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Virus World provides a daily blog of the latest news in the Virology field and the COVID-19 pandemic. News on new antiviral drugs, vaccines, diagnostic tests, viral outbreaks, novel viruses and milestone discoveries are curated by expert virologists. Highlighted news include trending and most cited scientific articles in these fields with links to the original publications. Stay up-to-date with the most exciting discoveries in the virus world and the last therapies for COVID-19 without spending hours browsing news and scientific publications. Additional comments by experts on the topics are available in Linkedin (https://www.linkedin.com/in/juanlama/detail/recent-activity/)
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F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away - The New York Times

F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away - The New York Times | Virus World | Scoop.it
From www.nytimes.com - December 11, 2020 11:15 PM

An initial shipment of about 2.9 million doses of the vaccine will be sent around the United States over the next week. The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days.  The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks. The F.D.A.’s decision followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day. The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.

 

Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public. Every state, along with six major cities, has submitted to the federal government a list of locations — mostly hospitals — where the Pfizer vaccine is to ship initially. In populous Florida, the first recipients will be five hospitals, in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny, rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies. McKesson Corporation, a giant medical supplier, is sending kits of syringes, alcohol pads, face shields and other supplies to the same sites, where they will meet up with the vaccines that Pfizer is shipping in special boxes, packed with dry ice, designed to keep them at minus 94 degrees Fahrenheit. The Pfizer packaging will include a device that tracks the location of the box, plus a thermal probe that will make sure the deep freeze is maintained throughout the journey from the company’s distribution sites in Michigan and Wisconsin.

 

The decision is a victory for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago. Vaccines typically take years to develop. The companies’ late-stage clinical trial, which enrolled nearly 44,000 people, was found to be 95 percent effective. An expert panel advising the F.D.A. on Thursday gave its approval of Pfizer’s vaccine for people 16 and older, and the agency was planning to release the formal authorization on Saturday. That timeline was accelerated by half a day after President Trump attacked Dr. Hahn for failing to authorize a vaccine more quickly. But the accelerated announcement was not expected to speed up the delivery of vaccines around the country. Mr. Trump told Dr. Hahn on Twitter on Friday morning to “stop playing games and start saving lives!!!” He called the F.D.A. “a big, old, slow turtle,” flush with funds but mired in bureaucracy. Mr. Trump has repeatedly accused the F.D.A. and the drugmakers themselves of slow-walking the approval process in order to harm him politically. Allies of Dr. Hahn have been on tenterhooks for weeks, expecting him to be fired any day. The president wrote that with “my pushing,” the administration had shaved years off the development of vaccines. “Get the dam vaccines out NOW, Dr. Hahn,” he wrote, misspelling the expletive.  The threat to Dr. Hahn’s job was first reported by The Washington Post. In a statement, Dr. Hahn denied that Mr. Meadows told him he should consider seeking another job, calling it “an untrue representation of the phone call." Instead, Dr. Hahn said, his agency was “encouraged to continue working expeditiously.” Even though the F.D.A. was going to approve the Pfizer vaccine in any case, some experts warned that the pressure from the White House could undermine public trust in the agency’s decision-making...

 

FDA letter of Authorization (Dec. 11, 2020): 

https://www.fda.gov/media/144412/download

more...
raph's curator insight, January 31, 2023 8:03 AM

 

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Quando si tratta di questioni di salute, è fondamentale sapere quali sono le farmacie buone e cattive. Devi imparare cosa cercare in una farmacia per sapere se è quella giusta. Ricorda, hai a che fare con la vita, ecco perché devi stare attento a dove acquistare i tuoi farmaci e altre necessità farmaceutiche.


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Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine | Business Wire

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine | Business Wire | Virus World | Scoop.it
From www.businesswire.com - November 20, 2020 10:40 AM

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.

 

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” “Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

 

The companies have already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. In some cases, governments may have regulatory pathways similar to an EUA. The companies will be ready to distribute the vaccine candidate within hours after authorization.  Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making....

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