New top story from Time: FDA: Pfizer-BioNTech Vaccine Doesn’t Need Ultra-Cold Freezer Storage

https://ift.tt/2ZUK7jG

When Pfizer-BioNTech’s vaccine became the first authorized for use in the U.S., the good news came with a catch: the vaccine, the first of its kind using a new mRNA-based technology, needs to be stored at ultra-cold temperatures (-80°C to -60°C) until thawing just before being injected into people’s arms.

State health centers, hospitals and other potential vaccination sites scrambled to acquire special freezers that could reach these deep-freeze temperatures, and Pfizer developed a special shipping container that could keep doses appropriately chilled for up to a month as long as the container was continuously supplied with dry ice. Still, the temperature requirement meant some locations opted not to order the Pfizer-BioNTech vaccine.

But in the past few weeks, the U.S. Food and Drug Administration reviewed data submitted by the companies on the stability of the doses at normal freezer temperatures (-25°C to -15°C), and on Feb. 25, the agency issued new guidance that says the vaccine can be safely shipped and stored for up to two weeks at these relatively higher temperatures. While that’s a shorter time period than the six months that the vaccine can be stored in freezers reaching ultra-cold temperatures, the option could give more hospitals, doctors’ offices, pharmacies, and health clinics the flexibility they need to effectively store and administer doses of the vaccine. “It gives people more storage options, and more accessibility in locations that today may not be ordering the Pfizer vaccine,” says Tanya Alcorn, vice president of Pfizer’s BioPharma Global Supply Chain.

The data that led to the FDA’s decision was generated as part of the companies’ routine quality-control studies, which include analyses of how stable the vaccine is even if it wasn’t kept at the recommended -80°C to -60°C. Much of that work occurred in Pfizer’s Andover, Mass. facility, which also produces the mRNA that goes into the vaccine. “We take multiple lots and do a full battery of testing, including putting them in temperature-controlled stability chambers,” says Margaret Ruesch, Pfizer’s vice president of worldwide research and development, and site leader for the Andover location. “We collect those stability data and if we have enough that gives us assurance that all the vaccines meet with our specifications under those storage conditions, then we request an update of the recommendation for how the vaccine is stored.”

The companies initially launched the vaccine with the -80°C to -60°C temperature requirement because that was the temperature range at which they produced the doses used in their clinical trials. “We had plenty of data on stability at the ultra-cold temperatures,” says Ruesch. “As we made more commercial-scale lots, we took those lots and put them in our stability program and gathered enough data on the [regular] freezer temperatures” to confirm that they could be safely stored at those temperatures for up to two weeks.

Pfizer-BioNTech will continue shipping doses in its ultra-cold temperature containers, but once received, facilities will now be able to keep the vials in those shipping containers for a month and then place them in a regular freezer for up to two weeks.

“The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement announcing the decision.

Pfizer-BioNTech has been scrambling to meet aggressive production targets after a slower-than-expected rollout has left states and jurisdictions short on doses. Part of that slower manufacturing was due to initial challenges in getting sufficient raw materials needed for the vaccine, and a less-than-optimal production process. But as manufacturing has ramped up, Alcorn says, production is on pace to more than double from January to mid-March, from five million doses a week to about 13 million. The companies have contracted to deliver 200 million doses to locations in the U.S. by May, and hope to ship 2 billion doses globally by the end of the year. “We are very, very confident in our ability to meet targets,” says Alcorn.

Comments

Soldier killed in encounter with terrorists in J-K's Pulwama https://ift.tt/2XGQfvf

A soldier was killed in an encounter with terrorists in Jammu and Kashmir's Pulwama district on Wednesday. After receiving information about the presence of terrorists, security forces launched a search operation in an orchard in Kamrazipora village of Pulwama in the early hours of the day.

New top story from Time: R. Kelly Found Guilty in Sex Trafficking Trial

https://ift.tt/3kMSmKc (NEW YORK) — The R&B superstar R. Kelly was convicted Monday in a sex trafficking trial after decades of avoiding criminal responsibility for numerous allegations of misconduct with young women and children. A jury of seven men and five women found Kelly guilty of racketeering on their second day of deliberations. The charges were based on an argument that the entourage of managers and aides who helped the singer meet girls—and keep them obedient and quiet—amounted to a criminal enterprise. Read more: A Full Timeline of Sexual Abuse Allegations Against R. Kelly [time-brightcove not-tgx=”true”] Several accusers testified in lurid detail during the trial, alleging that Kelly subjected them to perverse and sadistic whims when they were underage. For years, the public and news media seemed to be more amused than horrified by allegations of inappropriate relationships with minors, starting with Kelly’s illegal marriage to the R&B phenom Aaliya...

How Muni is Tackling the 10 Worst Delay Hot Spots Across SF

How Muni is Tackling the 10 Worst Delay Hot Spots Across SF By Cassie Halls The SFMTA has had its fair share of ribbon-cutting ceremonies over the last two years. These celebrations draw attention to some of our biggest projects. Also attention-worthy are some of the more incremental efforts happening at the agency. One such effort led by the Muni Forward team is the Transit Delay Hot Spots Program , launched in February 2020 . Muni Forward is known for corridor projects such as the L Taraval Improvement Project , 16 th Street Improvement Project , and M Oceanview Transit and Safety Project . These efforts are increasing the already sizeable 80 miles of transit reliability upgrades since 2014. There are also other ways we’re working to slash travel times and improve reliability across the Muni network. The Transit Delay Hot Spots Program aims to tackle the 10 worst “delay hot spots” each year, where buses crawl between stops at four miles an hour or less. We’re looking cl...

Bus Testing on the New Van Ness BRT Corridor a Success

Bus Testing on the New Van Ness BRT Corridor a Success By Nehama Rogozen Muni and Golden Gate Transit staff recently conducted important bus operations testing that is an important step towards the Van Ness Bus Rapid Transit (BRT) corridor opening this spring. This testing included emergency turns and maneuvers, repositioning buses, verifying signals are working, clearances between passing buses and safe turns while bike racks are deployed. The training also included several staff. Traffic engineers made sure traffic and transit signals were working and reviewed street markings. Transportation planners coordinated closely with operations, training, engineering and construction staff to make necessary adjustments. Outreach staff and ambassadors answered questions and made sure customers knew testing was taking place. Field manager...

New top story from Time: Germany Has Officially Recognized Colonial-Era Atrocities in Namibia. But For Some, Reconciliation Is a Long Way Off

https://ift.tt/3fVRkaO The German government formally recognized colonial-era atrocities against the Herero and Nama people in modern-day Namibia for the first time, referring to the early 20th century massacres as “genocide” on Friday and pledging to pay a “ gesture to recognize the immense suffering inflicted.” “In light of the historical and moral responsibility of Germany, we will ask Namibia and the descendants of the victims for forgiveness,” said German Foreign Minister Heiko Maas in a statement , adding that the German government will fund projects related to “reconstruction and the development” of Namibia amounting to €1.1 billion ($1.3 billion). The sum will be paid out over 30 years and must primarily benefit the descendants of the Herero and Nama, Agence France-Presse reported . [time-brightcove not-tgx=”true”] Although it’s a significant step for a once colonial power to agree such a deal with a former colony, there’s skepticism among some experts and ob...

New top story from Time: A Conversation with Filmmaker Adam Curtis on Power, Technology and How Ideas Get Into People’s Heads

https://ift.tt/2NQRzcY The British filmmaker Adam Curtis may work for the BBC, a bastion of the British elite, but over a decades-long career, he has cemented himself as a cult favorite. He is best known as the pioneer of a radical and unique style of filmmaking, combining reels of unseen archive footage, evocative music, and winding narratives to tell sweeping stories of 20th and 21st century history that challenge the conventional wisdom. “I’ve never thought of myself as a documentary maker,” he says. “I’m a journalist.” On Feb. 11, Curtis dropped his latest epic: Can’t Get You Out of My Head , an eight hour history of individualism, split up over six episodes. Subtitled “An emotional history of the modern world,” the goal of the series, Curtis says, was to unpack how we came to live in a society designed around the individual, but where people increasingly feel anxious and uncertain. It’s a big question, and Curtis attempts to answer it by taking us on a winding journ...

New top story from Time: America’s War in Afghanistan Is Over. But in the Horn of Africa, its War On Terror Rages On

https://ift.tt/2ZEtko9 In a remote corner of eastern Africa, behind tiers of razor wire and concrete blast walls, it’s possible to get a glimpse of America’s unending war on terrorism. Camp Lemonnier, a 550-acre military base, houses U.S. special-operations teams tasked with fighting the world’s most powerful al-Qaeda affiliates. Unfolding over miles of sun-scorched desert and volcanic rock inside the tiny country of Djibouti, the base looks—the troops stationed here will tell you—like a sand-colored prison fortress. Inside, two subcamps sit behind opaque 20-ft. fences ringed with yet more razor wire. The commando teams emerge anonymously from behind the gates and board lumbering cargo planes to fly across Djibouti’s southern border with Somalia for what they call “episodic engagements” with local forces fighting al-Shabab , al-Qaeda’s largest offshoot. General Stephen Townsend, commander of military operations in Africa, describes it as “commuting to work.” The Pentagon has ...

New top story from Time: In New Zealand, ‘Hello’ Has Become ‘Kia Ora.’ Will That Save the Māori Language?

https://ift.tt/2LMKZ6a Kenny Williams began to study the Māori language during his second COVID-19 lockdown . Williams, 36, lives alone and the isolation made him yearn to feel closer to his identity as an indigenous New Zealander—an identity he had spent most of his childhood trying to hide. After he ordered some Māori language books, he found his studies helped him build a connection to his Māori history. “I didn’t know it was a gap that was missing in my life,” he says. It’s not just lockdown isolation—New Zealanders of all stripes are signing up to learn the language of the Māori people, New Zealand’s original inhabitants—“te reo Māori,” as it is widely called. But COVID-19 may have provided a boost: One university reported that 7,000 people accessed a free online Māori language and culture course in a 10-day period during lockdown. The New Zealand government has pledged to ensure 1 million residents are able to speak basic Māori by 2040—an effort to revive a langu...

New top story from Time: Here Are the 8 New Books You Should Read in October

https://ift.tt/3uBUac3 The best new books arriving this month dive deep into a range of topics, from a wrenching portrait of homelessness and poverty in America to the dissection of a marriage and its eventual unraveling. October welcomes the return of best-selling novelist Amor Towles as well as a posthumous book from British spy master John le Carré . Between thought-provoking nonfiction, thrilling examinations of fictional relationships and more, there’s something for everyone this month. Here, the best new books to read this October. Invisible Child: Poverty, Survival & Hope in an American City , Andrea Elliott (Oct. 5) [time-brightcove not-tgx=”true”] In her debut book, Pulitzer Prize-winning journalist Andrea Elliott tells the harrowing story of a girl’s coming-of-age against the backdrop of the homeless crisis in New York City. Invisible Child traces almost a decade of Dasani Coates’ life, beginning in 2012 when she lived in a Brooklyn shelter at 11 years old...

Take Muni’s Safety Survey!

Take Muni’s Safety Survey! By Greer Cowan Everyone should feel safe on Muni. Help make Muni safer by taking the SFMTA’s survey about personal safety and harassment in the Muni system. As part of the MuniSafe Safety Equity Initiative launched in August 2022, the SFMTA has partnered with the UCLA Institute of Transportation Studies to better understand Muni riders’ experiences and develop safety recommendations, tools and policies aimed at preventing harassment and assault on Muni. Take the 5-minute survey Survey information will also help the SFMTA understand Muni customers’ specific safety needs and challenges, and help us identify valuable trends and patterns so we know where, when and how harassment shows up in the Muni system. Incidents often go unreported, but the SFMTA is working to change that with new reporting options. As of October 2022, Muni customers can report incidents of harassment by calling 311, using the 311 mobile app or using t...

My precise view

Search This Blog