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.

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Sanofi details €2B plan to make France an mRNA leader

French drugmaker Sanofi (Nasdaq:SNY) said it would spend €935 million (about $1.1 billion) between 2022 and 2026 to produce mRNA-based vaccines.

That funding is part of a larger €2 billion (about $2.4 billion) initiative to accelerate its mRNA development capability, Sanofi explained on its French-language website.

The company plans to use the funds to ramp up its lipid nanoparticle production capability and identify six candidate mRNA vaccines.

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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…

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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…

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Lancet study could bode well for mix-and-match COVID-19 vaccination

[Image by Sam Moqadam on Unsplash]

The mRNA vaccines from Pfizer-BioNTech and Moderna appear to work well as a second dose in recipients of a single dose of the AstraZeneca AZD1222 vaccine.

A report in Lancet found that two doses of AstraZeneca’s AZD1222 vaccine were 50% effective. Recipients who received a dose of the AZD1222 vaccine followed by a dose of Moderna’s mRNA-1273 vaccine had adjusted vaccine effectiveness of 79%. Those who received an initial dose of AZD1222 followed by the Pfizer-BioNTech BNT162b2 vaccine saw vaccine effectiveness of 67%.

The report authors stopped short of claiming that a heterologous AZD1222 and mRNA prime-boost vaccination strategy is superior, concluding that it “may be an effective alternative to increase population immunity against COVID-19.”

“These results could have important implications for vaccination strategies and consequently in the battle against the…

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Sanofi to spend nearly half a billion dollars a year on mRNA vaccine research

Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development.

Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccine “mRNA Center of Excellence” to accelerate the development and delivery of next-generation vaccines.

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Sanofi to spend nearly half a billion dollars a year on mRNA vaccine research

Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development.

Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccines “mRNA Center of Excellence,” where work will be conducted to accelerate the development and delivery of next-generation vaccines.

Approximately 400 employees will integrate end-to-end mRNA vaccine capabilities with dedicated R&D, digital and chemistry, manufacturing and controls (CMC) teams at sites in Cambridge, Mass., and Marcy l’Etoile, Lyon, France, according to a news release. The center will seek to accelerate the mRNA portfolio developed by Sanofi in collaboration with Translate Bio, the company said.

“During the COVID-19 pandemic, mRNA technologies demonstrated potential to deliver new vaccines faster than ever before,” Sanofi Pasteur global head of R&D Jean-Francois Toussaint…

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FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39. 

The conditions appear to be more common in males. 

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care. 

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

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mRNA vaccines do not negatively affect sperm county, study finds

One of the many urban legends related to COVID-19 vaccines is that they cause infertility. Researchers at the University of Miami set out to disprove that claim with a recent single-center prospective study. Unsurprisingly, the study that indicated the mRNA vaccines have no negative impact on male fertility. In fact, the researchers found that after the second vaccine dose, participants exhibited a significant increase in median sperm concentration and sperm motility.

In the study published in JAMA, the researchers stopped short of claiming that mRNA COVID-19 vaccines could boost fertility in men. “While these results showed statistically significant increases in all sperm parameters, the magnitude of change is within normal individual variation,” the study authors concluded.

The study only evaluated the BNT162b2 and mRNA-1273 vaccines from Pfizer-BioNTech and Moderna, respectively.

The study tracked participants approximately 70 days after administering…

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Preliminary JAMA analysis finds no link between COVID-19 vaccines and sudden hearing loss

[Photo by Daniel Schludi on Unsplash]

After the authorization of COVID-19 vaccines, a growing number of sudden sensorineural hearing loss (SSNHL) reports have emerged from recently vaccinated people. 

A recently published analysis in JAMA is among the first to consider whether COVID-19 vaccines play a role in SSNHL, which frequently occurs without a clear underlying cause.  

Drawing from a pool of SSNHL patients who presented at Johns Hopkins University and data from the Vaccine Adverse Events Reporting System (VAERS) database, the researchers compared the observed number of SSNHL with the expected rate in the broader population. In the latter, there were 147 SSNHL reports between December 14, 2020, and March 2, 2021, that occurred within three weeks of vaccination and had high credibility of reporting. In that time frame, 86,553,330 doses of COVID-19 were administered in the U.S. 

[Related: No …

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BioNTech and Moderna set their sights on treating cancer

Nodular melanoma. Image courtesy of Wikipedia.

COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company.

BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different cancer vaccines based on mRNA,” said Türeci, BioNTech’s chief medical officer.

Such therapy could be available to people within a “couple of years,” Türeci said, stressing that it is difficult to predict regulatory timelines involving emerging therapies. 

BioNTech is currently working on several novel immunotherapies for oncology targeting melanoma, prostate cancer and cancers associated with human papillomavirus. 

Moderna is also exploring the possibility of…

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