EMERGING TRENDS IN INFECTIOUS DISEASE
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mRNA
Replication Defective Live-Vector
Recombinant Subunit Adjuvant Protein
Platform Company Stage I Stage III ? FDA filing End Study
Pfizer / BIONTech BNT 16262 Moderna / NIAID mRNA 1273 AstraZeneca University of Oxford AZD 1222 Johnson & Johnson ( JNJ ) JNJ 78436735 Novavax NVX-CoV2373
TABLE 1 — COVID-19 CANDIDATE VACCINES PROGRESS
done start 7 / 20 end 11 / 20
3 / 20 ( 3 ) start 7 / 20 end 11 / 20 done start 8 / 20 end 12 / 20
7 / 20 start 11 / 20 1Q 2021
11 / 20 11 / 2022
11 / 20 10 / 2022
? 10 / 2022
? ?
3 / 2023
done start 11 / 20 ? 1 / 2022
Sanofi – GSK 9 / 20 start 12 / 20 ? unknown
2 . |
Sample sizes in phase III trials of at least 30,000 participants |
3 . |
The primary outcome measure is prevention of COVID-19 |
4 . |
A secondary outcome is prevention of the severe aspects |
of COVID-19 |
5 . |
Close follow-up of those who become COVID-19 positive |
6 . |
Subjects included in the trials will include high-risk populations |
including the elderly , those with chronic disease |
and minority populations |
7 . |
Multiple blood samples taken over time to measure antibody |
persistence |
8 . |
Long term follow-up for safety |
9 . |
Immune response with neutralizing antibodies and T cell |
stimulation |
Historically , vaccine development works in an orderly process , usually taking many years of development . OWS , with large amounts of federal funding , promotes a diverse panel of vaccine candidates and manufacturers . The goal is to accelerate development without compromising safety , efficacy or product quality . OWS supports companies involved with vaccine development in manufacturing and distribution . The vaccine must be mass-produced quickly and with appropriate distribution methods to widely disseminate the effective vaccines .
Vaccines showing safety and efficacy meeting initial FDA goals could receive emergency FDA approval for human use as early as December or in the first months of 2021 . It is likely that more than one vaccine may be approved . Manufacturing of the vaccines has already started prior to FDA approval so that millions of doses will be ready upon FDA approval . 4 The evaluation of COVID-19 vaccine candidates and the development of recommendations are appropriate activities for the traditional evidence / review processes of the FDA and CDC .
Public confidence in vaccines is obtained when the processes of evaluation determine they are safe and effective .
A platform primer :
mRNA = Genetic-code vaccines deliver specific genetic instructions that teach the body ’ s cells to make a protein from the targeted virus , which in turn induces an immune response
Replication defective live-vector = Uses a modified virus different from the targeted virus to serve as a carrier of the vaccine . The carrier virus presents the targeted virus to the cells , which teaches the body ’ s cells to make a protein from the targeted virus , which induces the immune response .
Recombinant subunit adjuvant protein = Vaccines incorporate a protein from the virus or a virus-like particle that will trigger an immune response .
References
1
Helmy YA , Fawzy M , Elaswad , S etol . The COVID-19 Pandemic : A Comprehensive Review of Taxonomy , Genetics , Epidemiology Diagnosis Treatment and Control . J Clin Med : 2020 ; 9 : 1225 .
2
Slaoui M , Hepburn M : Developing Safe and Effective COVID Vaccines – Operation Warp Speeds Strategy and Approach . N Eng J Med 2020 ; 382 : 1701-1703 .
3
Jackson LA , Anderson NG , Rouphael PC etol . An mRNA Vaccine Against SARS COV-2 Preliminary Report . N Engl J Med 2020 ; 383 : 1920-1931 .
4
Schwartz JL . Evaluating and Developing COVID-19 Vaccines . The Importance of Transparency , Scientific Integrity and Public Trust . N . Eng . J Med 2020 ; 383 : 1703-1705 .
Dr . Gall is a retired obstetrician / gynecologist .
8 LOUISVILLE MEDICINE