Vaccine Development – 101

Center for Biologics Evaluation and Research (CBER) ensures rigorous scientific and regulatory processes and review.

Typical process
It Starts in a Lab

Research Moves Forward

Testing the Vaccine in People

Special Considerations – Public health emergencies and more information

Assessment of Manufacturing is Also a Key Component

Seeking Approval

Prescribing Information/Labeling

FDA Oversight Continues After Approval

FDA Research Provides a Unique Perspective

NEW WEBSITE

Dec 10, Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss EUA of COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH

  • Public Meeting with outside scientific and public health experts from around the country
  •  Discussion about safety and effectiveness of vaccine
  • Help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.”

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BARICITINIB (+ REMDESIVIR )

Eli Lilly ( and Gilead)

INDICATION: Treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

ADDRESSING UNMET NEED: New treatment for COVID

MECHANISM OF ACTION: Janus kinase inhibitor (JAK) which blocks enzymes interfering with the pathway that leads to inflammation

EFFECTVENESS an SAFETY:

  • Based on totality of evidence
  • Randomized, double-blind, placebo-controlled clinical trial conducted by National Institute of Allergy and Infectious Diseases (NIAID), n=1,0333 with moderate-severe COVID-19, baricitinib + remdesivir vs placebo + remdesivir, followup for 29 days
  • Primary Endpoint: Recovery defined as either being discharged from hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care; 7 days for baricitinib + remdesivir vs. 8 days for placebo + remdesivir.
  • Odds of patient’s condition progressing to death or being ventilated at day 29 was lower in the baricitinib + remdesivir group vs placebo + remdesivir group (statistically significant)
  • Similarly, odds of clinical improvement at day 15 was higher in the baricitinib + remdesivir group (statistically significant)

REGULATORY PATHWAY: Emergency Use Authorization

  • Previously approved for treatment of moderately to severely active rheumatoid arthritis
  • Expedited by Coronavirus Treatment Acceleration Program (CTAP)

Fact Sheet

LUCIRA COVID-19 All-In-One Test Kit 

Lucira Health

INDICATION FOR USE: Single-use test kit intended to detect SARS-CoV-2 that causes COVID-19. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider.

Test is authorized for use at the Point of Care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation

Test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider.

Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.

PERFORMANCE CHARACTERISTICS:

  • Analytical sensitivity based on Limit of detection, Inclusivity, Cross-reactivity,
  • Human usability study, n=398 asymptomatic subjects, for safe and effective use
  • Community testing study, n=101 asymtomatic subjects, independent collection of Lucira nasal swab samples and running the test. Comparable results vs high sensitivity molecular FDA Authorized SARS-CoV-2 assay (Roche Cobas)

ADDRESSING UNMET NEED: First COVID-19 diagnostic test for self-testing at home and that provides rapid results

REG PATHWAY: Emergency Use Authorization

Instructions for Use

CASIRIVIMAB + IMDEVIMAB intravenous infusion 

Regeneron

INDICATION: Treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older or who have certain chronic medical conditions.

ADDRESSING UNMET NEED: Pandemic treatment option that may help outpatients avoid hospitalization and alleviate the burden on health care system

MECHANISM OF ACTION: Monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells

EFFICACY & SAFETY:

  • Randomized, double-blind, placebo-controlled clinical trial, n= 799 non-hospitalized adults with mild to moderate COVID-19 symptoms
  • Primary endpoint: Time-weighted average change in viral load from baseline; viral load reduction in patients treated with casirivimab and imdevimab was larger than placebo
  • Secondary endpoint: Hospitalizations and emergency room visits within 28 days after treatment; 3% of casirivimab and imdevimab-treated patients vs. 9% on placebo
  • Possible side effects: Anaphylaxis and infusion-related reactions, fever, chills, hives, itching and flushing. 

REGULATORY PATHWAY: Emergency Use Authorization

  • Part of Coronavirus Treatment Acceleration Program

FACT SHEET

Bioburden Reduction Systems

Bioburden: Whole population of viable microorganisms that inhabit a non-sterile surface or device

 Reduction : Dry heat, such as application of temperatures of 70° C for 60 minutes or 75° C for 30 minutes, will kill many of the moderately-resistant microbes present

Intention: To kill and reduce microorganisms on a non-sterile device surface. For use in addition to existing CDC reuse recommendations

Use: In shortage situations, when there is an insufficient supply of essential supplies such as new respirators

GUIDANCE

Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the pandemic

Policy to expand availability and capability of non-invasive remote monitoring devices

  • To facilitate patient monitoring while reducing patient and healthcare provider contact
  • To remain in effect only for the duration of the COVID-19 public health emergency
  • Enforcement policy applies to legally marketed non-invasive remote monitoring devices that measure or detect common physiological parameters to support patient monitoring
  • Devices can be connected to wireless network to transmit patient’s measurements directly to health care provider

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Image credit: FDA, Lucira Health, Regeneron