Moderna Archives - Page 6 of 21 - Medical Design Sourcing

Omicron-specific mRNA vaccine elicited similar protection as original in early primate study

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine.

In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine.

The study involved a total of eight macaques who received two initial 100-μg doses of the mRNA-1273 vaccine. Nine months after the second dose, four primates received a dose of the existing vaccine, while the remaining four received the omicron-based version.

The study authors performed a challenge test, exposing the non-human primates to the omicron variant to gauge their immune response. The researchers ultimately concluded that both…

FDA fully approves Moderna’s COVID-19 vaccine

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

Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine.

FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second fully FDA-approved COVID-19 vaccine after the Pfizer-BioNTech vaccine received approval in August 2021.

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

FDA fully approves Moderna’s COVID-19 vaccine

(U.S. Air Force photo by Airman 1st Class Anna Nolte)

Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine.

FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second fully FDA-approved COVID-19 vaccine after the Pfizer-BioNTech vaccine received approval in August 2021.

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

FDA fully approves Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine.

FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second fully FDA-approved COVID-19 vaccine after the Pfizer-BioNTech vaccine received approval in August 2021.

“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in an FDA release. “While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to indivi…

WHO concludes that updated COVID-19 vaccines may be needed

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary.

Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron variant.

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

7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory.

Researchers are now exploring dozens of new possibilities for the mRNA platform.

Here, we summarize several areas where mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

Moderna and Pfizer look forward to fourth dose of COVID-19 vaccine

Photo by Artem Podrez from Pexels

As COVID-19 case counts surge worldwide, executives at Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have voiced support for additional doses of their COVID-19 vaccines.

Moderna CEO Stéphane Bancel predicted that a fourth dose would be necessary by the fall as the protection of vaccine-induced antibodies fades.

In late December, Pfizer’s chief scientific officer Dr. Mikael Dolsten said a fourth dose could be necessary in the U.S. by spring.

Pfizer executives predicted that the COVID-19 wouldn’t become endemic across the world until 2024, according to Reuters. But, that said, the emergence of variants and global vaccination could influence the trajectory of the pandemic.

Several countries are considering moving forward with providing fourth doses of COVID-19 vaccine. Israel, Canada and Chile have already begun doling out fourth doses to some individuals. In t…

Moderna doses the first patient with its mRNA Epstein-Barr virus vaccine candidate

Moderna (NSDQ:MRNA) has dosed the first volunteer in the Phase 1 Eclipse study of mRNA-1189, an Epstein-Barr virus vaccine candidate.

The study will take place at roughly 15 sites in the U.S. and involve approximately 272 healthy adults between the ages of 18 and 30.

The study will be randomized, observer-blind, placebo-controlled and involve a range of doses.

Epstein-Barr virus (EBV) is one of the most common viruses, representing one of the viruses that cause infectious mononucleosis (mono). EBV is also linked to a heightened risk of multiple sclerosis and some cancers and autoimmune diseases.

EBV seroprevalence tends to rise with age, affecting 90–95% of adults.

“Adolescents who develop infectious mononucleosis are frequently absent from school for weeks and even months at a time, impacting the quality of their education and their families,” said Stéphane Bancel, Moderna CEO, in a press release.

Pfizer (NYSE:PFE) and BioNTech (NSD…

Israeli researchers release data on fourth dose of COVID-19 vaccine

Photo by cottonbro from Pexels

Early data from Israel’s Sheba Medical Center showed that an additional booster of COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) led to a fivefold increase in antibodies one week after receipt of the vaccine.

Pfizer had earlier announced that a third dose of the vaccine increased antibody levels 25-fold compared to a two-dose primary series.

Pfizer and BioNTech, along with their competitor Moderna (NSDQ:MRNA), continue to develop an omicron-specific version of their mRNA vaccine.

The prospect of a fourth dose of the original vaccine for immunocompetent people may be more controversial than a third.

While Israel has begun administering a fourth dose to some individuals, the head of the French vaccination program, Dr. Alain Fischer, said there was insufficient evidence at present to recommend an additional vaccine dose. France could dec…

COVID-19 vaccine makers adjusting to omicron

Photo from Pexels

Soon after the omicron emerged, notable companies such as Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced efforts to develop a booster specific to the variant.

But several pharmaceutical companies are developing custom versions of COVID-19 vaccines for the variant or testing the efficacy of existing vaccines against omicron.

In October, the Moscow-based Institute of Human Stem Cells announced its plans to test the efficacy of its Betuvax-CoV-2 vaccine against omicron and create a new version of the vaccine if needed.

Inovio (NSDQ:INO) announced in late November 2021 that it would conduct tests of its DNA vaccine candidates INO-4800 and INO-4802 against omicron and that it had begun preclinical development of an omicron-specific vaccine.

Valneva (NSDQ:VALN) is also testing the ability of its VLA2001 to protect against omicron. Read more

The top 5 drug discovery stories of 2021

Image courtesy of Pixabay

The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which drew revenue figures from the prior year. But in 2021, companies like Pfizer and Moderna sold tens of billions of dollars of COVID-19 vaccine alone. As a result of the ongoing pandemic, significant shifts are likely in 2022’s forthcoming ranking of pharma leaders.

Here, we provide an opportunity to review the 2021 pharma landscape, including stories that received the most attention on social media.

1. Pharma 50: The 50 largest pharmaceutical companies in the world

The top 50 largest pharmaceutical companies raked in $851 billion…

100-µg booster dose of Moderna’s vaccine increases antibody levels 83 times against Omicron

Moderna (NSDQ:MRNA) is touting preliminary data suggesting that its COVID-19 vaccine booster led to robust antibody increases against the Omicron variant, both at the 50 µg and 100 µg dose levels.

The 50 µg booster dose, which is currently authorized under emergency use authorization, led to a 37-fold increase compared to pre-boost levels 29 days post-boost. A 100 µg booster dose led to an 83-fold increase in the same time window.

The National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center and Duke University Medical Center conducted the research on sera from 20 booster recipients for the mRNA-1273 vaccine at both 50 µg and 100 µg dose levels.

Two doses of the Moderna vaccine, however, did not offer robust protection against Omicron.

Moderna, like Pfizer, is also developing an Omicron-specific vaccine. Moderna’s is known as mRNA-1273.529.

Moderna anticipates to organize clinical trials for the Omicron-based va…