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%; the
company says; far above what many vaccine scientists were expecting just a few
weeks ago. More impressive still, Moderna’s candidate had 100% 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 weeks 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%, 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 in the Moderna trial 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
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.
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