By Peter Loftus and Jared S. Hopkins
Covid-19 vaccine makers are racing to create new shots that can
better protect people from dangerous new strains of the
coronavirus, after recent testing showed the variants present a
bigger-than-expected threat.
The chase marks a new phase in vaccine research to fight off the
virus, indicating it may shift into a kind of long-running contest
between a changing virus and shots that can keep up, rather than a
shorter effort that would once and for all derail the pandemic.
When new strains were first identified in the U.K., South Africa
and Brazil, the companies said they believed their shots would
still protect against Covid-19. Then several studies indicated
Covid-19 vaccines, while still working, aren't as effective against
the variant that spread widely in South Africa.
Now Moderna Inc., Pfizer Inc. and its partner BioNTech SE,
Johnson & Johnson and Novavax Inc. are designing new vaccines
that would target variants of the virus, particularly the variant
first identified in South Africa and now detected in other
countries including the U.S.
On Wednesday, British drugmaker GlaxoSmithKline PLC said it was
partnering with Germany's CureVac NV in a deal worth up to EUR150
million, equivalent to $181 million, to develop Covid-19 vaccines
that can tackle new variants, while AstraZeneca PLC and partner
University of Oxford said they plan to develop a new version of
their vaccine that would target variants and could be available by
autumn.
The U.S. Food and Drug Administration, meanwhile, is taking
steps such as requiring smaller trials in order to accelerate the
review and authorization of modified vaccines.
"It highlights this arms race we have right now between getting
enough people vaccinated and seeing the virus change," said Dr. C.
Buddy Creech, director of Vanderbilt University's vaccine-research
center.
All viruses mutate. Early in the pandemic researchers expressed
optimism the new coronavirus wouldn't change too significantly and
vaccines in development would be able to rid the world of the
virus.
Pfizer's and Moderna's vaccines, which were cleared for use in
the U.S. in December before the variants were identified, appear to
provide at least some protection against emerging strains in lab
tests.
Yet they weren't tested in humans exposed to the new strains.
And vaccines from J&J and Novavax recorded lower effectiveness
levels in studies in South Africa that took place after the variant
was identified there, compared with their performance in other
regions.
J&J's shot, for example, was 57% effective in South Africa
versus 72% in the U.S. J&J plans to seek U.S. authorization for
its vaccine this week.
While the current vaccines still work, it is important to start
developing potential follow-on vaccines to be prepared for even
more significant mutations that could evade current shots,
companies and infectious-disease specialists say.
Pfizer Chief Executive Albert Bourla said during the 2021 Davos
World Economic Forum last week that there is a "high possibility" a
variant would emerge rendering Covid-19 vaccines ineffective.
"It's very highly likely that one day that will happen," Mr.
Bourla said, adding this isn't the case right now.
The new shots would be given as booster doses after a person
gets one of the original vaccines, or companies could make new
vaccines that target both the common viral strain and one or more
of the new variants.
It would be akin to the tweaks that companies make each year to
seasonal influenza shots to target a specific flu strain.
Makers of flu shots use the same basic ingredients of a vaccine
but alter it depending on which strain is expected to be
predominant. Because of this process, flu shots don't undergo
full-scale clinical trials each year.
Like flu shots, Covid-19 vaccines could become a sizable market
for drugmakers beyond the pandemic emergency period if they have to
be modified regularly.
Pfizer anticipates $15 billion in Covid-19 vaccine sales this
year. Sales could prove durable, Mr. Bourla told analysts Tuesday,
because people will likely need booster shots, either to stay
protected against the virus or to combat emerging variants.
Pfizer -- which had waited longer than most other vaccine makers
to announce it was pursuing a new shot, should it be needed -- said
Tuesday it would study if using a booster shot provides additional
protection, and it is tweaking its vaccine so it could guard
against the strains found in Brazil and South Africa.
Pfizer hasn't decided whether it would test a new vaccine in
people, but would aim to finish any study in 100 days, Mr. Bourla
said in an interview. "We don't want to develop a vaccine if we
don't need to," he said. "But we want to be able to develop it with
the speed of light if there is a need."
Moderna President Stephen Hoge said the company will monitor new
variants and develop strain-specific vaccine booster shots if
necessary. Within a few months, Moderna plans to start studying in
people a booster shot targeting the variant first identified in
South Africa.
Novavax is manufacturing some of the variant proteins for use in
potential new vaccines, including the strain seen in South Africa,
said Gregory Glenn, the company's head of R&D.
J&J is preparing an antigen -- the substance that a vaccine
relies upon to induce an immune response -- for testing that would
target the variant that spread in South Africa, according to Mathai
Mammen, head of research and development at J&J's
pharmaceutical unit.
"We're acting in anticipation of a variant being a potential
problem," he said on a conference call with reporters last
week.
Vaccine makers are focused initially on the variant first
identified in South Africa because it is more contagious and has
shown signs of evading the effects of the original vaccines and
some treatments.
The variant that spread widely in South Africa has a large
number of mutations in the spike protein, which researchers say may
account for the reduced potency seen for some of the vaccines.
Pfizer and Moderna say they can modify their vaccines to target
new strains fairly quickly because they can simply insert the
genetic code of a new virus strain into the same basic building
blocks used to make their original vaccines.
Their vaccines, using messenger RNA technology, don't require
the growth of viral material or proteins as some other vaccine
types do.
GSK and CureVac are also using mRNA technology to develop their
vaccines, one of which the companies say could be ready for use in
2022. "The increase in emerging variants with the potential to
reduce the efficacy of first-generation Covid-19 vaccines requires
acceleration of efforts to develop vaccines against new variants to
keep one step ahead of the pandemic," the companies said.
It also shouldn't be difficult to tweak vaccines from J&J,
AstraZeneca and Novavax because of the new technologies used to
make those shots, though the process could take slightly longer,
said Robert Garry, professor of microbiology and immunology at
Tulane Medical School.
The FDA plans to speed up the approval process for such
follow-on vaccines by requiring smaller, shorter clinical trials
demonstrating they induce certain immune responses, rather than the
large efficacy trials that were conducted for the original
vaccines, Peter Marks, director of FDA's biologics center, said
Friday in an online discussion hosted by the American Medical
Association.
--Jenny Strasburg contributed to this article.
Write to Peter Loftus at peter.loftus@wsj.com and Jared S.
Hopkins at jared.hopkins@wsj.com
(END) Dow Jones Newswires
February 03, 2021 10:28 ET (15:28 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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