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By Rose Hoban and Anne Blythe
At Atrium Health in Charlotte, the first person to get the new COVID vaccine was medical director of infection prevention, Katie Passaretti. At UNC Health in Chapel Hill, it was the nurse manager of the medical intensive care unit. At Cape Fear Valley Health, it was a nurse in the inpatient COVID-19 unit.
Across North Carolina, health care workers have spent months turning patients on their stomachs in order to breathe, helping those patients say goodbye to family members via iPads, and holding those peoples’ hands as they took their last labored breaths. Now those same people are rolling up their sleeves to get the first of the COVID vaccines.
She didn’t cry. She wasn’t jubilated. She didn’t get emotional as she spoke. She just sounded exhausted.
Due to limited initial supply and based on national and state guidance, the first batch of the Pfizer vaccine is being given to workers in high priority, patient-facing areas such as the emergency department and medical intensive care unit, and areas where healthcare workers are at a higher risk for COVID-19 exposure.
Over the coming months, vaccine distribution will continue to scale up across the state. In the meantime, we’ll work to answer your questions.
How do vaccines work?
Quite simply, your body’s immune system is very good at recognizing “foreign” elements that enter your body. Most notably, your body reacts to proteins that get where they’re not supposed to be, those proteins are usually on the surface of an invading virus or bacteria. Your body creates immunity to those proteins in two ways: 1) you create antibodies that are specific to the foreign protein and 2) you create specialized cells that “remember” that protein for the rest of your life and that help you make new antibodies each time you’re exposed to the foreign protein.
When you receive a vaccination, in general, you expose your body to a weakened version of the virus or bacteria you’re trying to fight, so that your body’s immune system learns what to target, but you don’t get too sick in the process.
In the case of COVID-19, the vaccines that have been developed target a snippet of protein that’s on the surface of the virus, that “spike” protein that is so distinctive to the coronaviruses.
I’ve heard a lot about mRNA vaccines, what are those?
In the past, vaccines used weakened viruses or weakened bacteria to prompt an immune response. But in the past few decades, researchers have been looking for different ways to target foreign viruses.
Instead of the traditional approach, the Pfizer and the Moderna vaccines use a snippet of genetic code called messenger RNA that temporarily tricks your body’s own cells to manufacture that spike protein.
“Your body makes the SARS CoV2 spike protein, then your body makes antibodies to the protein,” said noted vaccine researcher Paul Offit from the University of Pennsylvania Offit.
The vaccine itself consists of the messenger RNA and four lipid nanoparticles, one of which is polyethylene glycol, or PEG, which is used in other injectables, laxatives and some cosmetic products. For that reason, the CDC guidance focuses on previous severe reactions to other injectables, which are extremely rare. There are no preservatives or other ingredients in the vaccine.
Wait! Is that RNA altering my genes?
The messenger RNA doesn’t change your own genetic code, known as your genome, said Offit. It acts more like computer software that instructs the hardware of your cells to do something specific for a short period of time.
“When people hear that, they think I’m going to alter my genome,” he said. “Your genome, the DNA, is in the nucleus of the cell. It’s not in the cytoplasm of the cell. And it’s virtually impossible for the messenger RNA to get into the nucleus.”
The messenger RNA quickly degrades once it delivers its message.
These vaccines have been developed pretty quickly. It seems like it’s too fast to be safe.
Since the 1980s, researchers have been working to find a vaccine against HIV, the virus that causes AIDS, said Cindy Gay, an associate professor of infectious diseases at the University of North Carolina at Chapel Hill.
Because of those decades of research, Gay said, “we have so many new technological tools, for example, compared to the last time we had a real big outbreak, which is HIV.”
That means scientists didn’t need to start from scratch when the SARS CoV2 virus went global at the beginning of 2020. Immunologists in Europe and the U.S. had been working on mRNA vaccines for more than a decade, but there had not been a big enough outbreak to merit a full-fledged vaccine effort.
“This is a vaccine technology that really allows the scientists to pivot from one virus to another much quicker,” Gay said.
Money was also a restriction to more widespread vaccine studies before 2020. Researchers spend almost as much time at their computers writing grants, looking for funding to do their research, as they do in laboratories looking through microscopes.
Finally, scientists compete to publish papers and they often compete for the same pots of money.
COVID-19 changed all that. It was so widespread, so profound and so dangerous that governments and pharmaceutical industries decided to spend big on finding a vaccine fast. All that basic mRNA research had already been done and found to be safe in animals and in initial human trials already. Not to mention that to do Phase 3 human trials usually requires years of finding volunteers, and then it takes time for those volunteers to be exposed to the disease being addressed by a vaccine candidate.
But in 2020, it was no problem to find tens of thousands of volunteers for Phase 3 trials. Those people who received the actual vaccine and those who got the placebo shot were also able to be exposed to plenty of COVID-19 in their communities at a high rate.
“Unfortunately, we’re in such a state with this pandemic, that the number of cases that we’re seeing also allows us to get the cases we need to be able to show where the vaccines make a difference between those who get it and those who get the placebo,” Gay said.
“In the case of the COVID-19. Phase three trials, we’re running actually larger trials than usual,” said Moncef Slaoui, chief scientific advisor to Operation Warp Speed. Before he was tapped to manage the initiative, Slaoui worked as the head of the vaccines section of GlaxoSmithKline for three decades.
The trials included 43,000 participants in the Pfizer study and 30,000 for the Moderna vaccine.
Finally, because of the global disruption caused by the pandemic, money was not an obstacle as governments opened the taps and the research dollars flowed.
“Operation Warp Speed is taking processes that take years and compressed it into months,” Slaoui said in a video produced by the federal Department of Health and Human Services explaining the processes behind the initiative. “The way we do that is by running different processes in parallel rather than sequentially.
“We ramped up manufacturing of the vaccines while we are running the Phase 3 trials before we know whether the vaccines are efficacious or not. If they turn out to be efficacious, and the FDA approves them, we will use them. If they are not efficacious, then we won’t use them.”
Finally, the imperative created by the COVID-19 pandemic spurred many scientists to collaborate rather than compete.
“When you have all of those groups coming together, and making a real commitment of thousands of people working into the night, working on weekends, you can accomplish a lot,” Gay said.
That sounds fine, but I’m still not interested in being a guinea pig.
If you don’t want to take an mRNA vaccine, other more “traditional” vaccines are currently in Phase 3 trials, such as the one under development by Johnson & Johnson/ Janssen. It’s unclear when that vaccine will get approval, it’s still enrolling volunteers to take the vaccine so that one will likely roll out sometime in 2021.
Another vaccine, being developed by AstraZeneca and researchers from Oxford University is also wrapping up Phase 3 trials and should start being available in early 2021. That one uses an inactivated cold virus to deliver the proteins that will spur antibody development.
I’m ready! When do I get my shot?
Not so fast. It’ll take a while to get vaccines rolled out to everyone.
The first priority in December 2020 will be health care workers who’ve been putting their lives and their health on the line for the past 10 months.
After those people will come the 36,000 residents and thousands of staff at senior living facilities. Those places have been dangerous places for vulnerable seniors.
As of the first day of vaccine rollout, Dec. 15, there have been more than 28,500 cases of COVID in nursing homes and assisted living facilities in North Carolina, with more than 2,850 deaths, fully 48 percent of the deaths in the state. Plus, North Carolina has 7.9 million adults and 472,000 health care workers who are at greater risk because of their exposure to the public. Most of us will be getting in line behind them.
The New York Times created a tool to help you determine when you would get a vaccine. Individual timing depends on a person’s age, what medical conditions they already have, what type of work they do and how much risk they face at their jobs.
Should you get vaccinated if you tested positive for COVID-19?
The CDC guidance says yes, the vaccine should be offered to people even if they are among those who have had either symptomatic or asymptomatic COVID-19. Testing for antibodies from prior infection is not recommended as part of the decision-making process on whether to vaccinate.
Will I have side effects?
Common side effects with any vaccine include pain or swelling on the arm where you got the shot. Other effects include fever, including occasionally high fever, in about 10 or 15 percent of people. As many as 40 to 50 percent can have fatigue, headache, chills, muscle aches, enough that they could possibly miss a day from work, according to Offit.
“This is just what happens when you respond to, in this case, a foreign protein, the SARS CoV2 spike protein,” Offit said, referring to the protein on the surface of a COVID-19 virus that’s the target for most of the vaccines being developed.
You should actually expect some side effects when you get a vaccine, Offit said. “That means you’re having a vigorous immune response.”
During a webinar for the American Public Health Association, he recounted the experience of a friend from North Carolina who volunteered for the Pfizer vaccine trial.
“He didn’t know whether he got vaccine or placebo,” Offit said. “After the second dose, the next morning he woke up, had fatigue, headache, looked to his wife and said, ‘Yes! I got the vaccine.’”
The side effects should go away in a day or two. If not, check in with your health care provider, suggests the Centers for Disease Control and Prevention.
What if I have allergies? Are the vaccines safe for me?
That’s something to discuss with your doctor. The Centers for Disease Control and Prevention changed their guidance on Sunday that recommends anyone with allergies to discuss them with their physician to assess their risk, according to a report by STAT. That’s because two vaccine recipients in Britain, which started vaccinating people last week, had allergic reactions.
Even if you have a history of anaphylactic reaction to other injectable medicines, the CDC does not rule out vaccination. They do recommend 30 minutes of monitoring afterward if one is administered, people may stick around their doctor’s offices for even longer to be sure.
If I’m allergic to cats, dogs, other animals or certain foods, should I get the vaccine?
Again, the CDC recommends sharing any concerns with a health care provider but does not suggest abstaining from vaccination unless there are known allergies to the components of the vaccine. Food allergies or reactions to other common allergens such as dust, animals or molds should not keep you from being able to get a vaccine.
When do you develop protection with a two-shot vaccine?
Vaccines with two shots might not protect you until a week or two after the second shot, according to the CDC.
It’s also likely you’ll have more of a reaction after the second shot than the first, that’s because the first shot starts to stimulate your immune system. By the time you receive the second shot, your immune system has already “seen” the target protein, which in this case is the spike protein on the surface of the virus. So, when you have that second shot, you will likely have more of a reaction: more fever, more flu-like symptoms, more achiness.
It’s important to continue to wear a mask, keep a safe distance from others and rigorously wash your hands because one thing that’s not certain is whether the vaccination will prevent you from being a carrier of COVID-19, even if it doesn’t make you sick. Until there’s widespread community immunity, masks, distancing and handwashing will remain important.
What’s the difference between the Pfizer and the Moderna vaccines?
The first difference is the timing. When the two companies tested their vaccines, Pfizer targeted to have the second shot to be about 21 days after the first shot; with the Moderna vaccine, the second shot should come about 28 days after the first.
The second difference is how cold the vaccines need to be stored. The RNA molecule used in each of the vaccines is very fragile, that’s why they each need to be kept very cold. Pfizer recommends that its vaccine be kept at about 80 degrees below zero, colder than an Antarctic winter. Moderna recommends providers keep its vaccine at about 20 degrees below freezing, more like winter in Vermont.
The two vaccines are not interchangeable.
What if I forget which vaccine I got for the first dose before I go for the second dose?
Because it’s important that people get the correct second dose, governmental and pharmaceutical companies have developed several methods for helping people to track their vaccines accurately.
Every vaccine recipient will be given a card listing which vaccine they received and the date they received it, according to state Health and Human Services Secretary Mandy Cohen.
“We are asking providers to fill out those shot cards, give it to the vaccine recipients, if they have a smartphone ask them to take a picture of it,” Cohen told reporters during a press conference on Dec. 10.
In addition, people’s information and which vaccine they were given will be entered into a database, similar to the database used to track childhood vaccines.
In addition, guidance is being given to health care providers about how to get people back to clinics for their second shots. Those providers are some of the most influential voices for patients, said Noel Brewer, who researches health behavior at the Gillings School of Global Public Health at UNC Chapel Hill.
“Provider recommendations, by far, are the most important influence on anything going on with vaccines, it trumps everything else,” he said during a webinar sponsored by the American Public Health Association.
He suggested that practitioners “do what dentists do just make an appointment before they walk out the door, so they need to already be scheduled.”
Cohen also said her department is planning a “robust” public communications campaign. She also said she is looking to federal leaders to help drive people to get vaccinated.
“I think it’s going to be really important that we’re all singing off the same sheet of music, if you will,” she said. “I think that coordination between the federal government, state government, and all of our partners, that we are all giving good quality, high quality, consistent and simple information to everyone about vaccines.”