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Washington Post, May 18, 2020 at 8:54 a.m. EDT
Moderna’s coronavirus vaccine shows encouraging early results in human
safety trial
By Carolyn Y. Johnson
The Washington Post is providing this important information about the
coronavirus for free. For more free coverage of the coronavirus
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stories are free to read.
Moderna, the Massachusetts biotechnology company behind a leading effort
to create a coronavirus vaccine, announced promising early results from
its first human safety tests Monday. The company plans to launch a large
clinical trial in July aimed at showing whether the vaccine works.
The company reported that in eight patients who had been followed for a
month and a half, the vaccine at low and medium doses triggered blood
levels of virus-fighting antibodies that were similar or greater than
those found in patients who recovered. That would suggest, but doesn’t
prove, that it triggers some level of immunity. The antibody-rich blood
plasma donated by patients who have recovered is separately being tested
to determine whether it is an effective therapy or preventive measure
for covid-19.
Moderna’s announcement comes days after one of its directors, Moncef
Slaoui, stepped down from the board to become chief scientist for
Operation Warp Speed, a White House initiative to speed up vaccine
development. Watchdogs called out Slaoui’s apparent conflict of
interest, noting he owns Moderna stock options worth $10 million.
Moderna also received $483 million from the Biomedical Advanced Research
and Development Authority, a federal agency.
“Slaoui’s blatant financial conflicts of interest disqualify him for the
role of vaccine czar, unless he commits immediately to global vaccine
access conditions over the obvious profit interests of the corporations
he serves,” said Peter Maybarduk, director of the Access to Medicines
Program at Public Citizen, a consumer advocacy group.
Sen. Elizabeth Warren (D-Mass.) called for Slaoui to divest his stock
options, tweeting it is “a huge conflict of interest for the White
House’s new vaccine czar to own $10 million of stock in a company
receiving government funding to develop a covid-19 vaccine.”
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All stories linked in the newsletter are free to access.
The data released Monday by Moderna is encouraging, but represents only
a first step in a long process to bring a vaccine to market. It comes
from an interim report on dozens of patients followed over weeks,
whereas vaccine studies require broad testing in thousands of patients
followed over many months or years.
Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia,
said the data looked promising and it made sense to proceed to a large
trial this summer.
“The fact that the vaccine elicited neutralizing antibody amounts
comparable or higher to those found in convalescent sera [plasma] is
very encouraging,” said Arturo Casadevall, chair of molecular
microbiology and immunology at the Johns Hopkins Bloomberg School of
Public Health, who is spearheading the initiative to test plasma as a
treatment.
Peter Jay Hotez, who is working on developing a coronavirus vaccine at
the Baylor College of Medicine, said it would be important to understand
the level of antibodies detected in the patients beyond the information
provided in a company news release. He pointed to emerging evidence that
many recovered patients do not muster high levels after they recover —
and that high levels of antibodies are needed to neutralize the virus.
The vaccine showed no worrisome safety signals, aside from redness at
the injection site for one patient and some transient “systemic”
symptoms in three patients given the highest dose, the company said.
The interim data comes from a clinical trial aimed at showing the safety
of its experimental vaccine and helping the company select the correct
dose. The company has not yet picked the final dose, or announced the
size or length of the large trial that it will start in July, which will
be the key one that regulators consider to decide whether the vaccine is
safe and effective.
“We are very, very happy because first the vaccine was generally safe,”
Stephane Bancel, chief executive of Moderna said in an interview. “The
piece that was really exciting and was the big question, of course, was
can you find antibodies in people in enough quantities” to prevent disease.
Moderna also reported that the vaccine protected mice who were
vaccinated and then exposed to the virus, preventing it from multiplying
in their lungs. The animal and human data being released by the company
have not yet been published.
Moderna’s vaccine uses a genetic material called messenger RNA that
codes for the distinctive spike protein that studs the outside of the
novel coronavirus. The vaccine delivers the messenger RNA to cells,
which then follows the genetic instructions to create the virus protein
— allowing the body to learn to recognize and neutralize the pathogen.
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