COVID-19 News: Janssen vaccine pause Q/A, Vaccine quality, #VaccineReady campaign, 2020 CDRH innovation, Bamlanivimab EUA revoked, Pooling and serial testing of diagnostics, Remote interactive inspections

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

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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

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


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


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 


Image credit: FDA. CDC. Emergent, Lilly

COVID-19 News: FDA-CDC statement on J&J vaccine, SYMBIOTICA antibody test, PREPP plan update, Addressing health disparities, OTC and POC Tests

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

CDC and FDA are reviewing data involving six reported U.S. cases, out of 6.8 M doses administered, of a rare and severe type of blood clot in individuals after receiving the J&J vaccine

  • Blood clot called cerebral venous sinus thrombosis (CVST) seen in combination with low levels of blood platelets (thrombocytopenia)
  • Occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination
  • Heparin, commonly used for clots, should not be used this type of clot

Advisory Committee on Immunization Practices (ACIP) on 4/14 to further review these cases and assess potential significance

  • Recommending pause in vaccine use out of an abundance of caution
  • Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at


SYMBIOTICA COVID-19 Self-Collected Antibody Test System


INDICATION: Qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick blood dried blood spot (DBS) specimens that are self-collected at home by an individual age 18 years or older or
collected by an adult from an individual 5 years of age and older using the COVID-19 Self-Collected Antibody Test System Collection Kit

Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection

ADDRESSING UNMET NEED: First prescription use, home collection antibody test. Important in identifying individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection


  • Enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick dried blood spot (DBS) specimens
  • COVID-19 Self-Collected Antibody Test System Collection Kit for home collection
  • eSTAD ELISA assay used in combination with Calibrator (IgG, Human), Positive control and Negative control

REGULATORY PATHWAY: Emergency Use Authorization

Letter of Authorization

Update on COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative

An independent committee PREPP report identified a number of options for strengthening FDA’s COVID-19 response; five areas have been identified for initial focus

  • Improving EUA process
  • Timely and accurate information to public
  • Further inspectional approaches by using next-gen technologies
  • Improve supply chain resilience


Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities

All authorized vaccines tested in clinical trials including participants from racial and ethnic minority, American Indian and Alaska Native, and other diverse communities

  • FDA review adheres to rigorous standards for safety and effectiveness
  • Working working hand-in-hand with the FDA’s Office of Minority Health and Health Equity (OMHHE) to address concerns about vaccines among diverse communities.


Advancement of Over-the Counter and Other Screening Test Development

Point of Care (POC) testing and Over-the-Counter (OTC) tests important part of pandemic response

  • Quidel QuickVue At-Home OTC COVID-19 test – authorized for OTC at-home serial screening
  • Abbott BinaxNOW (multiple configurations)
    • Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
    • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test – authorized for OTC at-home serial screening with telehealth proctor
    • Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription 
  • BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription

These authorizations based on efforts to streamline the process for test developers and information to help schools, workplaces, communities, and others establish screening programs. 


Image credit: FDA

Marketing Authorizations: ABECMA for multiple myeloma, PoNS for gait in multiple sclerosis, HARMONY for pulmonary valve regurgitation, Q-COLLAR for brain injury protection, ClearUP for sinus pain

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ABECMA (idecabtagene vicleucel) injection

Bristol-Myers Squibb

INDICATION: B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody

USE: Each dose of Abecma is a customized treatment created by using a patient’s own T-cells which are collected and genetically modified to include a new gene that facilitates targeting and killing myeloma cells. Once the cells are modified, they are infused back into the patient. 

ADDRESSING UNMET NEED: First cell-based gene therapy for adult patients with multiple myeloma

MECHANISM OF ACTION: Chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), expressed on normal and malignant plasma cell surfaces. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells


  • Open-label, single-arm, multicenter study in adults (n=127) with relapsed and refractory multiple myeloma who had received at least 3 prior lines of antimyeloma therapy
  • Endpoints: Overall response rate (ORR), stringent complete response (sCR) rate, Very good partial response (VGPR), duration of response (DOR) based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
  • ORR=72%, sCR=28%, VGPR=25%, PR=19%, median DOR (PR or better)= 11 mo.


  • Boxed warning:  Cytokine release syndrome (CRS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), neurologic toxicity, and prolonged cytopenia, all of which can be fatal or life-threatening.
  • Most common side effects: CRS, infections, fatigue, musculoskeletal pain, and a weakened immune system
  • REMS: Certified staff involved in the prescribing, dispensing or administering of Abecma trained to recognize and manage CRS and nervous system toxicities and other side effects


  • Orphan Drug and Breakthrough Therapy designations
  • Post-marketing observational safety study involving patients treated with Abecma


Portable Neuromodulation Stimulator (PoNS)

Helius Medical

INDICATION FOR USE: Short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis

ADDRESSING UNMET NEED: New aid in physical therapy for those who live with MS on a daily basis

DESCRIPTION: Portable, non-implantable delivery of mild neuromuscular electrical stimulation to dorsal surface of tongue

  • Consists of controller and mouthpiece connected to each other by a cord
  • Mouthpiece is held lightly in place by the lips and teeth and control unit is worn around the neck
  • Controller sends signals to mouthpiece; receptors on tongue send millions of neural impulses to the brain
  • Additionally, therapist can connect the control unit to a computer and view usage data to improve a patient’s therapy by identifying potential areas of missed or shortened sessions


  • Two clinical studies and a retrospective analysis of real-world data (RWD)
  • First Study: Randomized, double blind controlled trial (n=20 MS patients), PoNS vs sham control : Dynamic Gait Index (DGI) at 2, 6, 10, 14 weeks showed statistically and clinically significant imporvement with PoNS
  • Second Study: Randomized controlled trial (n=14 MS patients). PoNS vs sham control : Effect on cognitive and physical rehab. Sensory Organization Tasks (SOT) and DGI scores at 14 weeks showed significant improvement
  • RWD study: Retrospective analysis of patient feedback Functional Gait Assessment in clinical rehabilitation settings
  • Safety: Prescription use only in accordance with warnings and precautions (inducing electrical safety) in labeling

REGULATORY PATHWAY: De Novo, Breakthrough designation

Product Code QCF

HARMONY Transcatheter Pulmonary Valve (TPV) System


INDICATION FOR USE: To improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care. Patients have a native or surgically-repaired right ventricular outflow tract (RVOT). The use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime.

ADDRESSING UNMET NEED: New less-invasive treatment alternative to open-heart surgery for adult and pediatric patients with certain types of congenital heart disease. May help patients improve their quality of life and return to their normal activities more quickly.

DESCRIPTION: Pulmonary Valve Prosthesis percutaneously delivered

  • Intended to replace patient’s pulmonary heart valve; different from heart valves in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement
  • During the implantation procedure, a thin, hollow tube (catheter) with a collapsed Harmony valve on the end is inserted through a vein in the groin or in the neck and into the right side of the heart, and then into the RVOT where it is placed into position
  • Valve is then released from the catheter; it expands on its own, and anchors to the RVOT
  • Once new valve is in place, it opens and closes like a door to force the blood to flow in the correct direction


  • Prospective, non-randomized, multi-center clinical study, n=70 patients
  • Follow-up examinations at study start, at implant procedure, discharge, and post implant at one month, six months, and annually through five years
  • Primary effectiveness endpoint: 89.2% patients had no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at six month
  • Primary safety endpoint: No procedure- or device-related death within 30 days following implant
  • Adverse events: Irregular or abnormal heart rhythm, ventricular tachycardia), leakage around the valve, minor bleeding, narrowing of the pulmonary valve, movement of implant


  • Breakthrough Device Designation 
  • Part of the U.S.-Japan Medical Device Harmonization by Doing Collaboration, to promote timely access to innovative devices in both the U.S. and Japan
  • Post-approval study with 10 years followup

Product Code NPV

Q30 Sports Science

INDICATION FOR USE: Non-invasive device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts. For OTC use.

ADDRESSING UNMET NEED: Protective equipment for athletes when playing sports to help protect their brains from the effects of repetitive head impacts


  • C-shaped collar that provides compressive force to the internal jugular veins, which in turn increases the blood volume in the skull’s blood vessels
  • Blunt trauma accidents cause brain moves unrestrained in the skull – “slosh”
  • Q-Collar’s increase in blood volume in those blood vessels creates a tighter fit of the brain inside the skull and reduces the “slosh” movement
  • By reducing brain movement within cranial space, Q-Collar may aid in protection from effects of head impacts


  • Prospective, longitudinal study, n=284 subjects 13 years or older from a high school football team, Q-collar vs no collar; all wore accelerometer device that measured every head impact during play
  • Diffusion Tensor Imaging (MRI type) of brain to compare structural changes pre-season and post-season
  • Significant deep tissues changes (involved in transmission of electrical nerve signals) in 73% no-Collar group vs. 13% in Q-collar group
  • No significant adverse events with device use

REGULATORY PATHWAY: De Novo classification


ClearUP Sinus Relief

Tivic Health Systems

INDICATION FOR USE: Transcutaneous electrical nerve stimulator that electrically stimulates the skin overlying the paranasal sinuses and is intended to be used for the temporary relief of moderate to severe congestion. ClearUP Sinus Relief is a treatment to be used at home by individuals 18 and older

ADDRESSING UNMET NEED: OTC availability of device for sinus pain treatment

DESCRIPTION: Transcutaneous electrical nerve stimulator for the relief of congestion.

  • Electrically stimulates the skin overlying the paranasal sinuses to relieve congestion

REGULATORY PATHWAY: De Novo reclassification


Image credit: Bristol-Myers Squibb, Helius Medical, Medtronic, Q30 Sports, Tivic Health