Absolutely remarkable’: No one who got Moderna’s vaccine in trial developed severe COVID-19-

Jon Cohen
Continuing the spate of stunning news about
COVID-19 vaccines, the biotech company
Moderna announced the final results of the
30,000-person efficacy trial for its candidate in a
press release today: Only 11 people who received
two doses of the vaccine developed COVID-19
symptoms after being infected with the pandemic
coronavirus, versus 185 symptomatic cases in a
placebo group.

That is an efficacy of 94.1 percent,
the company says, far above what many vaccine
scientists were expecting just a few weeks ago.
More impressive still, Moderna’s candidate had
100 percent efficacy against severe disease. There
were zero such COVID-19 cases among those
vaccinated, but 30 in the placebo group. The
company today plans to file a request for
emergency use authorization (EUA) for its vaccine
with the U.S. Food and Drug Administration (FDA),

and is also seeking a similar green light from the
European Medicines Agency.
The data released today bolster an interim report
from the company two Mondays ago that only
analyzed 95 total cases but produced similarly
impressive efficacy. “I would still like to see all of
the actual data, but what we’ve seen so far is
absolutely remarkable,” says Paul Offit, a vaccine
researcher at the Children’s Hospital of
Philadelphia who is a member of an independent
committee of vaccine experts that advises FDA.
Moderna’s vaccine against SARS-CoV-2, the virus
that causes COVID-19, relies on a novel
technology that uses messenger RNA (mRNA) to
code for a protein called spike that studs the
surface of the pathogen. Pfizer and BioNTech
have developed a similar mRNA vaccine against
COVID-19 and also reported excellent results, with
an efficacy of 95 percent, in the final analysis of
their 45,000-person trial. In that study, which
ended after 170 cases of COVID-19 were
identified, only 10 severe cases occurred, and just
one was in the vaccinated group.

Moderna and the Pfizer/BioNTech collaboration
say their vaccines worked to about the same
degree in all different groups, ethnicities, and
genders. (More than 7000 participants were over
age 65 and more than 5000 were under 65 but
had diseases putting them at a higher risk of
severe COVID-19; the study also included more
than 11,000 people from communities of color.)
That equal success is vital information for bodies
trying to prioritize the use of the new vaccines,
such as an advisory panel to the Centers for
Disease Control and Prevention (CDC) that is
meeting tomorrow. The committee’s
recommendations influence CDC’s decisions
about vaccine prioritization, but individual states
come up with their own guidelines.
Moderna received $1 billion from the U.S.
government’s Operation Warp Speed to help
develop its mRNA vaccine. (Pfizer passed on such
development money, but has signed an advanced
purchase order for its vaccine with Warp Speed.)
Moderna CEO Stéphane Bancel says all of the
federal money went toward staging the clinical

trials, and that without it, progress surely would
have been delayed. Investors in May contributed
another $1.3 billion to help the young company,
which has no products on the market, build
facilities to produce its vaccine.
Pfizer filed an EUA request for its vaccine last
week, which led FDA to announce it will convene
a meeting of its vaccine advisory committee to
discuss the data in depth on 10 December. Bancel
says FDA has told the company it might convene
the committee again as early as 17 December to
review its EUA application. He says the agency
could issue an EUA 24 to 72 hours later.
Bancel imagines the Moderna vaccine, given its
high efficacy against both mild and severe
disease, will have the most impact if given to
people at the greatest risk from SARS-CoV-2.
“Give it to health care workers, give it to the
elderly, give it to people with diabetes,
overweight, heart disease,” he says. “A 25-year-
old healthy man? Give him another vaccine.”
Moderna plans to charge $32 to $37 per dose of
the vaccine in developed countries, Bancel says,

but will have cheaper pricing for other parts of the
world. The company is negotiating with the
COVID-19 Vaccines Global Access (COVAX) Facility,
a nonprofit that aims to reduce global vaccine
inequities by purchasing and distributing
approved products. “We want to have this vaccine
available at a tiered price for low-income
countries,” he says.
Bancel stresses that he wants other COVID-19
vaccines to succeed as well. “The world needs
several manufacturers to make it to the finish line
to stop this awful pandemic,” he says. U.K.
pharma giant AstraZeneca, in partnership with the
University of Oxford, has reported preliminary
evidence of efficacy for its COVID-19 vaccine, as
has the Gamaleya Research Institute of
Epidemiology and Microbiology in Russia.
Moderna hopes to provide the U.S. government
with 20 million doses by the end of the year, and
Pfizer says it should have 50 million doses to split
between the United States and other countries
that made advanced purchase agreements.-
SOURCE – Sciencemag.org/news.

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