Happy Friday morning, folks. This write-up comes a day late: my plan was to offer a coronavirus update on Thursday and coverage of the Dec. 17 Floyd Town Council meeting in today’s edition. However, the council meeting was cancelled due to weather and this COVID-19 report took longer to compile than I expected. (A very misbehaved pup who barked *all day* yesterday as I attempted to work-from-home didn’t help matters.)
In any case, I hope this run-down of commonly-asked questions about the vaccine, its safety and efficacy and when it might be widely available, quell any misgivings you have about getting vaccinated. I spent a lot of time reading trusted reporting from other outlets, watching town halls and press conferences featuring medical professionals and checking data about the prevalence of COVID-19 in our region.
Thanks for reading along, and have a fantastic weekend. As always, I can be reached at aspinksdugan@gmail.com.
-Ashley
COVID-19, the vaccine and the NRV
The Covid vaccine, explained.
How was the vaccine developed? And why/how did it go so quickly?
Speaking for myself, this was probably my biggest reservation about getting the COVID-19 vaccine. In the past, vaccines have taken years, even decades, to develop. So how did we go from zero to Emergency Use Authorization in 11 months? I think most people’s gut instinct is that they must have rushed the process.
The truth though, is not only reassuring, it’s really freaking cool. The scientific principles that support this vaccine—specifically, the use of synthetic mRNA rather than clipped or inactive virus—have been studied since the 1970s. Using mRNA is safe, brilliant and a lot more efficient, in terms of vaccine production, than growing “real” virus on cell culture.
Scientists were able to transcribe the genome (a.k.a the genetic identity) of the COVID-19 virus really quickly—it only took a couple weeks. Once they had that, they could focus on key parts of the virus to help develop the vaccine. In this case, the mRNA. mRNA is genetic code that scientists have described as a “blueprint” or “script,” which tells the virus how to produce certain proteins. The mRNA instructions in the Pfizer vaccine produces the “spike protein,” the part of the virus typically colored red in artists’ renderings.
According to Dr. Costi Sifri, who works in infectious disease at UVA Health System and spoke during Wednesday’s Vaccinate Virginia Town Hall, “research that was the foundation for these vaccines has occurred for the last ten years or so with other coronaviruses” (such as SARS and MERS.) The differences this year were multifold: Fist, technology has progressed in the last decade, and we learned more about how to transport mRNA from a vaccine into the body (we use lipids, or fat molecules). Second, the federal government was willing to front the capital investment needed to do the research and early clinical trials. It invested billions. If vaccines hadn’t been successful, they would have been thrown out. (And several candidates have failed.) Luckily, a few are still standing and one, so far, has been authorized for emergency use.
Which raises one important subpoint—what is Operation WarpSpeed? Sounds scary! Sounds like scientists did rush the process. In fact, the poorly-named project is basically just federal funding for research & development and/or manufacture of vaccinate candidates. Some pharmaceutical companies took money (like AstraZeneca and Moderna) and some didn’t (like Pfizer, although Pfizer did accept a government preorder of 500 million doses of its eventual vaccine.)
Mostly, according to the New York Times, the money just helped manufacturers scale-up their existing capacity. Because obviously, you need more than the raw vaccine material to vaccinate hundreds of millions of people. You also need to invest in syringes, glass vials, needles and more. The Operation WarpSpeed money supported that effort.
Because the mRNA principle was already widely understood, it didn’t take long to produce vaccine candidates. And no corners were cut when it came to thoroughly vetting the safety and efficacy of the vaccines. The Food and Drug Administration held a press conference on Dec. 12, following EUA of the Pfizer vaccine. “Let me be clear,” FDA Commissioner Stephen Hahn said during the event. “Efficiency does not mean any cutting of corners…Our career scientists and staff have been working around the clock.”
He added that the agency “applied our high standards of review…so Americans can have trust and confidence” that the vaccine meets regular standards of safety and efficacy. It’s worth noting: According to the New York Times, the FDA sets a bar of 50% efficacy for vaccine makers who request emergency use authorization. The Pfizer vaccine is 95% effective.
Here’s the coolest part of why the process went so quickly, though. Yes, scientists already understood the foundational principles and saw historic investment and cooperation. But in a typical vaccine, production is actually what slows down clinical trials, not data collection and review. In the past, vaccines have been comprised partially of actual virus, usually deactivated, clipped or partial virus. Nonetheless, that viral material needed to be produced in mass quantity—grown on cell culture—before vaccines could be produced. That takes a long time.
With the synthetic mRNA vaccine, the mRNA can be produced rapidly and then your body becomes the production facility. The vaccine injects protein-building instructions into your muscle tissue, but your body builds the proteins. So production happens on the back end, instead of the front end. In fact, the Pfizer vaccine went through nearly 10 months of trials, and more than 70,000 people participated, according to Virginia Department of Health Commissioner Dr. Norm Oliver. An overwhelming interest in participating in trials also helped speed up the process. Normally, it takes months to recruit a large enough pool of people to conduct a clinical trial.
How does the mRNA vaccine work?
Phew. Okay. That was a long-winded way to start. Now you know that the COVID-19 vaccine uses mRNA instead of actual virus, but how does that mRNA actually help protect you against coronavirus?
As explained, mRNA tells your body how to produce the spike protein on the outside of the virus. This means two things: Fist, and really importantly, you cannot get coronavirus from getting this vaccine. The entire virus isn’t even encoded; it’s biologically impossible.
Second, the spike protein alone will trigger an immune response in your body so that it can build up antibodies against the real virus. That means if you are exposed to COVID-19, it’s very likely that you won’t get sick or experience symptoms. Basically, your immune system is going to encounter the virus and say, “We’ve got this. We’ve seen this before,” and protect you. However, we don’t have enough research yet to know whether the vaccine prevents transmission of the virus. That is to say, you personally won’t get sick after you’ve received your two-part dose of the vaccine (both Pfizer and Moderna come in two doses). However, you can be infected by the virus, and it’s possible you could pass that infection on to an unvaccinated person who would get sick. That’s why it’s important that everyone continues to wear masks and maintain physical distance until we reach a critical mass of vaccinated people in the country—somewhere near 70% of people.
Are there dangers or side effects associated with getting vaccinated?
As with all vaccines, you’re likely to experience pain at the injection site after the first dose. There have been slightly more severe side effects for folks in clinical trials after the second dose, Dr. Sifri said. Those who had side effects experienced a flu-like illness, including a low-grade fever, muscle aches and fatigue.
People with severe allergies, especially to the ingredients found inside the vaccine, should consult their personal physician before getting vaccinated, as extreme cases have occurred. It’s rare, but some patients have experienced anaphylaxis shortly after being vaccinated. Everyone who has had an allergic reaction to the vaccine has fully recovered.
Was there equity in the vaccine clinical trials? Is it safe for everyone?
According to several public health officials, there was a concerted effort to make vaccine trials as representative as possible. Especially in the Black community, there is a warranted distrust of the medical system that’s rooted in decades, if not centuries, of white doctors failing to properly treat Black patients; dismissing legitimate symptoms; or exploiting Black folks for scientific experimentation. Biases against people of color are systemic and still manifest in medical practice all the time. These include clinical trials often not including Black folks, or not including enough to be confident that new vaccines or medications are safe for everyone.
A recent Pew Research poll found that only 32% of Black respondents were willing to get a COVID-19 vaccine, compared with 52% of white people.
In the Pfizer trials, there was an equal balance of male and female participants. About 10% were Black; 25-30% were Hispanic or Latino. The trial also made sure to include patients with comorbidities and preexisting conditions that can make COVID-19 more deadly. Pulitzer Prize-winning journalist Nikole Hannah-Jones, a Black woman who spearheaded the 1619 Project about the legacy of the slave trade, offered an alternative point of view on the relationship between Black people and the vaccine.
In the past, she pointed out, as with the infamous Tuskegee Experiment, medical treatment was cruelly withheld from Black patients. In the case of the vaccine, essential medical care and protection is being offered. Black folks are also more likely to die from COVID-19 than white folks, so the vaccine is all the more important to that community.
Right now, the vaccine is recommended for anyone over the age of 16.
How is the vaccine being distributed? Who gets it first?
The Pfizer vaccine must be kept incredibly cold during transport and stored in expensive, high-tech freezers once it arrives at hospitals. If it’s thawed, it only remains usable for five days. This makes distribution a little tricky.
According to the Virginia Hospital and Healthcare Association, vaccines are shipped in maximum loads of 975 doses. Starting last week, 18 hospitals throughout the state received shipments of the vaccine. Virginia as a whole received 72,000 doses of the vaccine in its first shipment, said VDH epidemiologist Marshall Vogt. The state’s initial allocation is 480,000 doses, and Pfizer and BioNTech say they can ramp up production to nearly 1.3 billion doses per year eventually. But that will still fall far short of the world’s need.
With respect to the distribution schedule, hospitals are following the CDC’s guidelines for how to prioritize people for vaccination. Healthcare workers and residents of long-term care facilities come first. Then, other front-line workers like people who serve us food and provide transportation will be in line, as well as medically vulnerable people.
When can I get vaccinated? And what can I do in the meantime to keep myself safe?
Unfortunately, the vaccine likely won’t be available to the general public until late spring or early summer 2021, although Oliver did say getting vaccinated will be free of charge for everyone in the Commonwealth.
While we all wait, we can take other precautions to stay safe. First and foremost, medical experts in every single source I consulted emphasized the importance of getting your flu shot. The flu can be dangerous, so avoiding it any time you can is a good idea. But this year, because COVID-19 cases have spiked this fall and hospitals are overburdened, it’s particularly important that extra patients steer clear of the emergency room. It’s possible that if you show up to the hospital with a bad case of the flu, you’ll be turned away.
You can also download the COVIDWISE app on your phone. This app uses digital keys to let you know if you’ve potentially been exposed to coronavirus, so you can self-isolate for two weeks and get tested. It also helps public health officials, who are currently too busy to provide independent contact tracing for every positive case, to track an infection in a community.
As always, you should also continue to wash your hands regularly, maintain physical distance when possible and wear a mask when you can’t, especially indoors.
The state of the virus in the New River Valley
Dr. Noelle Bissell, head of the New River Health District, provided a COVID-19 update via YouTube on Dec. 14. Covid-related hospitalizations are at an all-time high throughout the state and the country, she said.
In our region, outbreaks are being driven primarily small, indoor gatherings of friends and family. Carilion received its first shipment of the vaccine on Dec. 16, and is providing updates about distribution and vaccination on its website.
Dr. Karen Shelton described a very similar situation in the nearby Mt. Rogers Health District. Cases have been rising since the beginning of November, she said. “We think a lot of it has to do with really small family gatherings...and when the weather turned cold, they started coming indoors,” Shelton said during the Vaccinate Virginia Town Hall. “We know that in (Southwest Virginia), people tend to get together multiple generations at a time…(And) as we expected, there was an increase after Thanksgiving.”
In the Ballad Health system, which provides care to far southwest Virginia and northeast Tennessee, case counts are likewise at all-time highs. According to its daily report released Dec. 18, “This marks the highest number (328) of COVID-19 patients in Ballad Health hospitals to-date, and the 99 deaths in the last week is the highest-reported seven-day death total so far.”
Using this tool provided by the Richmond Times-Dispatch, you can investigate available hospital capacity in your area. At both Carilion hospitals and Lewis Gale Montgomery, beds are about 95% full. Some SWVA hospital systems have no or only a handful of ICU beds remaining.
Hey, it’s me again, Ashley! If you made it to the end of this super-long explainer, congratulations, and I hope it helped! I’m making this post free to everyone, so please share the link widely if you think friends, family members or neighbors could benefit from reading it. And if you’d like to support work like this, in addition to my regular coverage of Floyd County, I’d love it if you’d sign up for a free email subscription or even a paid monthly or yearly subscription to my writing. Thanks so much. Stay safe out there, and happy holidays.