TLP:GREEN

• Janssen COVID-19 Vaccine EUA Letter of Authorization
• Janssen COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers
• Janssen COVID-19 EUA Fact Sheet for Recipients and Caregivers

• Ad26.COV2.S is a replication-incompetent adenovirus type 26 (Ad26)-vectored vaccine that encodes a stabilized variant of the SARS-CoV-2 S protein, intended to be administrated in a single dose.
• Initial data on the vaccine suggests the following vaccine efficacy rates: 
  • 66.9% efficacy rate when assessing moderate to severe/critical cases occurring at least 14 days after the single-dose vaccination
  • 66.1% efficacy rate when assessing moderate to severe/critical cases occurring at least 28 days after the single-dose vaccination
  • 76.7% efficacy rate when assessing severe/critical cases occurring at least 14 days after the single-dose vaccination 
  • 85.4% efficacy rate when assessing severe/critical cases occurring at least 28 days after the single dose vaccination 
• Approximately 40,000 participants were enrolled in the Phase 3 randomized, double-blind and placebo-controlled clinical trial.
• No specific safety concerns were observed during the trials.
• On February 26, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened and voted to recommend that the FDA issue an EUA for this vaccine. 

• Due to initial demand of the vaccine outweighing available supply, initial allocation and distribution of the vaccine will be handled by the federal government.
• Distribution of the Janssen vaccine will begin 24 hours after the EUA. State and local health departments will have the most accurate information about when, where, and how individuals can get a vaccine. 
  • The Federal strategy includes the creation of ancillary supply kits to accompany the vaccine distribution. The kits will include needles, syringes, alcohol pads, vaccination cards, and limited PPE for vaccine administrators. 
• The US Centers for Disease Control and Prevention (CDC) has partnered with CVS and Walgreens though the Pharmacy Partnership for Long-Term Care Program to provide on-site vaccinations to residents and staff of nursing homes and long-term care facilities when the vaccine supply becomes available for these populations.
• Several advisory committees have released distribution and allocation recommendations for a vaccine:
  • The Advisory Committee on Immunization Practices (ACIP) offered interim recommendations that both 1) health care personnel and 2) residents of long-term care facilities be offered the COVID-19 vaccine first. 
    • On December 20, ACIP updated their allocation recommendations to include recommendations:
      • Phase 1b: Offered to all persons older than 75 years and non-health care frontline essential workers 
      • Phase 1c: Offered to all persons aged 65-74 years, persons aged 16-64 with high-risk medical conditions, and essential works not included in phase 1b. 
  • The National Academies of Sciences, Engineering, and Medicine (NASEM) published A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus.
• Each state was required to file a COVID-19 vaccination plan with the CDC. The Kaiser Family Foundation has compiled the plans for each state in a table available for download.  

• Janssen stood up a COVID-19 page to share information and updates about their vaccine and how the company is responding to the pandemic. Additionally, Johnson & Johnson is also maintaining a page dedicated to their COVID-19 response efforts. 
• Documents from the VRBPAC February 26 meeting on the Janssen vaccine are available online and include the FDA review of efficacy and safety data for the vaccine.
• CDC created a resource consisting of EUA fact sheets for recipients and caregivers. These fact sheets are for any vaccine that has received an EUA for preventing COVID-19, including the Moderna, Pfizer-BioNTech vaccines.
  • The Janssen vaccine fact sheet will be posted to the page when it becomes available. 
• Johns Hopkins University published a list of FAQs on EUAs and how they relate to COVID-19 vaccines.
• COVID Vaccine Facts, stood up by the Biotechnology Innovation Organization (BIO), answers questions related to the development, safety, and efficacy of COVID-19 vaccines.
• The National Governor’s Association (NGA) provided their recommendations on how to equitably distribute a COVID-19 vaccine.
• The Pharmaceutical Research and Manufacturers of America (PhRMA) has several resources on vaccine development and safety. These include:
  • An illustrated timeline of how safety is prioritized in vaccine development
  • A fact sheet of the ongoing clinical trials for COVID-19 related vaccines and medications
  • A step-by-step guide to COVID-19 vaccine development
  • A fact sheet on what Emergency Use Authorization means for a COVID-19 vaccine
  • Suggested guiding principles for how to safely and effectively develop, distribute, allocate, and use vaccines for COVID-19, from the Pharmaceutical Supply and Payment Chain Coalition