management methods and related tools to determine remote interactive evaluation
• For pre-approval and pre-license, post-approval, surveillance, for-cause and bioresearch monitoring programs 

READ

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Image credit: FDA. CDC. Emergent, Lilly