Archiv: Pfizer Inc / BionTech (corporations)


20.01.2021 - 12:15 [ BioProcessintl.com ]

AstraZeneca: ‘Manufacturing should take lion’s share of credit for vaccine success’

Back in March, Oxford University had “a limited manufacturing and supply capacity so they needed a partner,” Srinivasan said. “We decided to immediately offer our capacity in terms of the global reach. But that was only the beginning. Then we had to establish various alliances whether public partnerships that have been governments, or with for profit organizations or CMOs [some of which can be found here, here, and here], or not for profit organizations such as The Gates Alliance, GAVI, CEPI, and other organizations.”

20.01.2021 - 11:41 [ MDR ]

Biontech/Pfizer halbiert Corona-Impfstoffmenge für Thüringen

(19.01.2021)

Wie Gesundheitsministerin Heike Werner (Linke) am Dienstag mitteilte, wird der Hersteller Biontech/Pfizer in der nächsten Woche nur die Hälfte der ursprünglich geplanten Impfstoffmenge in den Freistaat liefern. Konkret sind das 11.700 Dosen.

20.01.2021 - 11:31 [ RBB24.de ]

Brandenburg bekommt nächste Woche 25 Prozent weniger Impfstoff

Gesundheitsministerin Ursula Nonnemacher (Grüne) erklärte, dass die Lieferreduzierung ein „schwerer Schock“ sei. „Bis Montagabend mussten wir unsere gesamte Planung anhalten“, sagte Nonnemacher am Dienstag.

Die jetzt vorliegenden Informationen zum weiteren Lieferzeitplan und Lieferumfang des Biontech/Pfizer-Impfstoffs seien nicht zufriedenstellend, sagte Nonnemacher weiter.

20.01.2021 - 11:17 [ ORF.at ]

Pfizer reduziert Lieferung an Italien

Kommende Woche wird es zu einer weiteren Reduktion der Lieferung von Impfdosen durch Pfizer und Biontech kommen, kündigte der zuständige Regierungskommissar Domenico Arcuri laut Medien an. Der Pharmakonzern hatte bereits diese Woche seine Lieferungen an Italien um 29 Prozent verringert.

20.01.2021 - 11:10 [ DailyMail.co.uk ]

Slow vaccine rollout could make lockdown last PAST Easter as Priti Patel blames AstraZeneca and Pfizer for causing ’supply issues‘ by ‚upgrading their factories‘ – even though ’21m doses are already in UK‘ and Scotland is ’sitting on 400k‘

Priti Patel today blamed AstraZeneca and Pfizer for an alarming slowdown in the UK’s vaccine rollout – amid warnings the target of giving jabs to the 14million most vulnerable people by mid-February is now ‚very tight‘.

The Home Secretary pointed the finger at the firms after the daily rate fell for a third consecutive day, saying ‚upgrades‘ at factories and ‚reconfiguring‘ of supply chains were causing delays.

16.01.2021 - 18:44 [ The Norwegian Medicines Agency - legemiddelverket.no ]

Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail

(15.01.2021)

The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.

The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness – and included few participants over 85 years of age.

16.01.2021 - 18:33 [ Alex Berenson / Twitter ]

BIG news: Citing post-vaccination deaths, Norway now says “very frail” people should NOT receive the #Covid vaccine. Norway reports 23 post-vaccine deaths (out of only 25,000 shots). After examining 13, it says “side effects from the mRNA vaccines… may have led to deaths.”

(15.01.2021)

15.01.2021 - 17:20 [ Tagesschau.de ]

Corona-Impfstoff Pfizer kürzt Lieferungen für Europa

Hintergrund ist, dass Pfizer seine Anlagen ausbauen will, um die Impfstoffproduktion zu erhöhen – von derzeit 1,3 Milliarden auf zwei Milliarden Dosen jährlich. Dies werde vorübergehende Auswirkungen auf die Lieferungen Ende Januar bis Anfang Februar haben, so der US-Konzern. Im Werk im belgischen Puurs könne es bei Aufträgen und Lieferungen zu Schwankungen kommen.

14.01.2021 - 10:32 [ Heise.de ]

Neuartige mRNA-Impfstoffe gegen Corona?

Telepolis hat den beiden deutschen mRNA-Impfstoffentwicklern BioNTech in Mainz und CureVac in Tübingen die folgende Frage gestellt: Welche Wirkung ist bei der Impfstoffentwicklung beabsichtigt und wird in der Folge in den Studien überprüft?

Thorsten Schüller, Vice President Communications bei CureVac lässt sich dazu mit den folgenden Worten zitieren:

Das Ziel der Studien ist es, eine schwerwiegende Erkrankung an COVID-19 zu verhindern. Die sterile Immunität und/oder die Transmission müssen in Studien noch getestet werden, dazu ist ein spezielles Studiendesign notwendig.

14.01.2021 - 09:30 [ Public Health England / Twitter ]

Even if you’ve had your #COVID19 vaccine, it’s important that you continue to follow national restrictions. We don’t yet know if the vaccine prevents transmission – you could potentially still carry and transmit the virus to other vulnerable people, even if you are protected

13.01.2021 - 18:30 [ Nature.com ]

UK science advisers: publish evidence behind COVID vaccine changes

Pfizer–BioNTech say they do not have evidence of what happens to immunity beyond 21 days after the first dose.

(…)

The JCVI adds that: “Protective immunity from the first dose likely lasts for a duration of 12 weeks.” But it has not published evidence to support this.

13.01.2021 - 18:18 [ New York Times ]

Doctor’s Death After Covid Vaccine Is Being Investigated

Shortly after receiving the vaccine, Dr. Michael developed an extremely serious form of a condition known as acute immune thrombocytopenia, which prevented his blood from clotting properly.

In a statement, Pfizer, the maker of the vaccine, said it was “actively investigating” the case, “but we don’t believe at this time that there is any direct connection to the vaccine.”

13.01.2021 - 18:12 [ voanews.com ]

US Changes Vaccine Strategy, WHO Says Herd Immunity Will Not Be Achieved in 2021

Meanwhile, the World Health Organization is warning that mass vaccinations against the novel coronavirus will not produce herd immunity this year.

WHO chief scientist Dr. Soumya Swaminathan told reporters Monday that it takes time to produce and administer enough doses of a vaccine to finally stop the spread of COVID-19. Swaminathan stressed the need for countries to continue observing mitigation efforts such as mask-wearing, social distancing and hand-washing.

08.01.2021 - 18:09 [ Tagesschau.de ]

BioNTech/Pfizer: EU verdoppelt Impfstoff-Bestellung

Er rechne damit, dass die bisher vereinbarten 60 Millionen Impfdosen aus dem deutschen Anteil an EU-Verträgen sowie 30 Millionen aus einer bilateralen Zusatzvereinbarung noch in diesem Jahr ausgeliefert würden, sagt ein Sprecher des Gesundheitsministeriums.

Das Bundesgesundheitsministerium hatte im Dezember mitgeteilt, dass Berlin neben den Bestellungen über die EU national nochmals 30 Millionen Dosen bei Biontech und seinem US-Partner Pfizer geordert habe. Von der Leyen kritisierte das Vorgehen.

05.01.2021 - 18:17 [ Achse des Guten ]

Die wundersame Impf-Chronologie

Spätestens mit RKI-Veröffentlichungen vom 15. April 2020 kann jeder wissen, dass das Infektionsgeschehen in Deutschland seit Mitte März rückläufig und der R-Wert schon lange unter 1 gefallen war, bevor irgendeine Staatsmaßnahme zur Eindämmung hätte entsprechend wirken können.

Erinnern wir uns an die beiden Hauptgründe sowohl für die Herbeiführung des Ausnahmezustandes als auch die Idee, Herdenimmunität durch Massenimpfung zu erzeugen. Erstens: Asymptomatisch Kontaminierte tragen wesentlich zu einem Infektions-, gar Erkrankungsgeschehen bei. Deshalb müssen auch Gesunde zueinander auf Abstand gehen. Zweitens: „SARS-CoV-2 ist so neu, dass praktisch niemand immun dagegen ist.“ (tagesschau.de, 19.3.)

Urheber beider Ideen ist Drosten.

03.01.2021 - 08:21 [ Sky.News ]

COVID-19: Chief medical officer Chris Whitty warns coronavirus vaccine shortages will last months

(01.01.2021)

„At the moment it doesn’t look good – a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,“ BioNTech CEO Ugur Sahin told news weekly Spiegel.

03.01.2021 - 08:08 [ Times of India ]

Global partnership COVAX secures two billion COVID-19 vaccine doses

(19.12.2020)

UNITED NATIONS: Global vaccine partnership COVAX has lined up almost two billion doses of existing and candidate COVID-19 vaccines for use worldwide, including 200 million doses of the AstraZeneca/Oxford vaccine through an agreement between the Vaccine Alliance Gavi, the Serum Institute of India and the Bill and Melinda Gates Foundation.

02.01.2021 - 19:20 [ theSun.co.uk ]

First Oxford Covid vaccine doses arrive at UK hospitals with 530,000 jabs to be rolled out from Monday

While the Oxford vaccine uses a harmless, weakened version of a common virus in chimpanzees, the Pfizer jab is known as a messenger vaccine (MRNA), using a genetic code rather than a weakened form of the virus.

And experts have urged patients not to mix and match the two.

02.01.2021 - 08:17 [ Sky.News ]

COVID-19: Chief medical officer Chris Whitty warns coronavirus vaccine shortages will last months

„At the moment it doesn’t look good – a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,“ BioNTech CEO Ugur Sahin told news weekly Spiegel.

01.01.2021 - 08:45 [ ORF.at ]

Biontech-Chef: Ende Jänner Klarheit über weitere Produktion

Zu der Frage, ob Biontech andere Hersteller zur Produktion des neuen Impfstoffes lizenzieren könne, betonte Sahin die Komplexität bei der Herstellung von mRNA-Impfstoffen. „Da kann man nicht einfach umschalten, so dass statt Aspirin oder Hustensaft plötzlich Impfstoff hergestellt wird. Der Prozess braucht jahrelange Expertise und eine entsprechende bauliche und technologische Ausstattung.“

31.12.2020 - 07:14 [ ORF.at ]

Kein Zusammenhang von Tod und CoV-Impfung in Schweiz

Laut Swissmedic ist im Kanton Luzern eine 91-jährige Person, die an mehreren schweren Vorerkrankungen litt, einige Tage nach einer Covid-19-Impfung in einem Alters- und Pflegeheim verstorben.

„Weder die Krankengeschichte noch der akute Krankheitsverlauf legen einen direkten kausalen Zusammenhang zwischen der Covid-19-Impfung und dem Tod nahe“, informierte Swissmedic.

30.12.2020 - 16:07 [ ORF.at ]

Todesfall in der Schweiz nach Impfung bestätigt

Bisher ist in dem Land einzig die Schutzimpfung von Pfizer und BioNTech zugelassen. Anlässlich der Zulassung hatte Swissmedic am 19. Dezember geschrieben, dass die häufigsten in den Zulassungsstudien dokumentierten Nebenwirkungen vergleichbar mit jenen nach einer Grippeimpfung seien.

30.12.2020 - 03:58 [ mark cording / Twitter ]

What’s the update on the Oxford vaccine Mr Hancock

30.12.2020 - 03:50 [ Matt Hancock, secretary of State for Health & Social Care / Twitter ]

Fantastic to see Margaret Keenan receive her second dose of the @Pfizer /@BioNTech_Group #coronavirus vaccine

27.12.2020 - 19:51 [ Forbes ]

What Every Vaccine Skeptic Should Know About The New Coronavirus Vaccines

What hasn’t been demonstrated, at least so far, is that these vaccines prevent you from getting infected entirely. We’ve shown that these vaccines provide neutralizing immunity, where the virus will no longer severely harm you, but not necessarily sterilizing immunity, where you cannot pass the virus onto others. Additionally, it isn’t known how long your immunity will persist. This, very importantly, means that you still need to wear a mask, wash/sanitize your hands, and practice social distancing — and to be rigorous about doing them all — for now.

27.12.2020 - 12:04 [ Finanzen.at ]

Österreich im 3. Lockdown – Kurz: Normalität wieder im Sommer 2021

Er rechnet Anfang 2021 in ganz Europa mit einer dritten Infektionswelle. Dank der Impfungen und Tests sei danach Entspannung zu erwarten, sagte er.

27.12.2020 - 12:01 [ Stuttgarter Zeitung / Twitter ]

Coronavirus in Deutschland: Impfangebot an alle laut Spahn wohl im Sommer

27.12.2020 - 05:05 [ Telegraph.co.uk ]

Millions to receive Oxford coronavirus vaccine from Jan 4

The Government is aiming for two million people to receive their first dose of either the Oxford vaccine or the Pfizer jab within a fortnight as part of a major ramping up of the inoculation programme.

27.12.2020 - 04:30 [ ChildrensHealthDefense.org ]

5 Questions Fauci and FDA Need to Answer on Pfizer and Moderna COVID Vaccines

1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?

(…)

2. Why does the FDA seem surprised by the recent reports of life-threatening anaphylactic reactions after the agency approved emergency use of two mRNA COVID-19 vaccines that contain polyethylene glycol?

(…)

3. Why did FDA officials not acknowledge the valid and scientifically supported concerns regarding the use of PEG in COVID-19 vaccines when CHD first notified them in September?

(…)

4. Why did the FDA abandon its regulatory authority to the pharmaceutical companies developing COVID-19 vaccines?

(…)

5. Will FDA and NIAID now require mRNA vaccine manufacturers to conduct assessments of the immunogenicity of the pegylated lipid nanoparticles used in their COVID-19 vaccines, and will they also consider pre-screening of all mRNA vaccine recipients for the presence and titers of anti-PEG antibodies?

27.12.2020 - 04:14 [ ZDF ]

Vor offiziellem Impfstart – 101-Jährige als Erste in Deutschland geimpft

Der offizielle Impfstart ist in Deutschland für Sonntag geplant. Am Samstag wurden einige Zehntausend Impfdosen ausgeliefert. Sie werden von den zuständigen Landesbehörden an Impfzentren und mobile Teams verteilt.

21.12.2020 - 22:35 [ New York Times ]

How the Oxford-AstraZeneca Vaccine Works

The Oxford-AstraZeneca team used a modified version of a chimpanzee adenovirus, known as ChAdOx1. It can enter cells, but it can’t replicate inside them. (…)

The Oxford-AstraZeneca vaccine for Covid-19 is more rugged than the mRNA vaccines from Pfizer and Moderna. DNA is not as fragile as RNA, and the adenovirus’s tough protein coat helps protect the genetic material inside. As a result, the Oxford vaccine doesn’t have to stay frozen.

21.12.2020 - 20:10 [ Tagesschau.de ]

Genehmigung der Kommission: Corona-Impfstoff in der EU zugelassen

Die EU-Kommission erteilte dem Präparat des Mainzer Unternehmens Biontech und seines US-Partners Pfizer die bedingte Marktzulassung, wie EU-Kommissionspräsidentin Ursula von der Leyen sagte. „Heute fügen wir dem Kampf gegen Covid-19 ein wichtiges Kapitel hinzu.“

20.12.2020 - 10:00 [ theHill.com ]

FDA investigating allergic reactions to Pfizer vaccine reported in multiple states

“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said.

19.12.2020 - 09:46 [ CNN ]

Third Alaskan health care worker has allergic reaction to Covid-19 vaccine

For the third time in three days, an Alaska health care worker had an allergic reaction after receiving a dose of the new Pfizer Covid-19 vaccine.

18.12.2020 - 20:50 [ Newsweek.com ]

Nurse Fainting After COVID Vaccine Not Due to Shot Ingredients, Doctor Says

The nurse told reporters she has a condition that often causes her to faint when she experiences pain. As a result, Dover said she was not surprised that she had fainted after receiving the vaccine.

18.12.2020 - 20:43 [ Geisteslicht / Twitter ]

Krankenschwester erhält BioNtech mRNA-Impfstoff im Beisein von Medienvertretern und bricht kurz darauf zusammen. Vor laufenden Kameras.

Ergänzung: zwischen Impfung und Schwächeanfall vergingen 17 Min. Was die genaue Ursache des Schwächeanfalls war, klären Ärzte.

18.12.2020 - 20:41 [ Washington Times ]

Nurse faints at press conference after getting COVID-19 vaccine

(17.12.2020)

About 17 minutes after receiving the Pfizer-made vaccine against COVID-19, she started feeling dizzy, apologized and fell over before she was caught by doctors standing behind her.

“It just hit me all of a sudden, I could feel it coming on. I felt a little disoriented, but I feel fine now, and the pain in my arm is gone,” Ms. Dover said.

17.12.2020 - 09:19 [ USA Today ]

FDA says Pfizer’s COVID-19 vaccine vials may hold extra ‚obtainable‘ doses, adding to US supply

Pharmacists must throw away any extra amount of the vaccine if it does not consist of the 0.3 mL needed for a full dose, Pfizer said. The remaining amount „must never“ be combined with the vaccine from another vial.

The Pfizer vaccine, green-lighted by the FDA on Dec. 11, was developed in less than a year, a fraction of the time it would usually take as researchers worldwide frantically sought an antidote to a virus discovered in China in December 2019.

17.12.2020 - 08:55 [ New York Times ]

2 Alaska Health Workers Got Emergency Treatment After Receiving Pfizer’s Vaccine

One of the workers, who did not have a history of allergies, remained in the hospital on Wednesday night. Some reactions to the vaccine were also reported last week in Britain.

17.12.2020 - 08:51 [ ORF ]

„NYT“: Allergische Reaktion auf Impfstoff in Alaska

Die Person sei gestern noch zur Beobachtung im Krankenhaus gelegen, ihr Gesundheitszustand sei stabil, teilte ein Sprecher des Gesundheitsamts DHSS in Alaska mit. Es handle sich vermutlich um einen ähnlichen Fall wie in Großbritannien. Dort erlitten ebenfalls zwei Personen eine allergische Reaktion nach der Impfung.

15.12.2020 - 22:27 [ ORF ]

Fauci rät Biden zu rascher Impfung

Mit Blick auf den 78-jährigen Biden sagte Fauci dem US-Sender ABC News: „Er soll möglichst vollständig geschützt sein, wenn er im Jänner die Präsidentschaft antritt. Das wäre also meine starke Empfehlung.“

15.12.2020 - 22:20 [ ZDF ]

Ema zieht Entscheidung zu Impfstoff vor

Die EU-Medikamentenbehörde Ema prüft die Zulassung der Impfstoffe von Biontech und Pfizer gegen Corona am 21. Dezember, also noch vor Weihnachten. Es lägen alle nötigen Daten vor.

15.12.2020 - 10:15 [ ORF.at ]

D: Regierung drängt auf schnelle Impfstoffzulassung

Das deutsche Bundeskanzleramt und das Gesundheitsministerium verlangten intern von der EMA, das Vakzin bis 23. Dezember zur Verimpfung auf EU-Ebene und damit auch in Deutschland freizugeben, meldete die „Bild“ (Dienstag-Ausgabe) unter Berufung auf Regierungs- und EU-Kreise.

15.12.2020 - 10:12 [ BMJ ]

Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data

(26.11.2020)

Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown.

15.12.2020 - 09:38 [ Bloomberg ]

How a Covid-19 Vaccine Could End Up Helping the Virus Spread

(11.11.2020)

A vaccine that protects against symptoms of Covid-19 could contribute to the spread of the disease if — and this is still just an if — the people who get vaccinated remain capable of carrying and transmitting the virus. That’s a risk that’s gotten little attention amid the deserved jubilation over a Nov. 9 report from Pfizer Inc. and BioNTech SE that their vaccine candidate appears to be highly effective.

12.12.2020 - 19:43 [ New York Times ]

Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner

AstraZeneca was in part to blame for the delay, said the people with knowledge of the F.D.A. talks. The company was slow to provide the F.D.A. with all the data that regulators wanted to review before allowing the trial to start up again.

In late October, after 47 days, the F.D.A. cleared the U.S. trial to restart.

It was now even further behind the late-stage trials that Pfizer and Moderna had begun in the United States about a month before AstraZeneca’s trial started.

12.12.2020 - 19:40 [ New York Times ]

Covid-19: F.D.A. Clears Pfizer Vaccine and Millions of Doses Will Be Shipped Right Away

The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.

11.12.2020 - 14:15 [ Times of Israel ]

Israel said considering restrictions on those who refuse COVID vaccine

Under the proposal being considered, those who refuse to be inoculated will only be allowed to fly, attend certain events, dine at restaurants or frequent cultural venues by providing a recent negative result from a coronavirus test, according to Channel 12 news, which quoted unnamed senior officials.

Health officials were also reportedly considering barring medical personnel who refuse vaccination from working in coronavirus wards or intensive care units.

09.12.2020 - 20:31 [ Standard.co.uk ]

How does Oxford University’s coronavirus vaccine work and how is it different to Pfizer and Moderna’s?

Does it differ to PFizer and Moderna’s vaccines?

Yes. The jabs from Pfizer and Moderna are messenger RNA (mRNA) vaccines.

Conventional vaccines are produced using weakened forms of the virus, but mRNAs use only the virus’s genetic code.

09.12.2020 - 19:34 [ AzoNano.com ]

How Nanotechnology Helped Create mRNA COVID-19 Vaccines

(04.12.2020)

Vaccines that employ mRNA were in early development before COVID-19 brought the world to its knees, and nanotech has been central to these efforts — unsurprisingly, as viruses are just naturally occurring nanoparticles themselves.

The key to making effective nanoparticle vaccines, and medicines in general, lies in mimicking the natural behaviors and tricks that make viruses so successful, and dangerous, in the first place.

09.12.2020 - 19:32 [ davispetroleumcorp.com ]

Fact check: Lipid nanoparticles in a COVID-19 vaccine are there to transport RNA molecules

False. The lipid nanoparticles in the Pfizer-BioNTech COVID-19 vaccine protect and transport the vaccine component. They do not contain little computers or robots.

This article was produced by the Reuters Fact Check team. Read more about our work to fact-check social media posts here .

09.12.2020 - 19:30 [ factcheck.afp.com ]

Video shares false claim that Pfizer-BioNTech Covid-19 vaccine contains ’nanotechnology‘

A video viewed thousands of times in multiple posts on Facebook claims Pfizer-BioNTech’s Covid-19 mRNA vaccine contains lipid nanoparticles that could be concealing „little computers”. The claims are false; nanoparticles are microscopic particles that measure less than 100 nanometres, which have no relation to nanocomputers; an infectious diseases expert told AFP no technology currently exists by which computers could be inserted into an mRNA vaccine.

09.12.2020 - 19:06 [ Washington Post ]

I was part of a trial for Pfizer’s covid-19 vaccine. It’s a miracle for genetic medicine.

(09.11.2020)

The success of the Pfizer vaccine means that the plague year of 2020 will be remembered as the time when traditional vaccines began to be supplanted by genetic vaccines. Instead of delivering tiny and safe doses of the virus itself, these new vaccines deliver a piece of genetic coding that will instruct human cells to produce, on their own, components of a targeted virus. These safe components can then stimulate the patient’s immune system.

09.12.2020 - 18:55 [ Karl Lauterbach / Twitter ]

Guter Erklär-Artikel wie Covid Impfstoffe wirken und weshalb mRNA Impfstoffe nicht in Menschen Gene eingebaut werden. Impfgegner vergleichen mRNA oft mit Gentechnik. Damit hat mRNA nichts zu tun. Impf-mRNA baut Spike Proteine und wird abgebaut, das wars

(30.11.2020)

09.12.2020 - 18:30 [ Tagesschau.de ]

Biontech-Pfizer-Impfstoff: Britische Behörde warnt Allergiker

Laut dem von Pfizer veröffentlichten Studienprotokoll wurden in der zulassungsrelevanten Untersuchung aber keine Teilnehmer aufgenommen, die eine Vorgeschichte schwerer Nebenwirkungen im Zusammenhang mit einem Impfstoff und/oder schwerer allergischer Reaktionen auf einen Inhaltsstoff der Studie haben.

Das MHRA hatte als weltweit erste Regulierungsbehörde dem Impfstoff vor einer Woche eine Notfallgenehmigung erteilt. Sie will die Fälle nun untersuchen.

09.12.2020 - 18:18 [ Standard.co.uk ]

Warning after two NHS workers have allergic reaction to Pfizer/BioNTech Covid vaccine

They developed symptoms of “anaphylactoid reaction” shortly after receiving the vaccine, but both recovered after the appropriate treatment.

After the incident, the Medicines and Healthcare products Regulatory Agency (MHRA) told NHS trusts that anyone who has a history of “significant” allergic reactions – including to medicines, food or vaccines – should not currently receive the vaccine.

06.12.2020 - 15:48 [ Kulvinder Kaur MD, Physician / Twitter ]

There’s NO evidence that Covid candidate vaccines prevent infection, prevent/reduce transmission, reduce hosps or reduce mortality. Nor are clinical trials designed to determine these endpoints. Longterm efficacy/safety also unknowns All we know—may reduce “common cold symptoms”

06.12.2020 - 15:45 [ BMJ ]

Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data

(26.11.2020)

Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown. Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season). Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations.

I previously argued that the trials are studying the wrong endpoint, and for an urgent need to correct course and study more important endpoints like prevention of severe disease and transmission in high risk people. Yet, despite the existence of regulatory mechanisms for ensuring vaccine access while keeping the authorization bar high (which would allow placebo-controlled trials to continue long enough to answer the important question), it’s hard to avoid the impression that sponsors are claiming victory and wrapping up their trials (Pfizer has already sent trial participants a letter discussing “crossing over” from placebo to vaccine), and the FDA will now be under enormous pressure to rapidly authorize the vaccines.

04.12.2020 - 21:50 [ CNN ]

Vaccination cards will be issued to everyone getting Covid-19 vaccine, health officials say

(02.12.2020)

„Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due,“ Moore said. „Let’s do the simple, easy thing first. Everyone’s going to get that.“

04.12.2020 - 21:47 [ Zero Hedge ]

‚Immunity Cards‘ To Be Issued To All Americans; Enable CDC To Track COVID-19 Vaxx Status In Database

On Wednesday the Department of Defense released the first images of a COVID-19 vaccination record card as well as vaccination kits, according to CNN.

„Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due,“ says Dr. Kelly Moore, associate director of the Immunization Action Coalition.

04.12.2020 - 21:24 [ DailyMail.co.uk ]

No10 stops short of ruling out Covid ‚immunity passports‘ despite saying it is ’not something the PM wants‘ – as Wales raises fears of spot checks at pubs and shops by bringing in ID-style cards for people who get vaccine

– Pfizer vaccines licensed by UK regulator and will be distributed from next week
– Wales says people will be issued with ID-style cards to show they have had jab
– Fears that pubs and shops could demand proof of vaccine before allowing entry

04.12.2020 - 20:50 [ InfectiousDiseaseAdvisor.com ]

Challenges in Assessing the Efficacy of COVID-19 Vaccines

Determining whether a vaccine can protect against severe disease and death from COVID-19 may not be possible in phase 3 clinical trials and will often require long-term, ongoing studies after widespread deployment of a vaccine.

To ensure ongoing evaluation of vaccine safety, well-supported pharmacovigilance studies after licensure will be necessary.

04.12.2020 - 20:47 [ theHill.com ]

Pfizer chairman: We’re not sure if someone can transmit virus after vaccination

Pfizer chairman Albert Bourla told Dateline host Lester Holt that the pharmaceutical company was “not certain” if the vaccine prevented the coronavirus from being transmitted, saying, “This is something that needs to be examined.”

04.12.2020 - 20:15 [ ORF.at ]

WHO: Impfungen allein reichen nicht

„Die Impfungen alleine werden den Job nicht machen“, sagte WHO-Experte Mike Ryan heute in Genf. Sie seien zweifelsfrei ein mächtiges und wirkungsvolles Werkzeug. Aber viele bisherige Hygieneregeln wie soziale Distanz, das Tragen von Masken und häufiges Händewaschen müssten zunächst weiterhin beachtet werden.

04.12.2020 - 16:00 [ Radio Utopie ]

Warum der Pfizer / BioNTech „Impfstoff“ ein gigantischer Betrug und zudem gefährlich ist

1. Dieser sogenannte „Impfstoff“ schützt weder vor Infektion von SARS II (dem aktuellen Coronavirus), noch vor dessen Verbreitung. Er schützt, heisst es, lediglich vor der Krankheit Covid-19. Und das auch nur ca. 3 Monate. Es können allerdings trotzdem „Symptome“ wie Müdigkeit auftreten. Eine Immunität gegen SARS II gibt es durch diesen Impfstoff nicht.

Über diese Informationen herrscht weltweit faktisch Nachrichtensperre.

03.12.2020 - 19:54 [ DailyMail.co.uk ]

Why is the Pfizer vaccine so difficult to transport? Light, temperatures above -70C and movement ALL speed up the chemical reactions that destroy fragile mRNA — meaning care homes have been sidelined

The approval of Pfizer/BioNTech’s coronavirus vaccine on Wednesday was hailed as the light at the end of the lockdown tunnel that could finally revert Britain back to pre-pandemic normality.

But the breakthrough jab — shown to be 95 per cent effective at blocking Covid-19 infection — has thrown up a series of logistical hurdles that make getting the vaccine to those who need it most challenging, including care homes.

02.12.2020 - 15:25 [ theGuardian.com ]

Oxford AstraZeneca Covid vaccine: everything we know so far

(23.11.2020)

No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.

Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins.

02.12.2020 - 15:19 [ gab.ai/murali / Twitter ]

How many willing to bet that this case is part of pharma wars to sabotage Oxford vaccine?

(28.11.2020)

02.12.2020 - 15:13 [ apnrews.com ]

UK authorizes Pfizer coronavirus vaccine for emergency use

The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease.

01.12.2020 - 11:55 [ ORF ]

Biontech, Pfizer und Moderna beantragten EU-Impfstoffzulassung

Die EMA muss die Anträge nun prüfen. Wie lange das dauert, ist unklar. Sollte die Behörde eine bedingte Zulassung empfehlen, könnte der Impfstoff noch im Dezember eingesetzt werden, teilte Biontech mit. Die endgültige Entscheidung trifft die EU-Kommission, die in der Regel der EMA-Empfehlung folgt.

23.11.2020 - 17:11 [ Politico.com ]

AstraZeneca to seek FDA authorization for vaccine based on foreign trial data

The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer’s symptoms to the shot.

23.11.2020 - 17:04 [ Telegraph.co.uk ]

AstraZeneca shares slip after analyst says vaccine will struggle to get green light in US – live updates

SVB Leerink analyst Geoffrey Porges said the treatment may never gain approval from US regulator the FDA, and said Astra had highlighted results from a “relatively small” number of patients.

23.11.2020 - 16:40 [ theGuardian.com ]

Oxford AstraZeneca Covid vaccine: everything we know so far

No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.

Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins.

23.11.2020 - 16:31 [ ORF ]

Wie Impfstoffzulassung in EU funktioniert

„Unser Plan ist es, die Impfstoffe innerhalb von 24 Stunden nach Zulassung an die Impfzentren zu liefern“, sagte Slaoui in einem Interview mit CNN. Er rechne daher damit, dass bereits am 11. oder 12. Dezember mit den Impfungen begonnen werden könne. Voraussetzung ist eine Notfallzulassung des Impfstoffs.

23.11.2020 - 16:23 [ Tagesschau.de ]

Studienergebnisse von AstraZeneca: Britischer Impfstoff wirkt zu 70 Prozent

Das Ergebnis bleibt zwar hinter den Werten der Präparate von Pfizer/Biontech und Moderna zurück. Wenn man aber zunächst nur eine halbe Dosis verabreiche und erst einen Monat später eine volle, dann erreiche der Impfstoff eine Effektivität von 90 Prozent, lässt AstraZeneca wissen. Er soll zudem deutlich preiswerter sein, sich sehr viel leichter lagern und weltweit transportieren lassen als andere Vakzine.

12.11.2020 - 11:12 [ HeraldScotland.com ]

Top Scots academic warns ministers not to prioritise Pfizer vaccine

The vaccine, which is thought to be effective against Covid-19 in nine out of 10 people, could be ready for distribution by next month but it needs to be stored at -80C for it to work.

This ‚ultra-cold‘ state is part of the logistical challenge facing the country, particularly if the vaccine is manufactured overseas.

The professor, from the university’s Centre for Sustainable Road Freight, explained that it may make more sense to prioritise the AstraZenica Oxford vaccine which can be made in the UK.

12.11.2020 - 11:09 [ Mark Sanders / Twitter ]

So the Pfizer vaccine is expected to be up to seven times more expensive than the Oxford one, reports the Times.

Welcome to profit first, morals later America.

12.11.2020 - 11:01 [ eastdevonwatch.org ]

Oxford v Pfizer: how costs and logistics could still see Oxford’s vaccine win out

Matt Hancock has warned the mass distribution would be a “colossal exercise” involving not just the NHS but the Armed Forces.

The Health Secretary acknowledged there was “enormous complexity” in administering the Pfizer vaccine.

12.11.2020 - 09:26 [ NPR.org ]

Pfizer CEO Sold Millions In Stock After Coronavirus Vaccine News, Raising Questions

Daniel Taylor, an expert in insider trading and an associate professor of accounting at the Wharton School of the University of Pennsylvania, has closely monitored stock trades by executives at companies developing coronavirus vaccines. He told NPR that the close timing between the adoption of Bourla’s stock plan and the press release looked „very suspicious.“

„It’s wholly inappropriate for executives at pharmaceutical companies to be implementing or modifying 10b5-1 plans the business day before they announce data or results from drug trials,“ Taylor said.

12.11.2020 - 09:06 [ Tagesschau.de ]

Corona-Impfstoffdosen: Intransparente Verhandlungen

Deutschland habe sich „bis zu 100 Millionen“ Dosen des Biontech-Impfstoffs gesichert, so Gesundheitsminister Spahn. Dabei sieht der EU-Verteilungsschlüssel nur 56 Millionen Dosen vor. Gibt es heimliche Deals?

10.11.2020 - 17:51 [ Boris Johnson, Prime Minister of the United Kingdom / Twitter ]

Huge thanks to Kate Bingham and the Vaccine Taskforce for all their fantastic work in securing 40 million doses of the @pfizer & @BioNTech_Group vaccine and over 300 million doses of other promising vaccine candidates.

10.11.2020 - 17:36 [ Keir Shiels / Twitter ]

This vaccine needs to be kept at below -80 ^C because it uses mRNA. Not suitable for most clinics and GP practices. My money is still on Oxford to produce a more effective and ergonomic one.

10.11.2020 - 17:25 [ Tagesschau.de ]

Enges Rennen um den Impfstoff

Damit haben Biontech/Pfizer im Rennen um einen durchschlagenden Impferfolg die Nase vorn. Verbunden damit ist auch ein Durchbruch für die spezielle Technologie, die die beiden Partner, aber auch der deutsche Mitbewerber Curevac und der US-Konzern Moderna nutzen: Bei der Impfung auf mRNA-Basis „mit Erbgutschnipseln“ werden Baupläne für Proteine in die menschlichen Zellen eingeschleust, die dann Antigene herstellen – in diesem Fall gegen das Corona-Virus.

30.10.2020 - 13:20 [ DailyMail.co.uk ]

German Pfizer vaccine could be ready before Oxford-AstraZeneca injection and be given to Brits before Christmas

Ms Bingham was appointed chair of the UK’s Vaccine Taskforce for Covid-19 in May and reports directly to the Prime Minister on the progress of a coronavirus vaccine, which experts say is key to controlling the pandemic.

The taskforce, which Ms Bingham says was the ‚brainchild of Sir Patrick Vallance‘ — Number 10’s chief scientific adviser, is at the forefront of putting plans in place to get the UK population vaccinated.

02.09.2020 - 13:12 [ Times of India ]

In change of tack, EU leaves door open to COVID vaccines purchase through WHO

The move could allow EU governments to secure vaccines from companies that are not negotiating with Brussels, such as U.S. firms Merck, Inovio and Novavax. They are all in talks with the WHO scheme, dubbed COVAX, but have so far not been reported to be involved in negotiations with the EU Commission.

15.08.2020 - 16:28 [ Matt Taibbi / Rolling Stone ]

Big Pharma’s Covid-19 Profiteers

How the race to develop treatments and a vaccine will create a historic windfall for the industry — and everyone else will pay the price

20.07.2020 - 17:39 [ Bloomberg ]

U.K. Orders 90 Million Vaccine Doses from Pfizer and Valneva

“It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available,” Education Secretary Gavin Williamson told the BBC during the government’s media round on Monday.

11.07.2020 - 18:33 [ theGrayzone.com ]

Why the Bill Gates global health empire promises more empire and less public health

Behind a veil of corporate media PR, the Gates Foundation has served as a vehicle for Western capital while exploiting the Global South as a human laboratory. The coronavirus pandemic is likely to intensify this disturbing agenda.

16.03.2020 - 10:15 [ Marketscreener.com ]

Moderna : Germany tries to halt U.S. interest in firm working on coronavirus vaccine

CureVac in 2015 and 2018 secured financial backing for development projects from its investor the Bill & Melinda Gates Foundation, working on shots to prevent malaria and influenza.

In the field of so-called mRNA therapeutics, CureVac competes with U.S. biotech firm Moderna and German rival BioNTech, which Pfizer has identified as a potential collaboration partner.