Please ensure Javascript is enabled for purposes of website accessibility

US Supreme Court Lifts Order That Blocked Trump’s Mass Federal Layoffs

2 hours ago

Trump to Attend Club World Cup Final, FIFA Opens Office in Trump Tower

2 hours ago

Trump Says Pharmaceutical Tariffs Could Reach 200%

2 hours ago

Rescue Teams Find Three More Bodies After Central Texas Floods

2 hours ago

Valley Crime Stoppers’ Most Wanted Person of the Day: Rigoberto Simental Aguilar

2 hours ago

Trump Says He Is Not Happy With Russia’s Putin, Considering Sanctions

2 hours ago

Sean ‘Diddy’ Combs to Be Sentenced on October 3

2 hours ago

Israeli Military Says It Struck Key Hamas Figure in Lebanon’s Tripoli

3 hours ago

Madera County Sheriff Logs 29 Fire-Related Calls on Fourth of July, Most in 5 Years

3 hours ago

Trump Says He May Take Over Governance of Washington, DC

3 hours ago
Moderna Starting Last Trial of COVID-19 Vaccine, Expects to Make up to 1 Billion Doses a Year
TLBBHMAP3-U010ALB5ANM-348f959abae2-512-300x300-1
By Jim Jakobs, Digital Producer
Published 5 years ago on
July 16, 2020

Share

Moderna is targeting July 27 to begin phase 3 testing of their COVID-19 vaccine. The company is looking for thousands of volunteers to participate.

The Cambridge, Massachusetts-based biotech company is the first to announce an estimated start date for phase 3 trials in the United States.

Newly released data from earlier human trials showed their vaccine candidate appears to be safe and provide some immunity. The most commonly reported systemic adverse events following second vaccination at the 100 microgram dose were fatigue (80%), chills (80%), headache (60%), and myalgia (53%), all of which were moderate in severity. The most common local adverse event at the 100 microgram dose was pain at the injection site (100%), which was also transient and mild or moderate in severity.

(Moderna Facebook)

New data from early trials shows Moderna’s COVID-19 vaccine candidate appears to be safe and provide some immunity.

Guidance for Vaccine Volunteers

Information about the trial, including guidance for vaccine volunteers, was posted on clinicaltrials.gov on Tuesday.

A brief summary posted on the site says, “The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.”

Moderna describes mRNA as like software for the cell; mRNA medicines are sets of instructions. And these instructions direct cells in the body to make proteins to prevent or fight disease.

Below is a video Moderna posted to its Facebook page describing the use of mRNA therapeutics.

For inclusion in the study, volunteers must meet several criteria including the following:

  • Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
  • Understands and agrees to comply with the study procedures and provides written informed consent.
  • Able to comply with study procedures based on the assessment of the Investigator.
  • Female participants of non-childbearing potential may be enrolled in the study.
  • Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
    • Has a negative pregnancy test at Screening and on the day of the first dose (Day 1).
    • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
    • Has agreed to continue adequate contraception through three months following the second dose on Day 29.
    • Is not breastfeeding.
  • Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through three months after the second dose.
  • Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the three months before enrollment.

Moderna tweeted information and a link about the study Tuesday.

California Study Locations

Several locations throughout California will be utilized and volunteers will be needed for each.

  • Advanced Clinical Research, Rancho Paseo in Banning
  • University of California San Diego in La Jolla
  • eStudySite in La Mesa
  • UCLA Vine Street Clinic CRS  in Los Angeles
  • Paradigm Clinical Research Institute Inc. in Redding
  • Benchmark Research in Sacramento
  • Medical Center For Clinical Research, M3 Wake Research in San Diego

If you are interested, contact Moderna Clinical Trials at (855) 663-6762 or email clinicaltrials@modernatx.com

The randomized, placebo-controlled trial is expected to include approximately 30,000 participants at the 100 microgram dose level in the U.S.

Early Results Encouraging

Moderna’s experimental vaccine against the coronavirus showed encouraging results in early testing.

COVID-19 antibodies were found in all 45 participants, the biotech company announced in a May news release.

Neal Browning of Bothell, Washington, spoke to GV Wire via Zoom shortly after the early testing results were made public.

“I’m the second person to receive the vaccine in a small dose so that means I’ve got the antibodies,” Browning said. “One of the first people to reach out to me was Jennifer Haller, the lady who was the first to receive the vaccine. She was super excited, too. We chatted a little bit on text about that.”

Neal Browning becomes the second volunteer to receive the investigational COVID-19 vaccine in the NIH-supported clinical trial in Seattle. (AP File)

Moderna said the early vaccine data indicated that it provided full protection against viral replication in the lungs in a mouse challenge model.

An interim analysis just published in The New England Journal of Medicine shows mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.

In a press release, Moderna says, “After two vaccinations, mRNA-1273 elicited robust neutralizing antibody titers. At Day 43, neutralizing activity against SARS-CoV-2 was seen in all evaluated participants.”

Moderna has posted a video of a conference call on Wednesday providing more information to investors.

500 Million Doses a Year

Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network to conduct the Phase 3 study.

With the Phase 3 dose being finalized at 100 micrograms, the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Lonza.

In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. On July 9, Moderna announced a collaboration with ROVI for large-scale, commercial fill-finish manufacturing of mRNA-1273 intended in principle to supply markets outside of the U.S. starting in early 2021 at ROVI’s facility in Madrid, Spain.

DON'T MISS

What Are Fresno Real Estate Experts Predicting for 2025 and Beyond?

DON'T MISS

First California EV Mandates Hit Automakers This Year. Most Are Not Even Close

DON'T MISS

Netanyahu Nominates Trump for Nobel Peace Prize

DON'T MISS

Netanyahu Meets Trump at White House as Israel, Hamas Discuss Ceasefire

DON'T MISS

Trump Executive Order Seeks End to Wind and Solar Energy Subsidies

DON'T MISS

US Threatens California With Legal Action Over Transgender Sports Law

DON'T MISS

US Veterans Affairs Will Cut Nearly 30,000 Jobs, Far Fewer Than Planned

DON'T MISS

Houston Astros Donate $1M to Help Recovery From Texas Floods

DON'T MISS

Tucker Carlson Aired Interview With President of Iran

DON'T MISS

California Fails to Stop 23andMe Founder From Re-Acquiring Company

DON'T MISS

Madera County Multi-Agency Effort Leads to Arrest of Felony Suspect in Atwater

DON'T MISS

Fresno Police Arrest DUI Driver During Crackdown on Illegal Street Racing and Sideshows

UP NEXT

Netanyahu Meets Trump at White House as Israel, Hamas Discuss Ceasefire

UP NEXT

US Threatens California With Legal Action Over Transgender Sports Law

UP NEXT

US Veterans Affairs Will Cut Nearly 30,000 Jobs, Far Fewer Than Planned

UP NEXT

Tucker Carlson Aired Interview With President of Iran

UP NEXT

California Fails to Stop 23andMe Founder From Re-Acquiring Company

UP NEXT

US Proposes Rules That Could Boost Oil, Gas Output in US West

UP NEXT

Man Dead After Firing at US Border Patrol Station in Texas

UP NEXT

San Luis Obispo’s Madre Fire Injures 1 Firefighter, Burns Over 80,000 Acres

UP NEXT

Israeli Guilt Over Gaza Lurks Beneath Silence and Denial

UP NEXT

Iran President Says Open to Dialogue With US, Accuses Israel of Assassination Attempt

Trump to Attend Club World Cup Final, FIFA Opens Office in Trump Tower

2 hours ago

Trump Says Pharmaceutical Tariffs Could Reach 200%

2 hours ago

Rescue Teams Find Three More Bodies After Central Texas Floods

2 hours ago

Valley Crime Stoppers’ Most Wanted Person of the Day: Rigoberto Simental Aguilar

2 hours ago

Trump Says He Is Not Happy With Russia’s Putin, Considering Sanctions

2 hours ago

Sean ‘Diddy’ Combs to Be Sentenced on October 3

2 hours ago

Israeli Military Says It Struck Key Hamas Figure in Lebanon’s Tripoli

3 hours ago

Madera County Sheriff Logs 29 Fire-Related Calls on Fourth of July, Most in 5 Years

3 hours ago

Trump Says He May Take Over Governance of Washington, DC

3 hours ago

Judge Orders CVS’ Omnicare Unit to Pay $949 Million Over Invalid Prescriptions

3 hours ago

San Luis Obispo’s Madre Fire Near New Cuyama Grows to 80,615 Acres, 35% Contained

A massive wildfire burning near Highway 166 in San Luis Obispo County has scorched more than 80,615 acres since it ignited on July 2, CalFir...

20 minutes ago

The Madre Fire near New Cuyama has burned more than 80,615 acres, injured one firefighter, and prompted multiple evacuation orders as crews work to contain the growing wildfire. (CalFire)
20 minutes ago

San Luis Obispo’s Madre Fire Near New Cuyama Grows to 80,615 Acres, 35% Contained

U.S. financier Jeffrey Epstein appears in a photograph taken for the New York State Division of Criminal Justice Services' sex offender registry March 28, 2017 and obtained by Reuters July 10, 2019. New York State Division of Criminal Justice Services/Handout via REUTERS/File Photo
42 minutes ago

US Justice Department Scrambles to Defend Its About-Face on Release of Epstein Files

A general view of the U.S. Supreme Court building in Washington, U.S., June 1, 2024. (Reuters File)
2 hours ago

US Supreme Court Lifts Order That Blocked Trump’s Mass Federal Layoffs

President Donald Trump holds the key to the FIFA Club World Cup trophy in the Oval Office of the White House in Washington, D.C., U.S., March 7, 2025. (Reuters File)
2 hours ago

Trump to Attend Club World Cup Final, FIFA Opens Office in Trump Tower

Vials are seen in this undated handout photo. Pfizer/Handout via REUTERS/File Photo
2 hours ago

Trump Says Pharmaceutical Tariffs Could Reach 200%

A drone view shows the Guadalupe River and damage from flooding near Camp Mystic, in Hunt, Texas, U.S. July 6, 2025. (Reuters/Evan Garcia)
2 hours ago

Rescue Teams Find Three More Bodies After Central Texas Floods

Rigoberto Simental Aguilar is Valley Crime Stoppers' Most Wanted Person of the Day for July 8, 2025. (Valley Crimes Stoppers)
2 hours ago

Valley Crime Stoppers’ Most Wanted Person of the Day: Rigoberto Simental Aguilar

FILE PHOTO: Donald Trump and Russia's President Vladimir Putin are seen during the G20 leaders summit in Buenos Aires, Argentina November 30, 2018. REUTERS/Marcos Brindicci/File Photo
2 hours ago

Trump Says He Is Not Happy With Russia’s Putin, Considering Sanctions

Help continue the work that gets you the news that matters most.

Search

Send this to a friend