header image

[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

Inside
Weather
Santa Clarita CA
Sunny
Sunny
90°F
 
Calendar
Today in
S.C.V. History
August 15
1849 - Eight-pound gold nugget found in San Feliciano Canyon (Val Verde/Piru area) [story]
map


WASHINGTON — Touting some encouraging early results of its COVID-19 vaccine trial, the U.S. company Moderna said Monday that patients participating have begun producing virus-fighting antibodies.

Moderna, based in Cambridge, Massachusetts, was one of the first companies to receive a green light from the Food and Drug Administration to develop a vaccine for the novel coronavirus.

The company’s first human volunteers entered Phase 1 of vaccine development on Jan. 13 and, in the 63 days that followed, much has been gleaned at a rapid clip, Dr. Tal Zaks, Moderna’s chief medical officer, told reporters and investors in a teleconference call Monday.

Known as mRNA-1273, it is one of roughly 100 vaccines now in development by companies around the world. In Moderna’s study, which involved 45 volunteers, it was determined that injections of the trial vaccine appeared safe and, of equal importance, that the drug successfully stimulated the body’s immune response to fight off the virus.

Dr. Robert Gallo, co-founder and director of the Institute Human Virology at the University of Maryland School of Medicine, said in an interview Monday he was mostly encouraged to hear that the vaccine trial has so far been safe for humans.

“They were efficient, fast and well organized and the safety looks OK, so that’s an advance,” said Gallo, who is also the Homer and Martha Gudelsky distinguished professor in medicine at the University of Maryland.

Gallo tempered his expectations, however, with an acknowledgment of basic physiology.

Typically, he explained, when a foreign protein is inserted into the body, the body does what it is supposed to do in that situation: It creates antibodies to protect itself.

“So if you get an immune response, that’s fine. And if it is safe, that’s fine. But the real tests are what’s coming,” Gallo said. “We don’t know how long these antibodies will last or how protective they will be.”

Dr. Amesh Adalja, a physician and senior scholar at the Johns Hopkins University Center for Health Security, is also cautiously optimistic.

“It’s important to remember it’s a phase 1 clinical trial, which is designed to look at safety, not efficacy, so it is hard to draw any strong conclusions from some of the results that come out of phase one other than safety,” said Adalja, who is certified in emergency medicine and infectious diseases, among other areas.

Moderna broke up its test subjects into groups of 15 people each, giving them an injection of mRNA-1273 in amounts ranging from 25 to 250 micrograms. Zaks explained Monday that each subject received two doses through a shot to the arm roughly 28 days apart.

“The mRNA was generally safe and well-tolerated,” Zaks said. “There was one incidence of redness around the injection site reported in the 100-microgram dose.”

Just three participants taking the highest dosage administered reported more intense side effects to the vaccine including flu-like symptoms such as headache and fatigue. The symptoms subsided within a day.

But thanks to the early successes identified in low doses, Moderna will end its 250-microgram trials.

“The lower dose of 25 micrograms worked, so there is no need to go to ten times that,” Zaks said, noting that this lower dose rate will also be a boon for the supply chain since they fully expect demand to outstrip supply.

Globally the virus has killed more than 315,000 people, according to numbers compiled by Johns Hopkins University. The company expects to launch the second phase of its clinical trial in the first week of June. Another round will begin in July and that test pool will include thousands of people.

Animal tests found when mice received the trial vaccine and were infected again, mRNA-1273 appeared to neutralize Covid-19 from reproducing in the rodent’s lungs.

For humans, all participants ages 18 to 55 across all dosing levels showed improvement by the fifteenth day. By Day 33, the level of antibodies reached the level appearing in convalescent serum from people who recovered from the virus.

Gallo at the University of Maryland, who is also the co-founder and international scientific adviser of the Global Virus Network, said he would be particularly interested to learn what Moderna unearths in future trials.

“What about immune response of those who don’t get better? Please tell me more when there is a correlation with those people who got better,” he said, “because no one has any data that immune response has been corelated with people recovering that is accepted by those in the scientific community yet.”

Adalja, the Johns Hopkins expert, underscored the importance of understanding the duration of antibodies produced by new vaccines.

“We do this with all vaccines,” Adalja said in an interview. “We need to understand how long it is good for before you need a booster shot. For example, a vaccine for yellow fever is good for life, but there are other vaccines where you will need a booster after time.”

With the world having never used this type of vaccine before, the challenges are numerous.

“We have a neutralizing antibody study, and that data is really important, but you also want to see in clinical trials how it fairs in humans and how those individuals who are vaccinated are protected,” Adalja said. “You would see that in phase 3 where people who are in the community that are vaccinated would be exposed to the virus every day.”

Even if phase two proves successful, Moderna must scale up to meet the unprecedented demand for viral treatment needed in every corner of the world.

“We are currently getting manufacturing capacity up as fast as we can,” Moderna CEO Stéphane Bancel said Monday.

Both the U.S. Department of Health and Human Services as well as the National Institutes of Health have been working with Moderna to fast track the vaccine. Representatives for the agencies did not immediately respond to requests for comment.

— By Brandy Buchman, CNS

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


SCV NewsBreak
LOCAL NEWS HEADLINES
Friday, Aug 12, 2022
L.A. County Public Health Urges Public to Protect Pet Birds from Bird Flu
Avian influenza refers to a family of influenza or flu viruses that commonly infect birds.
Friday, Aug 12, 2022
Friday COVID Roundup: County Moves to Medium Community Level
The Los Angeles County Department of Public Health confirmed 19 new deaths throughout L.A. County, 3,995 new cases countywide and 112 new cases in the Santa Clarita Valley.
Friday, Aug 12, 2022
Wilk’s Measure Increasing Transparency Passes Assembly Committee
As part of his legislative package calling on accountability, transparency, and integrity in the state government's procurement process, Senator Scott Wilk, R-Santa Clarita, announced Senate Bill 1271 (SB 1271) passed out of the Assembly Appropriations Committee on Aug. 11.
Keep Up With Our Facebook

Latest Additions to SCVNews.com
1849 - Eight-pound gold nugget found in San Feliciano Canyon (Val Verde/Piru area) [story]
map
1986 - Canyon Country's Mitchell adobe demolished; components salvaged & later rebuilt at Heritage Junction [story]
Mitchell adobe
1961 - First Mass celebrated at new Our Lady of Perpetual Help Catholic Church (3rd building) in Newhall. Cardinal McIntyre attends [story]
OLPH
Are you worried about getting diabetes? Have you been told that you have pre-diabetes? One out of three American adults has prediabetes.
Aug. 16: Henry Mayo Hosts Diabetes Prevention Program
Avian influenza refers to a family of influenza or flu viruses that commonly infect birds.
L.A. County Public Health Urges Public to Protect Pet Birds from Bird Flu
The Los Angeles County Department of Public Health confirmed 19 new deaths throughout L.A. County, 3,995 new cases countywide and 112 new cases in the Santa Clarita Valley.
Friday COVID Roundup: County Moves to Medium Community Level
Marvel Comics’ best-known, tree-like sentient being, Groot, a character that became widely popular through the action comedy "Guardians of the Galaxy," gets his own animated show on Disney+ this week.
CalArts Alum Kirsten Lepore Brings ‘I am Groot’ to Disney+
Work along the I-5 corridor in Burbank continues and will include nighttime lane reductions and the closing of the Verdugo Avenue off-ramp during the week of Aug. 15 to Aug. 18.
I-5 Corridor Improvements Include Nighttime Lane Reductions
As part of his legislative package calling on accountability, transparency, and integrity in the state government's procurement process, Senator Scott Wilk, R-Santa Clarita, announced Senate Bill 1271 (SB 1271) passed out of the Assembly Appropriations Committee on Aug. 11.
Wilk’s Measure Increasing Transparency Passes Assembly Committee
The early portion of The Master's University women's soccer team's schedule in 2022 will have a national tournament-type feel.
TMU Women’s Soccer To Play Top Teams on Florida, Indiana Trips
Princess Cruises today announced updated COVID-19 protocols and guidelines, removing the vaccine requirement for most voyages of less than 16 days so that anyone can cruise and adjusting pre-travel testing requirements to make it less complicated.
Princess Cruises Removes Vaccine Requirement for Most Sailings
As the summer travel season wraps up, the Los Angeles County Sheriff’s Department reminds drivers to be responsible and never drive under the influence of alcohol and/or drugs.
Aug. 17-Sept. 5: LASD Will Increase End-of-Summer DUI Patrols, Checkpoints
Historically, California has been the most wildfire prone state in the United States. In 2021, the California Department of Forestry and Fire Protection, reported over 4,000 fires that burned 60,507 acres across the state.
Ken Striplin | Keep Your Family, Home and Property Safe from Wildfires
The county of Los Angeles Sheriff Civilian Oversight Commission is hosting a Special Hearing on Deputy Gangs in the Los Angeles County Sheriff’s Department.
Aug: 19 Special Hearing on L.A. County Sheriff’s Deputy Gangs
1944 - Newhall Refinery on Sierra Highway destroyed by fire (then rebuilt) [watch film]
Newsreel
As local students get ready to head back to class for the new school year, your Salvation Army Santa Clarita Corps wants to ensure they have the supplies and resources necessary for success.
Salvation Army Santa Clarita Hosting Back-to-School Drive
The Rancho Camulos National Historic Landmark Presents: "Sundays at the Landmark" on Sunday, Aug. 28, with Dave Berg. He will present "Stories to Share.
Aug. 28: Author Dave Berg Presents ‘Stories to Share’ at Rancho Camulos
The WiSH Education Foundation's much-anticipated Cocktails on the Roof event is back for the community to enjoy on Saturday, Nov. 19, from 6 p.m. to 10 p.m. at the Subaru of Valencia campus.
Nov. 19: Cocktails on the Roof Returns with ‘Share the Love’ Event
The Santa Clarita Valley Sheriff's Station is reminding residents that no one will ever call your home demanding payment for "outstanding warrants."
SCV Sheriff’s Station Warning Residents of Scam Calls
Carousel Ranch, in Agua Dulce, was presented with a $5,000 donation from the Logix Federal Credit Union Community Stars Foundation.
Logix Foundation Donates $5K to Carousel Ranch
The Los Angeles County Department of Public Health confirmed Thursday no additional deaths and 107 new cases in the Santa Clarita Valley, with a total of 15 new deaths and 4,345 new cases countywide.
Thursday COVID Roundup: 107 New SCV Cases; No Additional Deaths
The California Department of Transportation announces overnight full closures of Interstate 210 in the San Fernando Valley for striping and staging of a temporary lane configuration for a paving project.
Caltrans Announces Full I-210 Closures
The Valencia High School Band and Color Guard will hold a Clothes 4 Cash clothing drive fundraiser every Tuesday, Aug. 16 to Sept. 13.
Valencia Band, Color Guard Holding Clothes 4 Cash Fundraiser
2018 - Big Oaks Lodge in Bouquet Canyon burns down [video]
Big Oaks Lodge
SCVNews.com
%d bloggers like this: