by Dr. Mark Feanny, Dr. Andrew Butler, Amanda Trickey & Susannah Wollman
Flu season is always difficult but this year even more so as we deal with COVID-19 as well. Many people see their doctor in the fall to get their yearly flu vaccine, but what’s the deal with the COVID-19 vaccine? Here’s our take on the latest information.
Where are we getting our information?
It’s very important to know that the information we are receiving on the pandemic is up-to-date, so we rely on the Center for Disease Control and Prevention (CDC). They are responding to the novel coronavirus outbreak with information and protocols that are designed to protect individuals and limit the damage that we’re seeing due to the pandemic. Here’s what they have to say about the new vaccines that are now hitting the marketplace.
What is a vaccine, anyway?
According to Merriam-Webster, a vaccine is:
a preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms that is administered to produce or artificially increase immunity to a particular disease
Historically, a vaccination is the act of giving a small quantity of the disease in order to allow your body to develop antibodies so that if you are contaminated by the disease itself, your body is prepared to fight the disease. This is a natural process that we undergo throughout our lifetimes. Once you have the antibodies, the belief is, your body is immune to the disease. Usually. Some vaccines require multiple doses to ensure full immunity.
So what about the COVID-19 vaccine?
Currently in the United States, vaccines developed by Pfizer and Moderna have been approved by the FDA for use in preventing COVID-19. Because the novel coronavirus has been shown to prove fatal in so many individuals, a partnership that involves both the public and private sectors—called Operation Warp Speed—was initiated by President Trump to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The safety of any vaccine is an important part of developing and licensing, and despite the urgency of this need, the CDC is bent on making sure the authorized COVID-19 vaccine will help save lives and mitigate the effects of the disease.
Clinical trials are being conducted according to the rigorous standards set forth by FDA in their June 2020 guidance document.
How many vaccines are being studied?
Operation Warp Speed’s goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021. In addition, the CDC is developing a broader strategy that will increase the number and timeliness of countermeasures to combat COVID-19. (To learn more about Operation Warp Speed’s strategy and approach to combating the novel coronavirus, see the article in the New Jersey Journal of Medicine.) In addition to the Pfizer an Moderna vaccines, multiple other pharmaceutical companies have vaccines in development.
How effective will the COVID-19 vaccine be?
The Chief Advisor of Operation Warp Speed, Dr. Moncef Slaoui said, “My personal opinion, based on my experience and the biology of this virus, I think this vaccine is going to be highly efficacious,” he said. “I wouldn’t be surprised if it’s in the 90% [range].” What’s important to remember is that the vaccine will probably not be available to all Americans until the end of 2021. Also to note, some of the vaccines being approved for use will require an initial dose and a second one several weeks later to provide maximum protection.
What is in the vaccine?
Many people are concerned about the virus and equally concerned about the vaccine. What is in it? Most vaccines contain a tiny amount of killed or inactive pieces of the virus itself. When the patient receives a vaccination, the body’s immune system identifies those pieces and forms antibodies to “remember them” should the patient ever be exposed to the live virus. These vaccines help protect the body for most people without dangerous side effects.
What does the vaccine have to do with “herd immunity”?
The immune response is our bodies main defense against virus’ and bacteria. It is immediately triggered when our bodies first come in contact with new pathogens it has never seen before. Ultimately, antibodies are made to recognize and destroy the virus if it is introduced into your body again. If enough of a particular population are exposed and produce antibodies, a phenomenon called “herd immunity” is experienced where more people have had the virus and have antibodies than those who don’t. The result, the virus is contained, cannot reproduce in large amounts, and cannot spread through that population. To trick the body into thinking it has already been exposed and to artificially create “herd immunity,” vaccines were developed and administered to the population as a whole.
While most vaccines in the past simply injected weakened or inactivated viruses into the body to produce the same type of immune response experienced in a full-blown infection,
recent technology has allowed scientists to accurately target specific parts of the virus, instruct our body’s cells to “make” these parts, and in doing so “trick” the body into thinking it has been exposed to a particular virus in order to create the same response. And once our immune system “learns” that specific part of the virus, it can more efficiently fight the virus if we are later exposed to it. These types of vaccines are called mRNA vaccines. There are numerous types of vaccines, but the end result is the same; identify pathogen – produce antibodies – eliminate infection – save host.
Prior to the end of 2019, the human race had never been exposed to the COVID-19 virus and we had no way of fighting the disease on a large scale unless the majority of the world’s population became infected with the virus and “herd immunity” was achieved naturally. Because COVID-19 is both new and deadly, a vaccine needed to be developed to safely “expose” the majority of the world to coronavirus without the potentially fatal or life-threatening symptoms and outcomes so we could reach “herd immunity” faster with fewer deaths. Many companies are racing to create various types of vaccines and are in varying stages of testing and approval with governmental health agencies across the world.
Here in the US, both Pfizer and Moderna have created and tested an mRNA vaccine approved for use and distribution. Both the Pfizer and Moderna mRNA vaccines instruct our bodies to make “spike proteins” similar to the ones we found on the surface of COVID-19 molecules. We know antibodies are produced against COVID-19 and attach to the virus by these spike proteins. These vaccines will help the body generate the same immune response to the spike proteins with the goal of ultimately killing the virus.
The Pfizer vaccine has been authorized for emergency use in individuals 16 years and older. It is given as a shot and then a booster shot is given 3 weeks later to complete the series. Side effects include pain at the injection site, headache, tiredness, chills, muscle pain, joint pain or fever.
The Moderna vaccine is authorized for emergency use in individuals 18 years and older. After the initial shot has been given, patients will return four weeks later for a second shot to complete the series. A similar side effect profile is expected.
The downside to the Pfizer vaccine has to do with its storage and shelf life. It requires the facility to have access to a “deep freezer” because it must be stored at a much lower temperature (-80 degrees Celsius) and once thawed, it must be administered within 5 days. Other vaccines, including the Moderna vaccine, can be stored in a standard freezer and have longer shelf lives once thawed out.
Just as with many shots administered in a healthcare facility, patients will typically be watched for a brief period of time (15 minutes to 1 hour) to make sure that they do not have any life-threatening allergic reaction to the injection.
OTHER VACCINES ON THE HORIZON
These will include vaccines such as the one being developed by Astra Zeneca. Unlike the mRNA vaccines of Pfizer and Moderna, the Astra Zeneca shot will be a “viral vector vaccine”, which will attach the spike protein of the COVID-19 virus particle directly onto a genetically engineered virus similar to the common cold.
Will the vaccine interfere with my DNA?
Many are concerned about the safety behind genetic vaccines like those created by Pfizer and Moderna. Despite what we’ve seen in the movies, mRNA vaccines do not affect or interact with our own DNA in any way. The mRNA enters our cells, provides the necessary instructions to the replication molecules inside our cells that make the spike proteins, and is then is cleared out of the cell. That is how mRNA works. Inside the nucleus, on the other hand, is where our DNA is stored. The instructions in the DNA are copied into mRNA, not the other way around. Because of this, it will not affect our genetics.
Will the COVID-19 vaccine be expensive?
According to the CDC official website, “The federal government is committed to providing free or low-cost COVID-19 vaccines. Vaccine doses purchased with U.S. taxpayer dollars will be given to the American people at no cost. However, vaccine providers will be able to charge administration fees for giving or administering the shot to someone. Most public and private insurance companies will cover that fee so there is no cost for the person getting vaccinated. In addition, people without health insurance can get COVID-19 vaccines at no cost.”
Will the vaccine return us to “normal”?
According to Dr. Anthony Fauci, Lead member of the White House Coronavirus Task Force, “We’re already making doses, tens and hundreds of millions of doses to be ready, first at least, in graded numbers at the end of the year in November/December. By the time we get to April, we likely will have doses to be able to vaccinate anybody who needs to be vaccinated. But logistically by the time you get everybody vaccinated, it likely will not be until the third or even the beginning of the fourth quarter of 2021.”