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martinelligi

How Pfizer Will Distribute Its Covid-19 Vaccine - The New York Times - 0 views

www.nytimes.com/...covid-vaccine-coronavirus.html

vaccine pandemic

shared by martinelligi on 12 Nov 20 - No Cached
  • Now the drug maker, the government and the public health community face a new challenge: quickly making millions of doses of the vaccine and getting them to the hospitals, clinics and pharmacies where they will be injected, two separate times, into people’s arms.
  • But Pfizer — like other manufacturers that may soon be authorized to roll out their vaccines — does not fully control its own destiny
  • Employees at those locations will need to be trained to store and administer the vaccine. They will also have to ensure that, four weeks after people get the vaccine, they return for a second dose. And millions of Americans must be persuaded to get the shots in the first place
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  • Even in normal times, mass-vaccination campaigns involve many moving parts within a vast network of suppliers, transporters and middlemen.
  • Nine other candidates are also in the final stage of testing. If any of those win approval from the F.D.A., that will reduce the importance of Pfizer’s vaccine but also introduce new questions, such as which hospitals and people get the different vaccines.
  • Pfizer has said it expects to be able to produce 50 million doses this year.
  • “We’re working very closely, in the U.S., in particular, with Operation Warp Speed to identify those distribution points,” Ms. Alcorn said, referring to the federal initiative to produce and distribute Covid-19 vaccines. “We don’t have them today.”
  • Representatives of UPS and FedEx said they had been planning to play a major role in distributing vaccines and were ready to go.Once the Pfizer coolers reach their destinations, hospitals or pharmacies will have a few choices of how to store the vaccine. The easiest option is using ultracold freezers, but not many sites have them. Otherwise, the facilities can stash the trays in conventional freezers for up to five days. Or they can keep the vials in the cooler for up to 15 days, so long as they replenish the dry ice and don’t open it more than twice a day.
  • Pfizer does not yet know where the government wants the vaccine sent or who will be first in line to receive it, said Ms. Alcorn, the supply-chain executive.
  • “If you’re talking about 12.5 million people, you’re going to have to make some very tough-minded decisions about who this goes to,” said J. Stephen Morrison, senior vice president at the Center for Strategic and International Studies, a research firm. “It’s a pretty small number of doses that are going to be distributed.”
  • For all the difficulties of making and distributing the vaccine, public health experts said the hardest part of the process could soon be complete.
  • One of the biggest early challenges may be distributing the vaccine in rural areas, which may not be able to administer doses quickly enough before they go bad. It isn’t clear how states with large rural populations are going to deal with this.
  • f Pfizer receives authorization for its vaccine from the Food and Drug Administration in the coming weeks, as expected, the company in theory could vaccinate millions of Americans by the end of the year, taking advantage of months of planning and decades of experience
  • So it was cause for celebration this week when Pfizer announced that an early analysis showed its vaccine candidate was more than 90 percent effective.
  • The effort will hinge on collaboration among a network of companies, federal and state agencies, and on-the-ground health workers in the midst of a pandemic that is spreading faster than ever through the United States.
  • Before Pfizer can begin shipping its vaccine, federal and state governments must tell it where to send how many doses. McKesson, a major medical supplier, will have to provide hospitals and other distribution sites with the syringes, needles and other supplies necessary to administer the vaccine.
  • The vaccine, developed with the German company BioNTech, has to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before it is injected
  • If an analysis planned for next week confirms the vaccine’s safety, the company is likely to ask the F.D.A. this month for emergency authorization to distribute its vaccine. In that case, limited doses will most likely be shipped to large hospitals and pharmacies to be provided to health care workers and other vulnerable groups.
  • Then there is the thorny question of who will receive vaccines first. That will be up to state governments.
  • The chief executives of Pfizer and BioNTech have suggested that half of those may go to the United States. Since each person needs two doses, about 12.5 million Americans could be vaccinated.
lmunch

Pfizer's Early Data Shows Coronavirus Vaccine Is More Than 90% Effective - The New York... - 0 views

www.nytimes.com/...covid-vaccine-pfizer.html

politics vaccine pfizer Trump pandemic culture Policy

shared by lmunch on 09 Nov 20 - No Cached
  • The drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19, a promising development as the world has waited anxiously for any positive news about a pandemic that has killed more than 1.2 million people.
  • The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection.
  • Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this month, after it has collected the recommended two months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people, company executives have said.
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  • Eleven vaccines are in late-stage trials, including four in the United States. Pfizer’s progress could bode well for Moderna’s vaccine, which uses similar technology. Moderna has said it could have early results later this month.
  • Operation Warp Speed, the federal effort to rush a vaccine to market, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government, which will be given to Americans free of charge. But Dr. Jansen sought to distance the company from Operation Warp Speed and presidential politics, noting that the company — unlike the other vaccine front-runners — did not take any federal money to help pay for research and development.
  • “We have always said that science is driving how we conduct ourselves — no politics,” she said.
  • Work on the vaccine began in Mainz, Germany, in late January, when Ugur Sahin, the chief executive and co-founder of BioNTech, read about the virus in the Lancet that filled him with dread. “I almost instantly knew that this would affect us,” Mr. Sahin said in an interview. That same day, the first European cases were detected, in France.Mr. Sahin assembled a 40-person team to work on the vaccine. Many employees canceled vacations and Mr. Sahin authorized overtime pay. They called it Project Lightspeed.
  • BioNTech used a technology that had never been approved for use in people. It takes genetic material called messenger RNA and injects it into muscle cells, which treat it like instructions for building a protein — a protein found on the surface of the coronavirus.
  • Even before it began, the Trump Administration placed a bet that Pfizer and BioNTech would succeed, announcing its advance purchase deal on July 22. At the time, it was the largest such commitment from the U.S. government.
  • As they descended toward a factory in Austria that would produce their vaccine, they discussed how to ensure a wary public would trust their vaccine. Days later, Pfizer organized an effort by major drug companies to pledge that any coronavirus vaccine would stand up to scientific scrutiny.
  • Wide distribution of Pfizer’s vaccine will be a logistical challenge. Because it is made with mRNA, the doses will need to be kept at ultra cold temperatures. While Pfizer has developed a special cooler to transport the vaccine, equipped with GPS-enabled thermal sensors, it remains unclear where people will receive the shots, and what role the government will play in distribution. Adding to the challenge, people will need to return three weeks later for a second dose to complete the immunization.
Javier E

Why Pfizer didn't report that its rheumatoid arthritis medication might prevent Alzheim... - 0 views

www.washingtonpost.com/...9-8bb7-0fc796cf2ec0_story.html

medication alzheimer Research ethics medical

shared by Javier E on 05 Jun 19 - No Cached
  • “I’m frustrated myself really by the whole thing,’’ said Clive Holmes, a professor of biological psychiatry at the University of Southampton in Great Britain who has received past support from Pfizer for Enbrel research in Alzheimer’s, a separate 2015 trial in 41 patients that proved inconclusive.
  • He said Pfizer and other companies do not want to invest heavily in further research only to have their markets undermined by generic competition. “Someone can pop up and say, ‘Look, I’ve got a me-too drug here,’ ’’ Holmes said, referring to the advent of generic versions of Enbrel. “I think that is what this is all about.’’
  • Drug companies often are criticized for extending the patent life of a drug — and winning new profits — by merely tweaking a drug’s molecule or changing the method of delivery into the body. But it is a “heavy lift’’ for a company to win regulatory approval to use a drug for a completely different disease, said Robert I. Field, a professor of law and health care management at Drexel University.
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  • “Our patent laws do not provide the appropriate incentives,’’ Field said. Drug therapy for early Alzheimer’s “would be a godsend for American patients, so we should be doing everything we can as a country to encourage development of treatments. It’s frustrating that there may be a missed opportunity.’’
  • Wagering money on a clinical trial of Enbrel for an entirely different disease, especially when Pfizer had doubts about the validity of its internal analysis, made little business sense, said a former Pfizer executive who was aware of the internal debate and spoke on the condition of anonymity to discuss internal Pfizer matters.
  • “It probably was high risk, very costly, very long term drug development that was off-strategy,’’ the former executive said.
  • “I think the financial case is they won’t be making any money off of it,’’ the second former executive said.
  • Drug companies frequently have been pilloried for not fully disclosing negative side effects of their drugs. What happens when the opposite is the case? What obligation does a company have to spread potentially beneficial information about a drug, especially when the benefits in question could improve the outlook for treating Alzheimer’s, a disease that afflicts at least 500,000 new patients per year?
  • A medical ethics expert argued that Pfizer has a responsibility to publicize positive findings, although it is not as strong as an imperative to disclose negative findings.
lmunch

Pfizer's Vaccine Offers Strong Protection After First Dose - The New York Times - 0 views

www.nytimes.com/...covid-vaccine-pfizer.html

politics US pfizer vaccine crisis pandemic

shared by lmunch on 08 Dec 20 - No Cached
  • The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group.
  • Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95 percent after two doses administered three weeks apart. The new analyses show that the protection starts kicking in far earlier.
  • What’s more, the vaccine worked well regardless of a volunteer’s race, weight or age. While the trial did not find any serious adverse events caused by the vaccine, many participants did experience aches, fevers and other side effects.
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  • Pfizer and BioNTech began a large-scale clinical trial in July, recruiting 44,000 people in the United States, Brazil and Argentina. Half of the volunteers got the vaccine, and half got the placebo.
  • Many experts have expressed concern that the coronavirus vaccines might protect some people better than others. But the results in the briefing materials indicate no such problem.
  • Even if the vaccine is authorized by the F.D.A., the trial will continue. In the briefing documents, the companies said that they would encourage people to stay in the trial as long as possible, not knowing whether they got the vaccine or the placebo, so that the researchers could continue to collect information about whether the vaccine was safe and effective.
  • The F.D.A. concluded that there were no “meaningful imbalances” in serious health complications, known as adverse events, between the two groups. The agency noted that four people in the vaccinated group experienced a form of facial paralysis called Bell’s palsy, with no cases in the placebo group. The difference between the two groups wasn’t meaningful, and the rate in the vaccinated group was not significantly higher than in the general population.
  • The new Pfizer analysis revealed that many volunteers who received the vaccine felt ill in the hours after the second dose, suggesting that many people might have to request a day off work or be prepared to rest until the symptoms subside. Among those between ages 16 and 55, more than half developed fatigue, and more than half also reported headaches. Just over one-third felt chills, and 37 percent felt muscle pain. About half of those over age 55 felt fatigued, one-third developed a headache and about one-quarter felt chills, while 29 percent experienced muscle pain.
rerobinson03

The UK Just Approved the Pfizer Covid Vaccine. What Happens Next? - The New York Times - 0 views

www.nytimes.com/...uk-covid-vaccine-pfizer.html

shared by rerobinson03 on 03 Dec 20 - No Cached
  • The first rigorously tested coronavirus vaccine was given a green light for use on Wednesday in Britain. Doses of the vaccine, made by the American pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected starting next week, the government said.
  • Rather than accepting the findings of vaccine makers, American regulators painstakingly reanalyze raw data from the trials to validate the results, poring over what regulators have described as thousands of pages of documents.
  • Regulators in Britain and elsewhere in Europe lean more heavily on companies’ own analyses. Instead of sifting through raw trial data and crunching the numbers themselves, regulatory agencies often will study a drugmaker’s reports and, unless there are anomalies, ground their decisions in company-provided documents.
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  • “In the U.K., they’ve just been able to say, ‘We have the data, we’re having the meeting,’” said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.
  • To speed the process, Britain’s Medicines and Healthcare Products Regulatory Agency had its experts review vaccine data as it became available, and separate teams worked in parallel on different parts of the process, rather than one waiting for another to finish.
  • The countries that remain in the European Union are waiting for its regulator, the European Medicines Agency, to authorize a vaccine. Like the F.D.A., the European regulator has scheduled a Dec. 29 meeting to consult outside experts and offer an opinion on the Pfizer vaccine.
  • Pfizer plans to ship 800,000 doses to Britain in the coming days. Starting Tuesday night, those doses were being prepared for shipping at a factory in Puurs, Belgium, BioNTech said.
  • A government advisory body released its list of vaccine priority groups on Wednesday. At the top of the list are nursing home residents and workers, followed by people older than 80 and health and social care workers.
  • The British decision will not in itself bring vaccinations closer anywhere else. But Pfizer executives said on Wednesday that they had already heard from other countries that, in light of Britain’s go-ahead, were looking to accelerate their own approval processes.American regulators, despite months of pressure from Mr. Trump, have maintained that they will follow their plan and review Pfizer’s vaccine to the F.D.A.’s standards.
  • The United States has pre-ordered 100 million doses of the Pfizer vaccine.
mariedhorne

Will Pfizer's Vaccine Be Ready in October? Here's Why That's Unlikely. - The New York T... - 0 views

www.nytimes.com/...pfizer-covid-vaccine.html

coronavirus crisis vaccine

shared by mariedhorne on 01 Oct 20 - No Cached
  • “Right now, our model — our best case — predicts that we will have an answer by the end of October,” the chief executive, Dr. Albert Bourla, told the “Today” show earlier this month. In other interviews, he has said he expected a “conclusive readout” by then, with an application for emergency authorization that could be filed “immediately.”
  • Day, Nov. 3. “We’re going to have a vaccine very soon. Maybe even before a very special date,” Mr. Trump said recently.
  • By repeating a date that flies in the face of most scientific predictions, Dr. Bourla is making a high-stakes gamble. If Pfizer puts out a vaccine before it has been thoroughly tested — something the company has pledged it will not do — it could pose a major threat to public safety. The perception matters, too: If Americans see the vaccine as having been rushed in order to placate Mr. Trump, many may refuse to get the shot.
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  • “There’s a huge financial advantage to being first out of the gate,” said Dr. Megan Ranney, an associate professor of emergency medicine and public health at Brown University. She was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.
  • The F.D.A. has also told vaccine makers that they will need to track at least half of the patients’ safety data for two months before the agency will grant emergency access. That would push the earliest possible date into at least November.
  • Participants in Pfizer’s trial are given two doses of a vaccine 21 days apart, whereas those in Moderna’s wait 28 days in between. Pfizer begins looking for sick volunteers seven days after the second dose, whereas Moderna does so at 14 days. And Pfizer’s plan allows an outside review panel to look at early data after just 32 volunteers have become ill with Covid-19. Moderna’s plan doesn’t allow for a first peek until 53 cases.
  • Ultimately, Pfizer’s strategy may be about managing the public’s expectations, said Brandon Barford, a partner at Beacon Policy Advisors, a research firm. Pfizer could now explain any delay past October by “saying, ‘We’re being extra cautious.’ And you get kudos for it.”But if the opposite occurs, and Pfizer is seen to be pushing a vaccine before it is ready, the “potential fallout is enormous,” said Dr. Ranney, of Brown University. “We cannot afford to have a vaccine released for Covid-19 that is either unsafe or ineffective.”
carolinehayter

Some Vials Of COVID-19 Vaccine Contain Extra Doses, Expanding Supply, FDA Says : Corona... - 0 views

www.npr.org/...n-extra-doses-expanding-supply

Science politics us trump culture policy pandemic vaccine

shared by carolinehayter on 17 Dec 20 - No Cached
  • The Food and Drug Administration says that some of the vials of Pfizer-BioNTech COVID-19 vaccine being distributed throughout the U.S. contain extra doses and the agency is encouraging hospitals and clinics to use the additional shots to speed up the nationwide immunization campaign.
  • The agency issued the guidance Wednesday after health care workers reported throwing out the excess vaccine, fearing it would be against the rules to use it. "At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable
  • As health care workers prepared for the vaccine's arrival, they expected to receive vials holding five doses. That left many surprised by the overfilled containers.
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  • Permission to use the additional portions means the limited supply could increase by up to 40%, Politico reported.
  • Leading health experts say that even if all goes well, the vaccine will not be available to the general public until the end of March or beginning of April.
  • Inoculations began in the U.S. on Monday with health care workers and the elderly being the first in line to get it.
  • Meanwhile, The New York Times reported that a second allotment of the Pfizer-BioNTech vaccine may not be available to the U.S. until next June, given the combination of short supply and global demand.
  • "It's pretty unusual to have a full extra dose or more though — but it does seem to be there!" Erin Fox, a pharmacist at University of Utah who monitors drug shortages, told the news outlet.
  • However, because there are no preservatives in the vaccines, partial doses from separate vials shouldn't be combined.
  • There are conflicting reports about when the U.S. is poised to receive another batch of the medicine from Pfizer.
  • A vaccine developed by Moderna is expected to get emergency use authorization from the FDA as early as this week. Clinical data shows it is nearly as effective as the Pfizer injections.
  • Dr. Anthony Fauci, the nation's senior official for infectious diseases, told NPR this week that half of all Americans would need to be vaccinated before seeing an impact on the spread of the virus, and that 75% to 85% of the population would need to be vaccinated to create herd immunity. He predicted the U.S. could begin to see early stages of herd immunity by late spring or summer.
mimiterranova

Pfizer And Moderna Make Progress On COVID-19 Vaccine Goals : Shots - Health News : NPR - 0 views

www.npr.org/...o-hit-vaccine-production-goals

pfizer vaccine progress health Pandemic

shared by mimiterranova on 12 Mar 21 - No Cached
  • President Biden's promise that there will be enough vaccines for every U.S. adult by the end of May has some Americans wondering if it's too good to be true.
  • Nearly 64 million Moderna doses and 61 million Pfizer doses had been distributed as of Wednesday afternoon. The first doses went out shortly after the Food and Drug Administration authorized the vaccines for emergency use in December.
  • Help has included using the Defense Production Act, a wartime power both Biden and former President Donald Trump have used to speed vaccine manufacturing. The Biden administration also helped Pfizer obtain equipment that it couldn't get during the Trump administration.
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  • "That's in an ideal situation," said Baylor, now president and CEO of Biologics Consulting. "But there could be fluctuations . . . So it doesn't mean that there are catastrophic issues, but it does mean that something has — most likely in the manufacturing process, could be in testing — something has delayed that entire manufacturing process to miss the mark."
  • "So much of drug manufacturing and vaccine manufacturing is pretty opaque. We don't ... have a lot of visibility there,"
  • There one's other wrinkle worth noting. Pfizer and Moderna only need to "release" the doses to the government to fulfill their contractual obligations, meaning the doses don't have to leave the factories to be counted toward the commitment. The companies just have to say they're ready to go for distribution. So the companies can hit their contractual targets before the doses are delivered to vaccination sites.
katherineharron

Here's what we know about Pfizer's vaccine - CNN - 0 views

www.cnn.com/...index.html

covid

shared by katherineharron on 13 Dec 20 - No Cached
  • A US Centers for Disease Control and Prevention advisory committee has voted to recommend the Pfizer and BioNTech Covid-19 vaccine for people 16 and older a day after the US Food and Drug Administration issued emergency use authorization (EUA) for the vaccine.
  • CDC Director Dr. Robert Redfield must accept the committee's recommendation before the vaccine can be administered. But on Sunday morning, the first shipments had left a Pfizer plant in Michigan, bound for all 50 states.
  • Once the CDC accepts the recommendation, vaccinations can begin.
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  • This CDC advisory group had previously recommended that health care workers and residents of long-term care facilities should be the first to receive a vaccine when it receives EUA. The first shipments of the vaccine will be limited, so states will have to prioritize who should receive the vaccine first.
  • Keeping doctors and nurses healthy will be important for the continuing fight against the virus, which will stretch on for months, even after a vaccine is authorized. But Romero said that first group includes other people working in health care institutions, like those who deliver food and perform housekeeping.
  • Residents of long-term care facilities like nursing homes also need the protection. So far, they account for about 40% of coronavirus deaths in the US.
  • "I would project by the time you get to April, it will be ... 'open season,' in the sense of anyone, even the non-high priority groups could get vaccinated," Fauci said.
  • "We'll be in facilities that day in states that choose to begin as soon as possible," spokesman Ethan Slavin said.
  • The FDA is set to make a decision on a separate vaccine candidate by Moderna in the coming days
  • it's possible that 20 million people could get vaccinated in the next several weeks
  • Phase 1a would be followed by Phases 1b and 1c, which could include essential workers at high risk of infection, other emergency personnel and people with underlying conditions who are at a higher risk of Covid-19 complications and death.
  • Army Gen. Gustave Perna, chief operating officer of the federal government vaccine initiative Operation Warp Speed, previously said he believed vaccine administration will be able to begin vaccinations within 96 hours of authorization.
  • In the meantime, it's important that people continue to wear masks and social distance. JUST WATCHEDDr. Fauci explains importance of vaccine approval processReplayMore Videos ...MUST WATCH Play</
  • It's important to note, however, that Pfizer's vaccine requires two doses administered several weeks apart to reach 95% efficacy. So 100 million doses would vaccinate half the number of people.
  • Azar said earlier this month that 6.4 million doses of Pfizer vaccine would be allocated for shipment the first week. The initial shipment would include half of the doses, followed by the second half three weeks later.
  • Slaoui said he believes most doses will be injected within three to four days, but after that, "I think it will take a week."
  • The first shipments of the vaccine departed a Pfizer plant in Michigan on Sunday morning. A total of 189 boxes of vials are expected to arrive in all 50 states Monday. Another 3,900 vials are expected to ship later Sunday to US territories. Another 400 boxes packed with about 390,000 vials are expected to ship Monday and arrive at their destinations on Tuesday.
  • The vaccines will then be flown across the country, and the Federal Aviation Administration has said its air traffic controllers will prioritize flights carrying the vaccines.
  • But Pfizer's vaccine needs to be stored at incredibly cold temperatures, making the logistics of delivery even more complicated.
  • According to a briefing document released by the FDA's vaccine advisory committee, the most common side effects were reactions at the point of injection on the body, fatigue, headache, muscle pain, chills, joint pain and fever.
  • Health authorities in the UK, where the vaccine roll out began earlier this week, said Wednesday that people with "significant history of allergic reactions" should not receive the vaccine. The advice came after two health care workers "responded adversely" following their shots.
katherineharron

Potential coronavirus vaccine being tested in Germany could 'supply millions' by end of... - 0 views

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shared by katherineharron on 29 Apr 20 - No Cached
  • A German company working with US pharmaceutical giant Pfizer has begun human trials of a potential Covid-19 vaccine that could supply millions by the end of the year, according to the two firms.
  • "Twelve study participants have been vaccinated with the vaccine candidate BNT162 in Germany since the start of the study on April 23, 2020," the company said in a statement.
  • Pfizer and BioNTech plan to initiate trials for BNT162 in the US on regulatory approval, expected shortly, the statement said.
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  • "The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in Europe and the U.S., across multiple research sites," Pfizer announced in its first quarter report, published online Tuesday.
  • Pfizer isn't the only group with a potential Covid-19 vaccine in the works. Last week, scientists at Oxford University's Jenner Institute in the United Kingdom began testing its vaccine on humans Thursday and, depending on the trial results, could be ready as early as September. Officials say that more than a half-dozen vaccine programs are in the clinical trial phase and more than 80 are in preliminary phases.
martinelligi

Covid-19 News: Live Updates - The New York Times - 0 views

www.nytimes.com/...covid-19-coronavirus

news new york times pandemic

shared by martinelligi on 30 Nov 20 - No Cached
  • The drugmaker Moderna said it would apply on Monday to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use.
  • Moderna’s application is based on data that it also announced on Monday, showing that its vaccine is 94.1 percent effective, and that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works.
  • The new data also showed that the vaccine was 100 percent effective at preventing severe disease from the coronavirus.
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  • Mr. Bancel said the company was “on track” to produce 20 million doses by the end of December, and 500 million to a billion in 2021. Each person requires two doses, administered a month apart, so 20 million doses will be enough for 10 million people.
  • Moderna is the second vaccine maker to apply for emergency use authorization; Pfizer submitted its application on Nov. 20. Pfizer has said it can produce up to 50 million doses this year, with about half going to the United States.
  • Meanwhile, federal officials have urged Americans returning from Thanksgiving travel to reduce unnecessary activity.
  • Speaking on “CBS This Morning” on Monday, Alex M. Azar II, the secretary of the Department of Health and Human Services, reiterated that distribution would begin quickly after the expected approvals of the Pfizer and Moderna vaccines. “We could be seeing both of these vaccines out and getting into people’s arms before Christmas,” he said.
  • Moderna has received a commitment of $955 million from the U.S. government’s Biomedical Advanced Research and Development Authority for research and development of its vaccine, and the United States has committed up to $1.525 billion to buy 100 million doses.
  • Asked about the role of states in the distribution process, Mr. Azar said that doses would be shipped out through normal vaccine distribution systems, and governors would be “like air traffic controllers” determining which hospitals or pharmacies receive shipments.
  • But generally, “Be thinking people in nursing homes, the most vulnerable, be thinking health care workers who are on the front lines,” he said.
  • More than 70 vaccines are being developed around the world, including 11 that, like Pfizer’s and Moderna’s vaccines, are in large-scale trials to gauge effectiveness.
  • F.D.A. scientists will examine the information, and the application is likely to undergo a final review on Dec. 17 by a panel of expert advisers to the agency, Mr. Bancel said, adding that he expected the advisers to make a decision within 24 to 72 hours. The F.D.A. usually follows the recommendations of its advisory panels.
  • The government has arranged to buy vaccines from both Moderna and Pfizer and to provide it to the public free of charge.
  • If authorization is granted, the first shots could be given as early as Dec. 21.
  • In response to a question about how officials can guard against people using money or connections to jump the proverbial line, Mr. Azar vowed to “call out any inequities or injustices that we see.”
  • The drugmaker Moderna said it would apply on Monday to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use.
  • The first injections may be given as early as Dec. 21 if the process goes smoothly and approval is granted, Stéphane Bancel, the company’s chief executive, said in an interview.
  • Moderna’s application is based on data that it also announced on Monday, showing that its vaccine is 94.1 percent effective, and that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The finding from the complete set of data is in line with an analysis of earlier data released on Nov. 16 that found the vaccine to be 94.5 percent effective.
  • The first shots of the two vaccines are likely to go to certain groups, including health care workers, essential workers like police officers, people in other critical industries and employees and residents in nursing homes. On Tuesday, a panel of advisers to the Centers for Disease Control and Prevention will meet to determine how to allocate initial supplies of vaccine.
  • According to Transportation Safety Administration data, about 800,000 to one million people passed through T.S.A. checkpoints each day in the days before and after the holiday — far lower than the same period last year, but likely far higher than epidemiologists had hoped to see.
  • There were 91,635 current hospitalizations as of Nov. 28, according to the Covid Tracking Project, almost twice as many as there were on Nov. 1, and triple the number on Oct. 1.
  • California on Sunday became the first state to report over 100,000 cases in a week, according to a New York Times database.
katherineharron

US Coronavirus: Daily deaths from Covid-19 just exceeded the deaths from 9/11 on this b... - 0 views

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covid

shared by katherineharron on 10 Dec 20 - No Cached
  • The United States should be celebrating a day of great hope today, as a Covid-19 vaccine could get authorized for emergency use very soon.
  • Vaccine advisers for the US Food and Drug Administration are meeting Thursday to discuss the Pfizer/BioNTech vaccine.
  • That's more deaths than those suffered in the 9/11 attacks.
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  • A new composite forecast from the US Centers for Disease Control and Prevention projects a total of 332,000 to 362,000 Covid-19 deaths by January 2.
  • Covid-19 hospitalizations also reached a new record high of 106,688 on Wednesday, according to the COVID Tracking Project.
  • more than 221,000 new infections were reported in just one da
  • "We are in a totally unprecedented health crisis in this country,"
  • Health care workers are exhausted. Hospitals are totally full."
  • "Unfortunately, with the volume of new cases that we are seeing and the implications it has on hospital utilization, during a period of widespread, community transmission, activities such as eating, drinking and smoking in close proximity to others, should not continue."
  • If the FDA grants emergency use authorization in the coming days, the first Americans outside of clinical trials could start getting inoculated this month.
  • in the coming months it's crucial that Americans stay vigilant and follow safety guidelines, like wearing face masks, social distancing and hunkering down in their social bubbles.
  • But the country will likely not see any meaningful impact until well into 2021 -- and that's if enough people get vaccinated, said Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases.
  • "Let's say we get 75%, 80% of the population vaccinated. I believe if we do it efficiently enough over the second quarter of 2021, by the time we get to the end of the summer ... we may actually have enough herd immunity protecting our society that as we get to the end of 2021, we could approach very much, some degree of normality that is close to where we were before,"
  • "We want to make sure that the vaccines are actually administered, and we're afraid that won't happen," Paul Ostrowski, who is leading supply, production and distribution for Operation Warp Speed, told "Good Morning America" Wednesday.
  • "Baltimore City has not had to implement such severe restrictions since the very earliest days of the pandemic and the implementation of the stay-at-home order," the city's health department tweeted.
  • The daily death toll from Covid-19 reached a record high of 3,124 Wednesday, according to Johns Hopkins University.
  • Indiana's Republican Gov. Eric Holcomb ordered hospitals to postpone or reschedule non-emergency procedures done in an inpatient hospital setting from December 16 through January 3 to preserve hospital capacity.
  • In Alabama, Republican Gov. Kay Ivey announced Wednesday she's extending the state's Safer at Home order, which includes a statewide mask mandate for another six weeks.
  • About 53% of respondents said they would get the vaccine promptly -- up from 51% before Thanksgiving and 38% in early October.
  • The first emergency use authorization for a vaccine is expected soon, and about 20 million people could likely get vaccinated in the next few weeks, Secretary of Health and Human Services Alex Azar said Wednesday.
  • In the UK, "thousands" of people were already vaccinated Tuesday, the first day of the Pfizer/BioNTech vaccine rollout there, according to the National Health Service (NHS).
  • The FDA will not "cut any corners" when deciding whether to authorize the vaccine, Azar said, saying he was sure what happened in the UK would be "something the FDA looks at."
  • "For now, we need to double down on the steps that can keep us all safe."
ethanshilling

Pfizer Begins Testing Its Vaccine in Young Children - The New York Times - 0 views

www.nytimes.com/...ldren-vaccinations-pfizer.html

world pandemic vaccine

shared by ethanshilling on 25 Mar 21 - No Cached
  • Pfizer has begun testing its Covid-19 vaccine in children under 12, a significant step in turning back the pandemic. The trial’s first participants, a pair of 9-year-old twin girls, were immunized at Duke University in North Carolina on Wednesday.
  • Moderna also is beginning a trial of its vaccine in children six months to 12 years of age. Both companies have been testing their vaccines in children 12 and older, and expect those results in the next few weeks.
  • AstraZeneca last month began testing its vaccine in children six months and older, and Johnson &amp; Johnson has said it plans to extend trials of its vaccine to young children after assessing its performance in older children.
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  • Immunizing children will help schools to reopen as well as help to end the pandemic, said Dr. Emily Erbelding, an infectious diseases physician at the National Institutes of Health who oversees testing of Covid-19 vaccines in special populations.
  • Children under 18 account for about 23 percent of the population in the United States, so even if a vast majority of adults opt for vaccines, “herd immunity might be hard to achieve without children being vaccinated,” Dr. Erbelding said.
  • Scientists will test three doses of the Pfizer vaccine — 10, 20 and 30 micrograms — in 144 children. Each dose will be assessed first in children 5 through 11 years of age, then in children ages 2 through 4 years, and finally in the youngest group, six months to 2 years.
  • “It sounds like a good plan, and it’s exciting that another Covid-19 vaccine is moving forward with trials in children,” said Dr. Kristin Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York.
  • More than 3.3 million children have tested positive for the virus, at least 13,000 have been hospitalized and at least 260 have died, noted Dr. Yvonne Maldonado, who represents the American Academy of Pediatrics on the federal Advisory Committee on Immunization Practices.
  • Children often react more strongly to vaccines than adults do, and infants and toddlers in particular can experience high fevers.
  • “But this is a little different, because we’ve already had experience with tens of millions of people with these vaccines,” Dr. Maldonado said. “So there’s a higher degree of confidence now in giving this vaccine to kids.”
  • Parents will want to know how the companies and the F.D.A. plan to monitor and disclose side effects from the vaccines, and how long they will continue to follow trial participants after the vaccines’ authorization, Dr. Oliver said.
katherineharron

Ongoing trial shows Pfizer Covid-19 vaccine remains highly effective after six months -... - 0 views

www.cnn.com/...index.html

covid

shared by katherineharron on 01 Apr 21 - No Cached
  • The ongoing Phase 3 clinical trial of Pfizer/BioNTech's coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday.
  • The question of how long vaccine protection lasts can only be answered once enough time has passed, and while six months of protection is a modest target, it's longer than previously known.
  • The vaccine remains more than 91% effective against disease with any symptoms for six months, the companies said.
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  • "The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA)," Pfizer and BioNTech said in a joint statement.
  • volunteers aged12 to 15 showed 100% efficacy in that age group.
  • "These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," Albert Bourla, Pfizer's chairman and chief executive officer, said in a statement. A BLA is an application for full approval. The vaccine currently has emergency use authorization, EUA, which falls short of full approval.
  • he company has been studying the vaccine in more than 46,000 volunteers and has noted 927 cases of confirmed Covid-19."From the 927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group, corresponding to vaccine efficacy of 91.3%," it said.
  • "Thirty-two cases of severe disease, as defined by the CDC, were observed in the placebo group versus none in the BNT162b2 vaccinated group, indicating that the vaccine was 100% efficacious in this analysis against severe disease by the CDC definition. Twenty-one cases, as defined by the FDA, were observed in the placebo group versus one case in the BNT162b2 vaccinated group, indicating 95.3% efficacy by the FDA definition."
  • he FDA's definition of severe disease included a raised respiratory rate indicating respiratory distress; raised heart rate, an oxygen saturation level of 93% or lower; respiratory failure severe enough to need additional oxygen or ventilation; a blood pressure drop indicating shock; significant kidney, liver or neurological dysfunction, admission to an intensive care unit or death.
  • CDC's definition includes a blood oxygen level of 94% or lower and an x-ray finding of lung infiltrates -- an indication of pneumonia -- of greater than 50%
  • "In South Africa, where the B.1.351 lineage is prevalent and 800 participants were enrolled, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%," the company said.
mattrenz16

Covid-19 Global News: Live Updates on Vaccine, Cases and Moderna - The New York Times - 0 views

www.nytimes.com/...covid-vaccine-coronavirus-mask

shared by mattrenz16 on 25 May 21 - No Cached
  • Moderna said on Tuesday that its coronavirus vaccine, authorized only for use in adults, was powerfully effective in 12- to 17-year-olds, and that it planned to apply to the Food and Drug Administration in June for authorization to use the vaccine in adolescents.
  • If approved, its vaccine would become the second Covid-19 vaccine available to U.S. adolescents. Federal regulators authorized the Pfizer-BioNTech vaccine this month for 12- to 15-year-olds.
  • Proof of the vaccines’ efficacy and safety for adolescents is helping school officials and other leaders as they plan for the fall. On Monday, Mayor Bill de Blasio said that all public school students in New York City, the largest school system in the United States, would return to in-person learning in the fall.
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  • The Moderna results, which the company announced in a statement, are based on a clinical trial that enrolled 3,732 people ages 12 to 17, two-thirds of whom received two vaccine doses. There were no cases of symptomatic Covid-19 in fully vaccinated adolescents, the company reported. That translates to an efficacy of 100 percent, the same figure that Pfizer and BioNTech reported in a trial of their vaccine in 12- to 15-year-olds.
  • Moderna also reported that a single dose of its vaccine had 93 percent efficacy against symptomatic disease.
  • The results were announced in a news release that did not contain detailed data from the clinical trial. And Dr. Rasmussen said that the vaccines’ efficacy can be trickier to evaluate in children, who are less likely to develop symptomatic disease than adults.
Javier E

Mexico says it's OK with getting less Pfizer vaccine for now - The Washington Post - 0 views

www.washingtonpost.com/...b-a849-6f9423a75ffd_story.html

mexico vaccine morality priority rich countries

shared by Javier E on 18 Jan 21 - No Cached
  • President Andrés Manuel López Obrador said Sunday that his government has agreed with a U.N. proposal to delay shipments of the Pfizer coronavirus vaccine to countries like Mexico that had exiting purchase agreements, in order to get more doses to poorer countries quicker.
  • López Obrador criticized wealthier countries that have stockpiled large amounts of vaccines but have not used them.
  • Mexico has so far received almost a half million doses of the Pfizer vaccine and used nearly all of them.
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  • “We are going to have more authority and rights than those who get vaccines and don’t administer them, who keep them frozen, as is happening in some countries in Europe,
  • Teams vaccinating front-line health care workers in Mexico have administered about 463,000 shots so far, far short of the country’s total of 750,000 such workers, each of whom will require two doses.
  • Mexico has now seen over 1.64 million total infections and registered over 140,000 deaths so far in the pandemic. With the country’s extremely low testing rate, official estimates suggest the real death toll is closer to 195,000.
mariedhorne

Europe's Covid-19 Vaccination Campaign Off to Slow, Uneven Start - WSJ - 0 views

www.wsj.com/...-slow-uneven-start-11610015400

coronavirus pandemic vaccine

shared by mariedhorne on 19 Jan 21 - No Cached
  • France has inoculated more than 45,000 people in more than two weeks since European regulators authorized the first coronavirus vaccine, made by Pfizer Inc. and BioNTech SE. Belgium launched mass vaccinations on Tuesday, while the Netherlands gave its first inoculations on Wednesday. Vaccinations in Italy stalled over the holidays and have recently started to pick up.
  • The U.S. has vaccinated more than five million people, the U.K. more than one million and Germany around 417,000. Israel has inoculated at least 16% of its population with the Pfizer-BioNTech vaccine.
  • “We lacked that kind of flexibility in our approach,” Mr. Rutte said. Dutch health-care workers started being inoculated as of Wednesday morning, with the government planning to increase vaccination to more than 60,000 a week.
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  • France is aiming to give 15 million people two vaccine doses by July 1, though it has placed orders for enough doses to vaccinate 27 million by then, officials said.
  • The French authorities are facing a population that is among the world’s most skeptical of vaccines. In a global Ipsos poll conducted in December, just 40% of French respondents said they wanted the vaccine, the lowest acceptance rate among the poll’s 15 countries, which also included the U.S., Germany and China.
  • On Wednesday, about 61,000 people were vaccinated, according to government figures. Italy must vaccinate about 300,000 people a day until April 1 to reach the government’s goal of having 13 million of the country’s 60 million residents vaccinated with the second shot at that point.
  • The European Commission is in talks with Pfizer to buy additional doses, on top of the existing order of 300 million doses that would inoculate a third of the bloc’s 450 million people. The commission has also preordered 160 million doses of Moderna Inc.’s vaccine, which the EU’s main drug regulator cleared for use on Wednesday.
Javier E

Single Covid vaccine dose in Israel 'less effective than we thought' | Israel | The Gua... - 0 views

www.theguardian.com/...l-less-effective-than-we-hoped

vaccine covid research israel

shared by Javier E on 22 Jan 21 - No Cached
  • Israel’s coronavirus tsar has warned that a single dose of the Pfizer/BioNTech vaccine may be providing less protection than originally hoped
  • In remarks reported by Army Radio, Nachman Ash said a single dose appeared “less effective than we had thought”, and also lower than Pfizer had suggested.
  • By contrast, those who had received their second dose of the Pfizer vaccine had a six- to 12-fold increase in antibodies,
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  • The issue of some vaccines being less effective after a single dose rather than two is well known, as well as the fact that protection is not immediate. While the first dose can take several weeks to promote an effective antibody response, the second dose can trigger different responses, supercharging the protection. Pfizer itself says a single dose of its vaccine is about 52% effective.
  • Questions over the effectiveness of the vaccine were raised amid reports that thousands of Israelis were still becoming sick after receiving the vaccine, although the public health services head, Sharon Alroy-Preis, said that in most cases this was because the individuals had not built up sufficient antibodies after being inoculated before being exposed to the virus.
rerobinson03

Early Data Show Moderna's Coronavirus Vaccine Is 94.5% Effective - The New York Times - 0 views

www.nytimes.com/...Covid-moderna-vaccine.html

shared by rerobinson03 on 16 Nov 20 - No Cached
  • The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.
  • Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.
  • “I had been saying I would be satisfied with a 75 percent effective vaccine. Aspirationally, you would like to see 90, 95 percent, but I wasn’t expecting it. I thought we’d be good, but 94.5 percent is very impressive.”
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  • Both companies said they expected to apply within weeks to the F.D.A. for emergency authorization to begin vaccinating the public. In addition to the evidence for effectiveness, the companies must also submit two months of safety data on at least half of the participants.
  • An additional concern is that both vaccines must be stored and transported at low temperatures — minus 4 degrees Fahrenheit for Moderna, and minus 94 Fahrenheit for Pfizer — which could complicate their distribution, particularly to low-income areas in hot climates.
  • Researchers say the positive results from Pfizer and Moderna bode well for other vaccines, because all of the candidates being tested aim at the same target — the so-called spike protein on the coronavirus that it uses to invade human cells.
  • The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, joining Pfizer as a front-runner in the global race to contain a raging pandemic that has killed 1.2 million people worldwide.
  • the Trump administration’s program to accelerate development of vaccines and treatments for Covid-19, said that if any early vaccine candidates received permission for emergency use, immunization could begin sometime in December.
  • Both companies plan to apply within weeks to the Food and Drug Administration for emergency authorization to begin vaccinating the public
  • But a vaccine that would be widely available to the public is still months away, while the need for one is becoming increasingly urgent
  • Covid-19 is killing more than 1,100 Americans a day, and the last million cases occurred in just six days.
  • This vaccine presents the opportunity of using doctors’ offices, clinics and pharmacies as vaccination sites,” he said, adding that he would not be surprised, should both vaccines become available, if vaccination sites requested Moderna’s.
  • Moderna said it would have 20 million doses ready by the end of 2020
  • Moderna is the second company to report preliminary results from a large trial testing a vaccine. But there are still months to go before it will be widely available to the public.
  • The company announced on Oct. 22 that it had completed enrollment of its 30,000-person study, and that 25,650 participants had already received two shots.
  • Moderna has received a commitment of $955 million from the U.S. government’s Biomedical Advanced Research and Development Authority for research and development of its vaccine, and the United States has committed up to $1.525 billion to buy 100 million doses.
rerobinson03

Opinion | Don't Get Too Excited About the Coronavirus Vaccine - The New York Times - 0 views

www.nytimes.com/...coronavirus-vaccine.html

shared by rerobinson03 on 10 Nov 20 - No Cached
  • To make the situation concrete, let’s consider the upcoming Thanksgiving holiday. With cases growing rapidly around the country, especially in the northern Midwest, indoor social gatherings are more dangerous than at any point since the spring. Thanksgiving dinners are ideal settings for “superspreader” events: They crowd people from all over around a table to talk, laugh and drink, often in poorly ventilated rooms. Many families stuff themselves into houses for an entire long weekend.
  • To make the situation concrete, let’s consider the upcoming Thanksgiving holiday. With cases growing rapidly around the country, especially in the northern Midwest, indoor social gatherings are more dangerous than at any point since the spring. Thanksgiving dinners are ideal settings for “superspreader” events: They crowd people from all over around a table to talk, laugh and drink, often in poorly ventilated rooms. Many families stuff themselves into houses for an entire long weekend.
  • The announcement that Pfizer’s coronavirus vaccine is more than 90 percent effective at preventing Covid-19 infections — much better than many anticipated — is cause for celebration. With a vaccine of this efficacy, suppression of the disease is entirely realistic.
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  • Unfortunately, this development doesn’t mean we can all relax and start doing more things. It means we need to tighten up even further until the vaccine becomes available.
  • The goal is now no longer to learn to live indefinitely with the virus. It’s to get as many people through the winter as possible without getting sick.
  • It’s always been hard to convince people to make good choices when considering sacrifices. Uncertainty around when we’d get an effective vaccine made it even harder. Cutting off in-person interactions for an uncertain stretch of time was excruciating. But it may be more palatable to hunker down if it’s only for a defined period.
  • And the costs are not just financial; mental health is at risk as well as physical health as people forgo care, including self-care, to remain free from infection. All of that becomes easier to swallow if it’s for a shorter period of time.
  • Cutting off in-person interactions for an uncertain stretch of time was excruciating. But it may be more palatable to hunker down if it’s only for a defined period.
  • The calculus is very different, however, if a vaccine is around the corner. While Pfizer’s still needs to be approved, manufactured and distributed, the company estimates that 50 million doses could be distributed before the end of the year. Another 1.3 billion would come in 2021. If other vaccines also show success, relief could come as soon as the spring.
  • While Pfizer’s still needs to be approved, manufactured and distributed, the company estimates that 50 million doses could be distributed before the end of the year. Another 1.3 billion would come in 2021. If other vaccines also show success, relief could come as soon as the spring.
  • The point generalizes. Without question, the sacrifices required to keep us safe from Covid-19 are costly. And the costs are not just financial; mental health is at risk as well as physical health as people forgo care, including self-care, to remain free from infection. All of that becomes easier to swallow if it’s for a shorter period of time.
  • To make the situation concrete, let’s consider the upcoming Thanksgiving holiday. With cases growing rapidly around the country, especially in the northern Midwest, indoor social gatherings are more dangerous than at any point since the spring. Thanksgiving dinners are ideal settings for “superspreader” events: They crowd people from all over around a table to talk, laugh and drink, often in poorly ventilated rooms. Many families stuff themselves into houses for an entire long weekend.
  • Pfizer’s announcement strengthens the case for federal financial support. Covid-19 is still going to hurt some businesses disproportionately, either because they’ll be forced to close again or because people have stopped going out as much. But Congress no longer needs to write a blank check to support them. It just needs to provide a lifeline for a number of months, a much more palatable prospect.
  • It’s a bad idea for restaurants and bars to be open for indoor dining this winter. Temporarily closing them down would be easier to stomach if these establishments are given the wherewithal to reopen next year.
  • The Pfizer announcement is unmitigated good news. But it would be a tragic mistake to relax our vigilance. Instead, continue to mask up, stay home and consider canceling or limiting your Thanksgiving plans. This is still a marathon, but the end is much closer than before.
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