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THE COVID-19 VACCINE MARKET IS GETTING CROWDED — AS DEMAND BEGINS TO WANE

By Helen Branswell March 21, 2022

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A droplet from a vial filled with the Covid-19 vaccine manufactured by Pfizer
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CureVac, a pioneer in the effort to use messenger RNA as a vaccine platform, and
its partner, pharmaceutical giant GSK, saw the writing on the wall last fall.

When CureVac’s Covid-19 mRNA vaccine candidate underwhelmed in a Phase 2b/3
trial, the pair shifted plans. Too many other vaccines had already proven
superior and been cleared by regulators. Rather than spend months tweaking a
candidate that would end up battling for a rapidly shrinking share of the Covid
vaccine market, they would focus instead on a second-generation product.

Soon, experts tell STAT, other would-be Covid vaccine manufacturers are set to
confront the same kinds of hard reality. With two new players — Novavax and a
Sanofi-GSK partnership — making or about to make their way into the already
crowded global Covid vaccine market, the prospects for those still struggling to
prove their vaccines are protective are becoming ever slimmer.

It doesn’t help that demand is contracting.

“We think there’s likely going to be long-term ongoing demand for Covid
vaccines, for boosters at least,” said Matt Linley, analytics director for
Airfinity, a London-based health analytics company that has been closely
tracking Covid vaccine development, regulation, sales and usage. “But it will be
a lot smaller than it is. We believe it’s kind of peaked.”

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The world can now produce more Covid vaccine than it needs or can administer —
more than 12 billion doses a year. For a number of existing manufacturers,
purchases have plateaued; some players are already scaling back production. A
company hoping to enter the market with yet another vaccine that targets the
original SARS-CoV-2 strain or that offers no advantages over existing products
will be hard-pressed to find buyers, experts warned.

Demand for newer vaccines — products that aren’t as difficult to use as the mRNA
vaccines — is either modest or stagnant, experts said. Even in countries where
the mRNA vaccines are impractical to use, they are seen as the gold standard.
Can the recombinant protein vaccines made by Novavax and Sanofi-GSK break
through? Unclear, Linley suggested. “I think there’s been a lot of hype around
Novavax, but really, only time will tell.”

Meanwhile, the virus is raising the bar that late-comers have to hurdle to show
their vaccines are protective.

The earliest market entrants — Pfizer/BioNTech, Moderna, AstraZeneca, Johnson &
Johnson, Russia’s Sputnik V, and multiple Chinese vaccines — conducted their
clinical trials when the only way to get vaccinated was to volunteer for a
study. Finding unicorns might be easier than locating people now who are both
unvaccinated and willing to enter a Covid vaccine trial.

The companies that developed the early vaccines also conducted their trials
before the arrival of a string of variants with mutations that have helped them
evade the immunity induced by Covid inoculations and by prior infection. The
Pfizer vaccine, with its initial, jaw-dropping 95% efficacy, would have looked
much less impressive had its clinical trial been conducted in the era of
Omicron. Testing a first-generation Covid vaccine now, one that was designed to
protect against the original genetic sequence of the virus shared in January
2020, is like issuing a wanted poster not of a suspect but of his
great-grandfather.

Furthermore, the urgency to speed vaccines into use that permeated the
regulatory and political landscape in the fall of 2020 is no longer the state of
play. The Food and Drug Administration and other regulatory agencies are
processing emergency authorizations with a much-less-rapid turn-around these
days. There is ample supply of other options.

All of this adds up to substantial challenges for companies still working on
Covid vaccines, and diminishing opportunities to score the sales they all seek.

That’s not to say there’s no opportunity at all. Experts agree there is still a
market for better vaccines.

“I would have to say none of the vaccines I’ve seen are the vaccines we need for
the future,” said Michael Osterholm, director of the Center for Infectious
Diseases Research and Policy at the University of Minnesota. “They’re very
important stopgap measures right now, but what we need for the future is going
to be a substantially improved version of what we have so far.”

Courtesy Airfinity

Those would include vaccines that reduce transmission of the SARS-CoV-2 virus by
protecting against even mild infections, perhaps via intranasal delivery. The
market would also have room for vaccines that are longer lasting, or can protect
more broadly against the various shapes SARS-2 viruses can come in — in other
words, vaccines that aren’t as vulnerable to the emergence of variants. It would
also have room for vaccines that could protect against multiple coronaviruses,
thereby cutting the risk of future coronavirus pandemics.

“Finding a way to future-proof them is, I think, the next big challenge for the
world,” said Phil Krause, who was deputy director of the FDA’s office of
vaccines until he abruptly quit last year. Krause is now a consultant, working
frequently with the World Health Organization. (He does not consult on Covid
vaccines with industry clients.)

Norman Baylor, a former director of the FDA’s office of vaccines, agreed there
is a need for better vaccines, but he warned getting new products into this
crowded field isn’t going to be easy. And the regulatory fast-track in the
United States — the FDA’s emergency use authorization — isn’t likely to be an
option for much longer, he said.

“I think that door is closing,” said Baylor, who now runs Biologics Consulting
and serves on scientific advisory boards for CureVac and Valneva, a French
company that has produced an inactivated Covid vaccine. “I mean if you just look
at the regulations, it should be closing because now we have plenty of
vaccines.”

According to the WHO’s Covid vaccine tracker, there are 149 candidate vaccines
in clinical development — being tested in people — and another 195 in earlier
stages of testing. In addition, at least 21 vaccines have been approved or
authorized for use around the world — some by multiple countries, others serving
a sole domestic market.

This kind of level of research isn’t sustainable, Baylor said. Countries like
the United States, which plowed billions of dollars into vaccine development
through Operation Warp Speed, are tightening purse strings.

“Remember, the big players, they were subsidized by the government. That subsidy
is going to dry up,” Baylor said. “And so now they’re going to have to go to the
venture capitalists and the venture capitalists are gonna say ‘Huh, another
Covid vaccine? Why?’”

Why indeed.

For most of the existing manufacturers, sales have flattened and production is
dropping, Airfinity’s Linley said in an interview.

”We’ve peaked at around 1.4 billion doses [per month] being produced,” he said.
“That was in around November time. And then now we’re around 0.8 billion doses
being produced per month.”

The exception to the trend is the mRNA vaccines produced by Pfizer and Moderna,
which continue to outperform the market even though their efficacy appears to
wane more quickly than that of some other competitors.

“They are the only vaccines to continue making, consistently, new deals and new
agreements to sell their vaccines. Only Pfizer and Moderna,” Linley said.

Airfinity modeling suggests that even in the most optimistic scenario —
countries vaccinating 80% of their people, then boosting once or twice a year
thereafter — the Covid vaccine market is going to contract.

Many countries will get nowhere close to that 80% figure. For context, in the
United States, the percentage of people who are eligible to be vaccinated — in
other words, the population aged 5 and older — who have completed a primary
series has hovered just shy of 70% for quite some time. (And only 46% of people
who are eligible for a booster have received one. Baylor, for one, doesn’t
believe regular boosters are going to find eager recipients. “Even if it was
mandated, people wouldn’t do it. People are tired,” he said.)

The WHO has set a target for 70% vaccination in all countries by June but Seth
Berkley, CEO of Gavi, the Vaccine Alliance, said it will likely take longer for
many countries to have all the components of vaccination programs in place —
vaccine plus enough trained vaccinators plus ancillary supplies like cold chain
for the mRNA vaccines and the right syringes — to hit that figure. Some won’t
even try to reach 70%. A number of countries have set more modest targets for
themselves, he said.

“I think we’re going to see a lot of countries miss those goals,” Berkley said,
noting that could change if a new variant that triggers more severe disease
emerges. If that happens, he said, the supply-demand equation could flip.

Future demand is likely to be determined by two factors: the path of future
variants, as well as how long protection against serious disease holds up. If
new variants emerge that evade the vaccines’ ability to protect against
hospitalization and death, countries will move to purchase updated vaccines.
Likewise, if immunity from vaccination or prior infection no longer prevents
severe disease, governments will order boosters. If these scenarios emerge, some
portion of people will again roll up their sleeves.

Manufacturers clearly hope to sell annual booster shots. Pfizer is already
seeking approval for an additional booster for people 65 and older. And Moderna
indicated last week it will ask the FDA for permission to offer a booster to all
adults. But the jury is still out on the booster question.

“I would have to say it is unclear whether we will need boosters for all,”
Berkley said. “We will have to follow the science.”

Krause agreed, noting the lack of clarity is tough on policymakers and industry.

A COMPROMISE IS REACHED ON AN INTELLECTUAL PROPERTY WAIVER FOR COVID-19
VACCINES, BUT DOES IT GO FAR ENOUGH?

“From a public health perspective I don’t think you can say ‘We’re sure we won’t
need to do that.’ And yet — and I think this, of course, creates a planning
problem — it’s not obvious that we certainly will need to do that either,”
Krause said.

Airfinity’s Linley said the company isn’t sure what the future holds over the
long term — a decade from now, say. But a number of wealthy countries have
purchased vaccine doses to use as boosters for the next couple of years. “If we
look at the next two to three years … I still think that that’s a reasonable
assumption,” he said. “Because it’s still fresh in people’s minds, the impact of
Covid. It really has been quite devastating.”

The company estimates that 11.3 billion doses were produced and delivered in
2021, but predicts that the number this year will be in the 7 billion to 9.5
billion dose range — and could drop to 2.2 billion and 4.4 billion doses in
2023. Pfizer/BioNTech alone could supply a good portion of that.

Manufacturers are aware this contraction is coming.

Some are trying to hedge their bets by announcing they will make a vaccine that
protects against both influenza and Covid — a product they would hope to sell
annually. But flu shots aren’t used much outside of wealthy countries; even in
those countries uptake doesn’t come close to replicating the sales bonanza Covid
vaccines have been in the past year.

“If we’re not sure that everybody’s going to need a Covid vaccine every year and
that the fall will be the best time to administer that, the question really is:
Is that going to be a sustainable strategy or not?” Krause wondered.

Linley noted there is one niche smaller companies that are still developing
first-generation Covid vaccines could still find — being a domestic producer in
a market without other such options.

“People are very conscious of the fact that the major countries that produce
vaccines were the ones that got access to those vaccines first,” he said,
suggesting a number of countries that are not traditional vaccine production
hubs may see value in purchasing from a company located within their borders as
a hedge against the next pandemic.

“Certainly countries want to have their own domestic vaccine. There is potential
for that.” Linley said.

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ABOUT THE AUTHOR REPRINTS

HELEN BRANSWELL

Senior Writer, Infectious Disease

Helen covers issues broadly related to infectious diseases, including outbreaks,
preparedness, research, and vaccine development.

@HelenBranswell

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