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Moderna says its mRNA Access program could help with the next pandemic

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases.

“It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships.

“mRNA Access was born of the idea that we are stewards of our platform, and by allowing researchers to access that platform, and leverage the preclinical, clinical, regulatory and manufacturing capabilities that we’ve created, we could accelerate the development of novel vaccines,” Bennett said.

Get the full story from our sister site, Drug Discovery & Development.

Moderna says its mRNA Access program could help with the next pandemic

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases.

“It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships.

“mRNA Access was born of the idea that we are stewards of our platform, and by allowing researchers to access that platform, and leverage the preclinical, clinical, regulatory and manufacturing capabilities that we’ve created, we could accelerate the development of novel vaccines,” Bennett said.

To prepare for future pandemics, the company is keeping tabs on known and emerging pathogens that pose a considerable risk with the potential for devastating impact on lives around the globe.

Before the pandemic, Moderna had mRNA de…

Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.

The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.

Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.

One dataset involved patient records from the Israeli Ministry of Health involving more than 1.1 million adults at least 60 years old with no known prior COVID-19 infection eligible for a fourth dose booster. That data suggested that individuals receiving an additional dose were half as likely to be infected and had one-fourth the risk of contracting severe illness than those who had received a single booster.

The companies also submitted data from an ongoing, open-label, non-randomized study focused on healthcare w…

NIH to launch clinical trial of three mRNA HIV vaccines

HIV-infected cell. Image courtesy of NIAID

The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences.

The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA.

Get the full story from our sister site, Drug Discovery & Development.

NIH to study allergic reactions to COVID-19 mRNA vaccine

Image courtesy of Pexels

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines.

The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants who experienced a mild or moderate systemic allergic reaction to either the Pfizer/BioNTech or Moderna COVID-19 vaccines.

Get the full story at our sister site, Drug Discovery & Development.

NIH to study allergic reactions to COVID-19 mRNA vaccine

Photo from Pexels

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines.

The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants who experienced a mild or moderate systemic allergic reaction to either the Pfizer/BioNTech or Moderna COVID-19 vaccines.

People who developed a severe allergic reaction to a first dose of a COVID-19 mRNA vaccine are not eligible to enroll.

According to a news release, participants will receive a second dose of the vaccine as inpatients under carefully controlled conditions at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. NIAID’s Laboratory of Allergic Diseases’ Dr. Pamela A. Guerrerio…

Countries in need will have access to Moderna COVID-19 vaccine tech

Moderna (Nasdaq:MRNA) announced four new initiatives within a global public health strategy for advancing mRNA vaccines.

Cambridge, Massachusetts-based Moderna plans to expand its global public health portfolio, accelerate research in an effort to advance additional vaccines, expand its patent pledge to never enforce COVID-19 patents in the Gavi COVAX AMC for 92 low- and middle-income countries and establish Kenya as the location for its mRNA manufacturing facility.

Get the full story at our sister site, Pharmaceutical Processing World.

Countries in need will have access to Moderna COVID-19 vaccine tech

Moderna (Nasdaq:MRNA) announced four new initiatives within a global public health strategy for advancing mRNA vaccines.

Cambridge, Massachusetts-based Moderna plans to expand its global public health portfolio, accelerate research in an effort to advance additional vaccines, expand its patent pledge to never enforce COVID-19 patents in the Gavi COVAX AMC for 92 low- and middle-income countries and establish Kenya as the location for its mRNA manufacturing facility.

According to a news release, Moderna intends to expand its global public health portfolio to 15 vaccine programs targeting priority pathogens that threaten global health, advancing those vaccines into clinical studies by 2025. The company plans to prioritize development efforts against pathogens identified as persistent global health threats, including HIV, tuberculosis (TB) and malaria, neglected tropical diseases and the priority pathogens of the World Health Organization (WHO) and the Coalition f…

Moderna skyrockets on Street-beating Q4 driven by COVID-19 vaccine sales

Vials containing the Moderna COVID-19 vaccine sit on a table in preparation for vaccinations at Kadena Air Base, Japan, Jan. 4, 2021. As part of the DoD strategy for prioritizing, distributing and administering the COVID-19 vaccine, those providing direct medical care and emergency services will be prioritized to receive the vaccine at units based in Japan, including Kadena AB. (U.S. Air Force photo by Airman 1st Class Anna Nolte)

Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast.

MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%.

Get the full story at our sister site, Drug Discovery & Development.

Moderna skyrockets on Street-beating Q4 driven by COVID-19 vaccine sales

Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]

Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast.

MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%.

The Cambridge, Massachusetts-based company posted profits of $4.9 billion, or $11.29 per share, on sales of $7.2 billion for the three months ended Dec. 31, 2021, for a massive bottom-line gain from losses of $272 million in this period last year on sales growth of more than 12 times the revenues produced in the fourth quarter of 2020 ($571 million).

Moderna’s earnings per share of $11.29 came in $1.39 ahead of expectations on Wall Street, where analysts were looking for sales of $6.8 billion.

Product sale…

CDC recommends eight-week interval for some COVID-19 vaccine recipients

The CDC has recommended extending the interval between the first and second doses of the Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) COVID-19 vaccines up to eight weeks for some individuals.

The guidance for those vaccines was formerly 21 and 28 days, respectively.

CDC notes that an eight-week interval could be preferred for some individuals 12 and older — especially males aged 12 to 39. The extended window may reduce the risk of myocarditis.

A three-week interval for Pfizer-BioNTech and a four-week interval for Moderna is preferred for individuals who are moderately to severely immunocompromised and adults who are at least 65.

While myocarditis associated with mRNA vaccines remains rare, passive surveillance reporting in the U.S. confirms an increase in the condition — especially in adolescent males and young men, according to a report in JAMA.

Extending the interval between the first and second doses may result in superior vaccine ef…

Moderna launches pivotal trial for mRNA RSV vaccine

The Data and Safety Monitoring Board for Moderna’s (NASDAQ:MRNA) respiratory syncytial virus (RSV) vaccine program has backed the launch of a Phase 3 clinical study of the mRNA-1345 vaccine candidate.

The study will focus on adults 60 years and older.

RSV leads to approximately 177,000 hospitalizations and 14,000 deaths among adults aged 65 years or older, according to CDC.

The Phase 3 trial will enroll roughly 34,000 volunteers internationally in the trial, known as ConquerRSV.

There are currently no authorized RSV vaccines available.

“We believe that our vaccine candidate against RSV has the potential to protect against over 1 million infections globally each year, improving quality of life for those at high risk of becoming infected and reducing the burden on health care systems.”

“RSV is one of the most widespread respiratory viruses, causing severe disease and hospitalization in older adults, and yet ther…