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FDA grants Moderna permission to increase doses in each vial from 10 to 14: report

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FDA grants Moderna permission to increase doses in each vial from 10 to 14: report

The Food and Drug Administration (FDA) granted Moderna permission to increase the number of COVID-19 vaccine doses per vial from 10 to 14, the New York Times reports. 

Moderna did not confirm the approval Friday but told Fox News it is currently in discussions with the FDA about a “potential increase in fill volumes, thus enabling extraction of additional doses from each vial delivered.”

One of the biggest constraints to Moderna’s manufacturing capacity is how many vials can be filled.

“In order to better maximize resources as well as maximize opportunities to deliver more doses into each market faster, Moderna has proposed filling vials with up to 15 doses of vaccine versus the previous 10 doses,” a Moderna spokesperson told Fox News Friday. 

The FDA said Friday it cannot comment on discussions it is having with a manufacturer. 

“Generally speaking, any changes to an [Emergency Use Authorization] must be requested by the company and include data supporting the requested change and would be authorized via a granting letter or reissuance of the letter of authorization, which would be posted on FDA’s web site,” an FDA spokesperson told Fox News. 

Moderna currently provides roughly half of America’s vaccine supply. Because the increased number of doses per vial would not require different vials than the ones currently being used, it would be a simple way to increase the number of doses available. The manufacturing change would take two to three months to implement. 

President Joe Biden said Thursday that the U.S. is on track to deliver more than 600 million doses of the COVID-19 vaccine between Modern and Pfizer by the end of July, enough to fully vaccinate almost every American. 

“Just this afternoon, we signed the final contracts for 100 million more Moderna and 100 million more Pfizer vaccines,” Biden said Thursday at the National Institutes of Health. “We’re also able to move up the delivery dates with an additional 200 million vaccines to the end of July, faster than we expected.”

The FDA is currently considering an emergency use authorization request by a third drug company, Johnson & Johnson, for its COVID-19 vaccine. 

Moderna is contracted to supply 300 million doses to the U.S. and another 341.5 million doses to countries around the world. 

So far, 69,014,725 doses have been distributed and 48,410,558 doses have been administered in the United States, according to the CDC. 

Moderna’s scaled-up manufacturing capacity comes as COVID-19 variants continue to rapidly spread throughout the country. 

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Newly-developed vaccine could prevent Lyme disease

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Newly-developed vaccine could prevent Lyme disease

A newly developed vaccine could prevent Lyme disease in humans.

The inoculation against the tick-borne disease, being developed at the University of Massachusetts Medical School, received federal approval last year and is now part of an initial clinical trial, Field & Stream reported.

Work on the vaccine is being spearheaded by Dr. Mark Klempner, a member of the school’s biologics program who has been working on a Lyme cure for a decade, the outlet said.

“A Lyme vaccine that used to be publicly available had been withdrawn and since we understood the mechanism of protection there, we were able to go right after the molecule that we thought would be protective,” Klempner told the Patriot-News.

The vaccine is being tested on 66 patients in Lincoln, Nebraska, and could be available to the public in the the spring of 2023, the reports said.

According to a report in January by the Centers for Disease Control and Prevention, Lyme disease is more prevalent than previously thought — with as many as 400,000 cases reported to the agency every year.

The disease is most commonly transferred to humans through bites from infected black-legged ticks, with the bites typically leaving a characteristic skin rash.

Lyme is rarely fatal but can be debilitating. Symptoms include fever, headaches and fatigue, and it can cause nerve damage, memory loss, and inflammation around the heart if left untreated.

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MS patient sues Austria over health impact of climate change

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MS patient sues Austria over health impact of climate change

BERLIN — A man in Austria with a temperature-dependent form of multiple sclerosis is taking his government to court in an effort to force it to do more against climate change, his lawyers said Tuesday.

The case being filed next month before the European Court of Human Rights is supported by the environmental group Fridays for Future, which is helping to crowdfund the legal costs.

It comes weeks after the Strasbourg-based court said it would continue to fast-track a case by brought six young Portuguese activists who argue European governments aren’t cutting greenhouse emissions in line with the requirements of the 2015 Paris climate accord.

The court, whose jurisdiction covers all countries that have ratified the European Convention for the Protection of Human Rights and Fundamental Freedoms, is also hearing a separate case brought by a group of elderly Swiss women.

“The case we are filing will be the third one and will be among the first bundle of cases upon which the court will base its jurisdiction with an effect on all 47 member states (that are subject to the court’s jurisdiction),” said Michaela Kroemer, a lawyer for the Austrian plaintiff.

Her client, identified only as Mex M. for privacy reasons, has Uhthoff’s syndrome, which affects his muscles when temperatures rise above 25 degrees Celsius (77 degrees Fahrenheit).

“The climate crisis already severely impacts his daily life, his personal dignity and his wellbeing,” said Kroemer. Under Austrian law, inaction by the Alpine nation’s legislature can’t be challenged in court, meaning the case is being brought directly to the European court, she said.

Kroemer said her client’s specific situation would be no hindrance to the court making a ruling that is applicable to the general public.

“In a legal context, in a strategic litigation context, it really only takes one person to make a huge difference,” she said.

Since January 2020, Austria has had a coalition government under center-right Chancellor Sebastian Kurz that includes the environmentalist Green party, which oversees the powerful climate, environment and energy ministry.

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Vernon Jordan, activist, former Clinton advisor, has died

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Vernon Jordan, activist, former Clinton advisor, has died

ATLANTA — Vernon Jordan, who rose from humble beginnings in the segregated South to become a champion of civil rights before reinventing himself as a Washington insider and corporate influencer, has died, according to a statement from his daughter. He was 85.

Jordan’s daughter, Vickee Jordan Adams, released the statement Tuesday to CBS News.

“My father passed away last night around 10p surrounded by loved ones his wife and daughter by his side,” she said.

After stints as field secretary for the Georgia NAACP and executive director of the United Negro College Fund, he became head of the National Urban League, becoming the face of black America’s modern struggle for jobs and justice for more than a decade. He was nearly killed by a racist’s bullet in 1980 before transitioning to business and politics.

His friendship with Bill Clinton took them both to the White House. Jordan was an unofficial Clinton aide, drawing him into controversy during the Monica Lewinsky scandal.

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