Moderna (MRNA) Covid-19 Vaccine Makes Antibodies in All Patients - Bloomberg

Moderna (MRNA) Covid-19 Vaccine Makes Antibodies in All Patients - Bloomberg

Moderna Fires Up Covid Vaccine Race
With Promising Early Results

By Robert Langreth

Updated on

 Closely watched shot
creates antibodies, but side effects seen

 Shares rise with
final-stage trial set to start on July 27th

Moderna Vaccine Produced Antibodies in All Patients
Tested

Moderna Inc.’s Covid-19 vaccine produced antibodies to the
coronavirus in all patients tested in an initial safety trial, federal
researchers said, clearing an important milestone as the U.S. continues to
grapple with a surge in new infections.

The U.S. biotech firm’s breakthrough is one of the most
promising developments yet in the race to develop a vaccine against the virus
that has paralyzed the world’s economy. Yet the road to a successful shot is
filled with hurdles, and some patients in the trial experienced severe side
effects.

“The good news is that this vaccine induced antibodies,”
said Anthony Fauci, director of the National Institute of Allergy and
Infectious Diseases. “Not just any kind of antibodies, but neutralizing antibodies.”

Fauci, in a telephone interview, called the Moderna data
“really quite promising.” Though he said the side effects seen were not
alarming and were typical of those experienced with other vaccines, some
experts sounded a note of caution.

More than half of participants who got the middle of
three doses administered in the trial suffered mild to moderate fatigue, chills, headache and muscle pain. Also, 40% of people in the middle-dose group
experienced a fever after the second vaccination. Three of 14 patients given the highest dose
experienced severe side effects, but that dose is not being used in
larger trials.

‘Adverse Events’

“Man, that is a lot of adverse events,” said Tony Moody, a
doctor and researcher at the Duke Human Vaccine Institute. He said it would be
“unusual” for a vaccine to have this rate of side effects.

On the plus side, Moody said that the antibody levels produced
were “really encouraging.” The neutralizing antibody levels in the trial
produced were equivalent to the upper half of what’s seen in patients who get
infected with the virus and recover, according to the results published
Tuesday in the New England Journal of Medicine.

Moderna’s shares gained about 16% in U.S. pre-market trading
Wednesday. The stock has more than tripled in value this year on hopes that the
company’s vaccine will gain rapid approval. The vaccine will move into a much
larger late-stage trial later this month that’s likely to determine whether
it’s fit for commercial use.

Although stimulating production of neutralizing antibodies
doesn’t prove a vaccine will be effective, it’s considered an important early
step in testing. The side effects reported weren’t severe enough in the
majority of patients to preclude further testing, according to the report
by researchers from the NIAID.

The biotech company's Covid-19 vaccine produces antibodies
in all patients tested

The vaccine news came as the pandemic continued thriving
throughout the U.S. Cases nationwide increased Tuesday to 3.4 million,
according to data collected by Johns Hopkins University and Bloomberg News.
More than 136,117 Americans have died.

While some states that suffered this spring have managed to
quell the contagion, fierce hot spots are breaking out in the Sun Belt.

45 Patients

Moderna’s initial results are from the first group of 45
patients who received the vaccine, called mRNA-1273. It evaluated three doses
that were given in a two-shot regimen. The middle one was selected for use in
the large final-stage study that is slated to begin on July 27th.

In the trial, participants received the two shots 28 days
apart. After the first dose, all of them generated antibodies that bound to the
coronavirus, but most did not yet produce antibodies capable of neutralizing
the virus.

But all 42 people who got both scheduled doses of the
vaccine generated antibodies capable of neutralizing the coronavirus, according
to the study results. The final-stage trial will compare the vaccine to placebo
shots in 30,000 healthy people at high risk of coming down with the
coronavirus.

One significant limitation of the data is it includes data
only from the first 45 patients in the study, all of whom were from age 18 to
55. Results from a second portion of the phase 1 trial that included people
older than this -- a key demographic for any Covid-19 vaccine, given the high
death rate in older patients -- are not available yet.

‘Respectable’ Levels

William Haseltine, a former Harvard Medical School
researcher who chairs Access Health International, said the levels of
neutralizing antibodies produced were “respectable” and possibly protective.
But he said “the jury is out” on safety of the vaccine.

Unlike traditional vaccines, which inject a weakened or
inactivated virus or a piece of a virus to trigger an immune response, the
Moderna product uses genetic material called messenger RNA to cause cells to
produce the coronavirus spike protein. The goal is to produce antibodies to the
virus that protect against the disease when someone is later exposed to the
coronavirus.

The vaccine “clearly worked in that antibodies against the
spike

protein were generated, including antibodies that had virus
neutralizing capability,” said Paula Cannon, professor of microbiology at Keck
School of Medicine of USC. A key
question will be how long will the antibodies last before they start to wane,
she said.

The initial findings from the Phase 1 trial are largely in
line with top-line results Moderna published in a press release in May, but
provide more details on the antibody levels produced and side-effects that were
seen.

At the time, Moderna was criticized by some scientists for
putting out a release describing positive results that temporarily drove up the
company’s stock price, but included few numbers that would allow scientists to
interpret the data.