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Researchers at the University of Washington Medicine Retrovirology Lab at Harborview Medical Center in Seattle process samples from Novavax’s phase 3 COVID-19 vaccine clinical trial in February 2021.
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Researchers at the University of Washington Medicine Retrovirology Lab at Harborview Medical Center in Seattle process samples from Novavax’s phase 3 COVID-19 vaccine clinical trial in February 2021.
Karen Ducey/Getty Images
A new kind of COVID-19 vaccine is about to roll out around the world. Although it won’t replace the highly successful vaccines currently available, it could make a difference in the course of the pandemic, especially in lower resourced countries.
These new vaccines are what’s called protein subunit vaccines. They work by injecting people with a tiny portion of the virus. In the case of the COVID-19 vaccine, that tiny portion is the so-called spike protein critical for the virus to enter cells.
An advantage of protein subunit vaccines is they tend to be very stable, so they don’t require freezers for storage. A regular refrigerator is adequate. This makes distributing the vaccine much easier.
“We were assuming that the protein subunit vaccines would play a big role in accelerating development of a COVID vaccine,” says Julie McElrath directs the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle. McElrath said she and her colleagues’ confidence came because there were already subunit vaccines on the market for infectious diseases.
When Operation Warp Speed began spending billions of dollars to facilitate the development of a COVID-19 vaccine, it chose three vaccine technologies to back: mRNA vaccines being developed Pfizer and Moderna, a viral vector vaccine proposed by Johnson & Johnson, and protein subunit vaccines to be made by Sanofi and Novavax.
The first two technologies were successful, and there are now billions of vaccine doses in this country and around the world.
A year ago, Novavax was confident its vaccine would also be out there.
“We have a massive number of people working on scaling up our vaccine,” Gregg Glenn, Novavax’s president of research and development said in an interview in September 2020. “I am very optimistic by the year-end we’ll have a lot of product and we’re talking about more than 2 billion doses in 2021.”
But Glenn’s optimism was misguided. A large study of the vaccine took longer to complete than was hoped, and the company ran into manufacturing problems.
Sanofi stumbled with its protein subunit vaccine, too.
McElrath is convinced that subunit vaccines can still play an important role in bringing the pandemic under control. “It’s just that they’re just a little further behind than the others,” she says.
“Having multiple options is always a good idea,” says Ali Ellebedy, an immunologist at Washington University in St. Louis.
Ellebedy primarily studies mRNA vaccines. He says these are new, and scientists are still trying to learn their strength and weaknesses. To do that, it would be useful to have a large group of people vaccinated with a more familiar vaccine for comparison.
Medical laboratory scientist Aniela Sobel tests serology samples from the Novavax phase 3 COVID-19 vaccine clinical trial at the University of Washington Medicine Retrovirology Lab at Harborview Medical Center in February 2021.
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Medical laboratory scientist Aniela Sobel tests serology samples from the Novavax phase 3 COVID-19 vaccine clinical trial at the University of Washington Medicine Retrovirology Lab at Harborview Medical Center in February 2021.
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“From a scientific perspective, it would be definitely great to have a subunit vaccine,” he says.
That day appears to be coming. Large studies of the vaccine have shown that it works extremely well, and so far there are no safety concerns.
Novavax has begun filing for emergency use authorization with various regulatory agencies.
“We have filed for authorization all over the world, including in the U.K., Australia, Canada, New Zealand,” says Silvia Taylor, vice president of global corporate affairs and investor relations for Novavax
These filings mean Novavax thinks it has licked its manufacturing problems, because getting an authorization requires convincing regulators you can reliably produce the vaccine.
Taylor expects the company will seek emergency use authorization in this country early next year. She says to boost manufacturing capacity, Novavax has teamed up with several vaccine manufacturers, including the Serum Institute of India, the world’s largest maker of vaccines.
“So we have a tremendous amount of confidence that with everything we have learned over the past year, as well as the expertise of all of our partners, that we’ll be in a great position to produce over 2 billion doses in 2022,” she says.
That may sound familiar. Perhaps now it is achievable.
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Three generations, (from left to right) grandmother Genoveva Calloway, daughter Petra Gonzales, and granddaughter Vanesa Quintero, live next door to each other in San Pablo, Calif. Recently their extended family was hit with a second wave of COVID infections a year after the first.
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Three generations, (from left to right) grandmother Genoveva Calloway, daughter Petra Gonzales, and granddaughter Vanesa Quintero, live next door to each other in San Pablo, Calif. Recently their extended family was hit with a second wave of COVID infections a year after the first.
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On a Friday afternoon in early October this year, 8-year-old Maricia Redondo came home from her third grade class in the San Francisco Bay Area with puffy eyes, a runny nose and a cough.
“On Saturday morning we both got tested,” says Vanessa Quintero, Maricia’s 31-year-old mother. “Our results came back Monday that we were both positive.”
Vanessa stared at her phone in shock and called her doctor’s test-result hotline again, in disbelief. “This is wrong,” she thought. “I hung up and dialed again. It’s positive. This is wrong. I hung up again. And then I did it again!”
She was freaking out for two reasons. First, her large, extended family had already fought a harrowing battle against COVID-19 last year — in the fall of 2020. The virus had traveled fast and furious through their working class neighborhood back then, in the East Bay city of San Pablo. Four generations of Vanessa’s family live next door to each other in three different houses there, all connected by a backyard.
Vanessa was also terrified because she couldn’t fathom another round of treatment against a more dangerous variant than she’d faced before. The pandemic has disproportionately struck Latino families across the United States, and delta is currently the predominant variant in the U.S., according to the U.S. Centers for Disease Control and Prevention. It’s twice as contagious and may cause more severe illnesses than previous variants in unvaccinated people.
The family’s bad luck was uncanny. Research suggests immunity against a natural infection lasts about a year. And here it was almost exactly the same time of year and the family was fighting COVID-19 again.
“Reinfection is a thing,” says Dr. Peter Chin-Hong, a specialist in infections diseases and professor of medicine at the University of California, San Francisco. “It probably manifests itself more when the variant in town looks different enough from the previous variants. Or enough time has elapsed since you first got it, [and] immunity has waned.” He says a second infection is still not common, but doctors are starting to see more cases.
Computer models in a recent study suggest that people who have been infected by the virus can expect a reinfection within a year or two if they do not wear a mask or receive a vaccination. The findings show that the risk of a second bout rises over time. A person has a 5{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} chance of catching the virus four months after an initial infection, but a 50{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} chance 17 months later.
“The second time it was scarier because I’m vaccinated,” says Vanessa referring to the family’s second bout with the virus in October 2021. “Her dad’s vaccinated. We’re protected in that sense, but she’s [Maricia] not.”
Her 8-year-old daughter was still too young to qualify for a vaccine. This fall the little girl lay in bed wheezing. Vanessa tripled down on Maricia’s asthma medication and the parents quarantined themselves inside, too. Vanessa shuddered at the prospect of telling her mother and grandma about a second round of positive test results.
During a 2020 family gathering on Halloween, Maricia complained she wasn’t feeling good. Over the next few days Vanessa, and Vanessa’s partner, mother, two cousins, two aunts, an uncle and two grandmothers all tested positive for COVID-19. Eventually at least 13 family members caught the virus at that time and several got quite sick.
Multiple family members had to be rushed to the hospital.
Vanessa, who, like her 8-year-old daughter Maricia, suffers from asthma, was the first person to need that emergency care. “I was on the floor,” Vanessa remembers. “I couldn’t even say ‘I’m hungry’ without coughing.”
Then Vanessa’s 51-year-old mother, Petra Gonzales, almost blacked out.
“I got a really high fever,” says Petra. “There were times when I’d fall asleep and I was OK if I didn’t wake up.”
In last year’s COVID bout, Petra landed in the ER with severe dehydration. Soon she heard that her 71-year-old mother, Genoveva Calloway, needed hospital care for dangerously low oxygen levels and was being treated at another hospital across town.
Unlike Petra and Vanessa, who were not admitted for an extended stay at the hospital in 2020, and slowly recovered at home, Genoveva’s condition was critical. She spent day after day under close supervision from doctors and nurses.
“It was really painful not to be able to help my family, because we always help each other,” says Genoveva, as her voice cracked with emotion. “We are always there for each other. It was so horrible.”
Finally, after nearly two weeks in the hospital, Genoveva was discharged. She was still connected to an oxygen machine as nurses shuffled her out. When Genoveva and Petra greeted each other on the street, they embraced fiercely.
“She hugged me so tight,” says Genoveva. “I’ll never forget that. We missed each other so much.”
A year later, though, Genoveva is still recovering. She’s now plagued by interstitial lung disease. That’s why another round of the virus this year is a terrifying possibility.
Fortunately the family’s worst fears did not unfold. Genoveva was out of town when her great-granddaughter, Maricia, brought the virus home this time, and Maricia herself recovered. The other adults did not develop symptoms — they credit the COVID vaccinations they’d been able to get before the delta surge this fall. Research published by the Centers of Disease Control and Prevention concludes that vaccines offer better protection against reinfections than a natural infection. However, if a breakthrough infection occurs after someone’s been vaccinated it will act like a natural “booster” and result in hybrid immunity according to Chin-Hong. He suggests most patients who are not immunocompromised wait three months until after a recent infection before getting a vaccine or a booster.
“Each exposure we have, whether it’s from the infection or whether it’s from the vaccine, improves our ability to combat an infection the next time around,” says Dr. Julie Parsonnet, a professor of medicine and infectious diseases at Stanford University.
But Parsonnet also notes there are a lot of variables at play. First, immunity wanes. Second, the virus can mutate. Third, no vaccine provides 100{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} protection, and the shots may not be equally protective for everyone.
“There are certain people, including the elderly, people who are immunocompromised and people on dialysis, who really can’t mount a good immune response,” Parsonnet says. “They’re always also going to be at risk. So every child getting vaccinated helps protect all those other people in the family that they may live with, or their neighbors.”
Multi-generational living is common in Genoveva’s community in the Bay Area. And her city, San Pablo, is a hot spot in Contra Costa County, where 1 out of 11 people have tested positive for the coronavirus. At the height of the pandemic, nearly 800 people tested positive in the county every day.
“Our neighborhood has three, four generations living in the same house,” Genoveva says.
She says her recent booster shot allows her more peace of mind. Genoveva is looking forward to the day when her great-granddaughter and the rest of her family are finally vaccinated.
