Tag: Vaccine

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European Union Guarantees Additional Covid-19 Vaccine Doses From Pfizer

European Union Promises Extra Covid-19 Vaccine Doses From Pfizer

The European Union will receive an additional 50 million doses of the coronavirus vaccine developed by Pfizer and BioNTech this month, accelerating its efforts to accelerate vaccination amid difficulties with vaccines developed by AstraZeneca and Johnson & Johnson.

The announcement by Ursula von der Leyen, President of the European Commission, is part of the European Union’s tough pivot for mRNA vaccines like Pfizer, which is basing its future coronavirus response on it.

The measures come a day after Johnson & Johnson suspended rollout of its vaccine in the European Union and the block continued to suffer from the restrictions of the AstraZeneca vaccine after reports of extremely rare but serious potential side effects from both.

The 27-nation bloc has also started negotiations with Pfizer for the delivery of 1.8 billion new doses of vaccine – including booster shots to extend immunity and new vaccines to combat emerging variants – in 2022 and 2023, Ms. von der Leyen said .

In another setback for AstraZeneca, Denmark became the first country to permanently stop administering the company’s vaccine on Wednesday. The potential side effects are significant enough to do so, given that the pandemic was under control and two other vaccines could be used. from Pfizer and Moderna.

The European Union has not canceled its existing orders for the AstraZeneca and Johnson & Johnson vaccines, but has signaled that they will no longer be placing.

The European Medicines Agency, the bloc’s top medicine agency, goes on to say that the benefits of the AstraZeneca vaccine far outweigh the risks of a dangerous but extremely rare blood disorder for most people. On Wednesday, the agency said it was accelerating its investigation of “very rare cases of unusual blood clots” in recipients of the Johnson & Johnson vaccine and is expected to issue a recommendation next week.

During the ongoing evaluation, the Agency reiterated its view that it will reap the benefits Vaccine also outweigh the risks.

The European Union’s move away from AstraZeneca follows troubled months as relations between the company and the bloc deteriorated due to late deliveries and unpredictable deliveries. And since then, concerns about possible side effects have heightened skepticism about vaccines, which was already dangerously high in Europe.

These problems have contributed to the fact that Europe has lagged seriously behind vaccination campaigns in the US and UK. The block hopes the new Pfizer broadcasts will help it catch up and meet its goal of fully vaccinating 70 percent of its adult population, roughly 255 million people, by the end of the summer.

Pfizer’s commitment to move ahead with deliveries of the 50 million cans originally planned for the end of the year means the company will deliver a total of 250 million cans to the block by the end of June.

“We now have to concentrate on technologies that have proven themselves: mRNA vaccines are a clear example of this,” said Ms. von der Leyen.

Monika Pronczuk contributed to the reporting.

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Health

States Wrestle With Vaccine Pause as Federal Officers Reassure Public

States Struggle With Vaccine Pause as Federal Officials Reassure Public

Dr. Anthony S. Fauci sagte am Donnerstag, er hoffe, dass die Nation bald wieder in der Lage sein werde, den Johnson & Johnson-Impfstoff zu verwenden, als eine „Pause“, die nun auf unbestimmte Zeit droht, die Impfbemühungen in Übersee und in einigen der am stärksten ausgegrenzten Länder anzukurbeln Gemeinden in den Vereinigten Staaten.

Dr. Fauci, Präsident Bidens oberster medizinischer Berater für die Pandemie, äußerte sich während einer Anhörung des House Select-Unterausschusses zur Coronavirus-Krise, in der er und andere hochrangige Gesundheitsbehörden des Bundes die Amerikaner anflehten, sich weiterhin impfen zu lassen, und versuchten, die Nation zu beruhigen dass alle drei staatlich zugelassenen Impfstoffe sicher sind.

“Hoffentlich werden wir bald eine Entscheidung treffen, ob wir mit diesem sehr wirksamen Impfstoff wieder auf Kurs kommen können oder nicht”, sagte Dr. Fauci dem Gremium. Angesichts der zunehmenden Fälle im Mittleren Westen, fügte er hinzu, befindet sich die Nation in einer „prekären Situation“, und es ist unbedingt erforderlich, „so viele Menschen so schnell und so schnell wie möglich zu impfen“.

Es wurde jedoch zunehmend klarer, dass eine Suspendierung, die ursprünglich zwei bis drei Tage dauern sollte, erheblich länger dauern würde, da die Beamten mit Berichten über mindestens sechs seltene Fälle von Blutgerinnung bei Frauen rangen, die mit dem Schuss von Johnson & Johnson immunisiert worden waren. Die Gesundheitsbehörden des Bundes versuchen zu entscheiden, ob sie den Ärzten empfehlen sollen, den Impfstoff wieder aufzunehmen, möglicherweise mit neuen Einschränkungen.

Der Impfstoff war kein wesentlicher Bestandteil der Impfkampagne der Biden-Regierung. Ungefähr 7,7 Millionen Amerikaner haben den Schuss von Johnson & Johnson erhalten, was weniger als 4 Prozent der mehr als 198 Millionen Dosen entspricht, die im ganzen Land verabreicht werden.

Obwohl diese Zahlen gering sind, sind viele der Menschen, gegen die der Impfstoff gerichtet ist, gefährdet: Obdachlose in Baltimore, Bewohner des District of Columbia, Arme und Nichtversicherte in Massachusetts, Landbewohner in einer Reihe von Bundesstaaten. Alle Populationen sind mit einer Einzeldosis leichter zu erreichen als das Zwei-Dosis-Regime der Impfstoffe Pfizer und Moderna.

Etwa 10 Millionen Dosen, die in die Staaten verschifft werden, stehen jetzt in den Regalen und warten auf eine Entscheidung. Und viele Menschen, die möglicherweise keinen Schuss suchen, aber mit mobilen Kliniken und einer konzertierten Kontaktaufnahme hätten erreicht werden können, könnten zumindest vorerst zurückgelassen werden.

„Alle unsere Impfstoffe, Anbieter im ganzen Bundesstaat und unser Team im Gesundheitsministerium von Minnesota arbeiten intensiv daran, die Dinge zu planen und zu verschieben. Es handelt sich offensichtlich um eine Reihe von Dominosteinen “, sagte Jan Malcolm, Minnesotas Gesundheitskommissar. “Wir bedauern sehr die Kliniken, die wegen der Pause bei J & J kurzfristig abgesagt werden mussten, und das wird auch in den kommenden Wochen ein Problem sein.”

Der Pressesprecher des Weißen Hauses, Jen Psaki, kalibrierte erneut das Versprechen von Präsident Biden, bis Ende Mai genügend Impfstoffe für alle amerikanischen Erwachsenen zu beschaffen. Jetzt betont das Weiße Haus, dass alle Erwachsenen, die einen Impfstoff wollen, einen bekommen werden.

“Das bedeutet, dass bis Ende Mai für etwa 80 Prozent der Bevölkerung, bis Ende Juli etwa 90 Prozent der Bevölkerung”, sagte Frau Psaki gegenüber Reportern.

In Lexington, Kentucky, wurde eine Johnson & Johnson-Klinik für Freitag abgesagt, sodass rund 400 Personen ohne Termin waren. Allen wurde eine Last-Minute-Option angeboten, um einen Moderna-Impfstoff zu erhalten, aber nur etwa 65 nahmen das Angebot an, sagte Kevin Hall, ein Sprecher des Gesundheitsministeriums von Lexington-Fayette County.

“Dies war ein großer Erfolg für unsere Planung”, sagte Hall, dessen Agentur den Johnson & Johnson-Impfstoff bereits für Insassen und Obdachlose verwendet hatte und geplant hatte, in den kommenden Wochen Nachbarschaftskliniken anzubieten. “Die Logistik für den Abzug einer Klinik für die erste und zweite Dosis wird sehr viel schwieriger.”

Dr. Letitia Dzirasa, die Gesundheitskommissarin in Baltimore, sagte, die Stadt habe bisher nur etwa 1.400 Dosen des Johnson & Johnson-Impfstoffs erhalten, aber viele seien auf obdachlose Bewohner ausgerichtet. Die Stadt muss möglicherweise ihre Pläne für Pop-up-Kliniken im Freien überdenken und sich bemühen, die Bewohner des Heimatlandes diesen Sommer mit dem Impfstoff mit einer Dosis zu erreichen, sagte sie.

“Wir dachten, J & J wäre der ideale Kandidat, um diese Arbeit zu unterstützen”, sagte sie.

In Washington, DC, verzögern Beamte ein Programm, um mit Johnson & Johnson-Schüssen heimatgebundene Bewohner zu erreichen. Die Stadt hat diese Woche Termine für etwa 1.200 Personen abgesagt, aber inzwischen sollten alle eine Einladung zu einem neuen Termin für einen der beiden anderen von der Bundesregierung zugelassenen Impfstoffe erhalten haben, die von Pfizer-BioNTech und Moderna entwickelt wurden.

Andere staatliche und lokale Gesundheitsbehörden sagten, sie würden mit diesen beiden Impfstoffen auskommen. In der Region Flint, Michigan, die einige der höchsten Fallraten des Landes in jüngster Zeit aufweist, gaben Beamte an, dass sie alle geplanten Kliniken auch ohne den Impfstoff von Johnson & Johnson abdecken konnten.

“Bisher war es reibungslos”, sagte Dr. Pamela Hackert, die medizinische Gesundheitsbeauftragte des Gesundheitsministeriums von Genesee County, in einer E-Mail.

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15. April 2021, 16:49 Uhr ET

Am Des Moines Area Community College in Iowa konnten Administratoren diesen Monat drei Kliniken auf dem Campus einrichten, in denen die Studenten einen Impfstoff mit zwei Dosen erhalten können. Rob Denson, der College-Präsident, sagte, er sei erfreut und überrascht über seine Fähigkeit, diese zukünftigen Kliniken so schnell zu organisieren.

“Ich denke, wir werden in relativ kurzer Zeit mit Impfstoffen überflutet sein”, sagte er.

Eine längere Unterbrechung der Verfügbarkeit von Johnson & Johnson wird sich jedoch allmählich verschlechtern, insbesondere in ärmeren Staaten mit schwer erreichbaren Bevölkerungsgruppen. Eine Sprecherin von Dr. José Romero, dem Gesundheitsminister in Arkansas, sagte: „Die Pause sollte ausreichend lang sein, um Sicherheitsfragen zu beantworten, aber nicht länger als nötig verlängert werden.

“Seine Sorge ist, dass eine überlange Pause das Zögern erhöht und das Vertrauen verringert”, sagte die Sprecherin Danyelle McNeill. Dr. Romero leitet das Beratungsgremium zu den Zentren für die Kontrolle und Prävention von Krankheiten, die letztendlich empfehlen werden, wie mit dem Johnson & Johnson-Impfstoff verfahren werden soll.

Die Suspendierung in den Vereinigten Staaten kann tiefgreifendere Konsequenzen in Übersee haben, wo bisher nur ein Bruchteil der übrigen Welt geimpft wurde. Dr. Luciana Borio, eine ehemalige amtierende Chefwissenschaftlerin der Food and Drug Administration, die auch im Nationalen Sicherheitsrat des Weißen Hauses von Trump tätig war, sagte, der Impfstoff von Johnson & Johnson sei ein entscheidendes Instrument, um die Ausbreitung des Virus auf der ganzen Welt zu stoppen .

“Es ist ein Impfstoff, der schnell in sehr großem Maßstab hergestellt werden kann und viel einfachere Verteilungsverfahren hat”, sagte sie. “Die Welt braucht mehr Unternehmen wie J & J, die ihren Impfstoff liefern.”

Die Beamten zählten sowohl auf Johnson & Johnson als auch auf einen anderen leicht zu verteilenden Impfstoff von AstraZeneca, um Impfungen in schwer zugängliche Teile der Welt zu bringen. Jüngste Berichte über seltene Blutgerinnsel bei Empfängern des AstraZeneca-Impfstoffs haben jedoch eine Reihe von Nationen dazu veranlasst, seine Verwendung zu überdenken.

Einige Regionen beschlossen, zu Johnson & Johnson zu wechseln. Vor zwei Wochen hat die Afrikanische Union 400 Millionen Dosen erhalten, obwohl sich wohlhabendere Nationen gescheut haben. Die Europäische Union sagte, sie werde nicht mehr von Johnson & Johnson kaufen, und Australien kündigte an, keine Dosen zu kaufen.

In den Vereinigten Staaten schlugen Mitglieder des CDC-Beratungsgremiums am Mittwoch vor, dass es eine Woche bis 10 Tage dauern würde, bis sie über genügend Informationen verfügen, um die Risiken des Impfstoffs zu bewerten und eine Entscheidung über seine Zukunft in den Vereinigten Staaten zu treffen. Dr. Fauci und zwei weitere Beamte – Dr. Rochelle Walensky, der CDC-Direktor, und Dr. David Kessler, der die Impfbemühungen der Biden-Regierung leitet – forderten die Amerikaner auf, sich weiterhin impfen zu lassen.

“Ich hoffe, wir können alle zusammenkommen und diese Botschaft senden”, sagte Dr. Kessler, insbesondere angesichts der Verbreitung besorgniserregender Varianten, und fügte hinzu, dass die drei vom Bund zugelassenen Impfstoffe “ein ausgezeichnetes Sicherheitsprofil” haben.

Was Sie über die Johnson & Johnson Vaccine Pause in den USA wissen müssen

    • Am 13. April 2021 forderten die US-Gesundheitsbehörden eine sofortige Unterbrechung der Verwendung des Einzeldosis-Impfstoffs Covid-19 von Johnson & Johnson, nachdem sechs Empfänger in den USA innerhalb von ein bis drei Wochen nach der Impfung eine seltene Erkrankung mit Blutgerinnseln entwickelt hatten.
    • Alle 50 Bundesstaaten, Washington, DC und Puerto Rico, haben die Verwendung des Impfstoffs vorübergehend eingestellt oder von empfohlenen Anbietern unterbrochen. Das US-Militär, staatlich geführte Impfstellen und eine Vielzahl privater Unternehmen, darunter CVS, Walgreens, Rite Aid, Walmart und Publix, pausierten die Injektionen ebenfalls.
    • Derzeit werden weniger als eine von einer Million Johnson & Johnson-Impfungen untersucht. Wenn tatsächlich ein Risiko für Blutgerinnsel durch den Impfstoff besteht – das noch ermittelt werden muss -, ist dieses Risiko äußerst gering. Das Risiko, in den USA an Covid-19 zu erkranken, ist weitaus höher.
    • Die Pause könnte die Impfbemühungen des Landes in einer Zeit erschweren, in der viele Staaten in neuen Fällen mit einem Anstieg konfrontiert sind und versuchen, das Zögern des Impfstoffs anzugehen.
    • Johnson & Johnson hat auch beschlossen, die Einführung seines Impfstoffs in Europa zu verzögern, da Bedenken hinsichtlich seltener Blutgerinnsel bestehen, was dem Impfschub in Europa einen weiteren Schlag versetzt. Südafrika, das von einer dort auftretenden ansteckenden Virusvariante am Boden zerstört wurde, stellte die Verwendung des Impfstoffs ebenfalls ein. Australien kündigte an, keine Dosen zu kaufen.

Die Berichte über Blutgerinnsel waren der zweite Schlag gegen den Johnson & Johnson-Impfstoff. Anfang dieses Monats hat eine Verwechslung von Inhaltsstoffen in einer Produktionsstätte in Baltimore, die Emergent BioSolutions gehört, bis zu 15 Millionen Dosen des Impfstoffs ruiniert. Die FDA inspiziert nun die Anlage, um festzustellen, ob dort hergestellte Dosen der Öffentlichkeit zugänglich gemacht werden können.

Während einer mehr als zweistündigen Anhörung fragte jedoch nur ein Gesetzgeber – der Vertreter Mark E. Green, Republikaner von Tennessee, der Arzt ist – nach dem Impfstoff von Johnson & Johnson. Er forderte die Ärzte auf, vorsichtig zu sein, wenn sie über die Ermittlungen sprachen, und sagte, er befürchte, dass sie Ängste schüren würden, die die Menschen davon abhalten würden, sich impfen zu lassen.

Und es gibt frühe Beweise dafür, dass die Besorgnis gut aufgenommen wird. Eine am Donnerstag vom Boston Children’s Hospital veröffentlichte Umfrage unter Survey Monkey ergab, dass die Bereitschaft, den Schuss von Johnson & Johnson zu erhalten, bei Amerikanern, die sich impfen lassen wollten, innerhalb von zwei Tagen um 26 Prozentpunkte zurückging. Laut der Umfrage, einem Projekt der Outbreaks Near Me-Initiative des Krankenhauses, einem Crowdsourcing-System zur Überwachung von Infektionskrankheiten, betrug der Rückgang bei Frauen, die sich impfen lassen wollten, 31 Prozentpunkte.

“Jedes Mal, wenn auf Bundesebene Bedenken oder rote Fahnen gehisst werden, wird dies die breite Öffentlichkeit beunruhigen”, sagte Dr. Dzirasa.

Die Sitzung am Donnerstag hatte den Untertitel „Ein wissenschaftlich fundierter Ansatz zur schnellen und sicheren Beendigung der Pandemie“. Aber was auch immer über Wissenschaft diskutiert wurde, wurde von parteipolitischer Haltung und Streit überschattet.

Demokraten machten sich Sorgen um den Fox News-Moderator Tucker Carlson, der seine Show genutzt hat, um fälschlicherweise zu behaupten, dass die Impfstoffe nicht funktionieren.

Die Republikaner, die gerade erst an der Südgrenze des Landes waren, nutzten die Sitzung, um den Umgang der Biden-Regierung mit der Einwanderungskrise anzugreifen. Sie winkten mit Fotos von Migranten, die unter beengten Verhältnissen lebten, und beschwerten sich über Testregeln für diejenigen, die in das Land einreisen.

Der Vertreter Jim Jordan, Republikaner von Ohio, und Dr. Fauci wiederholten ihren hitzigen Zusammenstoß, als Dr. Fauci das letzte Mal vor dem Panel im Juli aussagte.

“Sie schimpfen wieder”, sagte Dr. Fauci an einer Stelle.

“Ich schimpfe nicht”, antwortete Herr Jordan.

“Ja, das sind Sie”, beharrte Dr. Fauci.

Die Repräsentantin Maxine Waters, Demokratin von Kalifornien, deren Schwester an Covid-19 gestorben ist, sagte zu Dr. Fauci: „Ich liebe dich“ und sagte zu Herrn Jordan: „Halt den Mund.“

Noah Weiland, Rebecca Robbins und Sharon LaFraniere trugen zur Berichterstattung bei.

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Business

C.D.C. Panel Retains Pause on Use of J&J Vaccine, Weighing Dangers

C.D.C. Panel Keeps Pause on Use of J&J Vaccine, Weighing Risks

“At the moment we believe these events are extremely rare, but we are also not sure we have heard of all possible cases as this syndrome may not be easily identified as being associated with the vaccine,” said Dr. Rochelle P. Walensky, the CDC director said at a White House press conference about the pandemic on Wednesday.

During the panel discussion, experts noted that the “risk window” for the disease was still open among vaccine recipients and that new cases could arise as nearly 3.8 million people had received the shot in the past two weeks. In the six women, the strong coagulation developed within about two weeks after the shot.

Other experts advocated the dissemination of health information about how to diagnose and treat the condition so that it could spread awareness among doctors, emergency rooms, and those who had received the vaccine. An important point to note is that the blood-thinning heparin, a common treatment for blood clots, can be harmful to these patients and should not be used.

Officials also noted that because the blood clots were so severe, people with the disease needed treatment as soon as possible. Some patients needed invasive procedures to remove large blood clots from the blood vessels in their brain.

Several panel members reiterated that two other vaccines – from Moderna and Pfizer-BioNTech – are available, neither of which are associated with the clotting problem. Continuing the hiatus would not stop most people in the US from getting vaccinated.

Speaking at the press conference, Jeffrey D. Zients, the White House pandemic coordinator, said the hiatus would not disrupt the momentum of the country’s vaccination campaign in general.

“In the short term, we expect some impact on the daily average as Johnson & Johnson locations and dates move to Moderna and Pfizer vaccines,” he said. “We have more than enough Pfizer and Moderna vaccines to continue or even accelerate the current rate of vaccination.”

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Business

Surgeon says pausing J&J vaccine for youthful populations is sensible, however could possibly be lifted for older age teams

Dr. Atul Gawande said he “thinks something special is going on here” when it comes to blood clotting and Johnson & Johnson’s Covid-19 single-dose vaccine.

“We have an unusual type of clotting syndrome, very specific to these vaccines, in women in the younger age group, and it’s not like the other cases where these rare incidents happen. I think there are probably adenovirus vaccines. A some risk for this rare disease, which is increased in a certain age group, “said Gawande.

Experts from a panel of the Centers for Disease Control and Prevention decided to postpone a decision on the use of J & J’s single-dose Covid vaccine on Wednesday. They found they needed more time to assess the data and risks.

The meeting comes a day after federal health officials advised the US to temporarily suspend use of J & J’s single-dose vaccine as a “caution” after six women out of approximately 6.9 million people who received the shot reported getting heavy blood clots. Due to the postponement of the vote, the pause remains in force for the time being.

Gawande, a surgeon and professor at TH Chan School of Public Health at Harvard, said he thought the J&J vaccine hiatus made sense for younger populations, and he also thought it could be lifted for older age groups.

“I think there is enough information to know that this is safe for people over 50 and I think they could possibly have left the break for the older age group,” Gawande said on CNBC’s “The News with Shepard Smith” . “I think this could end up here like you saw for AstraZeneca in Europe.”

More than 7.2 million J&J doses have been administered nationwide, and the vaccine is responsible for 9.5% of the roughly 75 million Americans who are fully vaccinated, according to CDC data.

Gawande noted that the Moderna and Pfizer vaccine supply can be used to contain the increase in cases in states in the United States. He told host Shepard Smith that he was in favor of increasing the second dose of the Moderna and Pfizer vaccines to two, four, six weeks “in order to double the number of people currently vaccinated.

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Health

Denmark says it’s completely stopping use of the AstraZeneca vaccine.

Denmark says it’s permanently stopping use of the AstraZeneca vaccine.

Denmark became the first country on Wednesday to plan to permanently stop administration of the AstraZeneca vaccine a month after it stopped using it after reports that a small number of recipients had developed a rare but serious bleeding disorder.

The country’s health authority director-general Soeren Brostroem said Denmark could stop using the vaccine as the pandemic was under control and it could rely on two other vaccines from Pfizer and Moderna.

The Danish announcement is another setback for the AstraZeneca shot, which is easy to store and relatively cheap, and should serve as the basis for vaccination campaigns around the world.

The country initially stopped using the vaccine on March 11, along with Iceland and Norway. Several other European countries including France, Germany and Italy followed suit last month.

The European Union’s Medicines Agency, the European Medicines Agency, later recommended countries continue to use the vaccine, saying its benefits far outweighed the potential risks for most people.

Last week, the European regulator listed blood clots as a possible very rare side effect of the vaccine.

Several countries that suspended and resumed use of the vaccine have since announced that they will discontinue use in younger people. The UK, which has given around 20 million AstraZeneca doses, said it would offer alternative vaccines to people under 30.

“Based on the scientific evidence, our overall assessment is that there is a real risk of serious side effects associated with using AstraZeneca’s Covid-19 vaccine,” said Danish health official Dr. Brostroem in a statement. “We have therefore decided to remove the vaccine from our vaccination program.”

“If Denmark were in a completely different situation, for example in the midst of a violent third outbreak and a health system under pressure,” he added, “then I would not hesitate to use the vaccine, even if it were rare.” but serious complications related to its use. “

Danish health officials said they might reintroduce the AstraZeneca vaccine “if the situation changes”.

Public health officials have warned that stopping vaccine delivery like AstraZeneca or Johnson & Johnson could do more harm than good. They find that out of seven million people in the United States who were vaccinated with the Johnson & Johnson single-dose vaccine, six women had developed the rare blood clots – fewer than one in a million. It is not yet known if the vaccine had anything to do with the clots, but even if it does, the risk is lower than being struck by lightning in any given year (one in 500,000).

Denmark, with a population of 5.8 million, managed to contain the pandemic better than its neighbor Sweden or many other European countries. As of Wednesday, Denmark had recorded 2,447 deaths related to Covid.

Nearly a million people in the country have received at least a first dose of a vaccine, 77 percent of them from Pfizer, according to the Danish Serum Institute. Around 15 percent received an initial dose of the AstraZeneca vaccine before authorities stopped using it last month, and the remaining 8 percent received the Moderna vaccine.

The country’s health officials said people who received a first dose of the AstraZeneca vaccine will be offered a different vaccine for their second dose.

Jasmina Nielsen contributed to the reporting.

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World News

Skilled Panel to C.D.C. to Vote on Johnson & Johnson Vaccine Pause

Expert Panel to C.D.C. to Vote on Johnson & Johnson Vaccine Pause

An advisory committee from the Centers for Disease Control and Prevention discussed the Johnson & Johnson Covid-19 vaccination break during a Wednesday afternoon meeting while investigating a possible association with a small number of rare blood clots.

The emergency meeting follows Tuesday’s announcement by the Food and Drug Administration to investigate six cases of rare and severe blood clots in women aged 18 to 48, one of whom died. All of the women had received the Johnson & Johnson vaccine before developing the clot, although it is unclear whether the vaccine was responsible. As of Tuesday, more than seven million people in the United States had received the shot, and another 10 million cans had been shipped to the states, according to CDC data.

Following the call from federal health officials, all 50 states, Washington, DC and Puerto Rico on Tuesday quickly paused or advised vendors to stop administering the vaccine. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.

The Advisory Committee on Immunization Practices (ACIP) is a panel of independent experts who advise the CDC on its vaccine policy. During the meeting, the experts will review and debate data from the rare blood clots, including a seventh case, and will later hear comments from the public before a possible vote on how to proceed. You could vote to recommend, for example, that the break continue, or to indicate that it should only apply to a specific age or gender.

Federal officials said Tuesday the hiatus could only last a few days, though it depends on what officials learned from the investigation. They said the break will give officials more time to alert doctors that patients with these rare blood clots should not be given the drug heparin, the standard treatment doctors give for typical blood clots, and that they also have time to to see if there are more cases.

The worrying coagulation disorder among vaccine recipients is different – and much less common – than the typical blood clots that occur in hundreds of thousands of people each year. In addition to having clots in the brain, the seven women also had remarkably low levels of platelets, parts of the blood that help make normal clots. The panel experts discussed the known background rates of each disease in the general population, but noted that insufficient data was available to accurately estimate how often they occur simultaneously.

“At the moment we believe these events are extremely rare, but we are also not sure we have heard of all possible cases as this syndrome may not be easily identified as being associated with the vaccine,” said Dr. Rochelle P. Walensky, the CDC director said at a White House press conference about the pandemic on Wednesday.

The US surgeon general Dr. Vivek Murthy reiterated Wednesday that the break in Johnson & Johnson’s vaccinations gives public health officials a chance to investigate the cases and discuss them with health professionals. He added that breaks are common when new vaccines and drugs are introduced.

“We are only doing the necessary care to ensure that everything is safe so that we can continue our vaccination efforts,” said Dr. Murthy on “CBS This Morning”.

The committee’s assessment will be of vital importance at a time when the nation is trying to vaccinate as many people as possible to curb the steady buildup of cases, especially when worrying variants become more prominent. Some public health experts were disappointed with the FDA’s recommendation to suspend the Johnson & Johnson vaccine, arguing that preventing these extremely rare side effects was not worth the compromise of slowing the vaccination campaign and potentially increasing public confidence in vaccines Generally undermine.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of vaccination.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily suspended use of the vaccine or suspended from recommended vendors. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.
    • The hiatus could complicate the country’s vaccination efforts at a time when many states are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson has also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots, which is taking another blow to the vaccine surge in Europe. South Africa, devastated by a contagious variant of the virus found there, also stopped using the vaccine. Australia announced that it would not buy cans.

Speaking at the press conference, Jeffrey D. Zients, the White House pandemic coordinator, said the hiatus would not disrupt the momentum of the country’s vaccination campaign in general.

“In the short term, we expect some impact on the daily average as Johnson & Johnson locations and dates move to Moderna and Pfizer vaccines,” he said. “We have more than enough Pfizer and Moderna vaccines to continue or even accelerate the current rate of vaccination.”

Noah Weiland, Denise Grady and Madeleine Ngo contributed to the coverage.

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Health

EMA says advantages of J&J Covid vaccine outweigh dangers

EMA says benefits of J&J Covid vaccine outweigh risks

Crystal Jones, 52, head of the Athens City Department of Health, loads syringes of the vaccine on the first day of Johnson and Johnson’s vaccine.

SOPA pictures | LightRocket | Getty Images

LONDON – The European Medicines Agency said Wednesday that the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh the risk of side effects following reports of extremely rare blood clotting.

It comes shortly after the US Food and Drug Administration asked states to temporarily suspend J & J’s use of the vaccine “out of caution” after six cases of bleeding disorder were detected with more than 6.8 million doses of the shot were.

All six cases in the United States occurred in women between the ages of 18 and 48, with symptoms developing six to 13 days after receiving the shot. The FDA said one woman died from complications from blood clotting and another was in critical condition.

The European Medicines Agency has currently investigated all reported cases and will decide whether regulatory action is required.

“The EMA is currently accelerating this assessment and is currently expecting to issue a recommendation next week,” the European Medicines Agency said in a statement.

“During the ongoing review, the EMA continues to believe that the vaccine’s benefits in preventing COVID-19 outweigh the risks of side effects.”

South Africa has stopped the launch of the shot while J&J has announced it is “proactively delaying” delivery of its vaccine to Europe, which began last week.

The vaccine was approved in the EU on March 11, but widespread use of the shot has not yet started.

“Right now, these adverse events seem extremely rare,” the FDA said on Tuesday in a joint statement with the Centers for Disease Control and Prevention. “The safety of COVID-19 vaccines is a top priority for the federal government and we take all reports of health problems following COVID-19 vaccination very seriously.”

Last week, the European Medicines Agency said it had identified a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems. AstraZeneca has not received approval for use in the United States

Oxford-AstraZeneca and J&J vaccines work in a similar way, and both use an adenovirus, a common type of virus that typically causes mild cold symptoms.

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Pausing use of J&J Covid vaccine is not going to have an effect on timeline of getting U.S. vaccinated, says physician

Pausing use of J&J Covid vaccine will not affect timeline of getting U.S. vaccinated, says doctor

America’s temporary hiatus from using Johnson & Johnson’s single-dose vaccine Covid-19 will not affect President Joe Biden’s goal of bringing the nation to a semblance of normalcy by Independence Day, said the dean of Brown University’s School of Public Health on Tuesday.

“I think this is going to be a blip on the calendar when it comes to getting Americans vaccinated,” said Dr. Ashish Jha. “I don’t think it will affect the timeline at all.”

Federal health officials advised on Tuesday that the US should temporarily stop using J & J’s single-dose vaccine after six of the roughly 6.9 million people who received the shot reported severe blood clots. The blood clots occurred in women between the ages of 18 and 48 years. One woman died and another is in critical condition. They all developed symptoms 6 to 13 days after the shot, according to the Centers for Disease Control and Prevention and the Food and Drug Administration.

Jha told CNBC’s “The News with Shepard Smith” that the precautionary measures are evidence that “the system is working” and that the government’s swift action could counter the hesitation of the vaccine.

“I hope that it actually builds trust in people, that we don’t take adverse events lightly and investigate them, and that we really make sure that these vaccines are very, very safe.”

Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, reiterated that the break is “out of caution” and will give health officials time to investigate.

“You want to make sure that security is the important issue here,” Fauci said during a press conference at the White House on Tuesday. “We are fully aware that this is a very rare occurrence. We want this to work as soon as possible.”

Jha told host Shepard Smith that he “expects the break to be days, not much longer,” reiterating Fauci’s claim about the rarity of blood clots.

“The key point here is that this is an incredibly rare, adverse event,” said Jha. “It won’t affect very many people and I think, out of caution, we’ll just pause to see what else we can find out about it.”

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J&J Vaccine and Blood Clots: A Danger, if It Exists, Is Tiny

J&J Vaccine and Blood Clots: A Risk, if It Exists, Is Tiny

On Tuesday morning, U.S. health officials recommended a break in using Johnson & Johnson’s Covid-19 vaccine while examining six reports of blood clots in women ages 18 to 48. One has died, another is in critical condition in the hospital.

As of Monday, 6.8 million people in the United States had received the vaccine with no other serious side effects reported.

Experts are yet to determine to what extent the vaccine may be responsible for the clots. However, the investigation follows action by European regulators who concluded that a vaccine made by AstraZeneca may also be the cause of a similar, extremely rare, coagulation disorder.

US and European public health experts have emphasized that for most people, the benefits of Covid vaccines far outweigh the risks.

Several countries in Europe last week restricted the use of the AstraZeneca-Oxford vaccine to older adults due to the rare occurrence of a blood disorder in younger people. The AstraZeneca vaccine was not approved in the United States.

Fewer than one in a million J&J vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.

The FDA recommends people who have received the Johnson & Johnson vaccine within the past three weeks to see their doctor if they have severe headache, abdominal pain, leg pain, or difficulty breathing. Doctors who see people with these symptoms, especially if the patients are young women, should ask if they have recently had a Covid shot, said Dr. Anthony Fauci, senior scientific advisor to the Biden administration, at a press conference Tuesday.

People shouldn’t worry about mild headaches and flu-like symptoms for the first few days after vaccination. These are common, harmless side effects caused by the immune system’s defense against the coronavirus.

For people who got the vaccine a month or two ago, the blood clot problem means “nothing,” said Dr. Fauci. The six cases occurred within a “fairly narrow window” of six to 13 days after people got the shot, he said.

During clinical trials and after the widespread use of vaccines, experts track all of the medical problems that arise in people who receive them. If an unusually large number of cases arise, regulators may decide to stop a study or stop using a vaccine for further investigation.

Breaks are frequent, and tests usually show that the medical problems were incidental. If the investigation reveals that a vaccine poses a risk, regulators can write new guidance on who should or should not receive it. The break also gives them time to advise doctors on how to recognize and treat the disease.

If so, the Food and Drug Administration and Centers for Disease Control and Prevention recommend a break States have already followed the advice of the agencies. Companies that are temporarily discontinuing use of the vaccine include CVS Health and Walgreens.

In a press conference Tuesday, federal officials said the government review would likely only take a few days. A CDC panel is expected to discuss the issue at a meeting on Wednesday.

Six women in the United States who received the Johnson & Johnson vaccine developed a rare blood clot disorder within about two weeks of being vaccinated. In people with this condition called cerebral venous sinus thrombosis, clots form in veins that drain blood from the brain. The results are “stroke-like,” said Dr. Anne Schuchat from the CDC.

Researchers studying a very similar disorder in AstraZeneca recipients in Europe say it appears to be caused by an intense immune system response to the vaccine, which makes antibodies that activate platelets, a blood component that helps to form normal blood clots in the Contributes to wound repair. In addition to clots, abnormal bleeding occurs. European researchers have named the disorder identified there as “vaccine-induced immune thrombotic thrombocytopenia”.

Dr. FDA’s Peter Marks said it was the unusual combination of clotting and bleeding that set a red flag for regulators as a possible safety signal.

So far, researchers have failed to find a way to predict who will develop the disorder and have not identified an underlying condition that could indicate a susceptibility.

Updated

April 13, 2021, 5:17 p.m. ET

Dr. Fauci said if scientists could identify a common core trait among the women who developed the blood clots, it could help identify who is at risk and allow regulators to pinpoint categories of people who are not receiving the J&J vaccine should.

A blood clot is a thickened, gelatinous clot of blood that can block blood flow. Clots form in response to injury and can also be caused by many diseases, including cancer and genetic disorders, certain medications, and prolonged sitting or bed rest. Covid itself can cause serious coagulation problems. Clots that form in the legs sometimes break off and travel to the lungs or, rarely, to the brain, where they can be fatal.

In the United States, 300,000 to 600,000 people each year develop blood clots in their lungs, leg veins, or other parts of the body, according to the CDC

Based on this data, approximately 1,000 to 2,000 blood clots occur daily in the US population. With millions of people being vaccinated every day now, some of these clots appear in those who just happened to receive the shots, regardless of the vaccine.

In the UK, about 1 in 1,000 people are affected by a blood clot in a vein each year, according to regulators.

However, the worrying coagulation disorder among vaccine recipients is much rarer and different from typical blood clots. In addition to clotting in the brain – cerebral venous sinus thrombosis for short, or CVST for short – all patients had remarkably low levels of platelets, which made them prone to abnormal bleeding.

On Tuesday, Johnson & Johnson announced that the company was aware of an extremely rare condition involving people with blood clots combined with low platelets in a small number of people who received the vaccine. “In addition, we have examined these cases with the European health authorities,” said the company in its statement. “We made the decision to proactively delay the launch of our vaccine in Europe.”

At the press conference on Tuesday, Dr. Marks from the FDA said the cases are “very, very similar.”

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

Both Johnson & Johnson and AstraZeneca use adenoviruses to transport DNA into human cells and begin the process of creating immunity to the coronavirus. It is not yet known if this technology is causing the problem.

German researchers have speculated that DNA from the vaccine could trigger the immune response in some people. However, the condition is so rare that researchers say patients likely also have an individual biological trait – which is still unknown – that predisposes them to the immune overreaction.

Last month, European regulators began investigating similar cases of cerebral vein thrombosis related to low platelets. They concluded that the disorder was a very rare side effect of the AstraZeneca vaccine. It’s too early to know if Johnson & Johnson’s vaccine is responsible for the same type of rare blood clot.

European regulators had recommended that recipients of the vaccine seek medical help for a number of possible symptoms, including leg swelling, persistent abdominal pain, severe and persistent headache or blurred vision, and tiny spots of blood under the skin outside of the area where the Injection was given was given.

However, these symptoms were so vague that the UK emergency departments almost immediately saw an increase in patients worried they were as they were described.

Still, German researchers say such symptoms need to be followed up in vaccine recipients. Blood tests can detect the antibodies.

Doctors in Germany and Norway have treated patients with blood-thinning drugs to stop the clot from growing and with intravenous immunoglobulin, which can help clear up the misdirected antibodies that are causing the problem.

The researchers there and the US federal health authorities advised against the use of a conventional blood thinner, heparin, on Tuesday and recommended that alternative drugs be chosen instead. The reason is that the disorder is very similar to a rare syndrome caused by heparin and it is possible that heparin could make the situation worse in these patients.

Heparin could “do a lot of damage,” said Dr. Marks.

German researchers have stressed that treatment should start as soon as possible as the condition can worsen quickly.

We do not know yet. The six cases studied in people who received the J&J vaccine all involved women. However, this number is so small that no clear conclusions can be drawn from it.

When asked on Tuesday whether the use of contraception could be a risk factor, US health officials said they knew no connection.

In Europe, it initially appeared that women were at a higher risk of blood clots associated with the AstraZeneca vaccine, although in some cases men who had received the vaccine were affected.

Upon closer inspection, it was found that in some countries more women overall received the vaccine because they were overrepresented among health workers. UK regulators now say they have no evidence as to whether men or women are more likely to be affected by blood clots.

The FDA did not find any similar cases in people who received the Moderna or Pfizer-BioNTech vaccines.

However, decreased platelet counts have been reported in a few patients who received the Moderna, Pfizer-BioNTech and AstraZeneca vaccines. One recipient, a doctor in Florida, died of a cerebral haemorrhage when his platelet counts failed to restore, and others were hospitalized. US health officials have stated that the cases are being investigated, but they have not reported the results of those reviews and have yet to advise that they are linked to the vaccines.

Benjamin Mueller contributed to the reporting.

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Panicked sufferers name medical doctors as Covid vaccine hesitancy rises with J&J blood clot challenge

Panicked patients call doctors as Covid vaccine hesitancy rises with J&J blood clot issue

More Americans are likely to refuse to receive the Covid-19 vaccine from Johnson & Johnson after U.S. health officials said six women developed a rare bleeding disorder with one dead and another in critical condition, experts said for public health and vaccines using CNBC on Tuesday.

The Food and Drug Administration asked states early Tuesday to temporarily stop using J & J’s single-shot vaccine “out of caution” after six women aged 18 to 48 out of the roughly 6.9 million people who received the shot developed blood. A coagulation disorder known as cerebral venous sinus thrombosis, or CVST.

All women developed the condition that occurs when a blood clot forms in the venous sinuses of the brain that prevents blood from flowing back to the heart within about two weeks of receiving the shot from the brain, health officials told reporters on a phone call .

“People who have recently received the vaccine in the past few weeks should be aware if they are looking for symptoms,” said Dr. Anne Schuchat, the deputy chief director of the Centers for Disease Control and Prevention, during a press conference on Tuesday. “If you have received the vaccine and have severe headache, stomach pain, leg pain, or shortness of breath, you should contact your doctor and see a doctor.”

Shortly after the FDA issued the warning, more than a dozen states, as well as some pharmacies, took steps to stop vaccination with J & J’s vaccine. Some replaced scheduled appointments with either the Pfizer or Moderna vaccine. Some doctors say they are already taking calls from worried patients.

People were already skeptical of vaccines before the coronavirus emerged as a new pathogen in China in December 2019, infecting more than 31.2 million Americans and killing at least 562,718 people in just over a year. Warning from U.S. health officials to states is likely to be even more reluctant to take J & J’s shot and the other vaccines, and threatens to hold back the nation’s recovery from the pandemic, health experts told CNBC.

“Unfortunately, this is likely to exacerbate those who are a little hesitant about getting a vaccine,” said Isaac Bogoch, an infectious disease specialist who served on several drug data and safety oversight panels. “Senior public health officials need to continue to be open, honest, transparent, and most importantly, contextualize that this is a low risk.”

According to Dr. Anthony Fauci, President Joe Biden’s chief medical officer, the goal is to vaccinate between 70% and 85% of the US population – or about 232 to 281 million people – to achieve herd immunity and suppress the pandemic.

To date, more than 120 million Americans, or 36% of the total US population, have received at least one dose of a Covid-19 vaccine, according to the CDC. Around 74 million Americans, or 22% of the total US population, are fully vaccinated, according to the CDC. Children under the age of 16 are not yet eligible to shoot in the United States, and some adults are likely to refuse to get a vaccine.

“This puts a wrench in the plans. It will slow down the rollout,” said Dr. Jeffrey Kahn, director of the Berman Institute of Bioethics at Johns Hopkins University. “People will say, ‘I don’t want this, I want one of the others who don’t have this problem,’ even if it’s an extremely rare occurrence.”

Some Americans, especially in black, Hispanic, and rural communities, have already been reluctant to get the J&J vaccine, especially because they found it to be worse than Pfizer and Moderna’s. The highly effective J&J shot, especially against serious illnesses, showed 72% effectiveness in protecting against Covid in the US about a month after inoculation. This is comparable to the effectiveness of Pfizer and Moderna vaccines with two doses of around 95%.

Single-dose vaccines like J & Js were critical to “getting into communities where a two-dose regimen was impractical or even possible,” Kahn said. US health officials used J & J’s vaccine primarily to reach poorer urban and rural areas where residents could not easily get to a vaccination clinic or did not have reliable internet access.

“These communities are also the hardest hit by Covid,” said Kahn. “Interrupting Use of J & J. [is] one stroke to do that effectively and quickly. “

Dr. Stephen Schrantz, who was part of the team leading a J&J vaccine study at the University of Chicago Medicine, said he already had patients who didn’t want the J&J vaccine and said the news would give them more evidence give to say, “See, I told you.”

“I suspect that vaccine adoption and uptake will slow down, there will be a move away from the J&J vaccine even if the CDC and FDA conclude that there is no causal link,” he said. “And as the wearing of masks wears off, there may be more cases like we have in Michigan.”

Dr. Scott Gottlieb, who sits on Pfizer’s board of directors, predicted the move will fuel “the reluctance” of some people to get a Covid vaccine.

“Even if there is no causal link, even if it is extremely rare, we will see that the whole conversation is now ignited on social media,” he told CNBC in an interview.

Dr. Purvi Parikh, an infectious disease allergy and immunology specialist at NYU Langone Health, described the FDA warning Tuesday as a “double-edged sword” and said it would likely raise concerns for already reluctant Americans. She also said she had already received “panic calls” from her own patients about the J&J vaccine.

“But if anything, I would like to repeat again: This only gives me more confidence in our system because these security checks work. Hopefully it will give some people peace of mind,” she added on “Squawk on the Street”. “” “Again, to look at the bigger picture, the benefits still far outweigh the risks of this vaccination.”

Dr. Archana Chatterjee, pediatric infectious disease specialist and member of the FDA’s Advisory Committee on Vaccines and Related Biological Products, echoed Parikh’s remark. She added that there is nothing “unusual” in the way US health officials are addressing the problem.

“This is a normal procedure that occurs,” she said.

“But of course whenever a serious adverse event is reported about a vaccine that raises public concern,” she added. “If you talk about vaccine trust or vaccine reluctance, could it have an impact? It certainly is possible.”

Dr. Paul Offit, another member of the Advisory Committee on Vaccines and Allied Biological Products, hopes Americans will be “rational” about the problem, adding that cases of blood clots seem extremely rare. He noted that convincing people in hard-to-reach communities could be a challenge.

“It should be reassuring to the people that the officials are still looking [at the vaccine], even for rare side effects, “he said.

– CNBC’s Kevin Stankiewicz contributed to this article.