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

EFFECTIVENESS, SAFETY, QUALITY:

Effectiveness

  • 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

Safety

  • 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)

Quality

  • 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

REGULATORY PATHWAY: EUA

  • 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

AUTHORIZATION

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

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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

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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

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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.

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Image credit: FDA, CDC