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A MORE TRADITIONAL CORONAVIRUS SHOT ON THE WAY FOR SOME UNABLE TO WAIT

By Carolyn Y. Johnson
June 5, 2022 at 7:00 a.m. EDT

Novavax developed a coronavirus vaccine with a more traditional approach than
earlier shots. (Matt McClain/The Washington Post)
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More than a year after people began rolling up their sleeves for cutting-edge
coronavirus shots, a new vaccine, this one based on a classic decades-old
technology, is expected to begin rolling out in the United States this summer.

WpGet the full experience.Choose your planArrowRight

Advisers to the Food and Drug Administration are scheduled to debate Tuesday
whether a shot developed by the Maryland biotechnology company Novavax, an
underdog in the vaccine race, is safe and effective. If the shot gets the green
light, it will become the fourth coronavirus vaccine in the nation.

For most people, some already on their third or fourth messenger RNA coronavirus
shot from Moderna or Pfizer-BioNTech, it looks like a puzzle: A new vaccine? Why
bother? But for a small contingent of holdouts who have closely tracked the
progress of the Novavax vaccine, this is a moment of truth.

“Some people can’t take the mRNA vaccines, and it is important to have a
choice,” said Victoria Dawson, 74, of New York, who is allergic to an ingredient
in the mRNA shots. She received a Johnson & Johnson shot and booster but hopes
her next shot will be from Novavax. “I’m being very cautious. I’m staying around
my apartment complex and not eating in restaurants,” she said. “I get up in the
morning and just stress the minute I get up.”



Even though Novavax lost the race to be first, company executives argue that
their shot will help fill in the margins of the pandemic vaccination campaign
and play an important role in helping people live alongside the virus into the
future. They argue their vaccine, which can stay stable at refrigerator
temperatures longer and may be better tolerated than alternatives, will have key
advantages once the exigencies of the pandemic recede.

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But hopes were dashed Friday that the vaccine would offer an alternative for
people worried about rare heart inflammation associated with mRNA vaccines. An
FDA review found that there were five cases of inflammation, mostly in men,
within two weeks of being vaccinated in Novavax trials, “raising concern for a
causal relationship.”


Novavax, a biotech company in Gaithersburg, Md., uses recombinant protein
technology to create its coronavirus vaccine. (Video: John Farrell, Brian
Monroe/The Washington Post)

The Novavax vaccine is poised to hit the U.S. market as more than three-quarters
of people 18 and older are already fully vaccinated. Among the unvaccinated,
some may be waiting for another option, but others may not be interested at all.
Novavax plans to seek expanded authorization for use of the shot in adolescents
and as a booster.

The rollout is likely to be slower than that of earlier coronavirus vaccines,
which were available days after FDA advisers met. An agency review released
Friday said testing and submission of manufacturing information about the
vaccine were “still in process” and would be essential “to ensure the vaccine’s
quality and consistency for authorization.”

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A meeting of Centers for Disease Control and Prevention vaccine advisers, a
critical step before a vaccine becomes available, has not been scheduled yet.
The company plans to have shots ready to supply “within a very short period of
time,” a few weeks after the FDA authorizes the shot, said John Trizzino, chief
commercial officer at Novavax.

Despite the late arrival of their vaccine, Novavax executives remain confident
it will fill a need. “If you would have asked anybody in the space 12 months ago
what would be happening in the pandemic now, they would have said, ‘Oh, by now
we’d be long past the pandemic,’” Trizzino said.


TINY VACCINE FACTORIES

In a brightly lit laboratory in Gaithersburg, Md., a cloudy, yellowish broth
swirls inside Erlenmeyer flasks. The glass containers, shaking back and forth
inside two incubators, are teeming with cells from a pest known as the fall
armyworm moth.

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Those moth cells are tiny vaccine factories, churning out coronavirus spike
proteins found in the newest omicron subvariants, BA.4 and BA.5. Even as Novavax
scientists wait for their first-generation vaccine to be authorized, based on
earlier versions of the virus, they are working on new formulations to be ready
for wherever the pandemic swerves next.

The winding path to this moment, a vaccine on the cusp of authorization a year
after it was shown to be 90 percent effective, underscores the speedy
development of the first vaccines. The lag for the Novavax vaccine reflects a
combination of factors, including the more time-consuming technology used in its
coronavirus shot, the growing pains of a small company that had to expand
quickly and manufacturing delays.

What makes the Novavax vaccine attractive to some people is that it is an older
and more familiar technology. That is also what made it trail other shots.
Protein-based shots are tried and true. They are used against influenza,
hepatitis B and shingles. However, the timeline to develop them is longer.

The newer mRNA vaccines instruct cells inside the body of vaccine recipients to
build the coronavirus spike protein. The Johnson & Johnson vaccine uses a
harmless virus to spur cells to churn out the spike protein. Novavax, by
contrast, manufactures and purifies the coronavirus spike proteins in a
laboratory.



Novavax scientists start with a baculovirus, which in nature infects insects. It
is engineered to carry genetic instructions for building the coronavirus spike
protein. The baculovirus, with its genetic instructions, is then introduced into
cells taken from the fall armyworm moth.

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In progressively larger vessels, researchers brew a cloudy broth of moth cells
capable of churning out the spikes. In a factory in India, where manufacturing
takes place, there are 6,000-liter stainless steel vats teeming with the insect
cells.

To recover the key vaccine ingredient, the coronavirus spike proteins,
scientists purify and filter out other cellular debris. Then, they add detergent
to create a spike-covered soap bubble that looks similar to the virus itself. An
adjuvant, a vaccine ingredient that revs up the immune system, is added.

Gale Smith, chief scientist at Novavax, said he started working on the
technology in the early 1980s as a graduate student. “I had this crazy idea when
I was a graduate student,” Smith said, talking over the loud hum of lab
equipment. “I knew it was important, and I can tell you, hardly anyone shared
that opinion.” The advantage of “bug cells,” as Smith calls them, is that they
are adept at making complex proteins.

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Still, cool science alone is not enough to get a vaccine across the finish line,
and at the beginning of the pandemic, Novavax started out with disadvantages.
The company had never launched a vaccine. Its staff had been slashed and key
manufacturing capabilities sold off to keep the company afloat after efforts to
develop a vaccine against respiratory syncytial virus foundered in 2016.

The Novavax coronavirus shot was one of six candidates backed by Operation Warp
Speed, the federal program established to accelerate vaccine development. The
government invested $1.6 billion in the Maryland company to support development
of the shots. Even with the influx of cash, the challenges to scale up were
enormous.

“We were not a developed company at that time. We started with 100 people in the
United States, without any laboratory space at the time,” chief executive
Stanley Erck said. “Starting Jan. 12, 2020, we had seven-day weeks for two
years. Every day, we would work to get to the next experiment, to the next data
point.”

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The Novavax workforce exploded during the past two years to 1,600 employees, and
a new headquarters is under construction. The growth is visible in every
department. In a glass corridor, scientists receive frozen patient samples from
vaccine trials around the world.

Last year, a staff of nearly 60 received and analyzed results from about 100,000
samples. So far this year, they have analyzed 87,000 and are looking to expand
the lab to double their capacity by next year.

The Serum Institute of India is manufacturing the Novavax vaccine, and U.S.
regulators needed to inspect that plant, which added to the time it took to
review the application for FDA authorization, Erck said.

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Novavax also lost time in manufacturing because of difficulties with tests used
to check the contents and quality of the vaccine. Vaccine makers must
demonstrate to regulators that their product is consistent in every batch and
every vial.

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“That can take a long time to both get that process right and to the level of
purity the FDA requires,” said Kathleen Neuzil, director of the Center for
Vaccine Development and Global Health at the University of Maryland School of
Medicine.

The company filed for emergency authorization in January.


WAITING FOR NOVAVAX

With more than three-quarters of U.S. adults fully vaccinated, few people expect
that a fourth shot will significantly boost vaccination rates. For Novavax
executives, one of their selling points has been the promise of helping to close
the vaccine hesitancy gap, but the experience in some European countries, where
the shot is available, has not borne that out.

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There is a niche group of people in the United States who connect on social
media and who have been holding out for the shot because they can’t or won’t
take the existing vaccines. But the true potential of the shot is global or as a
booster. It has already been approved in more than 40 countries. And if it is
eventually authorized in adolescents and children, that could also spur greater
use.

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“I still think there are quite a lot of people who are nervous about the mRNAs,
all these people who haven’t gotten boosted. I think there is a niche there for
people who feel safer with” the Novavax shot, said Kathryn Stephenson, a vaccine
expert at Beth Israel Deaconess Medical Center in Boston who led a Novavax
trial.

With the virus continuing to throw curveballs, adding another option to the
arsenal could be crucial for the future, experts said. Some people had hoped the
protein shot might be an attractive option in a world in which there are
choices, especially because mRNA shots have been associated with a risk of heart
inflammation in younger men. But the five cases of heart inflammation identified
recently “support a concern for causal relationship to vaccine,” FDA reviewers
wrote.

Novavax took issue with the FDA analysis, arguing that the rates of heart
inflammation were exceedingly low and were the same in the vaccine and placebo
groups. “We believe there is insufficient evidence to establish a causal
relationship,” the company said in a statement.

For Randy Cox, 42, of Ludington, Mich., the revelation that the same rare heart
risk may exist with this vaccine as with mRNA vaccines comes as a major
disappointment. Cox has been waiting on Novavax for months because he is fearful
that mRNA vaccines, with their rare potential to cause heart inflammation in
men, could exacerbate the large cyst on the right atrium of his heart. As much
of the country was vaccinated, boosted and even boosted again with mRNA
vaccines, Cox kept his mask on and continued wiping down his groceries.

It “comes as quite a shock” to learn about heart inflammation associated with
the Novavax shot, Cox said. He had been frustrated by the slowness of the
regulatory review and watched with envy as other countries authorized the
vaccine. When Canada authorized the Novavax shot, Cox applied for a passport,
thinking he could make the five-hour drive, only to learn that people who were
not Canadian citizens were not eligible to roll up their sleeves and get a shot.

Now, Cox said he is going to have to dig into the data, watch the FDA meeting
and think about whether he still wants Novavax or whether, if the risks are
about the same, he would settle for the Pfizer-BioNTech vaccine that has been
more widely used. “I’m really bummed,” Cox said.




CORONAVIRUS: WHAT YOU NEED TO READ

Vaccines: Will you need a fourth coronavirus vaccine? Officials have authorized
a second booster shot for Americans 50 or older. A vaccine for young kids could
also be available soon.

Mask guidance: A federal judge struck down the mask mandate on transportation,
but covid-19 cases are on the rise again. We created a guide to help you decide
whether to keep wearing face coverings. Most experts say you should keep wearing
on planes.

Tracking the virus: See the latest coronavirus numbers and how the omicron
variant has spread across the world.

At-home tests: Here’s how to use at-home covid tests, where to find them and how
they differ from PCR tests.

New CDC team: A new team of federal health scientists has been formed to provide
real-time data on the coronavirus and future outbreaks — a ‘National Weather
Service’ to forecast what’s next in the pandemic.

For the latest news, sign up for our free newsletter.

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