Though most people will probably have to wait months for COVID-19 shots to become available, Bartholomew County health officials are hoping people will be willing to roll up their sleeves when their turn comes.
“I just want most people to have faith in the vaccine, trust it, be comfortable getting it because it’s really going to help us make a big difference,” said Dr. Slade Crowder, vice president of physician enterprise operations and associate chief medical officer at Columbus Regional Health, which is operating a COVID-19 vaccination clinic in Columbus.
Limited numbers of health care workers in Bartholomew County and the surrounding area have been receiving vaccinations against COVID-19 since Dec. 17, when CRH started administering the initial doses of vaccines at a regional clinic in Columbus.
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As of Tuesday, 1,854 doses of the vaccines had been given out at the clinic, CRH officials said.
Statewide, 74,842 people in Indiana had received the first of two doses of a COVID-19 vaccine as of Tuesday, including 859 Bartholomew County residents, 400 Jackson County residents, 118 Jennings County residents and 85 Brown County residents, according to the Indiana State Department of Health.
Some experts say at least 70% of the U.S. population may need to be vaccinated to hold the virus in check, according to The Associated Press. That would require at least 4.7 million Hoosiers getting vaccinated, each requiring two shots, or 9.4 million doses of the vaccines.
Currently, the “primary focus” of public health officials in Bartholomew County is to “encourage everyone to obtain a COVID-19 vaccine as they become eligible,” said Dr. Brian Niedbalski, Bartholomew County health officer.
While health experts have stressed that no corners were cut during development of the vaccine, recent polls show that many Americans are on the fence about getting vaccinated, citing safety concerns and wanting to watch how the initial rollout fares, according to wire reports.
That skepticism could hinder the efforts to bring a pandemic under control that has killed at least 85 people in Bartholomew County and sickened thousands.
“People need to see the scientific data,” Crowder said. “Not everyone wants to get in the weeds of the scientific data, but they need to hear from experts that the data has been reviewed and that the vaccine is safe and effective. They need to understand that it went through a similar approval process as other vaccines.”
On Dec. 11, the Food and Drug Administration authorized the first COVID-19 vaccine for emergency use. The vaccine, developed by New York-based drugmaker Pfizer and German biotechnology company BioNTech, consists of two shots injected in the upper arm given 21 days apart. The vaccine was authorized for people ages 16 or older.
One week later, the FDA authorized a vaccine developed by Massachusetts-based biotechnology company Moderna Inc. and the U.S. National Institutes of Health. It consists of two shots injected in the upper arm given 28 days apart and was authorized for people ages 18 or older.
More COVID-19 vaccines are currently working their way through the pipeline but have not yet been authorized.
How it works
The Pfizer-BioNTech and Moderna vaccines work by introducing into the body non-infectious snippet of genetic material called messenger RNA, or mRNA, wrapped in a protective coating.
The mRNA contains instructions to cells to build a piece of the so-called “spike protein” that is unique to SARS-CoV-2, the virus that causes COVID-19, according to the Centers for Disease Control and Prevention.
After injection, the mRNA finds its way into cells, which read the instructions and build pieces of the spike protein over the course of a few days.
As the immune system detects the newly built protein pieces, it produces antibodies specifically designed to eliminate them, effectively training the immune system to recognize a distinctive characteristic of the virus and respond if it were to later encounter the real virus.
The mRNA never enters cell’s nucleus and cannot alter or interact with human DNA. The vaccines do not contain microchips.
After the cells make the piece of the spike protein, the mRNA is broken down and eliminated, leaving no permanent trace.
The main difference between the Pfizer-BioNTech and Moderna vaccines is that “Moderna was able to make theirs more stable at warmer temperatures,” Crowder said.
The Pfizer-BioNTech vaccine must be stored at minus-94 Fahrenheit, while the Moderna vaccine can remain stable for up to 30 days at 36 to 46 Fahrenheit.
“They work similarly in the body in terms of the mechanism,” Crowder said.
The mRNA approach is different than conventional vaccines that have been around for generations, which typically involved injecting dead or weakened viruses or specific pieces of them into the body.
The Pfizer-BioNTech and Moderna shots are the first vaccines using mRNA technology authorized for human use in the U.S.
How effective are the vaccines?
Both vaccines have been found in randomized trials to be effective at preventing symptomatic COVID-19 infections, according to independent reviews by the FDA and health regulators in Britain, Canada and several other countries.
The Pfizer-BioNTech vaccine was shown to be 95% effective, while the Moderna vaccine was shown to be 94.5% effective, according to federal regulators. FDA scientists found similar effectiveness across different age groups, genders, races and participants with health conditions associated with a high risk of severe COVID-19.
By contrast, flu vaccines have ranged from 20% to 60% effective in recent years.
The FDA authorized the Pfizer-BioNTech and Moderna vaccines for emergency use after analyzing data from randomized clinical trials with tens of thousands of participants.
In July, Pfizer launched a randomized clinical trial with about 44,000 participants in the United States, Germany, Turkey, South Africa, Brazil and Argentina, according to the FDA.
Participants were randomly divided into two groups: One group that received two doses of the vaccine, and another group that received dummy shots, called a placebo, that did not contain the vaccine.
After receiving the vaccine or placebo, the participants went about their daily lives and scientists compared how frequently people from the two groups fell ill with COVID-19.
None of the participants knew whether they received the vaccine or placebo to reduce the chances that people would alter their behavior and skew the results.
Of the more than 20,000 people who received the Pfizer-BioNTech vaccine, just eight contracted COVID-19 and only one person developed severe illness, according the FDA.
By comparison, 162 people who received the dummy shots contracted COVID-19, including nine who fell seriously ill.
Moderna, conducted a similar clinical trial with about 30,400 participants in the United States. Eleven participants in the vaccine group fell ill with COVID-19, compared to 185 in the placebo group, including 30 people who developed severe illness. None of the participants who received the Moderna vaccine fell seriously ill with COVID-19.
There also was some evidence that the first dose of both vaccines offered some level of protection against COVID-19, but there is not yet enough data to draw any firm conclusions, the FDA said. Currently, it not yet known how long the vaccines will offer protection, or whether boosters will be required.
Effectiveness numbers will likely change as the vaccine studies continue, but experts say the results so far provide strong signals that the vaccine could prevent a majority of COVID-19 infections when large groups of people are vaccinated.
How safe are the vaccines?
The Pfizer-BioNTech and Moderna vaccines underwent a “thorough evaluation” for safety before being authorized by federal regulators, according to the FDA.
Scientists at the CDC have said the vaccines were held to the same “rigorous” safety and effectiveness standards as all other vaccines.
During clinical trials, the most commonly reported side effects of both vaccines included pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever, though “more people experienced these side effects after the second dose than after the first dose,” according to the FDA.
These reactions are a sign that the immune system is revving up, according to wire reports. COVID-19 vaccines tend to cause more of those reactions than a flu shot, about what people experience with shingles vaccinations.
The Pfizer trial excluded individuals with a history of severe adverse reactions to any vaccine. The Moderna trial, however, did not exclude such individuals.
Reports of severe allergic reactions to the COVID-19 vaccines have been more frequent than with other vaccines but are still rare, according wire reports.
As of Wednesday, there had been 11 reports of severe allergic reactions out of the more than 2.1 million people in the U.S. who had received one of the vaccines, or roughly one in 190,900 people, according to The New York Times.
All 11 individuals recovered from the allergic reactions after treatment.
The CDC advises people to stick around for 15 minutes after vaccination, and those with a history of other allergies should be monitored for 30 minutes.
People with a history of severe allergic reactions to other vaccines or injectable therapies should talk to their doctor first, according to CDC guidance.
But people with a history of “serious allergies, including life-threatening allergies to things like shellfish or latex” are “absolutely okay” to get the vaccines, Crowder said.
“There’s probably some misunderstanding of who can and cannot get the vaccine,” Crowder said. “The only people who really shouldn’t get the vaccine are people who are known to be allergic to an ingredient in the vaccine. …Most people with allergies are fine.”
Fast track
Local health officials largely attribute the speedy development of the vaccines to decades of research into mRNA technology that laid the groundwork for the COVID-19 vaccines and the pandemic, which has provided an ideal environment to test whether the vaccines work.
“The technology has been around for a long time, and it’s been researched for a long time,” Crowder said.
Many vaccine-preventable diseases — including meningitis and human papillomavirus, or HPV, which causes cervical cancer — are relatively uncommon and it can take years during a clinical trial to accumulate enough data to detect a difference between the vaccine group and the placebo group, Crowder said.
For example, there are about 13,800 cases of cervical cancer reported in the U.S. every year, according to the American Cancer Society.
By contrast, there have been over 20 million confirmed cases of COVID-19 in the U.S. and over 81 million worldwide over roughly the last year, according to researchers at Johns Hopkins University.
“Not that many people get cervical cancer in a year, so to immunize people and then wait to see if they get cervical cancer and see if it works takes a long time because it is just not a common event,” Crowder said. “…But a pandemic is a perfect time to develop a vaccine because we’ve had (20) million people get the virus so far and so you don’t have to wait very long to see (if it works).”
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Earlier this week, Colorado and California health officials reported the first confirmed cases in the U.S. of a more contagious variant of SARS-CoV-2 initially detected in the United Kingdom, The Associated Press reported.
Scientists believe the variant, known as B.1.1.7, is more contagious than previously identified strains but not more deadly.
The vaccines being given now are thought to be effective against the variant, but experts are working to confirm that, according to wire reports
Health officials in Delaware and Massachusetts also are investigating virus samples for the variant, according to the Associated Press.
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