Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement. [1] Vaccines contain tiny fragments of the disease-causing organism or the blueprints for making the tiny fragments. They also contain other ingredients to keep the vaccine safe and effective. [2]
These latter ingredients are included in most
vaccines and have been used for decades in billions of doses of vaccine.
Ø Antigen
Ø Preservatives
Ø Stabilizers
Ø Surfactants
Ø Residuals
Ø Diluent
Ø Adjuvant [2]
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Stages of
Vaccine Development and Testing
First
Steps: Laboratory and Animal Studies
Exploratory
Stage
This stage involves basic laboratory
research and often lasts 2-4 years. Federally funded academic and governmental
scientists identify natural or synthetic antigens that might help prevent or
treat a disease. These antigens could include virus-like particles, weakened
viruses or bacteria, weakened bacterial toxins, or other substances derived
from pathogens. [2]
Pre-Clinical
Stage
Pre-clinical studies use
tissue-culture or cell-culture systems and animal testing to assess the safety
of the candidate vaccine and its immunogenicity, or ability to provoke an
immune response. Animal subjects may include mice and monkeys. These studies
give researchers an idea of the cellular responses they might expect in humans.
Researchers may adapt the candidate
vaccine during the pre-clinical state to try to make it more effective. They
may also do challenge studies with the animals, meaning that they vaccinate the
animals and then try to infect them with the target pathogen. The pre-clinical
stages often lasts 1-2 years and usually involves researchers in private
industry. [2]
IND
Application
A sponsor, usually a private company,
submits an application for an Investigational New Drug (IND) to the U.S. Food
and Drug Administration. The sponsor describes the manufacturing and testing
processes, summarizes the laboratory reports, and describes the proposed study.
An institutional review board, representing an institution where the clinical
trial will be conducted, must approve the clinical protocol. The FDA has 30
days to approve the application. Once the IND application has been approved,
the vaccine is subject to three phases of testing. [2]
Next Steps: Clinical
Studies with Human Subjects
Phase
I Vaccine Trials
This first attempt to assess the
candidate vaccine in humans involves a small group of adults, usually between
20-80 subjects. If the vaccine is intended for children, researchers will first
test adults, and then gradually step down the age of the test subjects until
they reach their target. Phase I trials may be non-blinded (also known as
open-label in that the researchers and perhaps subjects know whether a vaccine
or placebo is used).
The goals of Phase 1 testing are to
assess the safety of the candidate vaccine and to determine the type and extent
of immune response that the vaccine provokes. The participants in these studies
are carefully monitored and conditions are carefully controlled. In some cases,
an attenuated, or modified, version of the pathogen is used for the challenge. A
promising Phase 1 trial will progress to the next stage.
Phase II
Vaccine Trials
A larger group of several hundred
individuals participates in Phase II testing. Some of the individuals may
belong to groups at risk of acquiring the disease. These trials are randomized
and well controlled, and include a placebo group.
The goals of Phase II testing are to
study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule
of immunizations, and method of delivery.
Phase
III Vaccine Trials
Successful Phase II candidate
vaccines move on to larger trials, involving thousands to tens of thousands of
people. These Phase III tests are randomized and double blind and involve the
experimental vaccine being tested against a placebo (the placebo may be a
saline solution, a vaccine for another disease, or some other substance).
One Phase III goal is to assess
vaccine safety in a large group of people. Certain rare side effects might not
surface in the smaller groups of subjects tested in earlier phases. Vaccine
efficacy is tested as well. These factors might include
1) Does the candidate vaccine prevent disease?
2) Does it prevent infection with the
pathogen?
3) Does it lead to production of
antibodies or other types of immune responses related to the pathogen? [2]
Next Steps: Approval
and Licensure
After a successful Phase III trial,
the vaccine developer will submit a Biologics License Application to the FDA.
Then the FDA will inspect the factory where the vaccine will be made and approve
the labeling of the vaccine.
After licensure, the FDA will
continue to monitor the production of the vaccine, including inspecting
facilities and reviewing the manufacturer’s tests of lots of vaccines for
potency, safety and purity. The FDA has the right to conduct its own testing of
manufacturers’ vaccines.
Phase
IV Trials
Phase IV trial are optional studies
that drug companies may conduct after a vaccine is released. The manufacturer
may continue to test the vaccine for safety, efficacy, and other potential uses.
[2]
Organizations/institutions
Working on “CORONA VIRUS” vaccine
A COVID‑19
vaccine is a vaccine intended to provide acquired immunity against severe acute
respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the
virus causing Coronavirus disease 2019 (COVID‑19).
[3]
WHO, UNICEF, Gavi and partners are
working together to help prepare countries to be ready to introduce a COVID-19
vaccine. [4] Internationally, the Access to COVID-19 Tools Accelerator is a G20
and World Health Organization initiative announced in April 2020. National
governments have also been involved in vaccine development. As of February
2021, 66 vaccine candidates are in clinical research, including 17 in Phase I
trials, 23 in Phase I–II trials, 6 in Phase II trials, and 20 in Phase III
trials. Trials for four other candidates were terminated. In Phase III trials,
several COVID‑19 vaccines demonstrate efficacy as
high as 95% in preventing symptomatic COVID‑19 infections. [3]
A list of organizations working on “COVID-19” vaccine with their name of vaccine and country of origin is given below……. [3]
|
Name of vaccine |
Organizations/Institutions |
Country of origin |
|
Sinopharm: Beijing Institute of
Biological Products, Wuhan Institute of Biological Products |
China |
|
|
Gamaleya Research Institute of Epidemiology and
Microbiology |
Russia |
|
|
United States,
Germany |
||
|
United States |
||
|
United Kingdom |
||
|
China |
||
|
CanSino Biologics, Beijing Institute of
Biotechnology of the Academy of
Military Medical Sciences |
China |
|
|
Russia |
||
|
India |
||
|
Netherlands,
United States |
||
|
United States |
||
|
Anhui Zhifei
Longcom Biopharmaceutical Co. Ltd. |
China |
|
|
Zorecimeran (CVnCoV) |
Germany |
|
|
ZyCoV-D |
India |
|
|
Canada |
||
|
IIBR-100 (Brilife)[ |
Israel |
|
|
Name of vaccine |
Organizations/Institutions |
Country of origin |
|
FINLAY-FR-2 (SOBERANA 02) |
Instituto Finlay
de Vacunas |
Cuba |
|
INO-4800[ |
Inovio, CEPI, Korea National Institute of Health, International
Vaccine Institute |
South Korea,
United States |
|
Unnamed |
China |
|
|
AG0301-COVID‑19 |
AnGes Inc, AMED |
Japan |
|
Lunar-COV19/ARCT-021 |
|
|
|
France |
||
|
COVID‑19/aAPC |
Shenzhen
Genoimmune Medical Institute |
China |
|
LV-SMENP-DC |
Shenzhen
Genoimmune Medical Institute |
China |
|
LNP-nCoVsaRNA |
United Kingdom |
|
|
GRAd-COV2 |
ReiThera, Lazzaro Spallanzani
National Institute for Infectious Diseases |
Italy |
|
Bangavax |
Globe Biotech Ltd
of Bangladesh |
Bangladesh |
|
Nano Covax |
Nanogen
Pharmaceutical Biotechnology JSC |
|
|
PTX-COVID19-B |
Providence
Therapeutics |
Canada |
|
COVAC-2 |
Canada |
|
|
SARS-CoV-2 Sclamp/V451 |
Australia |
As of 10 February 2021, 151.49 million doses of COVID‑19 vaccine have been administered worldwide based on official reports from national health agencies. Pfizer, Moderna, and AstraZeneca predicted a manufacturing capacity of 5.3 billion doses in 2021, which could be used to vaccinate about 3 billion people (as the vaccines require two doses for a protective effect against COVID‑19). By December, more than 10 billion vaccine doses had been preordered by countries,with about half of the doses purchased by high-income countries comprising 14% of the world's population. [3]
References
1. https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
2. https://www.who.int/news-room/feature-stories/detail/how-are-vaccines-developed
3. https://en.wikipedia.org/wiki/COVID-19_vaccine
4. COVID-19 vaccine country readiness and delivery