COVID-19 News: MODERNA vaccine, App Design-a-thon winners, Holiday food safety tips

MODERNA COVID-19 Vaccine

ModernaTX, Inc

INDICATION: Prevention of COVID-19 in individuals 18 years of age and older

  • Administered via intramuscular injection as a series of two doses, one month apart

ADDRESSING UNMET NEED: Second vaccine to combat the pandemic

MECHANISM OF ACTION: Contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein; triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2  

EFFECTIVENESS & SAFETY:

  • Ongoing randomized, placebo-controlled U.S. study, n=28,207 participants without SARS CoV-2 infection
  • 94.1% effective in preventing COVID-19 disease; 11 cases in vaccine group vs. 185 in placebo with 30 severe cases
  • Data are not available to determine how long the vaccine will provide protection
  • No available evidence of prevention of person to person transmission
  • Most commonly reported side effects: Pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever; mostly after second dose

REGULATORY PATHWAY:EUA

  • Pharmacovigilance plan to the FDA to monitor the safety and complete complete longer-term safety follow-up
  • Continue clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure)

FDA website

Translations of Fact Sheet

CDC information

Design-a-thon for COVID-19 At-Anywhere Diagnostic Tests

AIM: To increase speed, quality, comprehensiveness, and utility of SARS-CoV-2 diagnostic test data

WINNERS:

Oracle: COVID-19 Immutable Test Results Submission and Visualization

Interpret-COVID: Consumer Dx Test App

Net Medical Xpress Solutions, Inc: Net Medical’s Telemed for COVID-19 Wireless Data 

READ

HAPPY HOLIDAYS

FDA Food Safety tips for the holidays


COVID-19 News: Moderna Vaccine update, Pfizer vaccine FAQ, BinaxNOW home test, ELLUME home test, PIXEL home sample collection

Moderna Vaccine: To receive FDA EUA

  • Positive Vaccines and Related Biological Products Advisory Committee Meeting
  • FDA has informed Moderna about finalization and issuance of EUA
  • FDA has notified CDC and and Operation Warp Speed to execute plans for timely vaccine distribution   

READ

Pfizer-BioNTech COVID-19 Vaccine FAQs

  • New webpage to cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions, such as how does a vaccine go from emergency use authorization to licensure

FAQ page

 BinaxNOW COVID-19 Ag Card Home Test   

Abbott

  • For prescription use at home with self-collected nasal swab samples, 15 years or older
  • Also for use with adult-collected nasal swab samples, 4 years or older
  • Antigen test that detects fragments of proteins from SARS-CoV-2
  • eMed portal and certified guide to support testing process to ensure a successful testing experience
  • Results within 20 minutes; also shared with public health authorities to monitor and manage virus spread
  • $25 / test

ANNOUNCEMENT

ELLUME COVID-19 Home Test

Ellume

  • First over-the-counter (OTC) fully at-home diagnostic test for COVID-1
  • Rapid, lateral flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample
  • From any individual 2 years of age or older
  • Can be sold in drug stores, where a patient can buy it, swab their nose, run the test and find out results in 20 minutes
  • Mobile app requires individuals to input their zip code and date of birth and reports results to public health authorities to monitor disease prevalence

EUA Letter

PIXEL Home Collection Kit

Labcorp

  • Allows a person to self-collect a nasal sample in their home and then send to LabCorp for testing
  • Can be used by anyone aged 18 or over, and purchased online or in a store without a prescription
  • For use with LabCorp’s COVID-19 RT-PCR Test

EUA Letter


Image credits: FDA, Abbott, Ellume, LabCorp

Emergency Use Authorization for First COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine

Pfizer

INDICATION & DOSING : For active immunization to prevent COVID-19 in individuals 16 years of age and older

  • Administered as a series of two doses, three weeks apart

DESCRIPTION: Contains SARS-CoV-2 virus’s mRNA that instructs cells to make virus’s distinctive “spike” protein; does not cause disease, but triggers the immune system to produce immune response against SARS-CoV-2    

EFFECTIVENESS:  

  • Ongoing randomized, placebo-controlled international study, vaccine vs placebo
  • Analysis of 36,523 participants, majority from US, did not have evidence of SARS-CoV-2 infection through seven days after the second dose
  • 95% effective in preventing COVID-19 disease; 8 cases (1 severe) with vaccine vs 162 (3 severe) in placebo
  • Data not available to conclusively determine duration of protection or prevention of person-to-person transmission

SAFETY:

  • Most commonly reported side effects: Pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever; more people experienced side effects after the second dose  
  • Mandatory FDA reporting of all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death

REG PATHWAY: Emergency Use Authorization

  • Pharmacovigilance plan to monitor and complete longer-term safety follow-up for enrolled patients
  • Continue clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure)

COVID-19 News: Vaccine Advisory Committee for Pfizer vaccine, RC COVID-19 +Flu RT-PCR for COVID-19 + Flu test, Precision immunology App-a-thon, Warning about face masks and MRI

Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement

The Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

Speaker presentations will be available by 8 AM on Dec 10, 2020

The online web conference meeting will be available at the following: 
https://youtu.be/owveMJBTc2I
https://twitter.com/US_FDA
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d

FDA Briefing Document

Pfizer Briefing Document

FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples

RC COVID-19 +Flu RT-PCR

Quest diagnostics

INDICATION FOR USE: Simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus and/or influenza B virus in nasal swab specimens self-collected at home using the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals suspected of respiratory viral infection

Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Specimens collected using the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu can be transported at ambient temperature for testing

Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.

REG PATHWAY: Emergency Use Authorization

Summary

 COVID-19 Precision Immunology App-a-thon

To develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors

  • Phase I: Extracting knowledge from molecular sequencing data from T Cell Receptors/B Cell Receptors and associated clinical variables. Facilitate understanding of relationship between personalized immune repertoires and COVID-19 disease characteristics such as severity and associated factors. For participants from the general data science community and the computational immunology community
  • Phase II: Create research tools and apps to report the outputs from Phase I to be incorporated into an easily interpretable format for healthcare professionals

Deadline: January 29, 2021.

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Reminder patients should not wear any metal during an MRI

Patients may be injured by face masks with metal parts and coatings during a Magnetic Resonance Imaging (MRI) exam. Metal parts may become hot and burn the patient

  • Patients should not wear any metal during an MRI

If burned by face mask during an MRI, please report the event to the FDA. 


Image credit: FDA