Local health officials are awaiting the arrival of a third COVID-19 vaccine authorized for emergency use in the U.S. that could speed up vaccinations against a virus that has killed 147 local residents and is mutating in increasingly worrisome ways.
On Saturday, the Food and Drug Administration authorized the use of a vaccine developed by Johnson & Johnson shot that works with just one dose instead of two, which health experts say is key given the limited supply of vaccines, The Associated Press reported.
J&J started shipping a few million doses to states earlier this week. By the end of March, the New Jersey-based pharmaceutical giant has said it expects to deliver 20 million doses to the U.S., and 100 million by summer.
However, it is not yet clear when or if local vaccination sites will receive doses of the J&J vaccine, as state health officials are still determining how and where to distribute the shots, local officials said.
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As of Tuesday morning, the Bartholomew County Health Department was still waiting to hear back from the Indiana State Department of Health to see whether its clinic will receive shipments of the J&J vaccine, said Amanda Organist, Bartholomew County Health Department director of nursing.
Columbus Regional Health does not intend to administer the J&J vaccine at its stand-alone clinic near the hospital campus in Columbus, but hospital officials are looking at how to “integrate it at other sites,” said Dr. Slade Crowder, vice president of physician enterprise operations and associate chief medical officer at Columbus Regional Health.
No further details were available on what CRH sites, if any, would receive the new vaccine.
“We won’t be giving it at our vaccine clinic, and the reason is we have found that it’s safer and more efficient to only give one vaccine,” Crowder said.
More specifically, Crowder cited challenges associated with what to do with leftover doses at the end of the day and “safety concerns,” including accidentally giving someone the wrong vaccine.
CRH was offering the Pfizer-BioNTech and Moderna vaccines at its clinic but has been phasing out Moderna and plans to only offer Pfizer-BioNTech vaccine going forward, Crowder said.
“If you’re doing three shots by three different companies, you could have nine Moderna shots (leftover at the end of the day), four Pfizer shots and four J&J. That gets very logistically hard to track down that many people that quickly who can come on a moment’s notice. There’s also a safety concern. …You could make a mistake and give the wrong person the wrong vaccine. You could let someone go who got a Pfizer vaccine and needs a second appointment. It’s just that we feel it’s a little bit safer if you just sort of have a single efficient operation that doesn’t have multiple paths and branch points.”
How effective?
The FDA’s analysis found that, in the U.S., the J&J COVID-19 vaccine was 72% effective at preventing all COVID-19 and 86% effective at preventing severe cases of the disease, according to wire reports. While there is still a chance a vaccinated person could get sick, this suggests they would be much less likely to need hospitalization or to die from COVID-19.
By contrast, the Pfizer-BioNTech vaccine was shown to be 95% effective, while the Moderna vaccine was shown to be 94.5% effective, though the trials for those two vaccines were done over the summer and fall of 2020, before newer more contagious variants were circulating widely, according to wire reports.
Crowder cautioned people against comparing the effectiveness of the vaccines because the conditions and timing of the clinical trials were different. The only way to truly compare the three vaccines is to do a head-to-head trial, he said.
“It’s human nature to compare,” Crowder said. “It’s probably not fair to compare. …(The trials) were done over different time frames. There are different strains in those time frames of what’s circulating. They were also (studied) in different parts of the world, with different populations, different age groups — and this might sound strange — with different definitions of COVID infection. And so you have to be very cautious comparing across studies that weren’t done the exact same way.”
The state’s vaccine registration portal lists the vaccines available at each vaccination site in Bartholomew County, meaning that people may be able to pick and choose, at least to some extent, which vaccine they want.
However, Crowder is advising people to take whichever vaccine is available when their turn comes.
“All the vaccines protect you from hospitalization and death,” he said. “That’s what we care about.”
How the vaccine works
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spike protein located on the surface of SARS-CoV-2, the virus that causes COVID-19. But the vaccines work in different ways.
The J&J vaccine uses a genetically modified version of a harmless adenovirus — called a viral vector — that contains a small piece of genetic instructions for the coronavirus’ spike protein, according to wire reports.
After this modified adenovirus is injected into someone’s arm, it enters the person’s cells. The cells then read the genetic instructions needed to make the spike protein and the vaccinated cells make and present the spike protein on their own surface. The person’s immune system then notices these foreign proteins and makes antibodies against them that will protect the person if they are ever exposed to SARS-CoV-2 in the future.
The adenovirus can’t replicate in human cells or cause disease, and the spike protein can’t cause COVID-19 without the rest of the coronavirus.
By comparison, the Moderna and Pfizer vaccines are both messenger RNA, or mRNA vaccines, which work by introducing into the body non-infectious snippet of genetic material wrapped in a protective coating that instructs cells to build a piece of the so-called spike protein, according to the Centers for Disease Control and Prevention.
J&J’s approach is not new, according to wire reports. The company used a similar method to make its Ebola vaccine, and the AstraZeneca-Oxford COVID-19 vaccine is also an adenovirus viral vector vaccine.
The other notable difference is that the J&J vaccine requires one dose instead of two, making logistics much easier compared with organizing two doses per person.
Also, the J&J vaccine can be stored at much warmer temperatures than the mRNA vaccines, which must be kept at below-freezing or subzero temperatures.
The Johnson & Johnson vaccine can be stored for at least three months in a regular refrigerator, making it much easier to use and distribute, according to wire reports.
“They all work very similarly,” Crowder said. “They make your body create that spike protein that’s on the COVID virus, and then your body has an immune reaction to that spike protein. So the real difference is sort of in your cell, how that protein is being manufactured.”
Safety questions
J&J tested its single-dose option in 44,000 adults in the U.S., Latin America and South Africa, and the FDA said the studies found no serious side effects, according to wire reports.
Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site, fever, fatigue, muscle aches and headache.
An FDA fact sheet for vaccine recipients says there is “a remote chance” that people may experience a severe allergic reaction to the shot. Such reactions are treatable, and vaccine recipients are supposed to be briefly monitored after the injection.
The vaccine has been authorized for emergency use in adults 18 and older for now.
But like other manufacturers, Johnson & Johnson is about to study how it works in teens before moving to younger children later in the year, and also plans a study in pregnant women.
Also, J&J is testing two doses of its vaccine in a separate large study.
“It’s just great to have more supply,” Crowder said. “The limiting factor for how quickly we can immunize is the supply. It’s hugely important. Any more options on getting vaccine are just hugely helpful to getting to that goal of getting most people vaccinated as quickly as possible.”
