Janssen COVID-19 Vaccine EUA

INDICATION: For the prevention of coronavirus disease 2019 for use in individuals 18 years of age and older; administered as a single dose

ADDRESSING UNMET NEED: Expands the availability of vaccines, the best medical prevention method to help us in the fight against the pandemic

MECHANISM OF ACTION: Uses modified Ad26 to deliver a piece of the DNA to make virus “spike” protein; body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2



  • Ongoing randomized, placebo-controlled study, n=39,321, being conducted in South Africa, South America, Mexico, U.S, did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine, Vaccine vs placebo
  • ~ 67% effective in preventing moderate to severe/critical COVID-19 occurring 14 days after vaccination
  • ~ 66% effective in preventing moderate to severe/critical COVID-19 occurring 28 days after vaccination
  • ~77% effective in preventing severe/critical COVID-19 occurring 14 days after vaccination
  • ~85% effective in preventing severe/critical COVID-19 occurring 28 days after vaccination
  • No evidence on prevention of person to person transmission


  • N= 43,783, vaccine vs. placebo, followup of 8 weeks (median)
  • Most commonly reported side effects: Pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.
  • Need to report adverse safety and vaccine administration errors to iVaccine Adverse Event Reporting System (VAERS)


  • All manufacturing facilities will comply with Current Good Manufacturing Practice
  • File Certificates of Analysis (CoA) established specifications and specific results for each quality control test
  • File quarterly manufacturing reports with listing of all Drug Substance and Drug Product lots produce


  • Provide fact sheets on dosing instructions, benefits and risks providers and recipients
  • Continue clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure)
  • Conduct post-authorization observational studies to evaluate adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19


close up of syringe

More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

Undiluted frozen vials can be transported and stored at conventional freezer temperatures

  • Based on data to demonstrate stability after storage up to two weeks at standard freezer temperature
  • Will help ease burden of procuring ultra-low cold storage equipment and help get vaccine to more sites


Vaccine Safety and Surveillance

Webpage to provides overview of surveillance systems to monitor safety of authorized COVID-19 vaccines

  • Data from FDA’s CBER + CDC + CMS + VA + other academic and large non-government healthcare data systems
  • Includes international pharmacovigilance efforts, including International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)

Passive surveillance: Reviewing data from FDA’s Vaccine Adverse Event Reporting System (VAERS) , CDC’s  v-safe text-based monitoring system 

Active surveillance: Analyzing large healthcare data systems such as Sentinel BEST (Biologics Effectiveness and Safety) System and the CMS system


Pulse Oximeter Accuracy and Limitations

Pulse oximeters may be less accurate in people with dark skin pigmentation

  • Risk that an inaccurate measurement may result in unrecognized low oxygen saturation levels
  • Important to understand the limitations of pulse oximetry and how accuracy is calculated and interpreted
  • Prescription oximeters are reviewed and authorized by the FDA an used in hospitals and doctor’s offices
  • Over-the-counter (OTC) oximeters are sold directly to consumers, are not cleared by the FDA and should not be used for medical purposes.
  • Important recommendations for patients and their caregivers on how to use pulse oximeters at home
  • Recommendations for health care providers on how to use pulse oximeters for better accuracy
  • Background on pulse oximeters and the FDA’s actions to evaluate factors that may affect pulse oximeter accuracy and performance
  • Instructions for reporting problems with pulse oximeters to the FDA


Policies for Addressing Virus Variants: Vaccines, Diagnostics and Therapeutics

Guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products

Vaccines : Updated October 2020 guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19

COVID-19 Tests: New guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests

Therapeutics: New guidance, Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency. Revised guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.


Image credit: FDA, CDC