Archiv: Moderna (corporation)


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.”

06.01.2021 - 20:03 [ ZDF ]

EU lässt Moderna-Impfstoff zu

Am Mittag hatte die Europäische Arzneimittelbehörde EMA die Zulassung des Corona-Impfstoffs des US-Herstellers Moderna empfohlen. Nun hat ihn die EU-Kommission zugelassen.

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 - 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?

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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?

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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?

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

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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?

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.

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.

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.

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.

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.

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.

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.

25.06.2020 - 19:23 [ Politico.com ]

House members, Senate aides traded stocks in early days of coronavirus

(31.03.2020)

Holmes traded out two stocks a week later, on Jan. 29, then on Feb. 27 made two purchases that could prove advantageous in the weeks ahead: Holmes purchased between $15,001 and $50,000 of stock in each of two more companies, the pharmaceutical company Gilead, Inc. — which makes remdesivir, a drug that is currently being tested to treat coronavirus — and wipe manufacturer Clorox.

16.03.2020 - 15:10 [ labiotech.eu ]

Battle of the Biotech Unicorns: CureVac vs. Moderna

(06.11.2017)

But despite being competitors, the companies’ CEOs seem to have quite a good relationship and consider each other collaborators rather than enemies. Every year, they organize an mRNA conference together that takes turns between Boston and Berlin to bring together all the stakeholders in the field. It was at this year’s edition, in Berlin, that I had the chance to bring them together for an interview regarding the future of mRNA therapies.

16.03.2020 - 14:55 [ Fox News ]

Coronavirus: Biotech company ships first batches of vaccine, to be tested on humans: report

The trials will be held at Kaiser Permanente Washington Health Research Institute in Seattle. Testing will involve 45 young, healthy volunteers and it uses Moderna’s mRNA-1273 vaccine.

„Unlike a normal vaccine, RNA vaccines work by introducing an mRNA sequence (the molecule which tells cells what to build) which is coded for a disease-specific antigen, once produced within the body, the antigen is recognized by the immune system, preparing it to fight the real thing,“ according to the University of Cambridge.

16.03.2020 - 10:19 [ Wikipedia ]

Coalition for Epidemic Preparedness Innovations: SARS-CoV-2

In January 2020, CEPI funded three teams working on a vaccine for SARS-CoV-2, being: Moderna, Inovio Pharmaceuticals, and the University of Queensland (UQ).[28][29] By February 2020, Inovio announced that it had produced a pre-clinical DNA-based vaccination to fight COVID-19 at its lab in San Diego.[30] Inovio collaborated with a Chinese firm to speed its acceptance by regulatory authorities in China for human trialing.[31] The strategy of the UQ team is to develop a molecular clamp vaccine that genetically modifies viral proteins to make them mimic the coronavirus and stimulate an immune reaction.[29][28]

In January 2020, CEPI announced a fourth SARS-CoV-2 project in a collaboration with their existing partner CureVac, to develop and manufacture a vaccine.

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.

16.03.2020 - 07:31 [ The Hill ]

Potential coronavirus vaccine trial set to start on Monday: AP

According to the AP, the trial will start testing 45 young, healthy participants with different doses of the vaccine, which was developed by both the NIH and Moderna Inc.

15.03.2020 - 20:50 [ Event201.com ]

Timetable For A Vaccine Against The New Coronavirus? Maybe This Fall: NPR

(12.02.2020)

CEPI is a global partnership of public, private and philanthropic organizations; it’s also supporting efforts at the biotech companies Moderna and CureVac.

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Even in the rosiest of scenarios, Hatchett says, once the vaccine is in hand, it still needs to get to the people who need it, and that takes time — at least weeks to months, depending on the urgency.