Here’s Why Development of a Vaccine Takes So Long

As the world battles the COVID-19 pandemic, the White
House has warned time
and time again that a vaccine for the SARS-CoV-2 virus won’t be available for another 12 to 18
months.

In a crisis, that sounds like forever.

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In the 2011 movie “Contagion,” the valiant researchers at the Centers for Disease Control and Prevention manage to discover the cause of the disease, develop the vaccine, and, by day 131, start inoculating Americans. 

So, why can’t we do the same?

It turns out that the real world is more challenging. Vaccine
development is a complex, multistep process that includes rigorous clinical testing
and regulatory hurdles.

Throughout the vaccine-development process, scientists,
policymakers, and government regulators must constantly walk the tightrope
between speed, efficacy, and product safety to produce a vaccine that creates a
neutralizing immune response to the virus.

With that in mind, let’s take a look at the process.

Step
1: Research

Identify the pathogen: Before a vaccine candidate can be
developed, the biological pathogen must be identified, isolated, and analyzed
in a laboratory. This process includes genetic sequencing to get an
understanding of the virus’s structure. 

Develop a candidate: Traditionally, vaccines are
developed by “growing” pathogens that are either inactive or reduced in potency.
Once injected into a host, these trigger an immune response to protect against
the real virus.

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Preclinical testing: Before a vaccine can be tested in
humans, it’s investigated carefully in a lab. This step usually involves animal
trials, but regulators have allowed researchers to skip
this step
to fast-track development of a SARS-CoV-2 vaccine.

Step
2: Human Clinical Trials

Once a vaccine candidate is identified and clears preclinical testing, scientists prepare it for human studies. What works in the lab doesn’t always work in human hosts.

Clinical trials are usually conducted in three phases.

Phase 1: Potential vaccines are given in small doses to
healthy human volunteers. These studies are designed to make sure the vaccine
is safe while determining proper dosage. Phase 1 studies rarely have more than
100 people, and many begin with fewer than two dozen volunteers.

While Phase 1 trials usually take at least a year, experts
predict they will take approximately
three months
for COVID-19 vaccine candidates.

Phase 2: If a vaccine candidate clears phase 1
successfully, it can be tested on larger numbers of people. During phase 2
trials, an established dosage is given to subjects to determine
“how reproducible and consistent the immune response is” and to identify possible
side effects.

Usually, scientists conduct several phase 2 studies
involving a few hundred patients per trial. Phase 2 trials for COVID-19
vaccines are expected to take eight
months
. For other vaccines, phase 2 studies usually take two to three
years.

Phase 3: Next, a vaccine is tested on a much larger
scale. Phase 3 trials can involve tens of thousands of people and screen for
rare side effects. They also determine whether a vaccine actually provides
protection against a disease.

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To speed up the process, COVID-19 vaccine developers may
combine
Phase 2 and Phase 3 trials. After Phase 3, the vaccine is submitted for
approval and then used clinically.

Phase 4: After a vaccine is on the market and in clinics, prescribers monitor its use for potential adverse reactions that are reported to the manufacturer to ensure its continued safety.

Step
3: Regulatory Hurdles

Before a vaccine can be distributed to the general
population, it undergoes careful scrutiny from government regulators at the
Food and Drug Administration (FDA).

Given the seriousness of the COVID-19 pandemic, the FDA
will likely continue doing everything it can to fast-track the regulatory
process for promising vaccines.

Step
4: Manufacturing and Distribution

Once a vaccine is approved, it must be produced in huge
quantities to provide immunity to a large number of people. Because
manufacturing a vaccine involves specialized equipment and skilled labor, it’s
a very costly process.

And,
once one or more COVID-19 vaccines are completed, manufacturing hundreds of
millions—if not billions—of doses will take time.

During
a congressional hearing in early March, Dr. Robert Kadlec, Health and Human
Services assistant secretary for preparedness and response, testified that the United States could “have a longer than a
six-month wait to basically produce vaccines on scale.”

Then, once a vaccine is produced, it must be distributed
across the country—and the world. Expect state governments and the Trump
administration to create plans and policies to guide vaccine distribution and
administration as we get closer to a rollout.

Ultimately, creating an entirely new vaccine is a challenging and lengthy  process. Indeed, there’s no guarantee of success. “Of vaccine candidates that begin clinical trials, only about 16% are ultimately approved,” the Wall Street Journal reported.

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Thankfully, many of the top minds in the scientific and pharmaceutical industries in this country and across the world are hard at work on this task.

With the Trump administration working to support
America’s private sector, a vaccine could be available in record time.

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