COVID-19 vaccine based on decades of research

HALEYVILLE - With COVID-19 vaccines finally making it into the arms of local healthcare workers and first responders, residents are wanting to learn more about the vaccine itself.
At Lakeland Community Hospital in Haleyville, which began administering the vaccine on Monday, Dec. 28, each recipient of the vaccine receives paperwork describing how the vaccine works, what side effects are possible and conditions that might keep someone from needing to take the vaccine.
The following is information regarding the Moderna vaccine that was provided to the Alabamian by Lakeland Community Hospital, with additional information from the Centers for Disease Control and the Federal Drug Administration.  It is presented in a question-and-answer format, similar to how it is being provided to local vaccine recipients.

Q:  What is the Moderna COVID-19 vaccine?  
A: The Moderna COVID-19 vaccine is an unapproved vaccine that may prevent COVID-19.  Currently, there is no vaccine that has been approved by the Federal Drug Administration, or FDA, that prevents COVID-19.  However, an emergency use authorization has been granted by the FDA to the Moderna vaccine to be used in persons 18 and older.

Q:  What is an emergency use authorization?  
A: An emergency use authorization, or EUA, is a process to make available treatment options, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.  According to the FDA’s website, under an EUA, the FDA may allow the use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved and available alternatives.

Q:  What steps did Moderna have to take to obtain the emergency use authorization?
A:  Once the vaccine was developed, clinical trials took place, according to the FDA.  In the phase 1 clinical trial, the vaccine was given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well it worked to induce an immune response in people.  
With no safety red flags raised in phase 1, the company began a phase 2 trial, which included more people from different demographic groups, both healthy people and people with medical conditions.  Various doses of the vaccine were given to the participants in randomized-controlled studies.  The phase 2 trial gave doctors and scientists more information regarding short-lived side effects and risks, as well as determine how large a dose was needed to trigger an immune response, along with some early information regarding how effective the vaccine is.
After the phase 2 trial was completed, phase 3 began, with thousands of people participating in a randomized, controlled study.  This time, broad demographic groups were chosen in a manner to mirror the nation’s population.  This phase provided the critical information needed on how effective the vaccine is, as well as the immune response it creates.
According to Science magazine, out of the 30,000 people who participated in the phase 3 trial for the Moderna vaccine, only 11 people who received the two doses of the vaccine developed COVID-19 symptoms afterward, making up less than one thousand of one percent of the participants.  Combined with those within the phase 3 trial that received a placebo, this shows the Moderna vaccine to be 94.1 percent effective in preventing COVID-19, and 100 percent effective in preventing severe cases of the virus.

Q:  How long did it take for the vaccine to be created and reach the market?
A:  The U.S. government - under Operation Warp Speed - helped bankroll Moderna’s efforts to make the vaccine, to the tune of nearly $1 billion.  Working with the National Institutes of Health, beginning in January, scientists discovered that the vaccine worked to protect monkeys from the virus.  The phase 1 human trial of the vaccine began in March, with phase 3 beginning in July.

Q:  How does the Moderna COVID-19 vaccine work?
A:  The vaccine uses messenger RNA, or mRNA, which is genetic material that human cells read to make proteins.  Once injected, the vaccine particles bump into cells and fuse to them, releasing the mRNA, which teach human cells how to make a spike protein that will trigger an immune response to COVID-19.    Once the protein is made, the cell breaks down the mRNA strand and disposes of it using enzymes within the cell. That immune response produces antibodies and memory cells that protect against getting infected by  COVID-19.
 mRNA vaccine possibilities have been studied for decades by researchers, with the technology used in trial settings to battle cancer, according to the CDC. The issue has been how to transport the mRNA into the body because it is very fragile and would be destroyed by humans’ natural enzymes if injected directly into the body.  In the Moderna vaccine, the mRNA is wrapped in lipid nanoparticles, which have been studied for nearly 50 years.
Lipids are naturally occurring molecules that contain substances that make up the building blocks of the structure and function of living cells.  Examples of lipids are fats and vitamins A, D, E and K.  Nanoparticles are ultrafine particles, with “nano” meaning one-billionth.

Q:  Does the vaccine contain a live COVID-19 virus?
A:  No, nor does it carry a risk of causing disease in anyone vaccinated, according to the CDC.  Also, the mRNA never enters the nucleus - or center - of any human cell and does not affect or interact with anyone’s DNA.  

Q:  How long does it take the vaccine to work?
A:  As with other vaccines, it typically takes two weeks for your body to produce antibodies to provide protection against the virus.  Also, as with all other vaccines, there is a possibility that  it may not protect everyone.

See complete story in the Northwest Alabamian.
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