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The Nuts and Bolts of mRNA Vaccines Against SARS-CoV-2

Imagine the day you can stop wearing a mask, or when you can gather indoors at your favorite restaurant again with friends and family for a celebratory meal. That day is coming...but only if we do what needs to be done today to keep ourselves, our families, our communities and our country healthy and safe. The groundbreaking cooperation between leading medical experts here in America and pharmaceutical companies globally has made a return to normal possible thanks to the COVID-19 vaccine. The speed of development was due to the sharing of research on a scale never attempted before – and every study, and every phase of every trial, was carefully reviewed and approved by a safety board and the FDA. The process was transparent and rigorous throughout, with continual oversight and expert approval. Data will continue to be collected two years after each vaccine is first administered to ensure that the long-term effects are safe.

Essential to emerging from a pandemic is developing 'herd immunity' – getting enough people immune to the infection so it can no longer spread. But throughout history, reaching herd immunity by getting infected has always taken an unacceptable human toll. The best and fastest way to return to normal and start to reverse the damage caused by lockdowns is to get as many people vaccinated as quickly as we can. Many people are skeptical or concerned about side effects, and we hear you. Good, evidenced-based information about the vaccine has been hard to come by, so we've put together the following FAQs to cut through the uncertainty.

The coronavirus pandemic is constantly changing. This information was last updated on January 25, 2021

In general, how do we know vaccines work?

Short Answer: In a vaccine study, half the people are given the vaccine, and half are not. If the people given the vaccine get sick less than half as much as those who got the vaccine, we consider that the vaccine worked.

Expanded Answer: The obvious way to prove a vaccine works is to vaccinate people, expose them to the virus, and see if they get sick. But that's unethical. Instead, we recruit people for whom the vaccine is appropriate and give half of them the real vaccine. The other half receives a placebo injection that contains no active vaccine (some trials use two thirds vaccine and one third placebo). Then everybody is monitored to see if they get sick. Statisticians can tell us how many people need to get sick in the placebo group before finding out if the vaccine worked. The FDA's standard of efficacy is 50% – people who received the vaccine need to get sick no more than half as often as those who did not receive the vaccine for it to be considered effective. Among the 43,448 participants in the Pfizer trial, the first COVID-19 vaccine trial to be completed, the half who received the vaccine experienced only nine infections. Those who did not receive the vaccine suffered 169 infections, showing a vaccine effectiveness rate of 95%. The FDA would have considered the vaccine effective if as many as 84 vaccinated participants became infected, but only nine of them actually did.

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What does the COVID-19 vaccine do?

Short Answer: The vaccine helps us make our own antibodies against what's called the 'spike' protein of the virus, which makes it much harder for us to get infected.

Expanded Answer: What makes the SARS-CoV-2 virus (the name of the virus that causes the disease we know as COVID-19) unique is its spike protein, which are the red things you see in the depictions of the coronavirus. They attach to a protein on human cells called the ACE2 receptor, allowing the virus to gain entry to our cells, where it takes over our cell machinery to make more copies of itself. So the strategy is to get people to make antibodies against this spike protein without getting infected. Once we have our own antibodies against the spike protein, if we then get exposed to the virus, our antibodies latch onto the spike protein. Once the spike protein is covered with antibodies, it can't attach to the ACE2 receptor and can't infect our cells. Unable to make more copies of themselves, the inactivated virus particles can be quickly eliminated by our immune system.

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What is an mRNA vaccine?

Short Answer: This is a newer vaccine technology that uses the genetic material for a virus's most crucial protein. A considerable advantage of this technology includes producing the vaccine directly and rapidly in the lab, rather than first cultivating large amounts of the actual virus as starting material. It is harder to distribute the vaccine because the genetic material has to be frozen, but the advantage is that there is no need to add any antibiotics or preservatives. Thus, mRNA vaccines are safer for people who are allergic to these things in other medications or vaccines. The mRNA breaks down in a few days, so there are no traces of the vaccine other than the antibodies we used it to produce.

Expanded Answer: Messenger RNA, or mRNA, is the genetic material that tells our cells how to make a specific protein. If we were to simply inject the spike protein into people, enzymes in our bloodstream would break down the proteins, preventing us from making antibodies against it. Instead, we first make the genetic material that holds the spike protein code. We would also break down plain mRNA that gets injected into us, so we have to wrap it up in material that helps it get into our cells. Once inside, the mRNA tells our cells how to make the spike protein. The muscle cells making this protein show it to our immune system, which recognizes that it is a foreign protein and starts to produce antibodies against it. Messenger RNA doesn't last a long time, so after our cells have used it for a few days to make the spike protein, the mRNA just breaks down inside the cells, and our cells recycle its parts as part of our day-to-day life.

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'Genetic material' sounds scary. Does it get into our DNA?

Short Answer: Absolutely not. That is not what mRNA does, and the claims we hear about mRNA vaccines changing our DNA is nothing more than an uninformed scare tactic.

Expanded Answer: Our cells make proteins coded by our DNA in the cells' nucleus. When our cells want to make proteins, parts of the DNA code is copied into mRNA. The mRNA moves out of the nucleus, where little organelles called ribosomes read the mRNA code using transfer RNA to make the correct proteins. After a few days, the mRNA is broken down and recycled by the cells. This process is a one-way street - mRNA does NOT go back into the nucleus to get back-translated into DNA. Ever.

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This new technology was developed awfully fast – is it really safe?

Short Answer: It is true that there are no other mRNA vaccines previously manufactured, but the technology is not new. mRNA technology has been used for fifty years, and efforts to use mRNA specifically for vaccines have been ongoing for the past twenty years.

Expanded Answer: The first time a cell made a foreign protein from injected mRNA was 1971. The first time we induced living mouse muscle tissue to make foreign proteins from mRNA was in 1993. The first mRNA vaccine was developed against rabies and entered clinical trials in 2013, but this was a proof-of-concept trial and was not used to make a commercial vaccine. We started to develop mRNA vaccines against SARS and MERS, but those viruses were so lethal that they burned themselves out, and there was no need to bring the vaccines to market. SARS-CoV-2 very rapidly showed that it would be a significant threat to the planet, so we picked up where we left off with mRNA vaccine development and hit the ground running. The first clinical trial of an mRNA vaccine started just 66 days after the genome of SARS-CoV-2 was sequenced - you can't move that fast if you're not well prepared for it.

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The trials were completed in only nine months or so – didn't they cut a lot of corners to do it so fast?

Short Answer: The time it takes to develop a vaccine depends on the population who needs it and how common the disease is. These vaccines are intended for all adults (initially) for a disease striking 60,000 to 100,000 people per day (in summer and fall 2020). That makes it easy to generate a lot of important information very quickly.

Expanded Answer: Many of the vaccines we use were developed for children, and that process can take a decade or more. That's why it's easy to think that the COVID-19 vaccine trials were rushed. But as we discussed about how we find out if a vaccine is effective, that is a function of the disease. There are several reasons why childhood vaccines take so long. First off is the slow recruitment rate - we can't enroll babies into these trials any faster than they're born. Secondly, many parents will not enroll their newborn in a clinical trial of a vaccine. So the trials are slow to enroll, and the diseases we're trying to prevent aren't very common in this country. So it takes a very long time to get enough infections in the placebo group to see if the vaccine did anything at all. But for COVID-19, practically anybody over age 17 who wasn't infected with SARS-CoV-2 at the time, didn't have any significant, unstable medical problems, and who wasn't pregnant or nursing was eligible. And instead of studying a vaccine for a relatively uncommon disease, we saw over 50,000 new cases in the US every day during these trials. In fact, that was a strategy for recruitment - the people running the trials specifically looked for parts of the country where the disease was most active. You'll get the required number of infections in the placebo group much faster if you conduct the trial in an area getting 1,000 new cases a day rather than 20.

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I've heard reports about reactions to the vaccine. Is that worrisome?

Short Answer: Adverse reactions to the vaccine are rare, because of the way the vaccine is prepared. The only people advised to be cautious about getting the vaccine are those who have had severe reactions to injectable medications in the past. If you have had a severe reaction to an injectable medication that required treatment, talk to your doctor or allergist/immunologist about whether to get the vaccine.

Expanded Answer: The mRNA in the vaccine is essentially the same as the mRNA for the spike protein in the virus. The main difference is the wrapper that is used to get the mRNA into our muscle cells. It does contain polyethylene glycol, which is known to cause allergy-like reactions in some people. Allergies to other common allergens like pollens, molds, dust mites, foods, or latex do not put people at increased risk of vaccine reactions. The vaccine is distributed in a deep freeze, so there is no need for any antibiotics or preservatives. Since we don't have to grow the viruses in the lab to make mRNA vaccines, there is also no egg or gelatin in the vaccine. So the vaccine should be used with caution in people who have reacted to other vaccines or medications containing polyethylene glycol, or if they have conditions such as mast cell activation syndrome that put them at greater risk of severe reactions to a variety of things. But the vaccine is safe for almost everybody.

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Can the vaccine make me sick? What about all the side effects I've heard about?

Short Answer: No. The vaccine is not made from live virus particles, so there is no possible way to get infected by the vaccine. Many people have some symptoms of a robust immune response to the vaccine, but this is expected, is typically mild, and lasts only one or two days.

Expanded Answer: You cannot get infected from the vaccine. There is no virus in the vaccine, only the mRNA for the spike protein, and not anything else required for viruses to cause an infection. However, what is critically important is that most of the symptoms that people associate with viral infections are symptoms caused by the immune system in its response to the vaccine, not the infection itself. Not everybody experiences these symptoms, but it is expected that many people will notice a mild fever, muscle aches, fatigue, chills, or joint pain that can last for 1-3 days after vaccination. This is only a sign that your immune system is doing what it is supposed to do. The reason this is important enough to use bold type is that there is a concern that people who experience these symptoms after the first dose will think that the vaccine made them sick, and they won't go back for the second dose. This would be a critical mistake. The studies have shown that while there is an antibody response after the first dose, that first dose "primes the pump" for the second dose, after which antibody levels soar to levels so high that the vaccine is 95% effective at preventing infection. You can't expect the vaccine to work that well after just one dose, so please be sure to go back for the second.

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I'm young and healthy, and COVID-19 doesn't seem to be a big deal in my age group. Shouldn't I just get it over with, and develop better immunity by getting the infection?

Short Answer: No. The mRNA in the vaccine helps us make antibodies against the spike protein, just like we do with COVID-19 infection. But with infection, the virus forces us to make ALL of its proteins and make more copies of the virus itself. That's what triggers the severe illness many people get with COVID-19, and the risk of long-term complications. None of that happens from the vaccine.

Expanded Answer: A major feature of SARS-CoV-2 is that it is so unlike any other viruses before it that essentially none of us are immune. That's why it's called a 'novel' coronavirus. If we are significantly exposed, we will get infected. Almost everybody will likely have to develop immunity either the hard way (getting infected) or the easy way (getting vaccinated). So it is useful to compare the risk of the vaccine with the risk of getting infected. That makes it easy – with vaccines for the spike protein, we start making the spike protein to show to our immune systems just like we would if we were to get infected – but without all the other proteins and without the genetic material of the virus as a whole. So it is far safer to get vaccinated instead of wait to get infected. And we see that in the numbers: more than one in 100 people with COVID-19 die from the infection, but only about 1 in 100,000 people have significant reactions from the vaccine. These are all treatable, so these folks do carry on with their lives. As of this writing, there have been 96 million COVID-19 infections resulting in over 2 million deaths, killing people of all ages, as young as two months. Of the 54 million people vaccinated worldwide so far at the time of this writing, there have been zero deaths. Protecting yourself with the vaccine is clearly the best way to go, so when the vaccine becomes available to you, please roll up your sleeve!

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