Tag: Pfizer

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HHS Secretary Azar says Pfizer retains U.S. at ‘arm’s size’ on manufacturing

HHS Secretary Azar says Pfizer keeps U.S. at 'arm's length' on manufacturing

Minister of Health and Human Services Alex Azar said Thursday he wanted “more insight” into how the Pfizer coronavirus vaccine is made. The US drug manufacturer kept the federal government on a “customary market basis” throughout the process.

Unlike other drug companies, Pfizer did not accept federal funding to develop or manufacture its vaccine. Pfizer has signed a contract with the United States to supply 100 million doses of its vaccine as part of Operation Warp Speed. This is enough to vaccinate 50 million Americans, as the vaccine takes two doses three weeks apart. Pfizer is also negotiating an additional 100 million doses with the US.

“You’re part of Operation Warp Speed, but … it’s a different relationship” than the government deals with Moderna and other federal drug companies that have received federal funding, Azar told CNBC’s “Squawk Box” during an interview Thursday. “We pull together, give [Pfizer] A guaranteed purchase that allows them to make capital investments has a predictable buyer, but we don’t have full visibility into their making because they kept this a bit more on-market. “

But Azar said he would like to see the federal government’s relationship with Pfizer change.

“We are working with Pfizer. We are very optimistic that we will be securing additional volumes in the second quarter, but they will need our help making them,” he said. Azar also noted that Pfizer originally said it would produce 100 million cans by the end of the year but “had to cut that in half to 50 million”.

Later on Thursday, Pfizer issued a statement saying the company “has no production issues with our COVID-19 vaccine and no shipments containing the vaccine will be put on hold or delayed”.

The company also “continuously” exchanged information on “all aspects of our production and sales capacities” in weekly meetings with HHS and Operation Warp Speed.

“They have visited our facilities, walked the production lines and were informed of our production planning as soon as information became available,” said Pfizer.

His emergency vaccine was approved by the Food and Drug Administration on Friday. The first doses of Pfizer’s vaccine were shipped to the United States over the weekend and the Americans received gunfire on Monday.

The initial doses of the Pfizer vaccine are limited as production begins. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The US shipped 2.9 million doses of the vaccine this week with an additional 2 million expected next week, General Gustave Perna, who oversees logistics for Operation Warp Speed, told reporters on Wednesday. The US hopes to vaccinate 20 million people by the end of the year.

Earlier this month, the Wall Street Journal reported that Pfizer’s target for vaccine launch of 50 million doses worldwide by the end of the year was only half of what it originally planned. In a statement, Pfizer said there were several factors influencing the number of estimated doses, including increasing the size of a vaccine at an “unprecedented” pace.

When asked Thursday why Pfizer is unable to produce more cans, Azar said the US would offer “to help them get a higher yield if they are willing to enlist our help” .

He said the problem was not a cost issue, adding, “We’re working with them.”

“The discussions are very productive,” he said. “We will use the full power of the US government to support and maximize production, as we have always wanted. I am very optimistic that we will find a good place there.”

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Health

Trump well being officers talk about Pfizer Covid vaccine as U.S. administers photographs

Trump health officials discuss Pfizer Covid vaccine as U.S. administers shots

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Health Department and Pentagon officials hold a joint briefing on the Trump administration’s Operation Warp Speed ​​Covid-19 vaccination program on Wednesday as Americans begin to receive Pfizer’s shots.

The briefing takes place the day before the FDA Advisory Committee on Vaccines and Related Biological Products votes on whether to recommend Moderna’s emergency vaccine. A positive vote from the committee will likely pave the way for Moderna’s vaccine to be the second approved for use in the United States after Pfizer.

US officials have announced that they will be distributing about 40 million doses of vaccine by the end of this year, enough to vaccinate about 20 million people, since the Moderna and Pfizer vaccines take two weeks two shots apart.

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.

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Trump well being officers talk about Pfizer Covid vaccine as U.S. begins administering pictures

Trump health officials discuss Pfizer Covid vaccine as U.S. begins administering shots

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Health and Human Services officials and the Pentagon are holding a joint conference Monday on the Trump administration’s Operation Warp Speed ​​Covid-19 vaccination program as Americans receive some of the first few shots.

The first doses of a Pfizer vaccine with BioNTech were shipped to the US over the weekend. Trucks carrying boxes of vaccine doses left Pfizer’s Kalamazoo, Michigan manufacturing facility on Sunday and should arrive on Monday, according to Pfizer.

New York’s Northwell Health administered the state’s first dose of vaccine just before 9:30 a.m. ET. Sandra Lindsay, a The critical care nurse at the Long Island Jewish Medical Center received the first shot, which earned the audience applause.

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.

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Pfizer negotiating with U.S. to supply a further 100 million doses, CEO says

Pfizer negotiating with U.S. to provide an additional 100 million doses, CEO says

Vials in cartons containing the Pfizer-BioNTech Covid-19 vaccine are being prepared for shipment on December 13, 2020 at Pfizer Global Supply’s Kalamazoo manufacturing facility in Kalamazoo, Michigan.

Morry Gash | AFP | Getty Images

Albert Bourla, CEO of Pfizer, said the company is negotiating with the federal government to provide an additional 100 million Covid-19 vaccine doses next year, as Americans will receive some of the first shots on Monday.

Pfizer and the US are working out timing details, Bourla said Monday morning in an interview with CNBC’s “Squawk Box”. The company could provide many of these cans in the third quarter of 2021, but the U.S. government is pushing for them in the second quarter, he said.

“We are working very cooperatively to find a solution and allocate that 100 million [doses] in the second quarter if possible or in many of them, “Bourla said, adding the company has not yet signed an agreement with the US.

The comment came after the Food and Drug Administration approved Pfizer and BioNTech’s emergency coronavirus vaccine late Friday. The vaccine has been approved for people aged 16 and over.

The first doses of a Pfizer vaccine with BioNTech were shipped to the US over the weekend. Trucks carrying boxes of vaccine doses left Pfizer’s Kalamazoo, Michigan manufacturing facility on Sunday and should arrive on Monday, according to Pfizer. The company said 189 boxes for a total of 184,275 cans will be shipped to locations in all 50 states and 4 boxes will be shipped to US territories. The vaccine consists of two doses, with the doses given three weeks apart.

Initial doses of the Pfizer vaccine will be limited as production begins. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The vaccine is expected to be distributed in phases where the most critical U.S. workers and vulnerable people receive it first. The CDC has given states an outline recommending that priority be given to health workers and nursing homes first. However, states may distribute the vaccine at their own discretion.

General Gustave Perna, who oversees logistics for Operation Warp Speed, said Wednesday the government would distribute 2.9 million doses of the vaccine within 24 hours of FDA approval, followed by another 2 , 9 million doses 21 days later for patients to get their second shot. Pfizer’s vaccine takes two doses three weeks apart.

Pfizer has already signed a contract with the U.S. government to supply 100 million doses of the vaccine under the Trump administration’s Operation Warp Speed ​​vaccine program, enough to vaccinate 50 million people. Under the agreement, the Americans will receive the vaccine for free.

The previous Monday, Pfizer board member Dr. Scott Gottlieb told CNBC that the US government turned down an offer to receive additional doses of the Pfizer vaccine in November.

The vaccine couldn’t come at a more crucial time. Hospitals in the U.S. already have higher numbers of Covid patients than ever before, and the country’s outbreak is poised to break even grimmer records. The director of the Centers for Disease Control and Prevention, Dr. Robert Redfield, warned earlier this month that the next few months of the pandemic would be “some of the most difficult in the history of this country’s public health.”

President Donald Trump previously said he would invoke the Defense Production Act if necessary to ensure Americans can get a vaccine.

Bourla said Monday it was “very positive,” he said. “I hope they will do that very soon as we are facing critical delivery restrictions on some components in particular. But I think they will, so it won’t be a problem.”

– CNBC’s Spencer Kimball contributed to this report.

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C.D.C. Panel Recommends Pfizer Vaccine for Sufferers as Younger as 16

C.D.C. Panel Recommends Pfizer Vaccine for Patients as Young as 16

An independent panel of experts advising the Centers for Disease Control and Prevention on Saturday afternoon voted to recommend the Pfizer coronavirus vaccine for people aged 16 and over. This confirmation, which only Dr. Robert Redfield, the director of the CDC, is an important signal for hospitals and doctors to continue vaccinating patients.

The confirmation follows the approval of the emergency vaccine on Friday night by the Food and Drug Administration, which oversees the licensing of medical devices.

The advisory board, which typically meets three times a year to review changes to routine vaccine schedules for children, adolescents, and adults, held numerous marathon sessions this fall to resolve a variety of gnarled questions related to the introduction of the novel vaccine to discuss, which is limited in availability during a pandemic.

In the Friday and Saturday sessions, the panel’s heated discussions focused on three main areas: whether the vaccine should be recommended for patients aged 16 and 17, for pregnant and breastfeeding women, and for patients with an anaphylactic reaction to other vaccines .

CDC officials and scientists will review the debate and provide more detailed guidance on these and other groups on Sunday and in the coming weeks as more information about the vaccine becomes available.

Shipments of nearly three million doses of the vaccine will go to the States this weekend. Most states are expected to follow CDC guidelines to reserve these doses for caregivers and residents of nursing homes and long-term care facilities.

Pregnant women were not included in clinical trials with the vaccine. The panel’s discussion on pregnancy centered on the fact that at least 330,000 health care workers in the first cohort of vaccine recipients are expected to be pregnant or breastfeeding women. While the committee urged that the decision on whether to fire the shot be left to pregnant women in consultation with their doctors, it also suggested that they object to the vaccine’s effectiveness and their personal risk of exposure to the virus the lack of data on weighing it up in relation to pregnancy.

The committee found it was not a live virus vaccine and therefore posed no risk to a nursing child.

Pfizer officials said Friday they had seen no evidence that the vaccine affects pregnancy or fertility. About two dozen women became pregnant during post-vaccination clinical trials, and the company is monitoring them.

Committee members responded to warning signs and instructions on anaphylaxis after two UK health workers had severe allergic reactions immediately after being vaccinated. Members tried to strike a balance: taking reasonable precautions without alarming a public who may already be upset about the vaccine. On Saturday, they tended to advise patients with “severe allergic reactions” like anaphylaxis to any component of the vaccine not to get the shot. They also recommended monitoring patients for 15 minutes immediately after vaccination and 30 minutes for patients with a history of anaphylaxis.

The road to a coronavirus vaccine ›

Answers to your vaccine questions

With a coronavirus vaccine spreading out of the US, here are answers to some questions you may be wondering about:

    • If I live in the US, when can I get the vaccine? While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.
    • When can I get back to normal life after the vaccination? Life will only get back to normal once society as a whole receives adequate protection against the coronavirus. Once countries have approved a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible that people spread the virus without knowing they are infected because they have mild symptoms or no symptoms at all. Scientists don’t yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.
    • Do I still have to wear a mask after the vaccination? Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the coronavirus can spread it without experiencing a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.
    • Will it hurt What are the side effects? The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It is possible that people will have to plan to take a day off or go to school after the second shot. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system’s encounter with the vaccine and a strong response that ensures lasting immunity.
    • Will mRNA vaccines change my genes? No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given moment, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive a few minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can hold for a few days at most before it is destroyed.

When asked whether the vaccine should be approved for 16- and 17-year-olds, several paediatricians on the committee expressed concern that Pfizer’s data to date on the youngest participants was “thin”.

However, other committee members pushed back, saying the physiological difference between a 16-year-old and an 18-year-old was minimal. People under the age of 18 who work in long-term care facilities and “important” jobs like groceries are at high risk of contracting the virus and would likely be recommended for initial admissions, they said.

Doctors determined that these teenagers may be disproportionately colored people. By disfellowshipping them, the doctors argued, the committee would inadvertently discriminate against them based on their age.

And, as they added, because the data on side effects and efficacy are so positive, the risk of teenagers getting the virus – as well as spreading it and disrupting their schooling – outweighed the known risks of the vaccine itself.

The committee also expressed its support for making the vaccine available to people who previously tested positive for the virus. Given the limited supplies, they asked those infected within 90 days to wait until that period had expired.

The CDC is expected to issue more detailed clinical recommendations on Sunday. In addition, a comprehensive “toolkit” for providers and patients has been published that is intended to provide detailed information on how to resolve potential concerns.

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CDC panel recommends Pfizer Covid vaccine for folks 16 years and older, clearing pivotal hurdle

CDC panel recommends Pfizer Covid vaccine for people 16 years and older, clearing pivotal hurdle

CDC headquarters in Atlanta

Elijah Nouvelage | Bloomberg via Getty Images

A key panel from the U.S. Centers for Disease Control and Prevention unanimously voted on Saturday to recommend Pfizer-BioNTech’s Covid-19 vaccine for people aged 16 and over. This cleared another crucial hurdle for the drug before the vaccinations begin in the coming days.

The CDC’s Advisory Committee on Immunization Practices, an external group of medical experts advising the agency, voted 11-0 in favor of recommending the vaccine for use in people aged 16 and over under the Food and Drug Administration’s emergency clearance. Three members withdrew due to conflicts.

The recommendation will now be sent to CDC Director Dr. Robert Redfield who must sign out before vaccinations can begin. A CDC spokesman was not immediately available for comment on when Redfield would sign the recommendation.

“This Covid-19 vaccine gives us hope,” said Veronica McNally, ACIP member and assistant dean of experiential education at Michigan State University College of Law. “It’s important to remember that while this vaccine was being developed at an incredible pace and incorporating new technologies, it went through all appropriate channels of regulation and the approval process was transparent.”

Dr. Beth Bell, an ACIP member and clinical professor of global health at the University of Washington, said she recognized people’s concern about this vaccine and new vaccines in general, but added that they were “safely” taking this vaccine when it is she will turn.

“I believe the process we have used here at ACIP to make this decision is transparent, science-based, fair-minded, and for this moment the absolute best we can do,” said Bell .

The vote marked the end of an hour-long meeting during which ACIP members heard presentations from CDC officials on clinical considerations for those vaccinated under the emergency license.

Dr. Sarah Mbaeyi, a CDC doctor, told the agency during a presentation that vaccines should be offered to people “regardless of a history of previous symptomatic or asymptomatic” coronavirus infection. However, Mbaeyi told the panel that a diagnostic or antibody test is not recommended to help decide whether someone should receive the vaccine.

More studies on the vaccine’s safety in pregnant women are ongoing, Mbaeyi said. However, if a pregnant woman is part of a group that is prioritized for the vaccine, Mbaeyi said she could opt for vaccination after making an informed decision with a health care provider.

The public was also asked to share comments and concerns about the vaccine and its dissemination. Claire Hannan, the executive director of the Association of Immunization Managers, told the committee that there needs to be more precise guidance on who is considered an essential worker, as definitions differ across the US.

On December 1, the group voted 13-1 for healthcare workers and residents of long-term care facilities to receive the first doses of vaccine once released for public use. The ACIP emergency meeting, postponed from Sunday to Saturday, followed the FDA’s decision to give Pfizer’s vaccine emergency approval on Friday evening.

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F.D.A. Clears Pfizer Vaccine, and Tens of millions of Doses Will Be Shipped Proper Away

F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away

Die Food and Drug Administration hat am Freitag den Covid-19-Impfstoff von Pfizer für den Notfall zugelassen und damit Millionen von stark gefährdeten Menschen den Weg frei gemacht, innerhalb weniger Tage mit dem Impfstoff zu beginnen.

Die Genehmigung ist ein historischer Wendepunkt in einer Pandemie, bei der in den USA mehr als 290.000 Menschen ums Leben kamen. Mit der Entscheidung sind die Vereinigten Staaten neben Großbritannien, Bahrain, Kanada, Saudi-Arabien und Mexiko das sechste Land, das den Impfstoff freigibt. Weitere Genehmigungen, auch von der Europäischen Union, werden innerhalb von Wochen erwartet.

Die Entscheidung der FDA folgte einer außergewöhnlichen Abfolge von Ereignissen am Freitagmorgen, als der Stabschef des Weißen Hauses, Mark Meadows, dem FDA-Kommissar Dr. Stephen Hahn sagte, er solle überlegen, ob er seinen nächsten Job suchen könne, wenn er die Notfallgenehmigung nicht erhalten würde am Freitag nach Angaben eines hochrangigen Verwaltungsbeamten, der unter der Bedingung der Anonymität sprach, weil er nicht befugt war, die Angelegenheit zu erörtern. Dr. Hahn befahl daraufhin den Impfstoffaufsichtsbehörden der Agentur, dies bis zum Ende des Tages zu tun.

Die Genehmigung löste eine komplizierte Koordinierungsmaßnahme von Pfizer, privaten Schifffahrtsunternehmen, staatlichen und lokalen Gesundheitsbehörden, dem Militär, Krankenhäusern und Apothekenketten aus, um die erste Woche mit etwa drei Millionen Dosen so schnell wie möglich an Mitarbeiter des Gesundheitswesens und Pflegeheime zu bringen möglich, während der Impfstoff bei ultrakalten Temperaturen gehalten wird.

Pfizer hat mit der US-Regierung einen Vertrag über die Lieferung von 100 Millionen Dosen des Impfstoffs bis zum nächsten März abgeschlossen. Im Rahmen dieser Vereinbarung sind die Aufnahmen für die Öffentlichkeit kostenlos.

Jedes Bundesland hat zusammen mit sechs Großstädten der Bundesregierung eine Liste der Standorte – hauptsächlich Krankenhäuser – vorgelegt, an denen der Pfizer-Impfstoff zunächst versandt werden soll. Im bevölkerungsreichen Florida werden die ersten Empfänger fünf Krankenhäuser in Jacksonville, Miami, Orlando, Tampa und Hollywood sein. Im winzigen ländlichen Vermont werden nur das Medical Center der University of Vermont und ein staatliches Lagerhaus versorgt.

Die McKesson Corporation, ein riesiger medizinischer Zulieferer, sendet Kits mit Spritzen, Alkoholtupfern, Gesichtsschutz und anderen Verbrauchsmaterialien an dieselben Standorte, wo sie sich mit den Impfstoffen treffen, die Pfizer in speziellen, mit Trockeneis verpackten Kartons versendet Halten Sie sie bei minus 94 Grad Fahrenheit.

Die Pfizer-Verpackung enthält ein Gerät, das den Standort der Box verfolgt, sowie eine Wärmesonde, die sicherstellt, dass die Tiefkühlung während der gesamten Fahrt von den Vertriebsstandorten des Unternehmens in Michigan und Wisconsin aufrechterhalten wird.

Die Entscheidung ist ein Sieg für Pfizer und seinen deutschen Partner BioNTech, die vor 11 Monaten mit der Arbeit an dem Impfstoff begonnen haben. Die Entwicklung von Impfstoffen dauert in der Regel Jahre. Die späte klinische Studie der Unternehmen, an der fast 44.000 Personen teilnahmen, erwies sich als zu 95 Prozent wirksam.

Ein Expertengremium, das die FDA am Donnerstag beriet, genehmigte den Impfstoff von Pfizer für Personen ab 16 Jahren, und die Agentur plante, die formelle Zulassung am Samstag freizugeben. Diese Frist wurde um einen halben Tag verkürzt, nachdem Präsident Trump Dr. Hahn angegriffen hatte, weil er einen Impfstoff nicht schneller zugelassen hatte. Es wurde jedoch nicht erwartet, dass die beschleunigte Ankündigung die Lieferung von Impfstoffen im ganzen Land beschleunigen würde.

Herr Trump sagte Dr. Hahn am Freitagmorgen auf Twitter, er solle “aufhören, Spiele zu spielen und Leben retten !!!” Er nannte die FDA “eine große, alte, langsame Schildkröte”, die voller Geld ist, aber in Bürokratie versunken ist.

Herr Trump hat wiederholt die FDA und die Arzneimittelhersteller selbst beschuldigt, das Zulassungsverfahren nur langsam durchlaufen zu haben, um ihm politisch Schaden zuzufügen. Die Verbündeten von Dr. Hahn sind seit Wochen in Atem und erwarten, dass er jeden Tag gefeuert wird.

Der Präsident schrieb, dass die Regierung mit „meinem Drängen“ die Entwicklung von Impfstoffen um Jahre verkürzt habe. “Holen Sie die Dammimpfstoffe JETZT raus, Dr. Hahn”, schrieb er und schrieb den Spruch falsch.

Die Bedrohung für Dr. Hahns Arbeit wurde erstmals von der Washington Post gemeldet. In einer Erklärung bestritt Dr. Hahn, dass Herr Meadows ihm sagte, er solle in Betracht ziehen, einen anderen Job zu suchen, und nannte ihn “eine unwahre Darstellung des Telefonanrufs”. Stattdessen, so Dr. Hahn, wurde seine Agentur “ermutigt, zügig weiterzuarbeiten. ”

Obwohl die FDA den Pfizer-Impfstoff auf jeden Fall genehmigen würde, warnten einige Experten, dass der Der Druck des Weißen Hauses könnte das Vertrauen der Öffentlichkeit in die Entscheidungsfindung der Agentur untergraben.

“Dies kann tatsächlich mehr schaden als nützen, denn alles, was es tun wird, ist, mehr Politik in einen wissenschaftlichen Prozess einzubringen”, sagte Dr. Aaron S. Kesselheim, Professor am Brigham and Women’s Hospital und an der Harvard Medical School.

Ein ähnlicher Impfstoff, der von Moderna entwickelt wurde, wird derzeit von der FDA geprüft und könnte bald für den Notfall freigegeben werden. Am Freitag gab die Bundesregierung bekannt, dass sie weitere 100 Millionen Dosen bei Moderna bestellt habe, was diesen Sommer zu einer Vereinbarung über die Erstversorgung mit 100 Millionen Dosen beitrage. Andere Impfstoffe, einschließlich der von Johnson & Johnson und AstraZeneca entwickelten, befinden sich in späten Studien und könnten in den nächsten Monaten zugelassen werden.

In Erwartung der Ankunft des Impfstoffs im ganzen Land äußerten die Amerikaner sowohl Hoffnung als auch Besorgnis.

Der Weg zu einem Coronavirus-Impfstoff ›

Antworten auf Ihre Impfstofffragen

Wenn sich der Coronavirus-Impfstoff der US-Zulassung nähert, sind hier einige Fragen, über die Sie sich möglicherweise wundern:

    • Wenn ich in den USA lebe, wann kann ich den Impfstoff bekommen? Während die genaue Reihenfolge der Impfstoffempfänger von Staat zu Staat unterschiedlich sein kann, werden die meisten Ärzte und Bewohner von Langzeitpflegeeinrichtungen an erster Stelle stehen. Wenn Sie verstehen möchten, wie diese Entscheidung getroffen wird, hilft dieser Artikel.
    • Wann kann ich nach der Impfung wieder zum normalen Leben zurückkehren? Das Leben wird erst wieder normal, wenn die Gesellschaft als Ganzes ausreichend Schutz gegen das Coronavirus erhält. Sobald die Länder einen Impfstoff zugelassen haben, können sie in den ersten Monaten höchstens einige Prozent ihrer Bürger impfen. Die nicht geimpfte Mehrheit bleibt weiterhin anfällig für Infektionen. Eine wachsende Anzahl von Coronavirus-Impfstoffen zeigt einen robusten Schutz vor Krankheit. Es ist aber auch möglich, dass Menschen das Virus verbreiten, ohne zu wissen, dass sie infiziert sind, weil sie nur leichte oder gar keine Symptome haben. Wissenschaftler wissen noch nicht, ob die Impfstoffe auch die Übertragung des Coronavirus blockieren. Selbst geimpfte Menschen müssen vorerst Masken tragen, Menschenmassen in Innenräumen meiden und so weiter. Sobald genügend Menschen geimpft sind, wird es für das Coronavirus sehr schwierig, gefährdete Personen zu finden, die infiziert werden können. Je nachdem, wie schnell wir als Gesellschaft dieses Ziel erreichen, könnte sich das Leben im Herbst 2021 einem normalen Zustand nähern.
    • Muss ich nach der Impfung noch eine Maske tragen? Ja, aber nicht für immer. Die beiden Impfstoffe, die möglicherweise in diesem Monat zugelassen werden, schützen die Menschen eindeutig vor einer Krankheit mit Covid-19. Die klinischen Studien, die diese Ergebnisse lieferten, waren jedoch nicht darauf ausgelegt, festzustellen, ob geimpfte Personen das Coronavirus noch verbreiten können, ohne Symptome zu entwickeln. Das bleibt eine Möglichkeit. Wir wissen, dass Menschen, die von Natur aus mit dem Coronavirus infiziert sind, es verbreiten können, ohne Husten oder andere Symptome zu haben. Die Forscher werden diese Frage bei der Einführung der Impfstoffe intensiv untersuchen. In der Zwischenzeit müssen sich selbst geimpfte Menschen als mögliche Spreizer vorstellen.
    • Wird es wehtun? Was sind die Nebenwirkungen? Der Impfstoff gegen Pfizer und BioNTech wird wie andere typische Impfstoffe als Schuss in den Arm abgegeben. Die Injektion unterscheidet sich nicht von denen, die Sie zuvor erhalten haben. Zehntausende Menschen haben die Impfstoffe bereits erhalten, und keiner von ihnen hat ernsthafte gesundheitliche Probleme gemeldet. Einige von ihnen haben jedoch kurzlebige Beschwerden verspürt, darunter Schmerzen und grippeähnliche Symptome, die normalerweise einen Tag anhalten. Es ist möglich, dass die Leute planen müssen, nach dem zweiten Schuss einen Tag frei zu nehmen oder zur Schule zu gehen. Obwohl diese Erfahrungen nicht angenehm sind, sind sie ein gutes Zeichen: Sie sind das Ergebnis der Begegnung Ihres eigenen Immunsystems mit dem Impfstoff und einer starken Reaktion, die eine dauerhafte Immunität gewährleistet.
    • Werden mRNA-Impfstoffe meine Gene verändern? Nein. Die Impfstoffe von Moderna und Pfizer verwenden ein genetisches Molekül, um das Immunsystem zu stärken. Dieses als mRNA bekannte Molekül wird schließlich vom Körper zerstört. Die mRNA ist in einer öligen Blase verpackt, die mit einer Zelle verschmelzen kann, so dass das Molekül hineinrutschen kann. Die Zelle verwendet die mRNA, um Proteine ​​aus dem Coronavirus herzustellen, die das Immunsystem stimulieren können. Zu jedem Zeitpunkt kann jede unserer Zellen Hunderttausende von mRNA-Molekülen enthalten, die sie produzieren, um eigene Proteine ​​herzustellen. Sobald diese Proteine ​​hergestellt sind, zerkleinern unsere Zellen die mRNA mit speziellen Enzymen. Die mRNA-Moleküle, die unsere Zellen herstellen, können nur wenige Minuten überleben. Die mRNA in Impfstoffen ist so konstruiert, dass sie den Enzymen der Zelle etwas länger standhält, sodass die Zellen zusätzliche Virusproteine ​​bilden und eine stärkere Immunantwort auslösen können. Die mRNA kann jedoch höchstens einige Tage halten, bevor sie zerstört wird.

Dr. Samu Queen, eine Ärztin in Portland, Oregon, sagte, ihre geriatrischen Patienten seien besonders gespannt auf den Impfstoff. “Sie sind alle sehr besorgt”, sagte sie. “So ziemlich jeder ist bei jedem Termin bereit, es zu bekommen.”

Dr. Queen sagte, sie habe genau beobachtet, wie die ersten Probanden in Großbritannien reagierten. Sie beschrieb sich selbst als “etwas besorgt darüber, wie sicher es ist, im Gegensatz zu nicht”.

Joshua Ball, stellvertretender Geschäftsführer von Shaping Our Appalachian Region, einer Wirtschaftsförderungsgruppe im Osten von Kentucky, war ein Hauptbetreuer seines Vaters, der Anfang dieses Jahres einen Schlaganfall hatte und andere gesundheitliche Probleme hat. Während der Pandemie musste er versuchen, so viel wie möglich aus der Ferne zu helfen.

Ein Impfstoff könnte das ändern. Es könnte ihm auch ermöglichen, in die Kirche zurückzukehren und an den saisonalen Festen teilzunehmen, die für viele kleine Städte in seiner Region ein kulturelles Grundnahrungsmittel sind.

“Ich vermisse die Gemeinschaft, Hände zu schütteln, Menschen zu sehen, Geburtstage, kirchliche Mahlzeiten und eine Ferienbibelschule zu feiern”, sagte er.

Dennoch sind die staatlichen Gesundheitsbehörden nach wie vor zutiefst besorgt darüber, was sie als unzureichende Finanzierung für die größte Impfkampagne bezeichnen, die das Land jemals gestartet hat. Staatliche Gesundheitsbeamte haben den Kongress um mindestens 8,4 Milliarden US-Dollar gebeten, um die Arbeit gut zu machen. Bisher haben sie jedoch nur etwa 350 Millionen US-Dollar von den Zentren für die Kontrolle und Prävention von Krankheiten für die Verteilung und Verabreichung von Impfstoffen erhalten. Zu diesen Aufgaben gehört die Erweiterung der Online-Systeme, um Informationen darüber zu verfolgen und auszutauschen, wer geimpft wurde. Rekrutierung und Ausbildung von Ärzten, Krankenschwestern und Apothekern zur Verwaltung der Aufnahmen; und die Öffentlichkeit davon zu überzeugen, wie wichtig es ist, geimpft zu werden.

Die ausreichende Zufuhr des Impfstoffs hat sich auch als Herausforderung ohne klare Lösung erwiesen. Pfizer musste frühere Schätzungen aufgrund von Rückschlägen bei der Herstellung zurückfahren und hat angekündigt, bis Ende des Jahres bis zu 25 Millionen Dosen und bis März insgesamt 100 Millionen Impfstoffe liefern zu können.

Diese Woche sagten Bundesbeamte, dass die Regierung drei Wochen nach ihrer ersten Impfung nicht alle 6,4 Millionen Dosen verwendet, die die Regierung ursprünglich von Pfizer zur Impfung von Menschen bestellt hatte, sondern die Hälfte des Angebots für einen Auffrischungsschuss an die Empfänger zurückhält. Obwohl in der ersten Woche nur etwa drei Millionen Menschen einen Impfstoff erhalten werden, haben die Beamten ihre Schätzung bestätigt, dass sie zwischen den Impfstoffen von Pfizer und Moderna, für die jeweils zwei Schüsse erforderlich sind, hoffen, mindestens 20 Millionen Menschen ihren ersten Impfstoff zu geben Dosis eines Impfstoffs bis Ende des Jahres.

Es bleiben auch Fragen offen, wie schnell ein Impfstoff für jeden verfügbar sein wird, der einen möchte. Bundesbeamte haben angekündigt, dass sie voraussichtlich Mitte nächsten Jahres den Großteil der US-Bevölkerung impfen können, aber die jüngsten Rückschläge haben diese Schätzungen in Frage gestellt. Pfizer hat der Bundesregierung mitgeteilt, dass sie aufgrund von Vereinbarungen mit anderen Ländern möglicherweise nicht in der Lage ist, den Vereinigten Staaten vor Mitte nächsten Jahres zusätzliche 100 Millionen Dosen zuzuführen. Drei weitere experimentelle Impfstoffe, die von Novavax, Sanofi und AstraZeneca entwickelt wurden, mussten Verzögerungen bei ihren klinischen Studien hinnehmen.

Ellen Barry und Will Wright haben zur Berichterstattung beigetragen.

Categories
Health

Trump Administration Handed on Probability to Safe Extra of Pfizer Vaccine

Trump Administration Passed on Chance to Secure More of Pfizer Vaccine

michael barbaro

Hey, it’s Michael. We know that 2020 has been a difficult year. But it’s also been a year of small victories, personal milestones, and moments of joy. If something good happened to you, we want to hear about it. So write us an email or better yet, send us a voice memo to thedaily@nytimes.com— that’s thedaily@nytimes.com— and tell us your story of good news this year, large or small. And thank you. From The New York Times, I’m Michael Barbaro. This is The Daily.

[music]

Today: From the start of the pandemic, the Trump administration said it was committed to ordering and stockpiling enough vaccine to end the pandemic as quickly as possible. But new reporting from The Times raises questions about whether it has actually done that. I spoke with my colleague, Sharon LaFraniere.

It’s Thursday, December 10.

So Sharon, tell me about this tip that you got.

sharon lafraniere

So it was on Saturday. I think I was playing bridge on my phone with the robots, which is how we spend Saturday nights now, right?

michael barbaro

Right.

sharon lafraniere

And I got a call from another New York Times reporter, mutual friend of ours, saying, I have heard this about Pfizer. You need to call this guy. Here’s his name. Here’s his number. Tell him you know me. And so I called the guy, and basically the tip was that the administration had muffed a chance to buy more of Pfizer’s vaccine, and now it couldn’t get it until, like, the middle of next year.

michael barbaro

Hm, that’s a very big tip.

sharon lafraniere

It’s a big tip because Pfizer’s vaccine has been shown to be 95 percent effective, and it’s the first one out of the gate, right? The Brits are already inoculating people with it. The Americans want it. And if we somehow missed out a chance to get twice as many doses as we had locked in, that would be a big deal.

michael barbaro

And I wonder what you thought when you heard this tip. I mean, it’s one of those things you hear, you’re sort of like, wait, could that be right?

sharon lafraniere

My reaction was, if this is right, it’s a big story.

michael barbaro

Mhm. And so what did you do?

sharon lafraniere

So I called my editors and my colleagues and said, we need to chase this as hard as we can. And so all Sunday we were calling everybody, and we’re getting like, sorry, can’t help you on this. Or, I never heard about this. Or, try some other people. And then finally on Monday afternoon, early Monday afternoon, we’re able to confirm it, that in fact Pfizer had tried to get the US government to lock in a hundred million extra doses but the government had turned them down.

[music]michael barbaro

So Sharon, what did you find out was the thinking behind this decision— which feels like a real head-scratcher on paper— not buying extra doses of a very effective vaccine from Pfizer?

sharon lafraniere

So to answer that, we really have to go back to the start of the administration’s whole crash program to develop vaccines, all the way back to March when it starts this initiative called Operation Warp Speed and comes up with a strategy to develop vaccines in record-breaking time.

michael barbaro

Right.

sharon lafraniere

So the initial strategy was that the government would pick three different technologies. And each technology would be pursued by a pair of companies, so six companies all together— six horses. They actually called them horses. And the idea of having a pair of companies is if one company fails, then you’ve still got one company standing to go after that technology. But nobody had any idea which of those vaccine technologies would work. So the government’s strategy was, we’ll back all six, and we’re going to pay this money even before we know whether the vaccines work or not.

But Pfizer was alone among the group in saying, we don’t want your money. And there’s really three reasons for that. So the C.E.O., Albert Bourla, told us, number one, it doesn’t need the money. Number two, it doesn’t want the government oversight. I mean, he actually felt that having government oversight over the vaccine project would not speed them up but it would slow them down. And number three, he was fearful about getting involved in the whole political drama that was starting to unfold with the White House pressuring the health agencies to act in one way or another. He just wanted to stay out of the political fray. And he thought if he takes the money, the money will come with strings attached, and he doesn’t want to be dragged into this.

michael barbaro

Got it. So what exactly is the arrangement with Pfizer? Because it sounds very different from the other five. What’s the eventual terms of it?

sharon lafraniere

So the contract called for Pfizer to deliver a hundred million doses to the U.S. government at a cost of $19.50 per dose by the end of the first quarter of 2021, but the U.S. government didn’t pay any money up front. In other words, only if this vaccine clears all the hurdles, gets approved by the F.D.A., and Pfizer’s able to manufacture it— only in that case will the US government have to actually pay the bill.

michael barbaro

Hm. So in some ways, this arrangement with Pfizer is better for the U.S. government than its arrangement with the five other companies. Doesn’t have to put any money down, and it seems like Pfizer is assuming most, if not all, of the risk.

sharon lafraniere

Exactly.

michael barbaro

This is a very good deal if you’re the United States government.

sharon lafraniere

Right. You get to lock in a hundred million doses, and you don’t have to pay up front.

michael barbaro

And so the U.S. takes that deal.

sharon lafraniere

Right.

michael barbaro

And when exactly was this?

sharon lafraniere

So the contract is signed in late July. But even at that time, we’re told, Pfizer is asking Operation Warp Speed officials, don’t you want more? Like, don’t you want to lock in an extra 100 million doses or 200 million doses? Because you don’t have to pay for them unless it works. And the answer was, no, we’re hedging our bets. We’ve got six candidates here. We’re not playing favorites among any of them. And Pfizer’s saying basically, yeah, but with us, it’s a free bet. But the government is saying, no, we’re sticking with our strategy. They don’t want to bet too heavily on any one of the six, even if the bet is free.

michael barbaro

And Sharon, as the U.S. government is turning down this offer from Pfizer, what does it actually know about Pfizer’s vaccine and how effective it may actually be?

sharon lafraniere

Well, remember this is July, and at this point, the government really doesn’t know very much, if anything, about which of these vaccines is going to work. But as time went on, it looks like suddenly that Pfizer is going to be the first over the finish line. But the problem is, a lot of other countries were also getting interested in Pfizer’s vaccine. They have a vaccine that is attracting so much attention that their executives are getting messages over LinkedIn from other countries, like, we want some. Can we lock this in?

And in early October, the U.S. government also gets interested in some extra doses and talks resume. But it’s no longer the same situation, because while the U.S. was hesitating, other countries were moving in. So in October, they don’t actually come to any agreement on a second contract because the U.S. is like, we need it sooner than it sounds like you’re delivering it. Or, you’re not promising us that we’re going to get it in time. Anyway, the talks are inconclusive. And then comes the big day of November 8.

archived recording

This is CNN breaking news. Pharmaceutical giant Pfizer reportedly making an enormous breakthrough with its Covid-19 vaccine, announcing today—

sharon lafraniere

Pfizer gets the interim results of its clinical trials.

archived recording

Pharmaceutical giant Pfizer just announced moments ago that its coronavirus vaccine is 95 percent effective. 95 percent effective— 95 percent effective, and they say with no serious side effects.

sharon lafraniere

And they are amazing.

archived recording

Pfizer’s C.E.O. is calling it, quote, “the greatest medical advancement in the last 100 years.” We will speak with—

michael barbaro

I remember that, Sharon. The results were stunning. And it suggested that this vaccine was going to be a blockbuster. But the U.S. still hasn’t ordered extra doses at this point?

sharon lafraniere

Right. And according to Scott Gottlieb, who is a member of Pfizer’s board and the former commissioner of the Food and Drug Administration, Pfizer was still offering— after the results came out— more doses, but the U.S. did not seal a deal then.

michael barbaro

Hm. So the Trump administration, the U.S. government, having missed this first chance back in July to lock in this deal for extra doses of this vaccine at no cost, is then told in October, and it sounds like even in November, we can’t offer you the exact same timeline. I mean, because months have gone by here. We’ve gotten other orders. And so as a result, despite how promising this vaccine turns out to be, the U.S. still decides not to order more. I just want to be clear.

sharon lafraniere

That seems to be the situation, yes. And then on November 11, which is basically two days after Pfizer has announced these amazing results, it announces that it has a deal to sell 200 million doses to the European Union. That was a contract that had been in negotiation for weeks and weeks. Nonetheless, the European Union has locked in 200 million doses, and the U.S. has locked in a hundred million doses.

michael barbaro

So it very much looks like the European Union got 200 million doses of the vaccine that could have gone to the United States if the United States had wanted them.

sharon lafraniere

Yes, that’s what it looks like.

michael barbaro

Sharon, do we know who exactly in the U.S. government made this decision repeatedly not to buy these vaccines?

sharon lafraniere

We’re not sure. We know that Pfizer was dealing with the guy who is the scientific leader of Operation Warp Speed. His name is Dr. Moncef Slaoui. But whether Dr. Slaoui was the one who was the final decision-maker or it was Alex Azar, the Health and Human Services secretary, or whether the White House was involved or not, we really don’t know now.

michael barbaro

So Sharon, if you could summarize it, what are the consequences of how the U.S. has approached these offers from Pfizer?

sharon lafraniere

So the consequence is that the U.S. might have to wait longer for as much supply of the Pfizer vaccine as it wants and needs. Because the state of play is that Pfizer is right on the brink of getting emergency approval from the Food and Drug Administration. It’s going to be the first vaccine to get that in the U.S. And the US government has locked in a commitment for a hundred million doses, enough to cover 50 million people, and it wants more. But it looks very unlikely that it can get it as soon as it wants it.

michael barbaro

So how much time have we lost here when it comes to the Pfizer vaccine orders that we never placed?

sharon lafraniere

So what we’re being told is that the U.S. government has now asked Pfizer for a hundred million doses, and they want them starting in March. But Pfizer is saying, sorry, we cannot guarantee you these doses until June. So if that’s how it all plays out, the way it’s looking now, then we would have lost three months.

michael barbaro

Three months. Three months of not having tens of millions of doses that the U.S. could have had.

sharon lafraniere

If it works out that way, that would be three months in which the U.S. is waiting for a Pfizer vaccine because it didn’t lock in more doses earlier.

[music]michael barbaro

We’ll be right back.

Sharon, having made this decision, which in retrospect feels like a pretty strange and bad decision, what does the United States now do to correct for this? Could we just beg Pfizer to make extra doses for us?

sharon lafraniere

No, because it’s not that Pfizer is not willing to make more doses for Americans. It’s making every dose that it can possibly make right now. It doesn’t have empty factories somewhere where it can go in and just flip on the lights and suddenly there’s lots more doses. It has legal commitments to other countries to provide supply. And those countries want it too. It’s not a matter of begging Pfizer to make more. If they had more to give the Americans, they would give it to them. Pfizer has a very big motivation to put the U.S. first, because Pfizer, number one, it’s an American company.

michael barbaro

Right.

sharon lafraniere

Number two, most of its customers are in the U.S. They do not want to be in this situation where their customers think, what, you’re making deals to save the lives of Europeans and you’re leaving Americans here waiting for lifesaving vaccines? They don’t want a consumer backlash.

michael barbaro

Could the U.S.— and here I’m just kind of exhausting American curiosity. Could the U.S. kind of forcefully take vaccine from Pfizer if it wanted to be extremely nationalistic and say, nobody gets doses outside the U.S. before we get doses?

sharon lafraniere

I mean, that seems highly unlikely that the U.S. government is going to move into Pfizer’s factories and rip up all its contracts and commandeer its doses. President Trump signed an executive order this week saying that Americans would get vaccine supplies first, but it seems pretty meaningless. It’s hard to imagine what the government could do to force Pfizer to redirect vaccine that it’s committed to other countries to Americans. I mean, some people have speculated, maybe could Pfizer team up with another pharmaceutical company like Merck? And then could there be some kind of partnership there that would allow it to increase production? But it cannot itself, now, just turn on a dime and create more production.

michael barbaro

OK, so with no great options for securing more doses from Pfizer right away, what can the U.S. do instead? How do we make up for those missing doses? I have to imagine the answer lies with these other companies that the U.S. has invested in.

sharon lafraniere

Exactly. Moderna is right behind Pfizer with a very similar vaccine that is proven to be equally effective. It’s likely to win emergency approval from the F.D.A. maybe a week after Pfizer does later this month. It too has committed to provide the U.S. with a hundred million doses. Like Pfizer, it has to deliver those doses by the end of the first quarter of next year. It’s easier to store than Pfizer’s, and it might be easier to ship. It’s a much smaller company than Pfizer, right? It spent 10 years without bringing a product successfully to market, but it’s done extremely well with this vaccine. So there’s the Moderna option.

michael barbaro

So if I’m keeping count correctly, 50 million Americans would be inoculated through Pfizer’s vaccine.

sharon lafraniere

Right.

michael barbaro

50 million Americans would be inoculated through Moderna’s vaccine. That still leaves a lot of Americans. So what about these other companies?

sharon lafraniere

So of the other four companies, two of them are sort of off the table right now because they haven’t even started their phase 3 clinical trials. Another one, AstraZeneca, which has developed its vaccine with University of Oxford researchers, is about halfway enrolled in its clinical trial here. And there are some questions about its data, its transparency. It’s had somewhat rocky relations with the F.D.A. And its early results have shown basically that for the full two-dose regime, it was shown to be about 62 percent effective. So you have to ask yourself, are Americans going to want to take a vaccine that’s 62 percent effective when they have two vaccines out there that are 95 percent effective?

michael barbaro

Right. And I think we all know the answer to that is probably no, not really. So it’s really kind of “Moderna and Pfizer or bust” for the moment.

sharon lafraniere

Well, there’s also Johnson & Johnson, and it expects to have clinical trial results early next year. But we don’t know if that vaccine worked or not. If it works, that gives us a third. But at the moment, the U.S. government has got, as you said, commitments for 200 million doses, which will cover a hundred million Americans. And the question is, what is going to happen at the end of March? Are we going to fall off some kind of vaccine cliff here? Or, is there going to be an interval in which people are not being vaccinated? Or, are there going to be enough doses to fill in the gap?

michael barbaro

Mhm. So what happens if we reach and go over a vaccine cliff?

sharon lafraniere

So the worst case scenario is that there is an interval in which Americans are waiting and that there’s some sort of break in the inoculation program. But we don’t know that’s true. We don’t know for sure that that’s going to happen. Moderna could fill in some of the gap. And at the moment, all we can say is that it kind of raises the anxiety level that we have two successful vaccines, and so far, we have not locked in enough doses to cover more than a hundred million Americans.

michael barbaro

Right. So no matter how you slice it, the chances of us going over a vaccine cliff, of suddenly having some period of some unknown duration where Americans are not being inoculated, which is not what we want, the chances of that are higher— correct me if I’m wrong— because the United States did not order more of these doses from Pfizer. Is that right?

sharon lafraniere

I think that’s right. The administration says that is not going to happen. We’re not going over this cliff. That there’s going to be enough vaccine for everybody, that there are more supplies coming in, that there are negotiations going all the time. That they feel confident that they are going to have enough vaccine doses for every single American who wants it by spring or the middle of next year.

michael barbaro

Mhm. But the government can’t assure that.

sharon lafraniere

Not yet.

michael barbaro

Sharon, it feels like the consequence of what the U.S. government, of what the Trump administration has done here, is time. You said that the decision-making here may have delayed this acquisition of vaccines by something like three months. Time is a very precious resource in this pandemic. Time is how we measure the number of people who get exposed to this virus, who get infected by it, who get killed by it. And so every single day matters. And so three months, 90 days, that really matters, right? It means more people are likely to get this virus and potentially to die from it.

sharon lafraniere

I mean, I really, really hope that’s not so. Well, the whole story is such a roller coaster, right? We get these amazing results from Pfizer and Moderna, and everybody is just ecstatic. And then we learn, whoa, we don’t have enough. And are we going to get enough? And everybody would feel much more comfortable if we had all these doses in the bank.

michael barbaro

Mhm. I mean, what makes this feel especially confounding is that vaccines have been the U.S. government’s approach to this pandemic, right? I mean, the Trump administration has not issued national lockdowns. It has not issued a national mask mandate. What it has said is that what will get us out of this pandemic is a vaccine. We are going all in on vaccines. It’s pretty much our only solution to the pandemic. So to have not done everything conceivably possible to get as many doses of the vaccine as we could, knowing that this is our solution, just becomes extremely hard to understand or explain.

sharon lafraniere

So in hindsight, some administration officials will say privately they wish that they had locked in more doses earlier. That this has exposed a kind of flaw in their strategy. And that now they’re scrambling to figure out how can they compensate for it. And that is weighing heavily on them.

michael barbaro

Sharon, thank you very much. We appreciate it.

sharon lafraniere

Thank you, Michael.

[music]michael barbaro

On Wednesday afternoon, Canada became the latest country to approve Pfizer’s vaccine, meaning that its citizens may start to receive it beginning next week. A few hours later, The Times reported that the United States had passed a grim new milestone on Wednesday— 3,000 deaths from the coronavirus in a single day. We’ll be right back.

[music]

Here’s what else you need to know today:

archived recording

No company should have this much unchecked power over our personal information and our social interactions.

michael barbaro

In a lawsuit filed on Wednesday, the Federal Trade Commission and attorneys general from 48 states called for breaking up Facebook.

archived recording

And that’s why we are taking action today and standing up for the millions of consumers and many small businesses that have been harmed by Facebook’s illegal behavior.

michael barbaro

The lawsuit accused the company of purchasing its rivals, including Instagram and WhatsApp, in order to eliminate potential competition and in the process, acting as an unlawful monopoly. In response, Facebook said that it would vigorously defend itself during what is expected to be a long and expensive legal battle.

[music]

That’s it for The Daily. I’m Michael Barbaro. See you tomorrow.

Categories
World News

Britain rolls out the Pfizer vaccine, an enormous process however an indication of hope.

Britain rolls out the Pfizer vaccine, a huge task but a sign of hope.

The UK’s National Health Service delivered its first footage of the Pfizer BioNTech Covid-19 vaccine on Tuesday. He opened a mass vaccination campaign with little precedent in modern medicine, making the British the first in the world to receive a clinically approved, fully tested vaccine for the disease.

Vaccine centers across the country are starting to carefully deliver vaccinations on a tight schedule, as the vaccine must be used or thrown away within five days of being thawed. “We do this with military precision, and indeed the military helped us with our planning,” said Fiona Kinghorn, who oversaw the launch of the vaccine at a site in Cardiff, Wales.

The effort marks a turning point in the remarkable race to manufacture a vaccine and global effort to end a pandemic that killed 1.5 million people worldwide. At a Welsh vaccination center, a retired nurse on the facility described the reaction of her youngest patient, another nurse. “She just cried and said it was such an emotional day,” she said, adding, “I think partly because she worked on a Covid ward so she saw the consequences and probably the results. Me assume she saw a lot. “

At 6:31 am Tuesday, 90-year-old Margaret Keenan, a former jeweler, rolled up the sleeve of her Merry Christmas T-shirt for the first shot, and her image quickly became a symbol of hope and resilience .

“I feel so privileged to be the first person to be vaccinated against Covid-19,” said Ms. Keenan, who lives in Coventry, Central England. “That means I can finally look forward to spending time with family and friends in the New Year after being alone for most of the year.”

UK regulators jumped ahead of their American counterparts last week to approve a coronavirus vaccine, which angered the White House and sparked a lively debate over whether the UK had moved too quickly or whether the United States was wasting valuable time when the virus was around 2,200 People killed Americans one day in the past week, as of Monday.

President Trump planned on Tuesday to issue an executive order proclaiming that other nations will not receive US vaccines until after Americans are vaccinated. This guideline seemed to have no real teeth, but it was indicative of the heated race to secure dose deliveries.

For the people who were vaccinated in the UK, including doctors and nurses who joined the country’s National Health Service this year, the footage was an early glimpse into life after the pandemic. Except for Ms. Keenan, none got as much attention as William Shakespeare, who was second in a shot in Coventry and whose real name, the National Health Service confirmed, is William Shakespeare. Twitter used the news of his vaccination as an opportunity for an enthusiastic play on words and jokes about the taming of the flu and the gentlemen of Corona.

“Today is a great day for medicine and the future,” said Chris Whitty, chief medical officer for England, on Tuesday. (A previous version of this article incorrectly stated that he was the chief medical officer for the whole of the UK.)

The first 800,000 doses of Pfizer BioNTech vaccine for the UK have been shipped from a manufacturing facility in Belgium to government warehouses in the UK and then to hospitals in the past few days.

50 hospitals will manage the admissions until the government can refine a plan for delivery to nursing homes and doctor’s offices. The vaccine must be transported in temperatures similar to the south pole before it can be stored in a regular refrigerator for five days, Pfizer said. Doctors and nurses, certain people aged 80 and over, and nursing home workers are given the vaccine first.

Some doctors and nurses have received invitations to register for appointments in the past few days. The first shots are for those who are at the highest risk of serious illness. The government has indicated that people aged 80 and over who have already had a doctor’s visit or are discharged from certain hospitals for this week will also be among the first to receive gunfire.

Nursing home residents, who should actually be the government’s top priority, will be vaccinated in the coming weeks once health officials start distributing doses across hospitals.

Hundreds of people are still dying from the virus every day in the UK, and the country has taken into account Christmas travel that scientists fear will trigger another surge in infections.

“It’s amazing to see the vaccine, but we can’t afford to relax right now,” British Prime Minister Boris Johnson said Tuesday morning when visiting a London hospital. Trying to calm a recipient’s nerves over needles, he suggested, “I always try to think of something else – recite poetry.”

Ms. Keenan, the first vaccine recipient, showed no such nerves. Nicola Sturgeon, Scotland’s first minister, said on Twitter that she had “a little lump in her throat” when Ms. Keenan was shot.

“Feels like a milestone after a tough year for everyone,” added Ms. Sturgeon.

Ms. Keenan’s shot was administered by May Parsons, a nurse originally from the Philippines who has worked for the National Health Service for 24 years.

“The past few months have been difficult for all of us who work in the NHS,” she said, “but now it feels like there is light at the end of the tunnel.”

Categories
Health

The UK Simply Accepted the Pfizer Covid Vaccine. What Occurs Subsequent?

The UK Just Approved the Pfizer Covid Vaccine. What Happens Next?

LONDON – The first rigorously tested coronavirus vaccine was given the green light for use in the UK on Wednesday. The vaccine doses of the American pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected from next week, the government said.

When the UK jumped before the United States to allow mass vaccination, it put pressure on American drug regulators, who were called to the White House by President Trump’s chief of staff on Tuesday to explain why they were unwilling to do the same.

The two countries study vaccines differently.

Rather than accepting the vaccine manufacturers’ results, American regulators are carefully re-analyzing the raw data from the studies to validate the results, considering what regulators described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner for the Food and Drug Administration, said Tuesday that the FDA is “one of the few regulators in the world actually looking at the raw data.”

Regulators in the UK and other European countries rely more on in-house analysis. Instead of sifting through the raw study data and figuring out the numbers themselves, regulators often examine a drug manufacturer’s reports and, if there are no anomalies, justify their decisions in company-provided documents.

Whether the UK was rushing to approve a vaccine or whether the US was wasting valuable time as the virus kills around 1,500 Americans a day sparked a lively debate among scientists and industry experts on Wednesday. European regulators said UK approval is so limited that it only applies to certain lots of the vaccine, a claim Pfizer denied and which UK officials failed to address.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s Vaccine Advisory Council, said in an interview Wednesday that regulators’ success in getting vaccines approved while minimizing unforeseen errors justifies a rigorous approach.

“It is remarkable that we were able to access viruses with so few casualties,” he said, adding that American regulators were only days away from completing their own review.

The FDA has scheduled a meeting of an independent panel of experts on December 10th to review Pfizer’s vaccine. UK regulators also seek opinions from a technical committee, but this group has the flexibility to review and meet data as needed so that it can be implemented more quickly.

“In the UK, they could just say, ‘We have the data, we have the meeting,” said Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

To speed up the process, the UK Medicines and Health Products regulator had their experts review vaccine dates as soon as they were available, and separate teams worked in parallel on different parts of the process rather than waiting for another to complete.

“If you are climbing a mountain, prepare,” said Dr. June Raine, executive director of the agency, on Wednesday. “We started this in June.”

When the first results came in on November 10, she said, “We were in base camp.” And later she said, “When we got the final analysis, we were ready for the final sprint.”

The UK has left the European Union’s regulatory orbit to get early approval for a vaccine as the bloc gives countries emergency powers in the event of a pandemic. Once the UK separates from the European Union on December 31, those vaccine-only powers will become permanent.

The countries remaining in the European Union are waiting for their regulator, the European Medicines Agency, to approve a vaccine. Like the FDA, the European regulator has scheduled a meeting on December 29th to consult outside experts and provide an opinion on the Pfizer vaccine.

The agency’s task is made more difficult by its obligation to seek the views of all 27 EU countries. This process was sped up during the pandemic, but it will be a few more days for countries to weigh in after the meeting, which will likely delay vaccinations until early January.

Pfizer plans to ship 800,000 cans to the UK in the coming days. As of Tuesday evening, these cans were being prepared for shipment at a factory in Puurs, Belgium, BioNTech said.

The cans are packaged in cardboard boxes, using dry ice to keep them at the south pole-like temperatures they need, before being placed on trucks or planes and taken to the UK. They will arrive at state distribution warehouses over the weekend, Pfizer said on Wednesday.

UK hospitals have already started emailing staff to inform them of vaccination schedules. A London hospital system states that the first doses are given on Monday at 7 a.m. The UK has placed pre-orders for 40 million doses of the Pfizer vaccine, but most of them are expected to be administered over the next year. Each patient needs two, one month apart.

A government advisory council released its list of vaccine priority groups on Wednesday. At the top of the list are residents and workers of nursing homes, followed by people over the age of 80 and health and social care workers.

In practice, however, government officials said Wednesday that they would initially limit vaccinations to a network of 50 hospitals due to the difficulty of storing and shipping the Pfizer vaccine. As a result, nurses, doctors, nursing home staff, and people 80+ who had made appointments would come first for the vaccine before residents of the nursing home.

Pfizer has said the vaccine can survive for five days in a regular refrigerator. However, the UK’s National Health Service has yet to consider issues such as staffing at locations outside the hospital and transportation difficulties within the country to decide how to administer the vaccine.

The National Health Service has around 150,000 doctors and more than 330,000 nurses and midwives.

The British decision will not in itself bring vaccinations any closer. However, Pfizer executives said Wednesday they had heard from other countries that they wanted to speed up their own approval processes in the face of UK approval.

American regulators, despite months of pressure from Mr. Trump, have claimed that they will follow their plan and review Pfizer’s vaccine to FDA standards.

The US has pre-ordered 100 million doses of the Pfizer vaccine. Most of the supply will come from a separate factory in Kalamazoo, Michigan. Still, many questions remain unanswered as to how vaccine manufacturers like Pfizer will fulfill the orders of wealthier nations that have pre-sourced supplies.