Tag: Vaccine

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EU medicines regulator finds doable hyperlink between AstraZeneca Covid vaccine and blood clots

EU medicines regulator finds possible link between AstraZeneca Covid vaccine and blood clots

Syringes are filled with Astrazeneca’s vaccine in the pharmacy.

Christopher Neundorf | Image Alliance | Getty Images

LONDON – Europe’s Medicines Agency announced on Wednesday a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems in adults who received the shot.

It comes after a review of all currently available evidence in extremely rare cases of unusual blood clots in some vaccinated individuals.

Emer Cooke, executive director of the European Medicines Agency, said in a televised press conference that the regulator’s safety committee “has confirmed that the overall benefits of the AstraZeneca vaccine in preventing Covid-19 outweigh the risks of side effects.”

“A plausible explanation for these rare side events is an immune response to the vaccine that is similar to that seen in heparin-treated patients,” said Cooke, noting that it was heparin-induced thrombocytopenia.

The EMA has commissioned further research to investigate the link between the vaccine and blood clots, and said its safety committee had concluded that unusual blood clots with low platelets should be listed as “very rare” side effects of the shot. It also drew the public’s attention to other possible side effects that are flagged as adverse drug reactions on the product information of the vaccine.

The European Medicines Agency said it was “of great importance” that health professionals and those receiving the Oxford-AstraZeneca vaccine are aware of these risks and look out for possible symptoms, typically in the first two weeks after vaccination occur.

“These include, for example, shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, neurological symptoms such as severe or persistent headaches or blurred vision and skin bruises beyond the injection site,” said Dr. Sabine Straus, chair of EMA’s security committee, said at the same press conference.

AstraZeneca’s shares fell nearly 1% during afternoon trading in London.

The Oxford-AstraZeneca shot has been followed by safety concerns in recent weeks, and several European countries temporarily stopped using the vaccine last month.

The EMA said on March 31 that it had found the shot to be safe and effective, but added that it could not rule out the possibility of a causal link between the vaccine and coagulation events, so the investigation will continue.

The World Health Organization, the UK Medicines Agency and the International Society on Thrombosis and Hemostasis have all stated that the benefits of administering the Oxford-AstraZeneca shot far outweigh the risks.

AstraZeneca previously said that its studies didn’t find a higher risk of blood clots as a result of its vaccine.

Most countries have since resumed the use of the shot, but many have suspended vaccinations for certain age groups.

A senior European Medicines Agency official said Tuesday that there was a clear “link” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, although the direct cause was not yet known.

In an interview with the Italian newspaper Il Messaggero published on Tuesday, Marco Cavaleri, chairman of the EMA’s vaccine evaluation team, said: “In my opinion, we can now say that there is a link to the vaccine, but we are still me don’t know what is causing this reaction. “

The EMA then denied in a statement to Agence France-Presse that it had made a connection between the Oxford-AstraZeneca shot and rare blood clots.

UK vaccine study in children paused

The drug and health products regulator, which approved the Oxford-AstraZeneca vaccine for use in the UK, examined the data after a handful of reports – in both the UK and continental Europe – of serious but rare blood clots, some of which were fatal .

A UK study of the Oxford AstraZeneca vaccine in children has already been paused while the drug agency investigated a possible link between the shot and the bleeding disorders, particularly cases of blood clots in veins in the brain known as cerebral venous sinus thrombosis (CVST) as well Thrombocytopenia (low levels of platelets in the blood that help blood to clot).

The UK government noted that as of March 24th inclusive, there were 22 reports of CVST and 8 reports of other low platelet thrombosis events totaling 18.1 million doses of the AstraZeneca vaccine (one shot with two doses). given up to this date.

People are waiting in a vaccination center in Cologne on April 5, 2021.

Marius Becker | Image Alliance | Getty Images

“We need to know more about those affected and understand exactly how the diseases came about while many other questions remain open,” said Adam Finn, professor of pediatrics at Bristol University, UK, ahead of the announcement on Wednesday.

“There are some things that are very clear, however. The first is that these cases are indeed very rare. The second is that the vaccines available and used in the UK are very effective in preventing COVID,” said Finn.

“In short, if you are currently offered a dose of Oxford AstraZeneca vaccine, your chances of staying alive and staying healthy will go up if you take the vaccine and go down if you don’t.”

– CNBC’s Holly Ellyatt contributed to this report.

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U.S. Wager on Covid Vaccine Producer At the same time as Issues Mounted

U.S. Bet on Covid Vaccine Manufacturer Even as Problems Mounted

Due to the pandemic, most auditors drew their conclusions from documents and video tours where emergent employees checked camera angles, a former company employee said.

Johnson & Johnson reviewers said monitoring reports for bacteria or other contaminants were submitted four to six months late. According to AstraZeneca, Emergent has repeatedly relaxed the monitoring criteria so that they appear to be meeting them, using measures such as “historical averages”. But even then, it failed the tests, the report said.

In another audit, BARDA officials documented similar concerns and rated some of them as “critical”, including the risks of microbiological contamination. This designation is reserved for the most serious problems that pose an immediate and significant risk.

Emergent’s internal audit in July also found that the flow of workers and materials through the plant was not being adequately controlled “to avoid mix-ups or contamination.”

The reports reflected quality control deficiencies documented during an FDA inspection in April previously reported by The Associated Press that concluded that the facility was “not ready for commercial operation.”

Several audits underline how poorly the company was prepared for the enormous workload.

The Covid-19 projects required significantly more testing to ensure the materials remained stable. However, Emergent only had one employee who coordinated everything, as the BARDA audit showed. Emergent admitted at this point that its test system was “not ideal” and promised to train at least one more Emergent employee and hire a third. BARDA did not respond to requests for comment on its review or any of the others, except to state that it “worked with Emergent to resolve the issues raised during the FDA inspection.”

Another internal investigation in August found that Emergent approved four raw materials for AstraZeneca’s vaccine production without fully testing them. This type of link, known as conditional release of material, occurred an average of twice a week in October, internal logs show. The move was deemed necessary as the company operated with reduced production times, residue testing and met the requirements of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviates from the standards,” the report said, batches of vaccines would not be released without quality and safety testing.

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The ‘Pleasure and Envy’ of Vaccine FOMO

The ‘Joy and Envy’ of Vaccine FOMO

At the beginning of the year, Shay Fan was relieved: Vaccinations were on the way. Her relief turned to joy when her parents and in-laws got their shots.

Three months later, Ms. Fan, a 36-year-old freelance marketer and writer in Los Angeles, is still waiting for hers, and that joy is gone.

“I want to be patient,” she said.

But as she flipped through Instagram and saw photos of people, she said, “In Miami with no masks spraying champagne into someone else’s mouth,” while sitting in her apartment, not having a haircut in more than a year, or in was a restaurant. made it difficult to exercise patience. “It’s like when every friend gets engaged before you and you say, ‘Oh, I’m happy for them, but when is my turn?'”

The same rules applied to much of the pandemic: stay home, wear a mask, wash your hands.

But now that the prevalence of vaccines is increasing in some areas while others are lacking due to a third wave of coronavirus cases or even warnings of a fourth wave, rules are diverging globally and even within the same country.

In the UK, people emerge cautiously after more than three months of lockdown and 47 percent of the population has had at least one dose of vaccine. In New York, where at least 34 percent of the people in the state have received at least one dose of vaccine, it is said that life feels almost normal.

France, where only 14 percent of the population received at least one dose of vaccine, has just launched its third lockdown. And Brazil, which has given at least one dose to 8 percent of the population, reports some of the world’s highest new cases and deaths per day. There are dozen of countries – including Japan, Afghanistan, Kenya, and the Philippines – that have given less than 2 percent of their population a single dose.

Juliette Kayyem, 51, a professor at the John F. Kennedy School of Government at Harvard, said the wait was made even harder because she kept hearing from acquaintances who she didn’t believe were members of priority groups that were up ahead got her vaccinated.

“Is there a word for joy and envy at the same time?” Mrs. Kayyem said.

Ms. Kayyem received her first dose in late March. But instead of relieving herself, she felt another bout of pandemic stress as her husband and teenagers still weren’t vaccinated.

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April 5, 2021, 4:37 p.m. ET

Tristan Desbos, a 27-year-old pastry chef who lives in London, recently received his first shot but said his family could not be vaccinated in France, despite many of them belonging to a risk category. “They don’t understand why they can’t get the vaccine in France,” he said.

In the European Union, the main problem is the supply of vaccines. Amid a new deadly wave of cases, Germany imposed a partial lockdown, Italy banned most of its population from going outside for essential reasons, and Poland closed non-essential businesses.

Agnès Bodiou, a 60-year-old nurse in France, said she had waited weeks for her first shot, despite the government’s promise to give priority to health workers. “The Americans managed to vaccinate, including the English,” she said. “We’re still waiting.”

The end of the pandemic is also a long way off in the Canadian province of Ontario, which fell into a four-week state of emergency on Saturday amid a record number of ICU patients. Massimo Cubello, a 28-year-old who lives in Toronto, said he is happy for his vaccinated friends in the US and UK, but his zoom fatigue is setting in and driveway visits with members of his family have not been easy because of the cold Weather.

“It’s good to see people getting vaccinated because that’s all part of the process of getting where we need to go, but it definitely makes you a bit jealous and concerned about when we as Canadians will be able to do that Experience it for yourself, ”said Mr Cubello, who works in marketing.

In the United States, this dichotomy evolved primarily by generation or race. Older people, who make up the majority of those vaccinated, have eaten indoors, hugged grandchildren and held parties, while many younger people are still ineligible or repeatedly get “no appointments” messages when trying to book.

Dr. Lynn Bufka, psychologist and senior director at the American Psychological Association, said the pandemic had placed a heavy burden on teenagers, and waiting long for vaccines to be distributed could add to the stress.

“Children, in many ways, are people whose lives have been disrupted like everyone else, but who have less life experience adapting to these types of disorders,” said Dr. Bufka.

For American adults at least, the fear of missing out shouldn’t last long. President Biden has promised enough doses by the end of next month to immunize all of the country’s 260 million adults. In fact, the pace of vaccination is accelerating so much that Biden government officials believe the supply of coronavirus vaccines will exceed demand by the middle of next month, if not sooner.

Ms. Fan, the Los Angeles freelance writer and marketer, can book a vaccine appointment in mid-April. She has no intention of doing anything wild – the basics are what she looks forward to most. “I just need a haircut,” she said.

Constant Méheut contributed to the coverage.

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Health

Researchers Are Hatching a Low-Price Covid-19 Vaccine

Researchers Are Hatching a Low-Cost Covid-19 Vaccine

Ein neuer Impfstoff gegen Covid-19, der in Brasilien, Mexiko, Thailand und Vietnam in klinische Studien geht, könnte die Art und Weise verändern, wie die Welt die Pandemie bekämpft. Der Impfstoff mit der Bezeichnung NVD-HXP-S ist der erste in klinischen Studien, der ein neues molekulares Design verwendet, von dem allgemein erwartet wird, dass es wirksamere Antikörper erzeugt als die aktuelle Generation von Impfstoffen. Und der neue Impfstoff könnte viel einfacher herzustellen sein.

Bestehende Impfstoffe von Unternehmen wie Pfizer und Johnson & Johnson müssen in spezialisierten Fabriken unter Verwendung schwer zu beschaffender Inhaltsstoffe hergestellt werden. Im Gegensatz dazu kann der neue Impfstoff in Hühnereiern in Massenproduktion hergestellt werden – dieselben Eier, die jedes Jahr in Fabriken auf der ganzen Welt Milliarden von Influenza-Impfstoffen produzieren.

Wenn sich NVD-HXP-S als sicher und wirksam erweist, könnten Grippeimpfstoffhersteller möglicherweise weit über eine Milliarde Dosen davon pro Jahr produzieren. Länder mit niedrigem und mittlerem Einkommen, die derzeit Schwierigkeiten haben, Impfstoffe aus wohlhabenderen Ländern zu erhalten, können möglicherweise NVD-HXP-S für sich selbst herstellen oder es zu geringen Kosten von Nachbarn erwerben.

“Das ist atemberaubend – es würde das Spiel verändern”, sagte Andrea Taylor, stellvertretende Direktorin des Duke Global Health Innovation Center.

Zunächst müssen klinische Studien jedoch nachweisen, dass NVD-HXP-S tatsächlich bei Menschen wirkt. Die erste Phase der klinischen Studien wird im Juli abgeschlossen sein, und die letzte Phase wird noch einige Monate dauern. Experimente mit geimpften Tieren haben jedoch Hoffnungen auf die Aussichten des Impfstoffs geweckt.

“Es ist ein Heimrennen zum Schutz”, sagte Dr. Bruce Innis vom PATH Center for Vaccine Innovation and Access, das die Entwicklung von NVD-HXP-S koordiniert hat. “Ich denke, es ist ein Weltklasse-Impfstoff.”

Impfstoffe wirken, indem sie das Immunsystem gut genug mit einem Virus bekannt machen, um eine Abwehr dagegen zu veranlassen. Einige Impfstoffe enthalten ganze Viren, die abgetötet wurden. andere enthalten nur ein einziges Protein aus dem Virus. Wieder andere enthalten genetische Anweisungen, mit denen unsere Zellen das virale Protein herstellen können.

Sobald das Immunsystem einem Virus oder einem Teil davon ausgesetzt ist, kann es lernen, Antikörper herzustellen, die es angreifen. Immunzellen können auch lernen, infizierte Zellen zu erkennen und zu zerstören.

Im Falle des Coronavirus ist das beste Ziel für das Immunsystem das Protein, das seine Oberfläche wie eine Krone bedeckt. Das als Spike bekannte Protein bindet sich an die Zellen und lässt das Virus dann mit ihnen fusionieren.

Die einfache Injektion von Coronavirus-Spike-Proteinen in Menschen ist jedoch nicht der beste Weg, um sie zu impfen. Das liegt daran, dass Spike-Proteine ​​manchmal die falsche Form annehmen und das Immunsystem dazu veranlassen, die falschen Antikörper herzustellen.

Diese Erkenntnis entstand lange vor der Covid-19-Pandemie. Im Jahr 2015 trat ein weiteres Coronavirus auf, das eine tödliche Form der Lungenentzündung namens MERS verursachte. Jason McLellan, damals Strukturbiologe an der Geisel School of Medicine in Dartmouth, und seine Kollegen machten sich daran, einen Impfstoff dagegen herzustellen.

Sie wollten das Spike-Protein als Ziel verwenden. Aber sie mussten damit rechnen, dass das Spike-Protein ein Formwandler ist. Während sich das Protein auf die Fusion mit einer Zelle vorbereitet, verzieht es sich von einer tulpenartigen Form zu etwas, das eher einem Speer ähnelt.

Wissenschaftler nennen diese beiden Formen die Präfusions- und Postfusionsformen der Spitze. Antikörper gegen die Präfusionsform wirken stark gegen das Coronavirus, aber Postfusionsantikörper stoppen es nicht.

Dr. McLellan und seine Kollegen verwendeten Standardtechniken, um einen MERS-Impfstoff herzustellen, endeten jedoch mit vielen Postfusionsspitzen, die für ihre Zwecke unbrauchbar waren. Dann entdeckten sie einen Weg, das Protein in einer tulpenartigen Präfusionsform zu halten. Alles, was sie tun mussten, war, zwei von mehr als 1.000 Bausteinen im Protein in eine Verbindung namens Prolin umzuwandeln.

Die resultierende Spitze – 2P genannt – für die beiden darin enthaltenen neuen Prolinmoleküle nahm mit weit größerer Wahrscheinlichkeit die gewünschte Tulpenform an. Die Forscher injizierten die 2P-Spikes in Mäuse und stellten fest, dass die Tiere Infektionen des MERS-Coronavirus leicht abwehren konnten.

Das Team meldete ein Patent für seinen modifizierten Spike an, aber die Welt nahm die Erfindung kaum zur Kenntnis. Obwohl MERS tödlich ist, ist es nicht sehr ansteckend und hat sich als relativ geringe Bedrohung erwiesen. weniger als 1.000 Menschen sind an MERS gestorben, seit es zum ersten Mal beim Menschen aufgetreten ist.

Ende 2019 tauchte jedoch ein neues Coronavirus, SARS-CoV-2, auf und begann, die Welt zu verwüsten. Dr. McLellan und seine Kollegen traten in Aktion und entwarfen einen 2P-Spike, der nur für SARS-CoV-2 gilt. Innerhalb weniger Tage nutzte Moderna diese Informationen, um einen Impfstoff für Covid-19 zu entwickeln. Es enthielt ein genetisches Molekül namens RNA mit den Anweisungen zur Herstellung des 2P-Spikes.

Andere Unternehmen folgten bald diesem Beispiel, nahmen 2P-Spikes für ihre eigenen Impfstoffdesigns an und begannen mit klinischen Studien. Alle drei bisher in den USA zugelassenen Impfstoffe – von Johnson & Johnson, Moderna und Pfizer-BioNTech – verwenden den 2P-Spike.

Andere Impfstoffhersteller verwenden es ebenfalls. Novavax hat in klinischen Studien starke Ergebnisse mit dem 2P-Anstieg erzielt und wird voraussichtlich in den nächsten Wochen bei der Food and Drug Administration eine Genehmigung für den Notfall beantragen. Sanofi testet auch einen 2P-Spike-Impfstoff und geht davon aus, dass die klinischen Studien noch in diesem Jahr abgeschlossen sein werden.

Dr. McLellans Fähigkeit, lebensrettende Hinweise in der Struktur von Proteinen zu finden, hat ihm tiefe Bewunderung in der Impfstoffwelt eingebracht. “Dieser Typ ist ein Genie”, sagte Harry Kleanthous, Senior Program Officer bei der Bill & Melinda Gates Foundation. “Er sollte stolz auf diese große Sache sein, die er für die Menschheit getan hat.”

Aktualisiert

5. April 2021, 4:37 Uhr ET

Aber als Dr. McLellan und seine Kollegen den 2P-Spike an Impfstoffhersteller weitergaben, wandte er sich für eine genauere Betrachtung wieder dem Protein zu. Wenn der Austausch von nur zwei Prolinen einen Impfstoff verbessern würde, könnten zusätzliche Optimierungen ihn sicherlich noch weiter verbessern.

“Es war sinnvoll, einen besseren Impfstoff zu versuchen”, sagte Dr. McLellan, der jetzt Associate Professor an der University of Texas in Austin ist.

Im März schloss er sich mit zwei anderen Biologen der Universität von Texas, Ilya Finkelstein und Jennifer Maynard, zusammen. In ihren drei Labors wurden 100 neue Spikes mit jeweils einem veränderten Baustein erstellt. Mit Mitteln der Gates Foundation testeten sie jeden einzelnen und kombinierten dann die vielversprechenden Änderungen bei neuen Spikes. Schließlich schufen sie ein einziges Protein, das ihren Wünschen entsprach.

Der Gewinner enthielt die zwei Prolinen in der 2P-Spitze sowie vier zusätzliche Prolinen, die an anderer Stelle im Protein gefunden wurden. Dr. McLellan nannte den neuen Spike HexaPro zu Ehren seiner insgesamt sechs Prolinen.

Die Struktur von HexaPro war sogar stabiler als die von 2P, stellte das Team fest. Es war auch widerstandsfähig, besser in der Lage, Hitze und schädlichen Chemikalien zu widerstehen. Dr. McLellan hoffte, dass sein robustes Design es in einem Impfstoff wirksam machen würde.

Dr. McLellan hoffte auch, dass Impfstoffe auf HexaPro-Basis mehr von der Welt erreichen würden – insbesondere Länder mit niedrigem und mittlerem Einkommen, die bisher nur einen Bruchteil der Gesamtverteilung der Impfstoffe der ersten Welle erhalten haben.

“Der Anteil der Impfstoffe, die sie bisher erhalten haben, ist schrecklich”, sagte Dr. McLellan.

Zu diesem Zweck hat die University of Texas eine Lizenzvereinbarung für HexaPro getroffen, die es Unternehmen und Labors in 80 Ländern mit niedrigem und mittlerem Einkommen ermöglicht, das Protein in ihren Impfstoffen zu verwenden, ohne Lizenzgebühren zu zahlen.

In der Zwischenzeit suchten Dr. Innis und seine Kollegen bei PATH nach einer Möglichkeit, die Produktion von Covid-19-Impfstoffen zu steigern. Sie wollten einen Impfstoff, den weniger wohlhabende Nationen selbst herstellen können.

Die erste Welle zugelassener Covid-19-Impfstoffe erfordert spezielle, kostspielige Inhaltsstoffe. Zum Beispiel benötigt der RNA-basierte Impfstoff von Moderna genetische Bausteine, sogenannte Nukleotide, sowie eine maßgeschneiderte Fettsäure, um eine Blase um sie herum aufzubauen. Diese Inhaltsstoffe müssen in eigens dafür errichteten Fabriken zu Impfstoffen verarbeitet werden.

Die Art und Weise, wie Influenza-Impfstoffe hergestellt werden, ist dagegen eine Studie. In vielen Ländern gibt es riesige Fabriken für billige Grippeschutzimpfungen, in die Hühnereier mit Influenzaviren injiziert werden. Die Eier produzieren eine Fülle neuer Kopien der Viren. Fabrikarbeiter extrahieren dann die Viren, schwächen oder töten sie und setzen sie dann in Impfstoffe ein.

Das PATH-Team fragte sich, ob Wissenschaftler einen Covid-19-Impfstoff herstellen könnten, der billig in Hühnereiern angebaut werden könnte. Auf diese Weise könnten dieselben Fabriken, die Grippeschutzimpfungen durchführen, auch Covid-19-Impfungen durchführen.

In New York wusste ein Team von Wissenschaftlern der Icahn School of Medicine am Mount Sinai, wie man einen solchen Impfstoff mit einem Vogelvirus namens Newcastle Disease Virus herstellt, das beim Menschen harmlos ist.

Seit Jahren experimentieren Wissenschaftler mit dem Newcastle-Virus, um Impfstoffe für eine Reihe von Krankheiten zu entwickeln. Um beispielsweise einen Ebola-Impfstoff zu entwickeln, fügten die Forscher dem eigenen Satz von Genen des Newcastle-Disease-Virus ein Ebola-Gen hinzu.

Die Wissenschaftler setzten dann das manipulierte Virus in Hühnereier ein. Da es sich um ein Vogelvirus handelt, vermehrte es sich schnell in den Eiern. Die Forscher hatten Viren der Newcastle-Krankheit, die mit Ebola-Proteinen beschichtet waren.

Am Berg Sinai machten sich die Forscher daran, dasselbe zu tun, indem sie Coronavirus-Spike-Proteine ​​anstelle von Ebola-Proteinen verwendeten. Als sie von Dr. McLellans neuer HexaPro-Version erfuhren, fügten sie dies den Newcastle-Krankheitsviren hinzu. Die Viren waren voller Spike-Proteine, von denen viele die gewünschte Präfusionsform hatten. In Anspielung auf das Newcastle-Virus und den HexaPro-Spike nannten sie es NDV-HXP-S.

PATH veranlasste die Herstellung von Tausenden von Dosen NDV-HXP-S in einer vietnamesischen Fabrik, in der normalerweise Influenza-Impfstoffe in Hühnereiern hergestellt werden. Im Oktober schickte die Fabrik die Impfstoffe nach New York, um sie zu testen. Die Forscher des Mount Sinai fanden heraus, dass NDV-HXP-S Mäusen und Hamstern einen starken Schutz verleiht.

“Ich kann ehrlich sagen, dass ich jeden Hamster, jede Maus auf der Welt vor SARS-CoV-2 schützen kann”, sagte Dr. Peter Palese, der Leiter der Forschung. “Aber die Jury ist sich immer noch nicht sicher, was sie beim Menschen tut.”

Die Wirksamkeit des Impfstoffs brachte einen zusätzlichen Vorteil: Die Forscher benötigten weniger Viren für eine wirksame Dosis. Ein einzelnes Ei kann fünf bis 10 Dosen NDV-HXP-S ergeben, verglichen mit einer oder zwei Dosen Influenza-Impfstoffen.

“Wir freuen uns sehr darüber, weil wir glauben, dass dies ein Weg ist, einen billigen Impfstoff herzustellen”, sagte Dr. Palese.

PATH verband dann das Mount Sinai-Team mit Influenza-Impfstoffherstellern. Am 15. März gab das vietnamesische Institut für Impfstoffe und medizinische Biologika den Beginn einer klinischen Studie mit NDV-HXP-S bekannt. Eine Woche später folgte Thailands Government Pharmaceutical Organization. Am 26. März kündigte das brasilianische Butantan-Institut die Genehmigung an, eigene klinische Studien mit NDV-HXP-S zu beginnen.

Inzwischen hat das Mount Sinai-Team den Impfstoff auch als intranasales Spray an den mexikanischen Impfstoffhersteller Avi-Mex lizenziert. Das Unternehmen wird klinische Studien starten, um festzustellen, ob der Impfstoff in dieser Form noch wirksamer ist.

Für die beteiligten Nationen war die Aussicht, die Impfstoffe vollständig selbst herzustellen, attraktiv. “Diese Impfstoffproduktion wird von Thailändern für Thailänder hergestellt”, sagte Thailands Gesundheitsminister Anutin Charnvirakul bei der Ankündigung in Bangkok.

In Brasilien hat das Butantan-Institut seine Version von NDV-HXP-S als „brasilianischen Impfstoff“ bezeichnet, der „vollständig in Brasilien hergestellt wird, ohne von Importen abhängig zu sein“.

Frau Taylor vom Duke Global Health Innovation Center war mitfühlend. “Ich konnte verstehen, warum das wirklich so eine attraktive Aussicht wäre”, sagte sie. “Sie waren den globalen Lieferketten ausgeliefert.”

Madhavi Sunder, ein Experte für geistiges Eigentum an der Georgetown Law School, warnte, dass NDV-HXP-S Ländern wie Brasilien nicht sofort helfen würde, da sie sich mit der aktuellen Welle von Covid-19-Infektionen auseinandersetzen. “Wir sprechen nicht über 16 Milliarden Dosen im Jahr 2020”, sagte sie.

Stattdessen wird die Strategie für die langfristige Impfstoffproduktion wichtig sein – nicht nur für Covid-19, sondern auch für andere Pandemien, die in Zukunft auftreten könnten. “Es klingt super vielversprechend”, sagte sie.

In der Zwischenzeit ist Dr. McLellan zum molekularen Zeichenbrett zurückgekehrt, um zu versuchen, eine dritte Version ihres Spikes herzustellen, die noch besser als HexaPro ist.

“Es gibt wirklich kein Ende für diesen Prozess”, sagte er. „Die Anzahl der Permutationen ist nahezu unendlich. Irgendwann müsste man sagen: ‘Dies ist die nächste Generation.’ “

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How White Evangelicals’ Vaccine Refusal Might Lengthen the Pandemic

How White Evangelicals’ Vaccine Refusal Could Prolong the Pandemic

These are questions that secular public health institutions are not equipped to answer, he said. “The deeper problem is that the white evangelicals are not even on their screen.”

Mr. Chang said he recently spoke to a colleague in Uganda whose hospital had received 5,000 doses of vaccine but was only able to give about 400 due to the reluctance of the strongly evangelical population.

“The way American evangelicals think, write, and feel about issues is quickly repeating around the world,” he said.

At this critical moment, even pastors have difficulty knowing how to reach their flocks. Joel Rainey, director of Covenant Church in Shepherdstown, West Virginia, said several colleagues were evicted from their churches after promoting health and vaccination guidelines.

Politics have increasingly shaped the faith among white evangelicals and not the other way around, he said. The pastors’ influence on their churches is diminishing. “They get their people for an hour and Sean Hannity gets them for the next 20,” he said.

Mr. Rainey helped his own Southern Baptist ward spread false information by publicly interviewing medical experts – a retired colonel who specializes in infectious diseases, a Church member, a logistics management analyst for Walter Reed, and an elder the Church, the nurse for the Department of Veterans Affairs.

On the worship stage in front of the worship band’s drums, he asked them “all the questions a follower of Jesus might have,” he said later.

“It is necessary that pastors instruct their people that we don’t always have to be opponents of the culture around us,” he said. “We believe that Jesus died for these people. Then why in the world should we see them as opponents?”

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AstraZeneca Covid vaccine will likely be Thailand’s ‘principal’ shot: Well being minister

AstraZeneca Covid vaccine will be Thailand's 'principal' shot: Health minister

A health worker holds a box of the AstraZeneneca vaccine at the Bamrasnaradura Institute for Infectious Diseases in Nonthaburi Province on the outskirts of Bangkok.

Chaiwat subprasome | SOPA pictures | LightRocket via Getty Images

The coronavirus shot developed by AstraZeneca and Oxford University will be Thailand’s “main vaccine” as the country seeks to revitalize its crucial tourism sector, the Thai health minister told CNBC on Monday.

Renewed safety concerns over the AstraZeneca-Oxford shot led countries such as Germany and the Netherlands to stop using the vaccine for those under the age of 60.

Before these final steps, several countries – including Thailand – suspended the use of the AstraZeneca vaccine after blood clots were reported in some people who received the shot. However, many lifted their suspension after the World Health Organization announced that a review of the available data found that the vaccine’s benefits outweigh the risks.

In Thailand, more than 150,000 people have been vaccinated with the AstraZeneca vaccine and the percentage of people who experienced side effects is considered “very low,” said Anutin Charnvirakul, the country’s deputy prime minister and health minister.

Anutin told CNBC’s Street Signs Asia that Thailand is waiting for further deliveries of the vaccine from AstraZeneca, which are expected to take place in June. In addition to the AstraZeneca vaccine, Thailand is also using one developed by China’s Sinovac Biotech, the minister said.

Almost 250,000 people have received Covid vaccines in Thailand since late February, Anutin said.

Attracting foreign visitors

Compared to many countries around the world, Thailand has reported relatively few Covid cases and deaths. Official data showed the country had confirmed more than 29,000 infections and 95 deaths as of Sunday.

However, the tourism-dependent economy was hit hard, shrinking 6.1% year over year in 2020 as countries restricted travel to avoid the spread of Covid-19, according to the Office of the National Council for Economic and Social Development to slow down.

Thailand is stepping up efforts to restart its tourism industry, including introducing vaccines in “significant” numbers in popular destinations like Phuket and Koh Samui, Anutin said.

“We want to make sure that our people are safe, that is our top priority. Once our people are safe, we believe that our guests, namely tourists or business people, would definitely come to visit our country,” he said Minister.

To attract visitors, Thailand has cut the quarantine period for foreigners entering the country from this month. The country is also striving to waive quarantine requirements for vaccinated foreign visitors to its largest holiday island, Phuket.

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Politics

U.S. Faucets Johnson & Johnson to Run Troubled Vaccine Plant

U.S. Taps Johnson & Johnson to Run Troubled Vaccine Plant

WASHINGTON – The Biden government on Saturday hired Johnson & Johnson to manage a troubled Baltimore manufacturing facility that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and prevented the facility from producing another vaccine from AstraZeneca manufacture.

The Department of Health and Human Services’ extraordinary move came just days after officials learned that Emergent BioSolutions, a contract manufacturer that makes both Johnson & Johnson and AstraZeneca’s vaccines, was mixing the ingredients in the two, which regulators did delayed the approval of the plant’s production lines.

By outsourcing the AstraZeneca vaccine, according to two senior federal health officials, the facility can be dedicated solely to Johnson & Johnson’s single-dose vaccine to avoid future breakdowns.

The Department of Health and Human Services directed Johnson & Johnson to establish a new leadership team to oversee all aspects of manufacturing and manufacturing at the Emergent Baltimore facility. The company said in a statement that it took “full responsibility” for the vaccine manufactured at the Emergent facility.

Given President Biden’s aggressive efforts to have enough doses for every adult by the end of May, federal officials fear the mix-up will undermine public confidence in Covid-19 vaccines. The AstraZeneca vaccine in particular has raised safety concerns. Germany, France and other European nations have temporarily discontinued use in some vaccine recipients after reports of rare cerebral blood clots.

The ingredient mix-up and the government move on Saturday is a major setback and PR debacle for Emergent, a Maryland-based biotech company that has built a profitable business by working with the federal government, largely selling its own Anthrax vaccines against the Strategic National Stockpile.

An Emergent spokesman declined to comment, except that the company will continue to manufacture AstraZeneca cans until it receives a contract amendment from the federal government.

Unlike Johnson & Johnson, AstraZeneca does not yet have an emergency approval from the Food and Drug Administration for its vaccine. With three federally approved vaccines (the other two are from Pfizer-BioNTech and Moderna), it’s not clear whether the AstraZeneca vaccine, which has had regulatory issues in the past, could even get approved in time to meet U.S. needs .

However, one of the federal officials said the Department of Health and Human Services is discussing working with AstraZeneca to adapt its vaccine to fight new coronavirus variants. AstraZeneca said in a statement that it would work with the Biden administration to find a new location to manufacture its vaccine.

To date, none of the Johnson & Johnson cans manufactured by Emergent have been cleared for distribution by the FDA. Officials have stated that it could take weeks to find out if other batches of vaccine were contaminated and that FDA inspectors are determining if the emergent facility can be cleared to release the doses it made.

Updated

April 3, 2021, 9:22 p.m. ET

Acting FDA commissioner, Dr. Janet Woodcock said in a statement on Saturday that the agency “takes its responsibility for ensuring the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously”.

However, she made it clear that the ultimate responsibility would rest with Johnson & Johnson, saying, “It is important to note that even if companies employ contract manufacturing companies, the ultimate responsibility lies with the company that has the emergency use authorization to do so ensure FDA quality standards are met. “

In another agreement brokered by the Biden administration last month, Johnson & Johnson is now working with Merck, one of the world’s largest vaccine manufacturers. Officials said Merck would help manage the Baltimore facility.

Emergent’s Baltimore facility is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” and was built with taxpayer support. Last June, the Emergent government paid $ 628 million to reserve space as part of Operation Warp Speed, the Trump administration’s rapid initiative to develop coronavirus vaccines.

Johnson & Johnson and AstraZeneca both signed a contract with Emergent to use the space. Both vaccines are called live virus vector vaccines, which means they use a modified, harmless version of another virus as a vector or carrier to deliver instructions to the body’s immune system. The Johnson & Johnson vaccine is given in one dose, AstraZeneca in two doses.

Experts in vaccine manufacturing said the FDA has historically had a policy of preventing such mishaps by not allowing a plant to make two live viral vector vaccines as it can lead to mix-ups and contamination.

Last month, Mr Biden canceled a visit to the Emergent Baltimore plant, and his spokeswoman announced that the administration would conduct an audit of the Strategic National Stockpile, the country’s emergency medical reserve. Both measures came after an investigation by the New York Times that looked at how the company had gained oversized influence on the repository.

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Health

NY expands Covid vaccine eligibility to all adults beginning April 6, Cuomo says

NY expands Covid vaccine eligibility to all adults starting April 6, Cuomo says

New York Governor Andrew Cuomo will receive a Covid-19 vaccine at a church in Harlem, New York on March 17, 2021.

Seth Little | AFP | Getty Images

New York will expand its Covid vaccine eligibility to all over 30s starting Tuesday, followed by all residents 16 and over on April 6, Governor Andrew Cuomo announced on Monday.

President Joe Biden is moving almost a month before May 1, which is when states can largely open their supplies to all residents.

“Today we are taking a monumental step forward in the fight against COVID,” Cuomo said in a statement. “As we continue to upgrade eligibility, New York will make the vaccine available to every community to ensure justice, especially for color communities too often left behind.”

Nearly 30% of all New Yorkers have been reported to have received at least one vaccine. The state has fired 9,056,970 shots so far.

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Health

Covid-19 Vaccine Facet Results: Your Questions Answered

Covid-19 Vaccine Side Effects: Your Questions Answered

Almost three million people in the United States receive the Covid-19 vaccine every day. And each new burst raises new questions about what to expect after vaccination.

Last week I asked readers to send me their questions about vaccinations. Here are some of the answers.

Short-lived side effects such as fatigue, headache, muscle pain, and fever are more common after the second dose of the Pfizer BioNTech and Moderna vaccines, which each require two shots. (The Johnson & Johnson vaccine only requires a single shot.) Patients who experience uncomfortable side effects after the second dose often describe feeling like they have a bad flu and use phrases like “it blew me out” or ” I was useless for two days. “During vaccine studies, patients were advised to take a few days off after the second dose, just in case they had to spend a day or two in bed.

The data collected by v-safe, the app that anyone can use to track side effects after vaccination, also shows an increase in reported side effects after the second dose. For example, about 29 percent of people reported fatigue after the first Pfizer BioNTech shot, but that increased to 50 percent after the second dose. The muscle pain increased from 17 percent after the first shot to 42 percent after the second. While only about 7 percent of people had chills and a fever after the first dose, that number rose to about 26 percent after the second dose.

The New York Times interviewed several dozen of the people who were newly vaccinated in the following days. They reported a wide range of reactions, from no reaction to symptoms such as uncontrolled tremors and “brain fog”. While these experiences are not pleasant, they are a sign that your own immune system is having a strong response to the vaccine.

An analysis of the first 13.7 million Covid-19 vaccine doses given to Americans found that side effects were more common in women. While severe reactions to the Covid vaccine are rare, almost all cases of anaphylaxis or life-threatening allergic reactions have occurred in women.

The finding that women are more likely to report and experience unpleasant side effects from the Covid vaccine is consistent with other vaccines as well. Women and girls after flu vaccinations and vaccines against measles, mumps and rubella (MMR) and hepatitis A and B can produce up to twice as many antibodies. One study found that in nearly three decades, women accounted for 80 percent of all anaphylactic diseases in adults.

Although women report side effects more often than men, the higher rate of side effects in women also has a biological explanation. Estrogen can stimulate an immune response, while testosterone can weaken it. In addition, there are many immune-related genes on the X chromosome, of which women have two copies and men only one. These differences may explain why far more women than men suffer from autoimmune diseases, which occur when a robust immune response attacks healthy tissues in the body. You can read more about women and vaccine side effects here.

Side effects get all the attention, but when you look at data from vaccine clinical trials and the real world, you will find that many people don’t experience side effects beyond an aching arm. In the Pfizer vaccine studies, about one in four patients reported no side effects. In the Moderna studies, 57 percent of patients (64 or younger) reported side effects after the first dose – these jumped to 82 percent after the second dose, meaning that almost one in five patients reported no reaction after the second shot.

A lack of side effects doesn’t mean the vaccine isn’t working, said Dr. Paul Offit, professor at the University of Pennsylvania and a member of the Food and Drug Administration’s Vaccine Advisory Board. Dr. Offit found that a significant number of people reported no side effects during the vaccine trials, and yet the studies showed that around 95 percent of people were protected. “That proves you don’t have to have side effects to be protected,” he said.

Nobody really knows why some people have a lot of side effects and others don’t. We know that younger people develop a stronger immune response to vaccines than older people, whose immune systems become weaker as they get older. Women usually have stronger immune responses than men. But even these differences don’t mean you aren’t protected if you don’t feel a lot after the shot.

Scientists still aren’t sure how effective the vaccines are in people whose immune systems may be weakened by certain conditions, such as cancer treatments, HIV infection, or because they are taking immunosuppressive drugs. However, most experts believe that the vaccines still offer these patients some protection against Covid-19.

Updated

April 1, 2021, 11:02 p.m. ET

The bottom line is that although individual immune responses can vary, the data collected so far shows that all three US-approved vaccines – Pfizer-BioNTech, Moderna, and Johnson & Johnson – are effective against serious illness and death from Covid-19 .

You shouldn’t try to prevent discomfort by taking a pain reliever before receiving the shot. The concern is that premedication with a pain reliever like acetaminophen (Tylenol) or ibuprofen (Advil, Motrin), which can prevent side effects like arm pain, as well as fever or headache, could also weaken your body’s immune response.

While it’s possible that taking a pain reliever before your shots may have dampened your body’s immune response, vaccine experts say you shouldn’t worry and shouldn’t try to get another shot. Studies of other vaccines suggest that while premedication can reduce the body’s immune response to a vaccine, your immune system can build strong enough defenses to fight infection. A review of studies involving more than 5,000 children compared antibody levels in children who took pain relievers before and after vaccinations and in children who did not. They found that pain medication had no significant effect on the immune response and that children in both groups produced adequate levels of antibodies after their shots.

The high effectiveness of all Covid vaccines suggests that even if taking Tylenol before the shot weakens your body’s immune response, there is some margin and you are likely still well protected against Covid-19. “You should feel reassured that you have enough immune response to be protected, especially with vaccines that are this good,” said Dr. Offit.

“It’s okay to treat side effects with pain relievers,” said Dr. Offit, but if you don’t really need one, “don’t take it”.

While most experts believe it is safe to take a pain reliever to relieve post-vaccination discomfort, they do not recommend taking it preventively after the shot or if your symptoms are manageable without the drug. The concern about taking an unnecessary pain reliever is that it may weaken some of the effects of the vaccine. (In terms of vaccine, there is no significant difference if you choose acetaminophen or ibuprofen.)

During the Moderna study, about 26 percent of people took acetaminophen to reduce side effects, and the vaccine’s overall effectiveness was still 94 percent.

Research and individual reports suggest that people with a previously diagnosed Covid-19 infection may react more strongly and experience more side effects after their first dose of vaccine than people who have never been infected with the virus. A strong reaction to your first dose of vaccine could also be a sign that you were previously infected, even if you weren’t aware of it.

If you’ve previously tested positive for Covid-19 or had a positive antibody blood test, be prepared for a stronger reaction to your first dose and plan a few days off just in case. Not only will it be more convenient to stay at home and rest in bed, the vaccine side effects may be similar to symptoms of Covid-19, and your staff won’t want to be around you anyway.

Studies suggest that a dose might be appropriate for people with a previously confirmed case of Covid-19, but medical guidelines have not changed so far. If you received the Pfizer-BioNTech or Moderna vaccines, you should plan to receive your second dose, even if you have had Covid-19. Skipping your second dose can cause problems if your employer or airline requests proof of vaccination in the future. If you live in an area where Johnson & Johnson’s single-dose vaccine is available, you can be fully vaccinated after just one dose. Read more about the vaccine response in people with Covid-19 here.

The vaccines appear to be effective against a new variant that originated in the UK and is rapidly dominating the US. However, some variants of the coronavirus, especially one first identified in South Africa and one in Brazil, appear to be better able to evade antibodies in vaccinated individuals.

That sounds worrying, but there is reason to be hopeful. Vaccinated individuals exposed to a more resistant variant still appear to be protected from serious diseases. And scientists have a sufficiently clear understanding of the variants that they are already working on to develop booster shots that target the variants. The variants identified in South Africa and Brazil are not yet widespread in the United States.

People who are vaccinated should continue to wear masks in public and follow public health guidelines, but they shouldn’t live in fear of variations, said Dr. Peter J. Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. “If you are vaccinated you should feel pretty sure how protected you are,” said Dr. Hotez. “It is unlikely that you will ever go to a hospital or intensive care unit with Covid-19. In time, you will see a recommendation for a booster. “

I hope these answers will reassure you about your own vaccine experience. For a more complete list of questions and answers, see our dedicated vaccine tool, “Answers to All Your Covid-19 Vaccination Questions”.

Categories
Health

U.S. begins testing Moderna’s Covid vaccine booster photographs for variant from South Africa

U.S. begins testing Moderna's Covid vaccine booster shots for variant from South Africa

A nurse draws a vaccine for Moderna Coronavirus Disease (COVID-19) on March 5, 2021 at the East Valley Community Health Center in La Puente, California.

Lucy Nicholson | Reuters

The National Institutes of Health have started testing a new coronavirus vaccine from Moderna, which is designed to protect against a problematic variant first found in South Africa, the agency said on Wednesday.

According to the agency, the phase 1 study, which is led and funded by the National Institute for Allergies and Infectious Diseases of the NIH, will test how safe and effective the new shot is against the variant known as B.1.351 in around 210 healthy adults .

The study, which has already had some of the first vaccinations, will include approximately 60 adults who participated in Moderna’s original Covid-19 vaccine studies last year, as well as approximately 150 people who have not yet received a Covid-19 vaccine at one Statement.

Returning participants, who were given two syringes of the original vaccine 28 days apart at different doses early last year, will split up.

Some of them get a single booster shot with the new vaccine at a higher dose while others get the new vaccine at a lower dose, the statement said. Remaining participants will be offered a booster shot with the original vaccine “as part of a separate clinical trial protocol”.

Researchers will take blood samples from participants throughout the study, which can be tested against other circulating strains of the virus to see if the vaccine elicits an immune response.

The study will recruit volunteers in the Atlanta, Cincinnati, Seattle and Nashville, Tennessee areas and should be fully enrolled by the end of April, the agency said.

Variant B.1.351, first discovered in South Africa at the end of last year, has given scientists more cause for concern compared to other variants. The variant appears to spread more easily than the original “wild-type” strains, and research shows that it may evade some of the safeguards created by therapeutics and vaccines.

So far, 312 Covid-19 cases with variant B.1.351 have been identified in the United States, according to the latest data from the Centers for Disease Control and Prevention.

“Preliminary data shows that the COVID-19 vaccines currently available in the US should provide adequate protection against SARS-CoV-2 variants,” said NIAID Director and Chief Medical Officer of the White House, Dr. Anthony Fauci, in a statement.

“However, out of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should an updated vaccine be required,” said Fauci.

The US Food and Drug Administration has already announced that it will accelerate the approval process for the updated vaccines, which target the problematic variants, so that no lengthy clinical trials are required.

However, an independent safety monitoring committee will continue to monitor the trials to ensure the shots are safe, the NIH statement said.