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F.D.A. Skilled Panel Endorses Johnson & Johnson’s Vaccine

F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine

Johnson & Johnson’s Covid-19 vaccine was approved on Friday by a group of experts advising the Food and Drug Administration and cleared the final hurdle before formal approval expected on Saturday, according to two people familiar with the agency’s plans are. The nation’s first shipments will run out in the days thereafter.

It will be the third shot made available to the United States in the year since the first wave of coronavirus cases washed across the country, and it will be the first vaccine to require just one dose instead of two.

The Johnson & Johnson formulation worked well in clinical trials, especially against serious illness and hospitalization, although it did not match the sky-high efficacy rates of the first two vaccines from Pfizer-BioNTech and Moderna.

The panel, made up of independent infectious disease experts, statisticians and epidemiologists, voted unanimously to approve the vaccine.

“We are dealing with a pandemic right now,” said Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, MO, and a board member. “It’s great that we have this vaccine.”

During Johnson & Johnson’s presentation to the panel, Dr. Gregory Poland, a virologist at Mayo Clinic and the company’s paid external consultant, noted the vaccine’s effectiveness, ease of use and low side effect rate. It “checks almost all the boxes,” he said. “It is clear to me that the known benefits far outweigh the known risks.”

The vaccine had an overall effectiveness rate of 72 percent in the US and 64 percent in South Africa, where a worrying variant emerged in the fall. The shot showed an effectiveness of 86 percent against severe forms of Covid-19 in the US and 82 percent against serious illnesses in South Africa.

These are strong numbers, but they are below the efficacy rates of Pfizer-BioNTech and Moderna’s vaccines against mild, moderate, and severe cases of Covid of around 95 percent.

The Johnson & Johnson vaccine is a single dose and uses a different technology from the approved vaccines. The scope and size of the Johnson & Johnson trial was huge, spanning eight countries, three continents, and nearly 45,000 participants.

Although the vaccine works with one shot, studies are currently being carried out to see if a second dose would increase the level of protection.

Dr. Paul Offit, a pediatrician at Philadelphia Children’s Hospital and one of the panellists, pointed out Friday that Johnson & Johnson found in early clinical trials that took place over the summer that a second dose resulted in levels of coronavirus antibodies that were almost three times higher than those produced by one dose alone.

The results of the Johnson & Johnson late-stage two-dose clinical trial are not expected until July at the earliest. If these results are found to be better than a single dose, Dr. Offit: “Will this be a two-dose vaccine?”

Dr. Johan Van Hoof, the global director of vaccine research and development at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, said the company decided to pursue the one-shot strategy after its studies on monkeys last spring showed that a single dose was sufficient to provide strong protection against the disease.

“It is clear that in a situation of an outbreak, in a raging epidemic, the big challenge is getting the epidemic under control,” he said. “The regime is very well positioned to be used in outbreak situations.”

Dr. However, Van Hoof also noted that it will be important to track volunteers who have received a single dose to see if their immunity changes over the coming months. Firing a booster shot may be required for long-term protection. “The big question mark is still how long does the protection last?” he said.

Following the vote, the FDA told Johnson & Johnson that it “will work quickly towards completion and emergency clearance,” a statement said. The FDA also said it had notified other government agencies “so they can implement their plans for timely vaccine distribution”.

Sharon LaFraniere contributed to the coverage.

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What to know earlier than key FDA panel vote

What to know before key FDA panel vote

Vials of Johnson & Johnson’s Janssen Coronavirus Disease (COVID-19) vaccine candidate are shown in an undated photo during the Phase 3 ENSEMBLE trial.

Johnson & Johnson | via Reuters

A key advisory body to the Food and Drug Administration is due to vote on Friday on whether to recommend Johnson & Johnson’s emergency approval of the Covid-19 vaccine to pave the way for a third preventive treatment to be distributed in the United States

A positive vote by the Advisory Committee on Vaccines and Allied Biological Products will likely pave the way for the US agency to approve J & J’s emergency vaccine. The committee plays a pivotal role in getting vaccines approved in the U.S. and verifying that the shots are safe for public use. While the FDA does not need to follow the committee’s recommendation, it often does.

On similar inquiries from Pfizer and Moderna, the FDA approved these companies’ vaccinations the day after the committee of external medical advisors endorsed approval for the emergency. If J&J follows the pattern, a third vaccine could be approved on Saturday.

According to data from Johns Hopkins University, the US will need a range of drugs and vaccines to end the pandemic that has infected more than 28.3 million Americans and killed at least 505,899 people as of Thursday. Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J&J only requires one dose, which makes logistics easier for healthcare providers. J & J’s vaccine, unlike the other two vaccines, can also be stored at refrigerator temperature for months.

Here’s what you can expect:

1. When do you vote?

The meeting is expected to take place from 9:00 a.m. to 5:30 p.m.

Prior to voting, medical experts will evaluate J & J’s clinical trial data and provide their opinion on the vaccine, including whether the benefits outweigh the risks of being approved for emergency use. The company is asking the FDA to approve use of the vaccine in people 18 years and older. Pfizer’s has been approved for use in people aged 16 and over. The poor data in younger teenagers was a sticking point for the few advisory board members who voted against approval of the Pfizer BioNTech vaccine in December.

2. What happens next?

The FDA will decide if J&J should clear the vaccine for emergency use. In the Pfizer and Moderna cases, the agency’s final decision came one day after the meeting.

Such approval by the FDA is not synonymous with full approval, which can usually take months longer. J&J, like Pfizer and Moderna, only submitted two months of safety data, but the agency typically takes six months for full approval

3. When will I get the vaccine?

Initially the doses would be limited. Jeff Zients, President Joe Biden’s Covid Tsar, told reporters Wednesday that the federal government expects to ship 3 to 4 million doses of J & J’s vaccine to states, pharmacies, and community health centers next week pending FDA approval .

The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature on Tuesday. J&J has signed a contract with the US government to supply 100 million doses of its vaccine by the end of June. Zients said the federal government will “do everything we can” to boost production.

4. Should I have the vaccine?

J & J’s vaccine provides 66% overall protection against Covid-19, compared to about 95% for Pfizer and Moderna’s vaccine. Some people have wondered if they should get the J&J vaccine because of the lower rate of effectiveness.

However, infectious disease experts point out that J & J’s results cannot be directly compared to the other two vaccines because it is a single dose and the company’s study was conducted when more infections emerged as well as new, more contagious variants .

The Chief Medical Officer of the White House, Dr. Anthony Fauci said Americans should take every approved vaccine they can get. He also notes that J & J’s vaccine prevented 100% of virus-related hospitalizations and deaths in its late-stage.

“The most important thing, more important than preventing someone from getting a pain and a sore throat, is preventing people from getting serious illnesses,” he told reporters when he called on Jan. 29. “This will relieve so much stress.” and human suffering and death in this epidemic. “

5. What are the side effects?

Analysis by age, race and comorbidity did not identify any specific safety concerns with the vaccine, according to an FDA report released on Wednesday.

Headache, fatigue, and muscle pain were some of the most common side effects in people who received the vaccination, the report said. There have also been reports of nausea, fever, and pain at the injection site. According to the report, there have been no reports of anaphylaxis, a severe and life-threatening allergic reaction.

The report identified a few cases of Bell’s palsy with half of your face drooping but “balanced” with the number commonly found in the general population. The FDA previously announced that the condition would be monitored in vaccine recipients after flagging it as a potential problem with Pfizer’s shots, and noted that this isn’t necessarily a side effect, but it is worth looking out for.

Medical experts say vaccine side effects are common and actually indicate that the shots are working as intended. The CDC recommends talking to a doctor about taking over-the-counter drugs if you experience pain or discomfort after the shot.

– CNBC’s Noah Higgins-Dunn contributed to this report.

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C.D.C. Panel Endorses Moderna Vaccine for Individuals

C.D.C. Panel Endorses Moderna Vaccine for Americans

Als das Coronavirus in den Vereinigten Staaten weiter anstieg, stimmte eine unabhängige Expertengruppe, die die Zentren für die Kontrolle und Prävention von Krankheiten beriet, am Samstag dafür, einen zweiten Coronavirus-Impfstoff für die Verwendung in den Vereinigten Staaten zu unterstützen.

Die Empfehlung des Ausschusses folgt einer am Freitag von der Food and Drug Administration erteilten Notfallgenehmigung. Die Bestätigung des Komitees wartet nun auf die endgültige Genehmigung durch Dr. Robert R. Redfield, Direktor der CDC, die in Kürze erwartet wird.

Etwa 5,9 Millionen Dosen des Moderna-Impfstoffs sollen ab Sonntag verteilt werden, und die ersten Impfungen werden voraussichtlich irgendwann am Montag beginnen.

Im Gegensatz zum Pfizer-BioNTech-Impfstoff, der zur Anwendung bei Personen ab 16 Jahren zugelassen wurde, ist der Impfstoff von Moderna nur für Personen ab 18 Jahren zugelassen. Während Pfizer im Oktober mit klinischen Studien zu seinem Impfstoff bei Kindern im Alter von 12 Jahren begann, begann Moderna erst in diesem Monat mit seinen pädiatrischen Studien und erwartet erst im nächsten Jahr vollständige Daten zur Sicherheit und Wirksamkeit.

Ein Großteil der Beratungen des Ausschusses konzentrierte sich auf die schweren allergischen Reaktionen, die in mehreren Fällen nach Injektionen des Pfizer-BioNTech-Impfstoffs gemeldet wurden, der ähnliche Inhaltsstoffe wie das Rezept von Moderna enthält.

Sechs Fälle von Anaphylaxie wurden inzwischen in den USA und zwei in Großbritannien dokumentiert. Es sind auch mehrere mildere allergische Reaktionen aufgetreten. Laut CDC wurden bereits am Samstag landesweit mehr als 272.000 Dosen des Pfizer-BioNTech-Impfstoffs verteilt

Allergische Reaktionen auf Impfstoffe treten typischerweise mit einer Rate von etwa einer von einer Million auf. Dr. Grace Lee, Kinderärztin und Impfstoffexpertin an der Stanford University, stellte auf der Ausschusssitzung fest, dass die bisherigen Schätzungen darauf hindeuten, dass das Risiko dieser mit dem Pfizer-BioNTech-Impfstoff verbundenen Ereignisse „qualitativ höher zu sein scheint als bei den meisten typischen Impfstoffen . ”

Dennoch fügte sie hinzu: “Für mich persönlich ändert dies nicht unbedingt das Risiko-Nutzen-Verhältnis des Covid-19-Impfstoffs zu diesem Zeitpunkt.”

Dr. Thomas Clark, Epidemiologe am CDC, stellte fest, dass Personen, bei denen nach einem Schuss eine Anaphylaxie auftritt, keine zweite Dosis erhalten sollten. Es ist immer noch unklar, ob ein Inhaltsstoff in Pfizers Impfstoff die direkte Ursache für die Reaktionen war.

Einige Experten haben auf Polyethylenglykol oder PEG hingewiesen, eine Chemikalie, die in vielen pharmazeutischen Produkten, einschließlich Abführmitteln wie Miralax, enthalten ist und die sehr selten allergische Reaktionen hervorruft. Sowohl die Pfizer-BioNTech- als auch die Moderna-Impfstoffe enthalten PEG, allerdings in leicht unterschiedlichen Formulierungen.

Dr. Sarah Mbaeyi, eine Ärztin bei der CDC, sagte, die Agentur empfehle Menschen, die wissen, dass sie schwere Allergien gegen einen der Inhaltsstoffe der Impfstoffe haben, vorerst auf die Aufnahme zu verzichten.

Personen mit einer Anaphylaxie in der Vorgeschichte gegenüber anderen Impfstoffen oder injizierbaren Therapien sollten ihren Arzt konsultieren und nach der Inokulation 30 Minuten vor Ort bleiben, um sich zu überwachen, falls sie sich krank fühlen. (Alle anderen – einschließlich Personen, die stark auf andere Substanzen wie Lebensmittel, Pollen oder Hautschuppen reagieren, und Personen mit leichten Allergien jeglicher Art – können nach 15 Minuten gehen.)

In den klinischen Studien von Moderna wurden drei schwere allergische Reaktionen berichtet, an denen mehr als 30.000 Erwachsene teilnahmen, von denen die Hälfte anstelle des Impfstoffs ein Placebo erhielt. Es wurde angenommen, dass keiner mit dem Impfstoff in Verbindung steht.

Covid19 Impfungen >

Antworten auf Ihre Impfstofffragen

Mit der Verbreitung eines Coronavirus-Impfstoffs ab den USA finden Sie hier Antworten auf 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. Hier ist der Grund. Die Coronavirus-Impfstoffe werden tief in die Muskeln injiziert und stimulieren das Immunsystem zur Produktion von Antikörpern. Dies scheint ein ausreichender Schutz zu sein, um die geimpfte Person vor einer Krankheit zu bewahren. Was jedoch nicht klar ist, ist, ob es möglich ist, dass das Virus in der Nase blüht – und geniest oder ausgeatmet wird, um andere zu infizieren -, selbst wenn Antikörper an anderer Stelle im Körper mobilisiert wurden, um zu verhindern, dass die geimpfte Person krank wird. Die klinischen Impfstoffstudien sollten feststellen, ob geimpfte Menschen vor Krankheiten geschützt sind – und nicht herausfinden, ob sie das Coronavirus noch verbreiten können. Basierend auf Studien zu Grippeimpfstoffen und sogar mit Covid-19 infizierten Patienten haben Forscher Grund zu der Hoffnung, dass geimpfte Menschen das Virus nicht verbreiten, aber weitere Forschung ist erforderlich. In der Zwischenzeit müssen sich alle – auch geimpfte Menschen – als mögliche stille Streuer vorstellen und weiterhin eine Maske tragen. Lesen Sie hier mehr.
    • 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 in Ihren Arm fühlt sich nicht anders an als bei jedem anderen Impfstoff, aber die Rate kurzlebiger Nebenwirkungen scheint höher zu sein als bei einer Grippeschutzimpfung. Zehntausende Menschen haben die Impfstoffe bereits erhalten, und keiner von ihnen hat ernsthafte gesundheitliche Probleme gemeldet. Die Nebenwirkungen, die den Symptomen von Covid-19 ähneln können, dauern etwa einen Tag und treten nach der zweiten Dosis wahrscheinlicher auf. Frühe Berichte aus Impfstoffversuchen deuten darauf hin, dass einige Menschen möglicherweise einen Tag frei nehmen müssen, weil sie sich nach Erhalt der zweiten Dosis mies fühlen. In der Pfizer-Studie entwickelte etwa die Hälfte Müdigkeit. Andere Nebenwirkungen traten bei mindestens 25 bis 33 Prozent der Patienten auf, manchmal mehr, einschließlich Kopfschmerzen, Schüttelfrost und Muskelschmerzen. Obwohl diese Erfahrungen nicht angenehm sind, sind sie ein gutes Zeichen dafür, dass Ihr eigenes Immunsystem eine starke Reaktion auf den Impfstoff zeigt, die eine dauerhafte Immunität bietet.
    • 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.

Während des Treffens äußerten Experten auch Bedenken hinsichtlich vier Fällen einer vorübergehenden Gesichtslähmung namens Bell-Lähmung, von denen drei in der Impfstoffgruppe in der Moderna-Studie auftraten. (Vier Fälle von Bell-Lähmung traten auch in Pfizers Studien auf, alle in der Impfstoffgruppe.)

Es gibt noch keine Beweise, die die Lähmung direkt mit einem der beiden Impfstoffe in Verbindung bringen, und Dr. Jacqueline Miller, Senior Vice President bei Moderna, sagte, ihr Unternehmen habe die Impfstoffempfänger weiterhin auf Nebenwirkungen überwacht.

Mehr als die Hälfte der Personen, die den Moderna-Impfstoff in klinischen Studien erhielten, berichteten nach ihrem zweiten Schuss, der etwa vier Wochen nach dem ersten gegeben wurde, über unangenehme Symptome wie Müdigkeit, Kopfschmerzen und Schmerzen. Einige Freiwillige entwickelten auch Fieber oder Hautausschlag an der Injektionsstelle.

Vorfälle wie diese scheinen bei Modernas Impfstoff weitaus häufiger zu sein als bei Pfizer, der eine geringere Dosis der Wirkstoffe enthält. Die meisten Nebenwirkungen verschwanden jedoch innerhalb eines Tages nach der Impfung.

Vorübergehende Symptome nach der Impfung sind relativ häufig. Oft sind sie die äußeren Anzeichen eines hart arbeitenden Immunsystems, das den Körper darauf vorbereitet, Krankheiten in Zukunft abzuwehren.

Weder Moderna noch Pfizer haben bisher Daten zu schwangeren oder stillenden Personen erhoben. Aber keine der 13 Freiwilligen, die während der Teilnahme an den klinischen Studien von Moderna schwanger wurden, von denen sechs den Impfstoff erhielten, berichtete über schädliche Wirkungen.

Mehr als 500 Amerikaner, die eine Dosis Pfizers Impfstoff erhalten haben, waren zum Zeitpunkt ihrer Injektion schwanger.

Viele Wissenschaftler glauben, dass das Coronavirus ein weitaus größeres Risiko für schwangere oder stillende Menschen darstellt als der Impfstoff. Stephanie Langel, eine Immunologin und Virologin an der Duke University, die seit Juli ihren neugeborenen Sohn stillt, sagte am Donnerstag, dass sie beabsichtige, so bald wie möglich geimpft zu werden.

Sie wurde priorisiert, um den Schuss zu erhalten, weil sie das Coronavirus erforscht. Wenn es darum geht, sich impfen zu lassen, “ist es für mich nur ein Kinderspiel”, sagte sie, weil sie häufig dem Virus ausgesetzt war. “Es geht um Ihre Risikobewertung.”

Während des Treffens unterstrichen Wissenschaftler und Kliniker, wie wichtig es ist, Impfungen in Gemeinden zu bringen, die von der Pandemie überproportional betroffen sind, einschließlich Menschen in Justizvollzugsanstalten.

Experten haben wiederholt darauf hingewiesen, wie wichtig es ist, mit Vertretern von Farbgemeinschaften zusammenzuarbeiten, um die Sicherheit und Wirksamkeit des Impfstoffs für Menschen zu bestätigen, die zögern oder skeptisch gegenüber den Aufnahmen sind. (Überaus wenige Personen, die sich als Indianer, Ureinwohner Alaskas, Ureinwohner Hawaiis oder Inselbewohner im Pazifik identifizierten, nahmen an Modernas Versuchen teil.)

Dionne Brown, die Leiterin der Krankenpflege bei Summit Rehabilitation and Care Community in Aurora, Colorado, sagte der New York Times, sie sei “ein wenig besorgt über die Nebenwirkungen” gewesen. Nach langwierigen Gesprächen mit ihren Kollegen darüber, wie sicher und wirksam die Impfstoffe sind, sagte sie: „Ich fühle mich wohl mit der Einnahme“.

Frau Brown, Mutter von sechs Kindern, hofft, ein Vorbild für ihre Familie und Gemeinde sowie für die anderen Mitarbeiter und älteren Bewohner ihrer Langzeitpflegeeinrichtung sein zu können.

“Das ist mein Ziel”, sagte sie. “Dass sie sehen, wie ich es bekomme und mich hoffentlich wohl fühle.”

In einer zweiten Sitzung am Sonntag werden CDC-Beamte und Wissenschaftler mehr Leitlinien für die Zuteilung der neu zugelassenen Impfstoffe liefern und über die Priorisierung von Personen abstimmen, die Impfungen erhalten sollen.

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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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FDA advisory panel meets at this time to vote on whether or not to advocate approval of Pfizer’s Covid vaccine

FDA advisory panel meets today to vote on whether to recommend approval of Pfizer's Covid vaccine

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A panel from the Food and Drug Administration will meet Thursday to vote on whether to recommend Pfizer and BioNTech’s emergency approval of the coronavirus vaccine.

Prior to voting by the Agency’s Advisory Committee on Vaccines and Related Biological Products, the independent panel of medical experts will evaluate the Pfizer clinical trial data and provide their opinion on the vaccine, including whether the benefits outweigh the risks in an emergency .

The FDA is not required to follow the advice of the advisory group, but it often does.

A recommendation from the advisory committee is the final step before the FDA is likely to give final OK to the distribution of the potentially life-saving doses in the United States. The vaccine would be the first to be approved for use in the United States

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

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F.D.A. Panel Provides Inexperienced Mild to Pfizer’s Covid Vaccine

F.D.A. Panel Gives Green Light to Pfizer's Covid Vaccine

Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.

The F.D.A.’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the F.D.A. follows the advice of its advisory panels.

With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The F.D.A. is expected to grant an emergency use authorization on Saturday, according to people familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.

The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the F.D.A., according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.

The arrival of the first vaccines is the beginning of a complex, monthslong distribution plan coordinated by federal and local health authorities, as well as large hospitals and pharmacy chains, that if successful, will help return a grieving and economically depressed country back to some semblance of normal, maybe by summer.

“With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said at the meeting.

The vote caps a whirlwind year for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago, shattering all speed records for vaccine development, which typically takes years. It is also a triumph for the F.D.A., which has upheld its reputation as the world’s gold standard for drug reviews despite months of political pressure from President Trump, who has sought to tie his political fortunes to the success of a vaccine. The Pfizer vaccine has already been given to people in Bahrain and Britain, where it was authorized on Dec. 2. Canada approved it on Wednesday.

The U.S. authorization of Pfizer’s vaccine is expected to be followed soon by one for Moderna’s version, which uses similar technology and has also shown promising results in clinical trials. Operation Warp Speed, the Trump administration’s multi-billion-dollar program to fast-track vaccine development, pre-ordered 100 million doses of Pfizer’s vaccine in July and heavily backed the development and manufacturing of Moderna’s vaccine.

More than 100 F.D.A. employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data.

Earlier this week, career scientists at the F.D.A. published an analysis showing the vaccine worked across a variety of demographic groups and that it was somewhat effective even after the first of two doses.

During the daylong meeting on Thursday, panel members peppered company and agency experts with detailed questions about the safety and efficacy of the vaccine, which was found to be 95 percent effective in a late-stage clinical trial. Some members expressed concern that there was not enough data from 16- and 17-year-olds to know whether the vaccine would help them, but the committee decided the benefits for that group outweighed the risks.

Some members asked about the likelihood for serious allergic reactions, given the news that regulators in Britain recommended this week that people with a history of anaphylactic allergic reactions to medicines and foods not get the vaccine while they investigate two cases of allergic reactions among health care workers. Pfizer officials said there were no cases of serious allergic reactions in the trial of 44,000 participants. People with a history of allergic reactions to vaccines were excluded from the study.

One of the panel members, Dr. Paul Offit of the Children’s Hospital of Philadelphia, said he feared that statements by British regulators as well as remarks by Moncef Slaoui, a top U.S. vaccine official, could lead “tens of millions” of people with severe allergies to reject the vaccine even though evidence of a link to the shots was unclear. He asked Pfizer to conduct a separate study of people with a history of severe allergies, because “this issue is not going to die until we have better data.”

The F.D.A. said that it had asked Pfizer to include allergic reactions in its safety tracking plan and would include a warning in its instructions on the use of the vaccine.

One of the most hotly contested issues was how the broad authorization of the vaccine might affect the continuing clinical trial. Some experts have argued that, ethically, trial volunteers who received a placebo should be offered the vaccine once it is authorized, but others worried that move could tarnish the long-term results of the trial.

During the public portion of the meeting, consumer and public health advocates largely pushed the agency to authorize the vaccine, noting the urgency of the pandemic. One speaker, who identified himself as Kermit Kubitz, noted that he had no conflicts of interest to declare except for “a lot of elderly relatives.”

“They need this vaccine yesterday,” he said.

But advocates also asked regulators to be transparent about potential safety issues and to closely track the vaccine once it becomes available. Several said such measures were necessary to reassure a public that is hesitant to take a new vaccine, particularly Black and Native American people who have historically been mistreated by the medical community. “Before authorization is granted, affected communities need to have confidence that the vaccine is safe and effective,” said Sarah Christopherson of the National Women’s Health Center.

By insisting that the advisory committee vote on any vaccine, regulators created a shield against White House pressure to approve a product before the presidential election. When the panelists met in October to discuss the F.D.A.’s guidelines for approving Covid-19 vaccines, they urged the agency to take its time and cautioned that rushing the process could risk missing vital safety data and further erode public trust.

The scene that played out on Thursday — in which outside experts spent hours engaging government officials in an intense but often highly technical discussion about vaccine science — did not always make for exciting viewing. But the circumstances were certainly dramatic, as the experts were being asked to carefully weigh the risks and benefits of the vaccine, even as the United States reached the grim milestone of recording more than 3,000 Covid deaths on Wednesday and as thousands of people in Britain had already received it.

The F.D.A. has struggled, internally and externally, to move fast on its vaccine and treatment deliberations in order to curb the deadly virus’s spread — but not so fast as to undermine public confidence. It was a thin line to walk, and not helped by the torrent of troubling accusations by Mr. Trump and his advisers that the agency was moving too slowly.

Just days before Pfizer submitted its application, the company sent an enormous tranche of manufacturing data to the F.D.A. — including materials on how it was scaling up production — leaving regulators scrambling to evaluate it in time for a possible authorization.

As part of its oversight, the F.D.A. also had teams review company production facilities and clinical trial sites, where they verified that records corresponded to the accounts Pfizer had submitted to federal regulators.

At the same time, regulators were evaluating an equally complex emergency authorization application submitted by Moderna, whose data will be examined publicly during another F.D.A. outside advisory meeting next week.

The Road to a Coronavirus Vaccine ›

Answers to Your Vaccine Questions

As the coronavirus vaccine get closer to U.S. authorization, here are some questions you may be wondering about:

    • If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
    • When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
    • If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered 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 by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.
    • Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.
    • Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

Regulators sometimes received documents from the companies as late as midnight and worked through the Thanksgiving holiday. Dr. Peter Marks, the top vaccine regulator at the F.D.A., joked last week at an event hosted by the American Medical Association that his team ate turkey sandwiches while examining documents.

“Among all global regulators, we are the ones that actually don’t just look at the company’s tables. We actually get down and dirty and we look at the actual adverse event reports, the bad spelling errors that are made by physicians sometimes, et cetera,” he said at the event.

Dr. Stephen M. Hahn, the F.D.A. commissioner, kept a careful distance from the review, according to people familiar with it.

Dr. Hahn had caved to pressure earlier in the summer to authorize an old malaria drug, hydroxychloroquine, for use in Covid patients even though there was little evidence that it worked. That decision was reversed after the agency found the drug was unlikely to be effective in Covid patients and carried a risk of potentially dangerous side effects. And Dr. Hahn faced withering criticism from the scientific community after he exaggerated the benefits of another treatment, convalescent plasma, an error he later corrected.

Mr. Trump accused agency officials of being part of the “deep state” and hinted that a vaccine could come before “a very special day” — Election Day. The F.D.A.’s reputation appeared to be headed in the same direction as that of the Centers for Disease Control and Prevention, which was widely criticized for not standing up to the president.

But senior regulators — and eventually Dr. Hahn himself — pushed back. The agency’s top career officials published an opinion piece in USA Today, acknowledging that the F.D.A.’s integrity had been called into question and insisting that they would “follow the science” during the pandemic. The agency prevailed in a battle with the White House over imposing more stringent guidelines for companies developing Covid vaccines.

“In this sort of environment, where there has been so much pressure and concern, the process does provide an important check and balance,” said Dr. Jesse L. Goodman, who previously served as the F.D.A.’s chief scientist. Holding an open meeting also allows the public to “be sure that a broader scientific and clinical community is comfortable with the decision.”

On Tuesday, the president held a summit intended to showcase the administration’s role in developing a vaccine. “We are just days away from authorization from the F.D.A. and we’re pushing them hard,” Mr. Trump said at the event.

Many health care workers around the country are already raring to get the vaccine. Dr. Andrew Barros, a critical care physician in Charlottesville, Virginia, who is scheduled to get his Pfizer shot at 2:30 p.m. on Dec. 15, said he is “looking forward to having a sore arm and hopefully being one step closer to having Covid under control.”

Pfizer’s clinical trial will continue even after its vaccine is authorized by the F.D.A., and the company and F.D.A. will continue to watch for safety concerns.

Pfizer said on Thursday that it planned to apply for full approval in April of 2021, after the company had collected six months of safety data. At that point, Pfizer would be allowed to sell its vaccine directly to hospitals and other health care providers.

Carl Zimmer and Katherine J. Wu contributed reporting.