Studied by 3 people
Research and discovery: identifying a problem and suggesting a solution
The mRNA technology used to create Pfizer’s COVID vaccine isn’t new technology. In fact, it’s been around for around 30 years.
Who created this mRNA technology?
Robert Malone discovered in 1987 that lipid nanoparticles could be used to transport small segments of mRNA
How does mRNA enter our body?
Through an injection. The mRNA codes instructions to our body. To hide the fact that it’s been synthesized, it is chemically modified with a pseudourine nucleotide.
When was the first mRNA vaccine created?
In 2001, researchers at the Karolinska Institute in Sweden injected a vaccine into mice that provided immunity against Influenza A.
PRE CLINICAL TRIALS: mRNA in animals
Before moving onto human test subjects, vaccines are often tested with animals first. It often shows how a vaccine will react in a human system.
When did animal testing begin?
The 2010s. Mice were used to test vaccines against Ebola, the flu, rabies, and more. However, as early as 1993, researchers infected the flu virus in mice, which produced an immunity response.
Clinical trials: human testing
With each vaccine, it requires different trials. For the COVID vaccine, human trials didn’t begin until May 2020. Researchers make revisions of the drug to maximize effectiveness.
Phase 1
Phase 1 is made for specifically testing the safety of the drug. You also identify any adverse reactions. Only around 100 participants are used.
Phase 2
Phase 2 focuses on identifying short term effects of the drug, as well as risks of taking it. This drug is usually tested in a larger scale at this point.
Phase 3
Phase 3 is where the drug is tested for its effectiveness. They see if there is a reduced instance of the disease because of the vaccine. Thousands of test subjects are used.
Seeking approval
After a company completes the drug trial, they must submit a Biological License Application and a Form FDA to request approval to produce it.
Who approves the drug?
A comprehensive team composed of individuals from all disciplines review BLA applications.
Form FDA 356h
An application to market a new drug, biologic, or antibiotic. Main components: clinical and preclinical data, draft labeling, manufacturing information, data summary
the vaccine today
How does the vaccine work? It works by entering the body as a specialized mRNA sequence, which enters the muscle cells around the injection site. It codes for a molecule known as a spike protein. This protein is known to be found on the COVID 19 virus, which activates in the body without giving the actual virus. Since the body recognizes the foreign protein, it triggers an immune response against it and makes us immune to the protein. This can help fight COVID if we get the virus because we’re immune to that specific protein on the virus. The most up to date development are the booster shots. You wait 6-8 months after getting the first dose to get another shot. This elongifies your immunity.
When and for what was the first mRNA vaccine created?
2001 to fight against influenza A
What molecule does the mRNA use as a vehicle to enter our cells?
Lipid nanoparticle
What is the modified nucleotide in the mRNA of the COVID-19 vaccine called?
\n Pseudouridine
What model organism has been commonly used to study the effects of various mRNA vaccines?
Mice
What was the first mRNA vaccine injected into humans intended to fight against?
Rabies
What is the major purpose of pre-clinical trials?
To help researchers understand how a drug or other medication will react when introduced to the human immune system
What is the main purpose of Phase 1 clinical trials?
To observe any adverse reactions to a new drug or medication
What type of patients normally participate in Phase 1 clinical trials?
Fully healthy volunteers
What is the main difference between a Phase 2 and a Phase 3 clinical trial?
The scale: Phase 2 typically includes hundreds of participants while Phase 3 typically includes thousands of participants
Which type of experts would NOT be found on an FDA approval team for a new drug?
A physicist
What protein does the mRNA in the COVID-19 vaccine code for?
Spike protein
How long is it suggested that you wait before receiving a booster shot for the COVID-19 vaccine?
6 - 8 months
Where in the cell does protein synthesis occur?
ribosomes
Does mRNA from the vaccine alter our DNA?
No: mRNA from the vaccine never enters the nucleus of our cells
