• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    High Drug Loading Amorphous Solid Dispersions

    Parenteral Drug Delivery Trends

    Selecting the Right Outsourcing Model for Emerging Biotech

    Inhaled Drug Delivery Technology

    The Future of Biologics: Accelerating Production, Reducing Costs
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    High Purity New England Bolsters Biopharma Solutions Services

    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    Covectra Introduces Next-Gen Serialization Solution
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    C2 Pharma Completes Multiple Regulatory Filings

    Bormioli Opens New Glass Research Center

    Why Increasing Solubility May Not Improve Bioavailability - In Vitro Predictions
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing

    PwC Joins Medicines Manufacturing Innovation Centre
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    CrownBio & JSR Life Sciences Partner with Cambridge Quantum Computing

    Stevanato Group Launches AI Platform
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Baxter BioPharma Solutions

    Emergent BioSolutions

    test company saurabh

    Alcami

    Reed-Lane
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Alcami

    Adare Pharma Solutions

    Almac Group

    Baxter BioPharma Solutions

    Reed-Lane
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Columns

    It Takes a Vaccine… To End The Pandemic [У нас есть хорошая вакцина]

    Race for the vaccines is heating up.

    It Takes a Vaccine… To End The Pandemic [У нас есть хорошая вакцина]
    Ben Locwin, Contributing Editor09.09.20
    There have been many competitive moves over the past 6 months regarding vaccine candidates and the ongoing clinical trials. Moderna’s mRNA-1273, an mRNA vaccine candidate, was the first and most aggressive out of the gate. We’ve since seen the University of Oxford and AstraZeneca’s adenoviral-vector vaccine, codenamed ChAdOx1 seemingly perform quite well in its early trials. Johnson & Johnson and Janssen have been working feverishly on their candidate, codenamed Ad26.COV2.S, which is also an adenoviral-vector vaccine. Pfizer and BioNTech have similarly been working on a pair of mRNA vaccines, codenamed BNT162b1 and BNT162b2.

    These candidates represent several ‘shots-on-goal’ from some stellar scientists, and it’s likely that many, if not all, will eventually attain approval. Keep note, though, that mRNA vaccines don’t have regulatory precedent, so while the technology could absolutely revolutionize and simplify the philosophy of vaccination in the future, the FDA and other agencies haven’t approved one yet, and they need to acknowledge that internally amidst their review and approval processes.

    In addition to the coded vaccines above, there are over 30 other candidate vaccines in various stages of research, development, and trial staging. Many have been granted Fast Track Designation, so they should fully confound and bottleneck the Fast Track system. We will see how the Theory of Constraints works when Fast Track candidates are competing with other Fast Track candidates. Suffice to say, there will be no shortage of effective and safe vaccines available, however likely not until we’re into calendar year 2021.

    The global vaccine race has been punctuated, and to some degree deflated, by recent announcements of a ‘Sputnik-like’ moment out of Russia, where claims are that they have already approved a SARS-CoV-2 vaccine. But do you do moonshots if they’re not safe? What if they’re effective?


    Figure courtesy: Moscow Times

    Safety & Efficacy
    When the FDA looks for Sponsors to have done their work properly on the development of a therapeutic treatment or vaccine, they look for safety first and foremost, and then at efficacy. This is necessarily the case in order for the approval candidate to do as little harm as possible, while still providing an effective benefit to the population under study within the candidate’s therapeutic indication.

    In addition to this safety hurdle, for a vaccine candidate for SARS-CoV-2 to be approved, the FDA is requiring that it demonstrates clinical protection from the novel pandemic coronavirus, and that it’s not enough for the vaccine to demonstrate serologically-present antibody levels associated with SARS-CoV-2. This is an important distinction and a departure from some other therapies in the past. This move is being done to ensure that a proxy, such as a biomarker, isn’t used in place of real-world (vis-à-vis clinical trial) evidence of the conferring of physiological protection. Part of the reason, too, is that media stories have weighed heavily over scientific decision-making (unfortunately) throughout the course of the pandemic, and there was wide broadcasting early on about uncertainty in the presence of antibodies to SARS-CoV-2 being associated with immunity to COVID-19.

    As clinical trials race to completion some are well within Phase III right now, including Moderna’s Ph. III trial with 30,000 patients, called COVE: COronaVirus Efficacy. The COVE study is testing 100 um doses, and from which the patient infection rate data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) organized by NIAID (National Institute of Allergy and Infectious Diseases) throughout the study.

    At the same time, in early August, Russia announced that they had successfully developed an effective SARS-CoV-2 vaccine, and had begun dosing civilians with it, throwing the global news media into vortices of incredulity. ‘How is that possible?’ they asked. Well, there are two answers to this question: 1) Coronaviruses are in-general a very well-characterized and understood family of viruses, and SARS-CoV-2 is very much NOT a superbug, nor is it particularly mysterious. It’s only a mystery when the press wants to carry on the story with each new ‘surprising’ finding, of which very few are. 2) If the various steps to vaccine development are not approached properly and carefully (i.e., recklessly), vaccines can be quickly developed for a target pathogen and assembled with great speed using existing vector and delivery technologies. This is one reason why J&J’s vaccine candidate could have a great shot at hitting the market very quickly, indeed, given its pre-existing adenovirus vector approach, contrasted against Moderna’s more-difficult-pathway-to-recognition with a novel mRNA technology.

    To-date, five Russian cabinet members have contracted SARS-CoV-2, and the country has recorded 937,321 (+) cases, and 16,000 deaths (1.7%). In relative context, the U.S. has recorded 5.5 million (+) cases, and 172,000 deaths (3.1%) attributed to COVID-19. The absolute difference in death rates is as much due to politics and global optics as it is to reality. Also, the uncertainty in case measurement and death attribution of COVID-19 is about +/- 30+% and +/- 80%, respectively. It’s been a global data tragedy to not capture and publish the uncertainty in these numbers, and has hampered case identification, tracing, and resolution.


    Sir Ronald Fisher. Not only is the "p-value" named for him, but he would have a big problem with anecdotal, 'observational' medicine.
    There have been plenty of displeased dissenters with the Russian decision over the past couple of weeks: “This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population,” said Francois Balloux, a geneticist at University College London, in a statement distributed by the UK Science Media Center.

    Here’s why the news about Russia’s vaccine is disconcerting: Their COVID-19 vaccine was approved by the national regulator, and was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow. However, the approval was given even though phase III trials of the vaccine had yet to be completed. It could be that safety studies have demonstrated that the vaccine candidate is safe ‘enough,’ so why not use it while being somewhat uncertain of its efficacy if it ‘could’ prevent illnesses? This is where risk calibration and tolerance come into the discussion. Seventy-six trial participants had been dosed with the vaccine candidate, which is comprised of two doses: an adenovirus Ad26 virus (the same as in J&J’s vaccine candidate), as well as an Ad5 virus (the same as in CanSino Biologics’ vaccine in China). Thirty-eight participants who were inoculated with one or two doses produced measurable serological antibodies to the spike (S) proteins of SARS-CoV-2, which the Russian authorities consider a good enough proxy for infection prevention. Remember that the contrast here is that FDA has required clinical efficacy in the U.S., not simply a measurable production of antibodies.

    The alleged approach in Russia isn’t wrong, as many news stories might have you believe—it’s just a different approach and governmental tolerance to risk. Thresholds for ‘how many’ adverse events (AEs) are acceptable are subjectively-created. If we were very much more risk-tolerant, we could have had a (maybe) viable vaccine candidate dosed into participants (willing or unwilling) back in late March (about 5 months ago). We would have had to been ready with market surveillance data flooding in of untoward adverse events, and we would be uncertain of long-term efficacy and safety, but we could have done it.

    The caveat is that medicine includes clinical trials for a reason—to give trial data a chance of falsifying the null hypothesis. This is different from observational ‘medicine,’ where treatments are applied to naïve patients, and effects are looked for a posteriori (i.e., after the fact). This is a dangerous game, because on average, most trials would fail, and therefore the inference is that running all medical trials in an observational way would subject the public to overall greater harm than NOT exposing them in the first place. But again, for situations like pandemics, that alone is a reason which should factor into the risk calculus and policies of each nation-state.


    Ben Locwin
    Contributing Editor
    A healthcare executive, he has worked on vaccine and virology advisory boards, and has been featured recently across media outlets and podcasts discussing coronavirus and its potential or likely impact to public health and world economies. Follow him on Twitter @BenLocwin
    Related Searches
    • Biologics, Proteins, Vaccines

    Related Columns

    • Biologics, Proteins, Vaccines
      Vaccines 2021

      Vaccines 2021

      Looking at the behavioral economics of vaccinations.
      Ben Locwin, Contributing Editor 01.27.21

    • Biologics, Proteins, Vaccines
      Outsourcing in China: How far can it go?

      Outsourcing in China: How far can it go?

      China’s biopharmaceutical services market is on pace to top $1 billion by 2021
      Vicky Qing Xia, BioPlan Associates 07.15.19

    • Biologics, Proteins, Vaccines | Drug Development
      The Future Is… Therapeutic

      The Future Is… Therapeutic

      As cell and gene therapies rise, so too does outsourcing
      Ben Locwin 06.13.19


    • Biologics, Proteins, Vaccines
      Innovate UK Grant Supports Viral Vector Manufacturing

      Innovate UK Grant Supports Viral Vector Manufacturing

      Cobra Biologics talks about its recently awarded $3.4 million capital infrastructure investment
      Betsy Louda, Associate Editor 04.10.18

    • Biologics, Proteins, Vaccines | Injectables
      A World of Innovation

      A World of Innovation

      The importance of innovation in the injectable business and the hurdles a CDMO faces
      Claudia Roth, Vetter Pharma-Fertigung GmbH & Co. KG 11.07.17

    • Biologics, Proteins, Vaccines
      India is an Emerging Hub  For Low-cost Vaccines

      India is an Emerging Hub For Low-cost Vaccines

      Improvising basic vaccines to enhance stability, efficacy and compliance
      S. Harachand, Contributing Editor 11.07.17


    • Biologics, Proteins, Vaccines
      Flu Season is Upon Us

      Flu Season is Upon Us

      My chance and capricious Monday afternoon run-in with antiscience nonsense
      Ben Locwin, Contributing Editor 11.07.17

    • Biologics, Proteins, Vaccines
      Trends in New Technologies & Budgets

      Trends in New Technologies & Budgets

      Budget increases in biopharmaceutical industry indicate future growth
      Eric S. Langer, BioPlan Associates 06.06.17

    • Biologics, Proteins, Vaccines

      Biomanufacturing Trends and Outlook 2017: Where Is It All Going?

      A look at the technological advances permeating (bio)pharma manufacturing
      Ben Locwin, Contributing Editor 04.20.17


    • Biologics, Proteins, Vaccines
      CMOs Hiring Constraints:  Cell Therapy Manufacturing Expecting Future Challenges

      CMOs Hiring Constraints: Cell Therapy Manufacturing Expecting Future Challenges

      Technically trained staff needed to run complex manufacturing platforms, automation
      Eric S. Langer, BioPlan Associates 03.07.17

    • Biologics, Proteins, Vaccines

      Year-End Trends in Biopharma Contract Manufacturing

      Budgets are flattening, but some CMOs are well positioned for growth
      Eric S. Langer, BioPlan Associates 11.09.16

    • Biologics, Proteins, Vaccines

      Economics of In-House Buffer Preparation

      Evaluating the cost effectiveness of keeping basic ops in-house
      Eric S. Langer, BioPlan Associates 09.08.16


    • Biologics, Proteins, Vaccines | cGMP Manufacture | GMPs/GCPs | Preclinical Outsourcing | Process Development | Risk Management

      Getting to Yes

      The critical attributes CMOs need to demonstrate to win business
      Eric S. Langer, BioPlan Associates 07.14.15

    • Biologics, Proteins, Vaccines | Biosimilars | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Inspections | Logistics | Lyophilization | Methods Development | Process Development | QA/QC | Serialization | Supply Chain | Validation

      CMOs Facing Significant Capacity Constraints

      Downstream purification creating chronic problems
      Eric S. Langer, BioPlan Associates 06.02.15

    • Biologics, Proteins, Vaccines | Biosimilars | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Process Development

      7 Top Trends in Biomanufacturing Outsourcing

      Keep your eye on these trends in 2015.
      Eric S. Langer and Jean-Claude Lupis, BioPlan Associates 01.29.15

    Trending
    • Catalent Acquires Delphi Genetics
    • Inside A Vaccine Trial
    • Wavelength Pharmaceuticals Acquires Majority Stake In Vanamali Organics
    • Century Therapeutics Significantly Expands Capabilities
    • Pfizer Selects Seven Bridges To Support RNA Sequencing Data
    Breaking News
    • High Purity New England Bolsters Biopharma Solutions Services
    • AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    • CatSci Opens New Site in UK
    • Pfizer Partners with Medicines Manufacturing Innovation Center
    • Covectra Introduces Next-Gen Serialization Solution
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • High Drug Loading Amorphous Solid Dispersions
    • Parenteral Drug Delivery Trends
    • Selecting the Right Outsourcing Model for Emerging Biotech
    • Inhaled Drug Delivery Technology
    • The Future of Biologics: Accelerating Production, Reducing Costs
    • Business Intelligence For (and From) the Lab
    • Communicating Your Contracting Priorities to Your Drug Company Customers
    • COVID-19 Impact Report
    • The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    New FDA Traceability Rule Appears to Omit Dietary Supplement Manufacturers
    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula
    JRF Technology Debuts Elderberry Oral Film Strip
    Coatings World

    Latest Breaking News From Coatings World

    OQ Chemicals Increases Carboxylic Acids, Esters Prices
    Sensory Analytics Announces Issuance of Broad New Patent Covering Coating Thickness Measurement
    Arkema Reports Full-year 2020 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Japan to Lead APAC Assisted Reproductive Technology Devices Market
    Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification
    FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump
    Contract Pharma

    Latest Breaking News From Contract Pharma

    High Purity New England Bolsters Biopharma Solutions Services
    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    CatSci Opens New Site in UK
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Inahsi Naturals Achieves EU Compliance
    Biden Prioritizes PPP Relief for the Beauty Industry
    Christie Brinkley Joins SBLA Beauty
    Happi

    Latest Breaking News From Happi

    Clean Beauty Collective Supports EarthDay.org
    Freckle Pens Are Spot On!
    The Detox Market Partners with Good Face Project
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Lowe-Martin Adds 2 KODAK NEXFINITY Digital Presses
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    UFlex adds capacity in packaging films
    CEC expands into labels and packaging with Heidelberg
    ABG delivers Digicon Series 3 to UK printer
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Forbes Ranks Rockline Among Best U.S. Employers
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    NuVasive Nabs Simplify Medical for $150M
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    RFID Locks Market to Reach $9.93 Billion by 2027: Allied Market Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login