Tag: Vaccine

Categories
Business

NY Gov. Cuomo holds a press briefing as state prepares to distribute Covid vaccine

NY Gov. Cuomo holds a press briefing as state prepares to distribute Covid vaccine

[The stream is slated to start at 11:30 a.m. ET. Please refresh the page if you do not see a player above at that time.]

New York Governor Andrew Cuomo will hold a press conference Friday on the coronavirus pandemic as the state prepares to receive a Covid-19 vaccine, which could be approved and dispensed in the coming days.

Cuomo is represented by Rep. Hakeem Jeffries (D-NY), Rep. Grace Meng (D-NY), Rep. Karen Bass (D-CA), Rep. Joaquin Castro (D-TX) and Rep. Deb Haaland (D- NY) accompanies D-NM).

The Democratic governor has announced that New York is expected to receive an initial allocation of 170,000 doses of Pfizer’s vaccine once the U.S. Food and Drug Administration approves the shots. New York could get the cans this weekend, Cuomo’s office said in a press release on Wednesday.

Meanwhile, New York is considering restricting indoor eating if state hospitals continue to be overcrowded with Covid-19 patients. Cuomo said Monday if New York hospital stays don’t stabilize within five days, the state could shut down indoor dining in the city as early as next week.

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

Categories
Health

Pfizer’s Covid vaccine permitted by FDA for emergency use

Pfizer's Covid vaccine approved by FDA for emergency use

The Food and Drug Administration has approved Pfizer and BioNTech’s coronavirus vaccine for emergency use. This is a monumental turning point in the one-time pandemic that killed nearly 300,000 Americans and devastated the US economy in less than a year.

FDA chief scientist Denise Hinton told Pfizer in a letter Friday that she approved the company’s emergency use of the vaccine.

President Donald Trump called it a “medical miracle” in a video tweet. “We delivered a safe and effective vaccine in just 9 months,” Trump said. “This is one of the greatest scientific achievements in history.”

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the decision “promises to change the course of this pandemic in the United States.” “With the science guiding our decision-making, the available safety and efficacy data to support the approval of the Pfizer-BioNTech COVID-19 vaccine because the known and potential benefits of the vaccine significantly outweigh the known and potential risks,” he said.

FDA approval for the emergency will now boost the federal government’s distribution of the potentially life-saving doses to 64 states, territories and major cities across the country. The government plans to distribute 2.9 million doses of the vaccine within 24 hours, followed by another 2.9 million doses 21 days later, for patients to receive their second shot, General Gustave Perna, who runs the logistics for the Operation Warp vaccination program Speed ​​monitored by President Donald Trump said Wednesday. Pfizer’s vaccine requires two doses three weeks apart.

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. According to a CNBC analysis of the Johns Hopkins University data, the US reported 3,124 new Covid-19 deaths on Wednesday, the pandemic’s deadliest one-day record to date. 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.”

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. Pfizer has announced that it will ship 50 million doses of vaccine this year, enough to vaccinate 25 million people. 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.

An emergency permit, or EEA, is not the same as a full permit, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval. The vaccine has been approved for people aged 16 and over.

On Friday, FDA Commissioner Stephen Hahn said the agency was “working fast” to clear the vaccine in case of emergency. Shortly after Hahn testified, Trump, who has repeatedly said he had urged the FDA to move faster in the vaccine development process, told the agency in a tweet: “Get the dam vaccines out NOW.”

The FDA’s announcement comes after a key agency advisory body voted 17 to 4, with one abstention, to recommend the vaccine for emergency approval on Thursday. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

FDA approval marks a record breaking time frame for a process that typically takes about a decade. The fastest vaccine development to date against mumps took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and filed an emergency clearance application with the FDA in November. Health authorities in Canada, the UK and Bahrain have approved Pfizer’s vaccine for most adults.

Pfizer’s vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Moderna, another front runner in the Covid vaccine race, also uses mRNA technology. Late-stage clinical trial data shows Pfizer’s vaccine is 95% effective against Covid, safe, and appears to ward off serious illness. For maximum effectiveness, the vaccine requires two doses about 21 days apart.

Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, which poses potential logistical challenges for rural areas and inner cities that may not have good health infrastructure. For comparison: According to Moderna, the vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.

FedEx and United Parcel Service on Thursday expressed confidence in their networks to distribute the vaccines across the country in a Senate hearing and outlined plans to monitor the location and temperatures of the shipments.

The Federal Aviation Administration asked the airports late Friday to ensure that they have adequate staff when the vaccines arrive. In a statement hours before the vaccine was approved, the FAA said airports should consider providing areas for trucks for vaccines to be picked up on arrival. The agency has announced that flights with cans and related supplies will be given priority.

U.S. officials plan to continue to monitor for side effects of the Pfizer vaccine among the health care workers and nursing homes who receive it, said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, during the agency’s meeting on Thursday. The officers will use an SMS system called v-safe, which is designed to provide early warning of possible side effects of the vaccine.

During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim found that the study data showed a “numerical imbalance” in Bell’s palsy, a condition that causes temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. Although the frequency of the cases was inconsistent with the general population, the FDA recommended further monitoring once the vaccine becomes more widely distributed.

Read the full letter from the FDA below:

Categories
World News

A Vaccine Is on Its Technique to Canada. Who Will Get It First?

A Vaccine Is on Its Way to Canada. Who Will Get It First?

When a polio vaccine was announced in 1953, the CBC reported that in Canada “the response was the same as at the end of a terrible war”. The 13,109 Canadians the Covid-19 has killed, the hundreds of thousands it has made sick, and the economic turmoil it has brought to the nation also appear to be the toll of battle. The vaccine approved by Canada this week also appeared to be a truce, if not a truce. The first shipment of the vaccine, made by the American company Pfizer and a German company, BioNTech, is expected to be on the way this weekend, and the first vaccinations could be given as early as Tuesday. Initial quantities will be small compared to the millions of cans expected to arrive in the New Year, making the first cans more of a starter than a rollout.

[Read: Canada Approves Vaccine and Could Start Shots Next Week]

Everything that has to do with the vaccine depends of course on who gets it and when. Or, as one journalist told officials during one of the vaccine approval press conferences, “How can you make sure this isn’t like The Hunger Games of vaccines?”

The province decides who gets the shots first. However, a federal body has drawn up a list of recommendations for selecting first recipients, a list of candidates, which limits officials to four groups: people over 80; Residents of nursing homes, a group that accounts for 71 percent of deaths so far, and the workers who serve them; Health care workers; and indigenous communities.

For the first few thousand cans that are on the way, plans vary by province. Quebec will focus on nursing homes while Saskatchewan will initially inject health care workers.

In the three areas – the Northwest Areas, Nunavut, and Yukon – no one will receive the Pfizer BioNTech vaccine anytime soon. Instead, governments in the far north have decided to wait for Moderna’s vaccine, which is nearing approval and will be easier to use, said Dr. Howard Njoo, the country’s deputy chief public health officer. It doesn’t require the extremely low temperatures that the Pfizer BioNTech vaccine provides.

Children also won’t get the Pfizer BioNTech vaccine right away. It is only approved for use by people aged 16 and over.

Dr. Njoo warned that decision-making would not end after officials determined which groups would receive them first. You may need to decide whether it makes sense to initially only vaccinate people who live in the cities where the 14 centers where the vaccine is delivered are located. Each province has at least one center, with two each in Ontario and Quebec, but none in rural areas.

“If you want to vaccinate health workers, where do you start?” Dr. Njoo asked at a press conference this week. “Could it be easier and more practical to do this in a facility in an urban setting? Not to say that health care workers who provide health care and direct health care in a remote or rural setting are not so important. “

Regardless of what decisions the provinces ultimately make, the plan is to only vaccinate people from the groups with the highest priority by the end of March. During this time, the federal government expects four million doses of Pfizer and, if approved, two million doses of Moderna’s vaccine. Until then, governments will have to figure out how to deal with the remaining 35 million Canadians.

It has been widely established that both the Pfizer BioNTech and Moderna vaccines use radically new technology. My colleagues Jonathan Corum and Carl Zimmer have prepared definitive guides to help understand both.

[Read: How the Pfizer-BioNTech Vaccine Works]

[Read: How Moderna’s Vaccine Works]

  • Fifty years have passed since the October Crisis was sparked by the kidnapping of UK Trade Commissioner James Cross and the kidnapping and murder of Quebec Deputy Prime Minister Pierre Laporte. Dan Bilefsky reports that a film made by the son of a leader of the FLQ, the violent extremist group that carried out the attacks, was a success and at the same time “underscores the sensitivity of the events of the time.”

  • On another grim anniversary, two years have passed since the Chinese government arrested Canadians Michael Kovrig and Michael Spavor. In their reporting, Javier C. Hernández and Dan noted that the two men “have now become symbols of the aftermath of Beijing’s increasingly aggressive foreign policy and that their fate is apparently intertwined with the future of China’s turbulent relations with Canada and the United States.” .

  • Catherine Porter reports that Christmas broke early in pandemic Canada and Christmas trees have become scarce in some communities.

  • After publishing an annual report on the Arctic, a climate specialist told Henry Fountain, who reports on climate problems for The Times, that “almost everything in the Arctic, from ice and snow to human activity, changes so rapidly that none.” there is reason to believe that in 30 years much will be as it is today. “

  • Lynn Marchessault set off from Georgia with her two children, two dogs, and a cat to reunite 6,000 kilometers with her husband, a US Army sergeant stationed in Fairbanks, Alaska. Snow turned the passage through western Canada into a nightmare. She was about to give up when Gary Bath, a Canadian veteran, came to the rescue.

  • A United States-appointed committee of 19 experts in medicine and other fields has concluded that the mysterious disease affecting American and Canadian diplomats known as Havana Syndrome is likely caused by “directional, pulsed radio frequency energy.” has been.

  • The Trump administration is on its way out, but is using the trade deal that NAFTA replaced to challenge Canada’s dairy supply management system, says Ana Swanson.

  • Fred Sasakamoose, who died at the age of 86, played only 11 games in the NHL but became a hero of the indigenous people and spent decades mentoring and encouraging young First Nations players.

  • As Pat Patterson, Montreal native Pierre Clermont played the villain in countless wrestling matches before becoming an executive in the wrestling world. In 2014, he announced that he was gay and breaking a barrier in that community. Mr. Patterson died last week at the age of 79.

Ian Austen is from Windsor, Ontario. He was trained in Toronto, lives in Ottawa and has been reporting on Canada for the New York Times for 16 years. Follow him on Twitter @ianrausten.

We look forward to your thoughts on this newsletter and on events in Canada in general. Please send them to nytcanada@nytimes.com.

Forward it to your friends and let them know they can sign up here.

Categories
Business

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
Health

Black well being leaders attempt to construct belief within the Covid vaccine amongst African People

Black health leaders try to build trust in the Covid vaccine among African Americans

A researcher works at a laboratory operated by Moderna Inc that said in an undated still image from a video on November 16, 2020 that his experimental vaccine was 94.5% effective in preventing COVID-19, based on interim data from one late clinical trial.

Modern | via Reuters

Dr. Lou Edje participated in the Moderna vaccine study in her healthcare system in Cincinnati, Ohio after three of her relatives died from the coronavirus earlier this year. This led her to do more to instill trust in her community and get vaccinated.

“I felt like I might be able to make a believable impact on the patients I care for every day who look just like me,” said Edje, Black and Associate Dean for Medical Education at the University of Cincinnati College of Medicine.

Although she wasn’t told if she received the actual vaccine during the trial, she had a slight swelling in her arm after the booster shot – which leads her to believe she did. This helps when patients ask what to expect.

“Some of the side effects were a little more robust the second time around, so I’m trying to tell them exactly what I went through,” she explained.

It can take months before the public are vaccinated with new vaccines once they are approved. The Food and Drug Administration is expected to quickly clear Pfizer’s vaccine for emergency use after an advisory panel overwhelmingly approved the shots on Thursday. Starting doses have been set for frontline health workers and the elderly in long-term care facilities such as nursing homes.

Still, African-American health professionals and community health groups across the country have already started reaching out in black communities hard hit by the coronavirus. According to a poll by Pew Research last month, seven out of ten African Americans know someone who was hospitalized or died of Covid. However, there is great skepticism about vaccines. Only 42% of blacks surveyed say they have been vaccinated, compared with more than 60% of Americans as a whole.

“They want to know, and have real reasons to trust. They want to know that the trial will be fair, that they are not guinea pigs for a system that is turned against them,” explained Dr. Reed Tuckson, co-founder of the Black Coalition Against Covid and former Washington, DC Commissioner for Health

The speed at which the Covid vaccine was being developed was one of the issues that many Americans have concerns about being in the first wave to get the shot. But for African Americans, the skepticism is also based in part on history. As part of the infamous Tuskegee study of syphilis, African American men were treated with placebo drugs instead of antibiotics, which they could cure, so officials could follow the disease over the years.

The Coalition on Covid has brought together major African American medical groups, including the National Medical Association and the National Black Nurses Association, as well as heads of four historically black medical schools, including Howard University and Morehouse College, to advocate for African American patients.

In the clinical arena, they have urged federal and local government officials to prioritize access for color communities where the prevalence of pre-existing conditions like high blood pressure and diabetes has increased people’s vulnerability to the virus.

“We shouldn’t let the proliferation of a life-saving vaccine worsen health inequalities. In fact, it should help narrow them down,” said Tuckson.

In terms of reach, they’ve held a number of informative town halls online with government leaders including Dr. Anthony Fauci, the country’s foremost infectious disease expert, to address specific concerns among African Americans.

They also work with community health groups, local churches, and stakeholders who can reach out to the grassroots personally from a place of trust.

“Fifty percent of one neighborhood must have the vaccine to burn out the virus in the other 50 percent,” explained Edje. “We really need to ensure that every neighborhood has some immunity so that we can make a global impact.”

The fact that it will take time for the public to gain access to the vaccine could prove to be a silver lining. Health officials say it will show people how the first wave of those who get the shot react, which can help fight skepticism and fear.

Categories
World News

White Home threatens to fireplace FDA chief until Covid vaccine OKed Friday: experiences

White House threatens to fire FDA chief unless Covid vaccine OKed Friday: reports

US President Donald Trump and Stephen Hahn, Director of the Food and Drug Administration, attend the daily meeting of the coronavirus task force at the White House in Washington, DC on April 24, 2020.

Drew Angerer | Getty Images

White House chief of staff, Mark Meadows, has urged the head of the Food and Drug Administration to resign if the agency does not clear Pfizer’s coronavirus vaccine for emergency use by the end of the day, the Washington Post reported on Friday.

The warning prompted FDA Commissioner Stephen Hahn and the agency to accelerate their schedule for the release of America’s first Covid-19 vaccine from Saturday morning to late Friday, according to the Post, citing anonymous sources.

The New York Times, Axios, and Reuters also reported that Meadows urged Hahn to resign if he wasn’t quick enough to remove the vaccine.

In a statement, Hahn called the Post’s report “an untrue account”.

“This is an untrue representation of the telephone conversation with the chief of staff,” Hahn told CNBC on Friday afternoon. “The FDA has been encouraged to continue working swiftly on Pfizer-BioNTech’s EEA request. The FDA is committed to swiftly granting this approval, as we noted in our statement this morning.”

The White House did not immediately respond to CNBC’s request for comment.

The reports come a day after a key FDA advisory body voted 17-4, with one abstention, to recommend the vaccine, which Pfizer partnered with BioNTech, for emergency approval. The FDA typically follows the recommendations of the Advisory Committee on Vaccines and Related Biological Products. After the overwhelming vote, the FDA should release the vaccine on Friday.

Hahn said earlier that day the agency was “working fast” to clear Pfizer’s emergency vaccine. “The agency has also notified the US Centers for Disease Control, Prevention and Operation Warp Speed ​​so they can implement their plans for timely vaccine distribution,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.

Shortly after Hahn ’s remarks, President Donald Trump, who has repeatedly urged the FDA to speed up the vaccine development process, tweeted the agency,” Get the dam vaccines out NOW. “

“Stop playing and save lives !!!”

FDA approval would mark a record-breaking timeframe for a process that typically takes about a decade. The fastest vaccine development to date against mumps took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and filed an emergency clearance application with the FDA in November.

An emergency permit, or EEA, is not the same as a full permit, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval.

– CNBC’s Amanda Macias contributed to this report.

Categories
Health

Australia Scraps Covid-19 Vaccine That Produced H.I.V. False Positives

Australia Scraps Covid-19 Vaccine That Produced H.I.V. False Positives

Australia on Friday canceled a roughly $ 750 million plan for a major contract for a locally developed coronavirus vaccine after vaccination resulted in false positive test results for HIV in some volunteers participating in an experimental study.

Of the dozen of coronavirus vaccines tested worldwide, the Australian one was the first to be abandoned. While the developers said the experimental vaccine was safe and effective, the false positives risked confidence in efforts to vaccinate the public.

Prime Minister Scott Morrison said Friday that his government would partially offset the loss of 51 million doses it planned to buy from the Australian consortium by increasing orders for vaccines from AstraZeneca and Novavax. The government has announced that it will start vaccinating citizens in March.

“We can’t have problems with trust,” he told reporters, “and now as a nation with a good portfolio of vaccines we are able to make those choices to best protect the Australian people.”

The Australian setback highlighted the missteps that can inevitably occur when scientists shorten the usual year-long process of vaccine development to a few months during a pandemic that killed more than 1.5 million people.

But just as the Australian scientists made their announcement, the fruits of this breed became clearer. The United States got one step closer to getting its first approval for a Covid-19 vaccine when a panel of experts advising the Food and Drug Administration endorsed a Pfizer vaccine that is already in use in the UK.

The problem with the Australian vaccine, developed by the University of Queensland and biotech company CSL, was related to the use of two fragments of a protein found in HIV

The protein was part of a molecular “clamp” that researchers placed on the spikes surrounding the coronavirus and allowed it to penetrate healthy cells. The bracket stabilizes the spikes and allows the immune system to respond more effectively to the vaccine.

Using the HIV protein did not pose a risk of infecting the volunteers with this virus, the researchers said. However, the clamp produced the production of antibodies that were detected by HIV testing at higher levels than scientists expected.

Because HIV tests couldn’t be quickly revised to take this into account, the researchers decided to stop developing the vaccine. The act could have created widespread fears among Australians that the vaccine could cause AIDS.

Early experiments on hamsters showed that the vaccine protected them from the coronavirus. When Phase 1 human trials began in July, the 216 volunteers were “fully informed about the possibility of a partial immune response” to the clamp, the University of Queensland and CSL said in a statement Friday.

Updated

Apr 11, 2020 at 1:26 am ET

The mistake, said John P. Moore, an immunologist at Weill Cornell Medical College in New York, was an “honest mistake” that cost money, not human life.

“I’m sure a lot of people are very embarrassed,” said Professor Moore. “It’s not great to be associated with a bug like this. But when you run at 90 mph, you sometimes trip. “

The coronavirus outbreak>

Things to know about testing

Confused by Coronavirus Testing Conditions? Let us help:

    • antibody: A protein produced by the immune system that can recognize and attach to certain types of viruses, bacteria or other invaders.
    • Antibody test / serology test: A test that detects antibodies specific to the coronavirus. About a week after the coronavirus infects the body, antibodies start appearing in the blood. Because antibodies take so long to develop, an antibody test cannot reliably diagnose an ongoing infection. However, it can identify people who have been exposed to the coronavirus in the past.
    • Antigen test: This test detects parts of coronavirus proteins called antigens. Antigen tests are quick and only take five minutes. However, they are less accurate than tests that detect genetic material from the virus.
    • Coronavirus: Any virus that belongs to the Orthocoronavirinae virus family. The coronavirus that causes Covid-19 is known as SARS-CoV-2.
    • Covid19: The disease caused by the new coronavirus. The name stands for Coronavirus Disease 2019.
    • Isolation and quarantine: Isolation is separating people who know they have a contagious disease from those who are not sick. Quarantine refers to restricting the movement of people who have been exposed to a virus.
    • Nasopharyngeal smear: A long, flexible stick with a soft swab that is inserted deep into the nose to collect samples from the space where the nasal cavity meets the throat. Samples for coronavirus tests can also be obtained with swabs that do not go as deep into the nose – sometimes called nasal swabs – or with mouth or throat swabs.
    • Polymerase chain reaction (PCR): Scientists use PCR to make millions of copies of genetic material in a sample. With the help of PCR tests, researchers can detect the coronavirus even when it is scarce.
    • Viral load: The amount of virus in a person’s body. In people infected with the coronavirus, viral loads can peak before symptoms, if any.

The University of Queensland’s vaccine was one of several vaccines under development that contain a coronavirus protein that triggers an immune system response. Protein-based vaccines have a longer track record than some of the newer approaches used by competing coronavirus vaccines, such as those based on viral genes or called adenoviruses.

Prominent protein-based vaccines include one from Novavax of Maryland, which is in Phase 3 trials, and another from Clover Biopharmaceuticals of China, which is in Phase 1.

In the case of the Australian vaccine, it was found to produce a strong immune response and, according to the scientists in the phase 1 study, did not cause any serious side effects. However, proceeding with the vaccine study would have required “significant changes” in longstanding HIV testing procedures, they said.

“This would delay development for another 12 months, and while this is a difficult decision, the urgent need for a vaccine must be everyone’s priority,” Paul Young, a virologist at the university who directed the vaccine effort, said in the Explanation. He did not immediately respond to a request for comment on Friday afternoon.

Australian Health Secretary Greg Hunt told reporters the country still has access to 140 million units of coronavirus vaccines – more than enough to feed its population of approximately 25 million people.

“This is the scientific process that works,” said Hunt. “It’s the planning process that works. It’s an honest explanation for some of the challenges we’ve faced. “

Carl Zimmer contributed to the reporting.

Categories
Business

Pfizer’s Covid Vaccine and Allergic reactions: How Involved Ought to You Be?

Pfizer's Covid Vaccine and Allergies: How Concerned Should You Be?

Dr. Fauci acknowledged that the problem could affect many people.

“That’s one of the reasons it’s important to cover the waterfront with different vaccine platforms,” ​​he said, adding, “When we actually find out that there is a consistent problem with a certain subset of people like people with allergic reactions, You will always have other vaccine platforms to use and hopefully you won’t see that with those other platforms. “

Dr. Paul Offit, a vaccines expert at Philadelphia Children’s Hospital, said the initial, sweeping recommendation in the UK to mention severe allergic reactions was an overreaction that could unnecessarily discourage many people from a much-needed vaccine in the midst of a raging pandemic.

Millions of people in the United States are allergic to foods such as eggs or peanuts, as well as drugs or bee stings, and have had reactions so severe that doctors advised them to wear adrenaline injectors. But that doesn’t necessarily mean the vaccine is risky for them, he said. According to the National Institute of Allergy and Infectious Diseases, about five percent of children and four percent of adults in the United States have food allergies.

Less than 1 in a million recipients of other vaccines each year in the U.S. has an anaphylactic reaction, said Dr. Offit.

These reactions are treatable and much easier to control than a severe case of Covid-19, he said.

Many people with allergies to food, bee stings, or medication have received multiple vaccines without any problems.

The road to a coronavirus vaccine ›

Answers to your vaccine questions

As the coronavirus vaccine nears U.S. approval, here are 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.

As a member of the FDA advisory board that met on Thursday, Dr. Offit for approval of the Pfizer vaccine. However, during the panel’s discussion of allergic reactions, he said, “This problem will not die until we have better data.”

He said it should investigate whether any ingredient in the vaccine can cause allergic reactions and whether people with other allergies might be particularly sensitive to it.

Categories
Business

AstraZeneca to work on vaccine with Russia’s Gamaleya

AstraZeneca to work on vaccine with Russia's Gamaleya

A laboratory technician oversees the filling and packaging tests for the large-scale manufacture and delivery of the Oxford University’s COVID-19 vaccine candidate AZD1222, which was conducted on a high-capacity aseptic vial filling line in Catalent, Anagni, Italy on September 11, 2020.

Vincenzo Pinto | AFP | Getty Images

LONDON – British pharmaceutical company AstraZeneca said Friday it would soon be working with Russia’s Gamaleya Institute to investigate whether the two coronavirus vaccine candidates could be successfully combined.

After the developers of the Sputnik V Covid-19 vaccine reached out to AstraZeneca on Twitter late last month, they asked if they should try combining the two cold virus-based vaccines to increase effectiveness.

“The ability to combine different COVID-19 vaccines can be helpful to improve protection and / or accessibility of vaccines. Therefore, it is important to study different vaccine combinations to make vaccination programs more flexible and to allow doctors more choice at the time of vaccine administration, “AstraZeneca said in a statement Friday.

“It is also likely that combining vaccines over a longer period of time will result in improved immunity,” he added.

AstraZeneca’s Covid-19 vaccine, made in partnership with Oxford University, is one of several looking to seek drug regulatory approval as hopes of a mass vaccination campaign to end the pandemic grow.

To date, more than 69 million people worldwide have contracted the coronavirus, with 1.58 million deaths, according to data from Johns Hopkins University.

Data published this week in The Lancet Medical Journal showed AstraZeneca’s vaccine had an average efficacy of 70.4%, based on the summary of interim data from late-stage clinical trials. The vaccine was also found to be safe and effective.

Russia has claimed Sputnik V is over 90% effective in preventing people from contracting the virus, citing preliminary results from ongoing studies.

“New level of cooperation”

The Russian direct investment fund, Russia’s sovereign wealth fund that financed the development of Sputnik V, said clinical trials of AstraZeneca’s vaccine, combined with its own, would begin by the end of the month.

“AstraZeneca’s decision to conduct clinical trials with one of two Sputnik V vectors to increase the effectiveness of its own vaccine is an important step in uniting efforts to combat the pandemic,” said Kirill Dmitriev, CEO of Russian direct investment fund said in a statement.

“We welcome the start of this new phase of collaboration between vaccine manufacturers. We are determined to expand this partnership in the future and begin joint production after the new vaccine has proven its effectiveness in clinical trials,” said Dmitriev.

The Editor in Chief of The Lancet, Dr. Richard Horton told CNBC on Wednesday that AstraZeneca’s vaccine had “a marked comparative advantage” over other leading candidates. He also claimed it was the one who could immunize the world “more effectively” and “faster” than their counterparts.

AstraZeneca’s vaccine is a viral vector vaccine based on a weakened version of the common cold virus that causes infections in chimpanzees. It is designed to prepare the immune system to attack the coronavirus known as SARS-CoV-2 when it later infects the body.