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    Test to Treat: pharmacists say Biden’s major new Covid initiative won’t work

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    Test to Treat: pharmacists say Biden’s major new Covid initiative won’t workProgram to facilitate access to antivirals will have a limited impact because pharmacists are restricted from prescribing the pills A major new Biden administration initiative to facilitate access to Covid-19 antivirals will have a limited impact and fail to mitigate certain health inequities, major pharmacist groups argue, because pharmacists are restricted from prescribing the pills.Announced in Joe Biden’s State of the Union address, the “Test to Treat” program is meant to address the maddening difficulty Americans have had in accessing Covid-19 treatments. The administration will channel newly increasing stocks of antiviral pills to major retail pharmacies that have in-house clinics, providing one-stop testing and antivirals access.The program, which the administration aims to provide for free (in the face of fierce Republican opposition to new Covid-19 spending), is also slated to roll out in Veterans Affairs clinics, community health centers and long-term care facilities.Major participants include some 250 Walgreens stores, 225 Kroger Little Clinics and 1,200 CVS MinuteClinics. CVS clinics in particular are staffed by nurse practitioners and physician assistants, authorized by the Food and Drug Administration (FDA) to prescribe the two currently available Covid antivirals, Pfizer’s Paxlovid and Merck and Ridgeback Biotherapeutics’ molnupiravir.In a 9 March letter to Biden calling for pharmacists to be granted authority to prescribe these pills, 14 organizations representing pharmacies and pharmacists insisted Test to Treat’s impact will be compromised by the fact that such in-house clinics are relatively limited in number and largely in urban areas.“Unfortunately, rural and underserved communities are less likely to benefit from your test to treat approach because of this limitation,” the letter states.According to the Centers for Disease Control and Prevention (CDC), 90% of Americans live within five miles of one of approximately 60,000 pharmacies.“The FDA is still blocking us from leveraging the most accessible healthcare provider out there to make sure that these patients can get these drugs easily,” said Michael Ganio, a Columbus, Ohio pharmacist, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, which is a signatory of the letter to Biden.“As far as expanding access,” said Ganio, Test to Treat is “not doing a lot”.The need for Covid-19 antivirals is likely to be greater in rural areas, at least on a per-capita basis. A recent CDC study found that through January, 58.5% of people aged five and older in rural counties had received at least one coronavirus vaccination shot, compared with 75.4% in urban counties.Paxlovid and molnupiravir are authorized for individuals at high risk of severe Covid-19, in particular unvaccinated people with certain medical conditions. Paxlovid was 88% effective at preventing hospitalization and death in its clinical trial. Molnupiravir proved just 30% effective. The FDA only authorizes its use when other treatments are unavailable or aren’t advised for an individual.Sufficient supply of Paxlovid will be key to Test to Treat. Since late December, the federal government has delivered a woefully inadequate 700,000 Paxlovid courses to states, the biweekly allotment increasing from 100,000 in January to 175,000 in March.The administration has claimed it will distribute 1m courses in March and 2.5m in April. A Pfizer representative would only state that the company plans to deliver a cumulative 10m courses by the end of June. The administration has agreed to purchase 20m courses, slated to be delivered by the end of September.In September 2021, the US Department of Health and Human Services amended a federal public health emergency law, the Prep Act, to grant licensed pharmacists the authority “to order and administer select Covid-19 therapeutics” – which at the time meant monoclonal antibodies and vaccines.But when the FDA authorized Paxlovid and molnupiravir in December, it explicitly restricted pharmacists from prescribing them.Authors of the letter to Biden say they submitted data to the FDA at the end of January, hoping to persuade it to grant pharmacists prescribing authority.These groups have also lobbied the federal government to ensure Medicare Part B would reimburse pharmacists for such prescribing – a move that would probably lead health insurers to follow.Prescribing Paxlovid safely can be challenging, because it may interact harmfully with other medications. Additionally, the FDA advises against providing the treatment to those with severe kidney or liver impairment. Experts have also raised concerns about molnupiravir’s potential toxicities. It cannot be prescribed to minors and is not advised for pregnant women.Chanapa Tantibanchachai, an FDA press officer, said the agency’s decision to forbid pharmacists from prescribing Paxlovid and molnupiravir “was based on several factors, including the drugs’ side-effect profiles, the need to assess potential for drug interactions, the need to assess potential kidney function problems (including the severity of potential problems), and the need to evaluate patients for pre-existing conditions” linked to severe Covid-19.Tantibanchachai said the FDA could revise the policy “as new data and information become available”.On 4 March, the American Medical Association said the “pharmacy based clinic component of the Test to Treat plan flaunts patient safety and risks significant negative health outcomes”. The AMA argued that by prescribing Covid antivirals at such clinics, providers may endanger patients for whom they lack a comprehensive medical history.The pharmacy groups insisted in their letter to Biden they have the expertise to prescribe these medications.In an email to the Guardian, Al Carter, executive director of the National Association of Boards of Pharmacy, stated: “Pharmacists have more complete access to the patients’ medication in comparison to physicians, especially since most patients have more than one prescriber, who don’t necessarily talk with each other.“Pharmacists spend their whole education focused on medications and their impacts on the body; whereas physicians take the minimal number of classes on pharmacology.”Katherine Yang, a clinical pharmacist at the University of California, San Francisco, said: “There are a lot of studies that show that when you increase services in community pharmacies, you improve care. In a lot of neighborhoods and rural areas, people may not have access to primary care, and pharmacists are the most accessible public health provider the patients can see.”TopicsCoronavirusBiden administrationUS domestic policyUS politicsPfizerPharmaceuticals industrynewsReuse this content More

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      Pfizer’s Noble Struggle Against the Diabolical Jared Kushner

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      These days it’s rare to read in the media a story with a happy ending designed to comfort our belief that, at least occasionally, we live in the best of all possible worlds. Forbes has offered such an occasion to a self-proclaimed benefactor of humanity, Dr. Albert Bourla, the CEO of Pfizer. (Disclaimer: Pfizer is a company to whom I must express my personal gratitude for its generosity in supplying me with three doses of a vaccine that has enabled me to survive intact a prolonged pandemic and benefit from a government-approved pass on my cellphone permitting me to dine in restaurants and attend various public events.)

      The Contradictory Musings of Biden’s Speculator of State

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      The Forbes article, an excerpt from Bourla’s book, “Moonshot,” ends with a moving story about how Pfizer boldly resisted the pressure of the evil Jared Kushner, Donald Trump’s son-in-law, who had no qualms about depriving the rest of the world — even civilized countries such as Canada and Japan — of access to the COVID-19 vaccine to serve the US in their stead.

      “He insisted,” the good doctor explains, “that the U.S. should take its additional 100 doses before we sent doses to anyone else from our Kalamazoo plant. He reminded me that he represented the government, and they could ‘take measures’ to enforce their will.”

      Today’s Weekly Devil’s Dictionary definition:

      Take measures:

      Go well beyond any measured response in an act of intimidation

      Contextual Note

      Bourla begins his narrative at the beginning, before the development of the vaccine, by asserting his company’s virtuous intentions and ethical credentials that would later be challenged by bureaucrats and venal politicians. “Vaccine equity was one of our principles from the start,” he writes. “Vaccine diplomacy, the idea of using vaccines as a bargaining chip, was not and never has been.”

      Embed from Getty Images

      Some readers may note that vaccine equity was only “one” of the principles. There were, of course, other more dominant ones, such as maximizing profit. But Bourla never mentions these other principles, instead offering a step-by-step narrative meant to make the reader believe that his focus was on minimizing profit. That, after all, is what a world afflicted by a raging and deadly pandemic might expect. A closer examination of the process Bourla describes as well as the very real statistics about vaccine distribution reveals that, on the contrary, Pfizer would never even consider minimizing profits. It simply is not in their DNA.

      Bourla proudly describes the phases of his virtuous thinking. The CEO even self-celebrates his out-of-the-ordinary sense of marketing, serving to burnish the image not only of his company but of the entire pharmaceutical industry. “We had a chance,” he boasts, “to gain back our industry’s reputation, which had been under fire for the last two decades. In the U.S., pharmaceuticals ranked near the bottom of all sectors, right next to the government, in terms of reputation.”

      Thanks to his capacity to tone down his company’s instinctive corporate greed, Bourla now feels he has silenced his firm’s if not the entire industry’s critics when he makes this claim, “No one could say that we were using the pandemic as an opportunity to set prices at unusually high levels.” Some might, nevertheless, make the justifiable claim that what they did was set the prices at “usually” high levels. A close look at Bourla’s description of how the pricing decisions were made makes it clear that Pfizer never veered from seeking “high levels,” whether usual or unusual, during a pandemic that required as speedy and universal a response as possible.

      Thanks to a subtle fudge on vocabulary, Bourla turns Pfizer’s vice into a virtue. He writes that when considering the calculation of the price Pfizer might charge per dose, he rejected the standard approach that was based on a savant calculation of the costs to patients theoretically saved by the drug. He explains the “different approach” he recommended. “I told the team to bring me the current cost of other cutting-edge vaccines like for measles, shingles, pneumonia, etc.” But it was the price and not the cost he was comparing. When his team reported prices of “between $150 and $200 per dose,” he agreed “to match the low end of the existing vaccine prices.”

      If Pfizer was reasoning, as most industries do, in terms of cost and not price, he would be calculating all the costs related to producing the doses required by the marketplace — in this case billions — and would have worked out the price on the basis of fixed costs, production and marketing costs plus margin. That would be the reasonable thing to do in the case of a pandemic, where his business can be compared to a public service and for which there is both a captive marketplace (all of humanity shares the need) and in which sales are based entirely on advanced purchase orders. That theoretically reduces marketing costs to zero.

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      But Bourla wrote the book to paint Pfizer as a public benefactor and himself as a modern Gaius Maecenas, the patron saint of patrons. Once his narrative establishes his commitment to the cause of human health and the renunciation of greed, he goes into detail about his encounter with Kushner. After wrangling with the bureaucrats at Operation Warp Speed created to meet the needs of the population during a pandemic, Bourla recounts the moment “when President Trump’s son-in-law and advisor, Jared Kushner, called me to resolve the issue.” That is when Kushner, like any good mafia boss, evokes his intent to “take measures,” a threat the brave Bourla resists in the name of the health of humanity and personal honor.

      That leads to the heartwarming, honor-saving denouement, the happy ending that Bourla calls a miracle. “Thankfully, our manufacturing team continued to work miracles, and I received an improved manufacturing schedule that would allow us to provide the additional doses to the U.S. from April to July without cutting the supply to the other countries.”

      Historical Note

      Investopedia sums up the reasoning of pharmaceuticals when pricing their drugs: “Ultimately, the main objective of pharmaceutical companies when pricing drugs is to generate the most revenue.” In the history of Western pharmacy, that has not always been the case. Until the creation of the pharmaceutical industrial sector in the late 19th century, apothecaries, chemists and druggists worked in their communities to earn a living and like most artisans calculated their costs and their capacity for profit.

      The Industrial Revolution changed all that, permitting large-scale investment in research and development that would have been impossible in an earlier age. But it also introduced the profit motive as the main driver of industrial strategy. What that meant is what we can see today. Pharmaceutical companies have become, as Albert Bourla himself notes, “ranked near the bottom of all sectors.” They exist for one reason: to make and accumulate profit. Industrial strategies often seek to prolong or extend a need for drugs rather than facilitate cures. Advising a biotech company, Goldman Sachs famously asked, “Is curing patients a sustainable business model?” The implied answer was “no.” The greatest fear of the commercial health industry is of a cure that “exhaust[s] the available pool of treatable patients.”

      Embed from Getty Images

      In any case, COVID-19 has served Pfizer handsomely and is continuing to do so. In late 2021, the Peoples Vaccine Alliance reported “that the companies behind two of the most successful COVID-19 vaccines —Pfizer, BioNTech and Moderna— are making combined profits of $65,000 every minute.” Furthermore, they “have sold the majority of doses to rich countries, leaving low-income countries out in the cold. Pfizer and BioNTech have delivered less than one percent of their total vaccine supplies to low-income countries.”

      At the beginning of the COVID-19 “project,” Bourla boasts, “I had made clear that return on investment should not be of any consideration” while patting himself on the back for focusing on the needs of the world. “In my mind, fairness had to come first.” With the results now in, he got his massive return on investment, while the world got two years and counting of a prolonged pandemic that will continue making a profit for Pfizer. At least he had the satisfaction of putting the ignoble Jared Kushner in his place.

      *[In the age of Oscar Wilde and Mark Twain, another American wit, the journalist Ambrose Bierce, produced a series of satirical definitions of commonly used terms, throwing light on their hidden meanings in real discourse. Bierce eventually collected and published them as a book, The Devil’s Dictionary, in 1911. We have shamelessly appropriated his title in the interest of continuing his wholesome pedagogical effort to enlighten generations of readers of the news. Read more of The Fair Observer Devil’s Dictionary.]

      The views expressed in this article are the author’s own and do not necessarily reflect Fair Observer’s editorial policy. More

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      in US Politics

      US officials call for more data on vaccine boosters as Pfizer pushes for third shot

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      PfizerUS officials call for more data on vaccine boosters as Pfizer pushes for third shot Pharma company presses case with senior health officials WHO urges priority for nations with low Covid vaccination rates Ankita RaoTue 13 Jul 2021 08.29 EDTLast modified on Tue 13 Jul 2021 08.49 EDTPfizer, the pharmaceutical company that created one of the first Covid-19 vaccines to be approved, has been making a hard sell for emergency approval of boosters – additional doses given to those already vaccinated, especially immunocompromised adults.But in private meetings with Pfizer on Monday, senior US officials said they needed more data – prompting the latest debate over how to curb a pandemic which has claimed more than 620,000 lives in the country. Last week, the US health department also rebuked Pfizer for pressing for a booster shot, and Anthony Fauci, Joe Biden’s chief medical adviser, has said there isn’t enough evidence to support needing a third shot.Pfizer pushes for US booster shots as WHO says greed is driving vaccine disparitiesRead more“It was an interesting meeting. They shared their data. There wasn’t anything resembling a decision,” Fauci said in a Monday evening interview with the New York Times. “This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”In the US, almost half of the population is fully vaccinated, while a little over half has received one dose, according to data from the Mayo Clinic. Still, vaccination rates lag in huge swaths of the country, giving the virus more opportunities for community outbreaks.Pfizer’s experts have pointed to Israel, where the government has decided to give a third Pfizer vaccine shot to vulnerable adults. But leaders from the World Health Organization and other organizations have pushed back, highlighting the vast lack of access and inequality in global vaccine distribution. More than 3.4 billion people have been vaccinated worldwide, but some countries, such as India, have rates as low as 5%.The debate over booster shots is the latest in the many public health decisions the Biden administration has faced since January. With the country largely relaxing Covid-19 rules and opening the economy, the path forward continues to be difficult, with emerging science being incorporated in real time.In next steps, Pfizer says it will submit more evidence to the government. The Centers for Disease Control and Prevention, meanwhile, will further study breakthrough infections – which happen when people who are vaccinated contract Covid-19.TopicsPfizerCoronavirusPharmaceuticals industryVaccines and immunisationUS politicsnewsReuse this content More

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      in US Politics

      Trump officials scramble to justify decision not to buy extra Pfizer vaccine doses

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      The Trump administration on Tuesday scrambled to justify a decision not to buy millions of backup doses of a Covid-19 vaccine developed by Pfizer as the vaccine appeared likely to become the first approved for use in the United States.Government regulators with the Food and Drug Administration (FDA) announced favorable preliminary findings on Tuesday from a review of Pfizer data, following approval for use in the UK and the first post-approval vaccination there.The Trump administration last spring made a deal for 100m doses of the Pfizer vaccine candidate, but the administration turned down an offer to reserve additional doses, Scott Gottlieb, a current Pfizer board member and former FDA commissioner, confirmed on Tuesday.“Pfizer did offer an additional allotment coming out of that plan, basically the second-quarter allotment, to the US government multiple times – and as recently as after the interim data came out and we knew this vaccine looked to be effective,” Gottlieb told CNBC.“I think they were betting that more than one vaccine is going to get authorized and there will be more vaccines on the market, and that perhaps could be why they didn’t take up that additional 100m option agreement.”With global demand for its vaccine soaring following successful trial results and approval in the United Kingdom, New York-based Pfizer cannot guarantee the United States additional doses before next June, the New York Times reported.The extent to which the decision not to acquire more of the Pfizer vaccine could impede the vaccination effort in the United States was unclear.The news came as the US was on the verge of surpassing 15 million coronavirus cases, the highest number in the world.A second vaccine candidate is currently up for emergency approval from the FDA, and multiple additional vaccine candidates – some of them easier to manage than the Pfizer vaccine, which must be stored at extremely cold temperatures – are in the final stages of clinical review.But Donald Trump and officials involved in the vaccine development program scrambled on Tuesday to head off the perception that the government had failed to get first in line for sufficient supplies of a vaccine produced by an American-based company. US-based Pfizer partnered and its German pharmaceutical partner, BioNTech, are on track to have the first vaccine approved in the US.To celebrate the good vaccine news and tout his role in it, Trump planned to host an event at the White House on Tuesday billed as a “vaccine summit”. He planned to unveil an executive order to prioritize vaccine shipments to “Americans before other nations,” but as with many headline-grabbing orders issued by Trump the decree did not appear to be impactful or enforceable, analysts said.Asked on ABC’s Good Morning America on Tuesday how the order would work, the official in charge of the government’s vaccine development program, Operation Warp Speed, Moncef Slaoui, said: “Frankly, I don’t know.”Health officials named by president-elect Joe Biden, who will lead the vaccine rollout effort after taking office next month, were not invited to the White House event, underscoring the risks of a lack of continuity in the effort.And executives from two drug companies, Pfizer and Moderna – whose own vaccine candidate is also up for approval from the FDA – were invited to the White House by Trump but declined, Stat News reported.Slaoui defended the administration’s decision not to buy more doses of the Pfizer vaccine, in his appearance Tuesday on ABC, saying they were looking at several different vaccines during the summer when it had the option to lock in additional Pfizer vaccine doses.“No one reasonably would buy more from any one of those vaccines because we didn’t know which one would work and which one would be better than the other,” said Slaoui. Before taking his current post, Slaoui resigned from the Moderna board.The US government has also contracted for 100m doses of the Moderna vaccine. Both vaccines require two doses per patient, although a preliminary report on the Pfizer vaccine issued on Tuesday by the FDA found some protection after just one dose.The report, which found “no specific safety concerns identified that would preclude issuance” of an emergency use authorization, accelerated the path to approval. “FDA has determined that [Pfizer] has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the report said.A spokeswoman for the Department of Health and Human Services told the Times that in addition to Pfizer and Moderna, the government had signed contracts for doses for other vaccine candidates that have not yet reached the stage of seeking regulatory approval.“We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna,” she said. More

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      in US Politics

      Trump administration refused offer to buy millions more Pfizer vaccine doses

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      The Trump administration passed up a chance last summer to buy millions of additional doses of Pfizer’s coronavirus vaccine, a decision that could delay the delivery of a second batch of doses until the manufacturer fulfills other international contracts.
      The revelation, first reported by the New York Times and confirmed to the Associated Press on Monday, came a day before Donald Trump aimed to take credit for the speedy development of forthcoming vaccines at a White House summit.
      Pfizer’s vaccine, one of the leading Covid-19 vaccine contenders, is expected to be approved by a panel of Food and Drug Administration scientists as soon as this week, with delivery of 100m doses – enough for 50 million Americans – expected in coming months.
      Under its contract with Pfizer, the Trump administration committed to buy an initial 100m doses, with an option to purchase as many as five times more. This summer, the White House opted not to lock in an additional 100m doses for delivery in the second quarter of 2021, according to people who spoke to the Associated Press on condition of anonymity.

      Days ahead of the vaccine’s expected approval, the administration is reversing course, but it is not clear that Pfizer, which has since made commitments to other countries, will be able to meet the latest request on the same timeline.
      The Pfizer vaccine is one of two on track for emergency FDA authorization this month, the other coming from drugmaker Moderna.
      The Trump administration insisted late Monday that between those two vaccines and others in the pipeline, the US will be able to accommodate any American who wants to be vaccinated by the end of the second quarter of 2021.
      Health and Human Services secretary Alex Azar told NBC the administration is “continuing to work across manufacturers to expand the availability of releasable, of FDA-approved vaccine as quickly as possible. We do still have that option for an additional 500m doses.”
      The “Operation Warp Speed” summit on Tuesday will address the Trump administration’s plans to distribute and administer the vaccine. But officials from president-elect Joe Biden’s transition team, which will oversee the bulk of the largest vaccination program in the nation’s history, were not invited.
      Both the Pfizer and the Moderna vaccines have been determined to be 95% effective against the virus that causes Covid-19. Plans call for distributing and then administering about 40m doses of the two companies’ vaccines by the end of the year – with the first doses shipping within hours of FDA clearance. Each of the forthcoming vaccines has unique logistical challenges, including storage, distribution and administration.
      The news comes as states across the US continue to experience some of the worst surges since the pandemic began. On Monday, millions in California went back under the nation’s harshest lockdowns, as Covid-19 cases hit record levels. New York is also weighing further restrictions as hospitalisations climb.
      Health officials are warning Americans not to let their guard down, even with a vaccine on the horizon. Dr Anthony Fauci, the nation’s leading infectious disease expert, said that “without substantial mitigation, the middle of January can be a really dark time for us”. More

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      in US Politics

      BioNTech chief rejects Trump claim it delayed Covid vaccine news

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      The scientist behind the BioNTech/Pfizer coronavirus vaccine has defended his company from Donald Trump’s accusation that it deliberately delayed news of its rapid progress until after the election, saying “we don’t play politics”.
      BioNTech, a German company, and the US pharmaceutical giant Pfizer announced on Monday that their jointly developed vaccine candidate had exceeded expectations in the crucial phase 3 vaccine trials, proving 90% effective in protecting people from coronavirus infections.
      Quick guide Who in the UK will get the new Covid-19 vaccine first?
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      The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:
      1. All those 80 years of age and over and health and social care workers.
      2. All those 75 years of age and over.
      3. All those 70 years of age and over.
      4. All those 65 years of age and over.
      5. Adults under 65 years of age at high at risk of serious disease and mortality from Covid-19.
      6. Adults under 65 years of age at moderate risk of at risk of serious disease and mortality from Covid-19.
      7. All those 60 years of age and over.
      8. All those 55 years of age and over.
      9. All those 50 years of age and over.
      10. Rest of the population

      The US president criticised the timing of their press release. Trump accused the companies of holding back the good news until after the American elections “because they didn’t have the courage to do it before”.
      But BioNTech’s chief executive, Prof Uğur Şahin, told the Guardian in a wide-ranging interview he only was notified of the outcome of the interim trials on Sunday at 8pm in a call from the Pfizer CEO Albert Bourla, who himself had only been informed three minutes earlier by the independent monitoring board.
      “We want to develop this vaccine as quickly as possible, and we have our own system of coordinates,” Şahin said in response to Trump’s accusation. “Every day counts, and we were desperately waiting for the day of the trial results. It couldn’t come early enough.”
      “Pharmaceutical research should never be politicised. It’s a question of integrity. Withholding information would have been unethical. What’s important for us is that we are developing a vaccine and we don’t play politics.”
      Others have criticised the two companies for not holding on to their information long enough. Bourla raised eyebrows when he sold $5.6m (£4.2m) in stock as company shares soared on Monday night.
      Pfizer says the shares were sold via an automated system after they hit a certain price, under a plan set up in August. More