After ruining 75M J&J doses, Emergent gets FDA clearance for 25M doses

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

The US Food and Drug Administration is making progress in its efforts to sort out the fiasco at Emergent BioSolutions’ Baltimore facility, which, at this point, has ruined more than 75 million doses of COVID-19 vaccines stemming from what the regulator identified as significant quality control failures.

In March, news leaked that Emergent ruined 15 million doses of Johnson & Johnson’s vaccine as well as millions more doses of AstraZeneca’s vaccine. The spoilage happened when Emergent cross-contaminated batches of the two vaccines with ingredients from the other.

Last week, the FDA told Emergent to trash about 60 million more doses of Johnson & Johnson’s vaccine due to similar contamination concerns, The New York Times reported.

Read 10 remaining paragraphs | Comments

#astrazeneca, #covid-19, #emergent, #fda, #infectious-disease, #johnson-johnson, #pandemic, #public-health, #science, #vaccine

0

Facebook changes misinfo rules to allow posts claiming Covid-19 is man-made

Facebook made a few noteworthy changes to its misinformation policies this week, including the news that the company will now allow claims that Covid was created by humans — a theory that contradicts the previously prevailing assumption that humans picked up the virus naturally from animals.

“In light of ongoing investigations into the origin of COVID-19 and in consultation with public health experts, we will no longer remove the claim that COVID-19 is man-made from our apps,” a Facebook spokesperson told TechCrunch. “We’re continuing to work with health experts to keep pace with the evolving nature of the pandemic and regularly update our policies as new facts and trends emerge.”

The company is adjusting its rules about pandemic misinformation in light of international investigations legitimating the theory that the virus could have escaped from a lab. While that theory clearly has enough credibility to be investigated at this point, it is often interwoven with demonstrably false misinformation about fake cures, 5G towers causing Covid and most recently the false claim that the AstraZeneca vaccine implants recipients with a bluetooth chip.

Earlier this week, President Biden ordered a multi-agency intelligence report evaluating if the virus could have accidentally leaked out of a lab in Wuhan, China. Biden called this possibility one of two “likely scenarios.”

“… Shortly after I became President, in March, I had my National Security Advisor task the Intelligence Community to prepare a report on their most up-to-date analysis of the origins of COVID-19, including whether it emerged from human contact with an infected animal or from a laboratory accident,” Biden said in an official White House statement, adding that there isn’t sufficient evidence to make a final determination.

Claims that the virus was man-made or lab-made have circulated widely since the pandemic’s earliest days, even as the scientific community largely maintained that the virus probably made the jump from an infected animal to a human via natural means. But many questions remain about the origins of the virus and the U.S. has yet to rule out the possibility that the virus emerged from a Chinese lab — a scenario that would be a bombshell for international relations.

Prior to the Covid policy change, Facebook announced that it would finally implement harsher punishments against individuals who repeatedly peddle misinformation. The company will now throttle the News Feed reach of all posts from accounts that are found to habitually share known misinformation, restrictions it previously put in place for Pages, Groups, Instagram accounts and websites that repeatedly break the same rules.

#astrazeneca, #biden, #china, #covid-19, #facebook, #government, #misinformation, #president, #social, #tc, #united-states, #white-house

0

States won’t receive J&J doses next week amid ongoing production failures

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

States will not receive shipments of Johnson & Johnson’s one-shot COVID-19 vaccine next week, according to a report by Politico.

White House officials told governors in a call Tuesday that there are no new doses available for order. It’s unclear if the federal government will be able to distribute doses through other channels, such as those that provide vaccines directly to pharmacies and community health centers.

The dried-up supply is just the latest trouble for Johnson & Johnson, which has consistently struggled to produce its vaccine in the US.

Read 6 remaining paragraphs | Comments

#astrazeneca, #covid-19, #emergent-biosolutions, #fda, #johnson-johnson, #public-health, #science, #vaccine

0

AstraZeneca’s troubled vaccine not renewed in EU; Pfizer gets big, new deal

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews)

The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

“We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters. “We’ll see what happens,” he added, leaving open the possibility of future orders.

Read 12 remaining paragraphs | Comments

#astrazeneca, #biontech, #covid-19, #eu, #fda, #infectious-disease, #pfizer, #public-health, #science, #sinopharm, #vaccine, #who

0

Contractor that ruined 15M doses of J&J vaccine is holding up vaccine to India

Funeral pyres of people who died of COVID-19 being prepared simultaneously at Gazipur crematorium on April 26, 2021 in New Delhi, India.

Enlarge / Funeral pyres of people who died of COVID-19 being prepared simultaneously at Gazipur crematorium on April 26, 2021 in New Delhi, India. (credit: Getty | Raj K Raj)

India’s skyrocketing surge of COVID-19 cases has launched the country into the most harrowing crisis yet in the pandemic.

While international aid pours into the country, many have called for the US to donate millions of doses from its stockpile of AstraZeneca’s COVID-19 vaccine to India, which has vaccinated less than 2 percent of its population and is running out of doses.

AstraZeneca’s vaccine is widely used around the world, including in India, but it is not yet authorized for use in the US. Even if it does earn authorization here, Biden administration officials say it’s unlikely that the US will need the vaccine, given the healthy quantity of supplies of the three COVID-19 vaccines already authorized in the country made by Moderna, Pfizer-BioNTech, and Johnson & Johnson.

Read 17 remaining paragraphs | Comments

#astrazeneca, #cdc, #covid-19, #emergent, #fda, #india, #public-health, #science, #vaccine

0

The very common vaccine ingredient at the center of J&J, AstraZeneca drama

Adenoviruses seen via transmission electron microscopy.

Enlarge / Adenoviruses seen via transmission electron microscopy. (credit: Getty | BSIP)

Out of an abundance of caution, US officials on Tuesday recommended pausing use of Johnson & Johnson’s COVID-19 vaccine. Officials linked the vaccine to six peculiar illnesses in which people developed life-threatening blood clots in combination with low levels of blood platelets, the cell fragments in blood that form clots. One person died from their condition and another is in critical condition.

It’s unclear if the vaccine caused the illnesses. Even if it did, the illnesses would represent an exceedingly rare side effect. The six cases occurred among more than 6.8 million people in the US who received the Johnson & Johnson vaccine. That would make it a side effect seen in fewer than one in a million. The risk of hospitalization and death from COVID-19, which the vaccine protects against, easily exceeds those odds. Without question, the benefits of the vaccine outweigh the potential risks.

Still, with robust supplies of vaccine from Moderna and Pfizer-BioNtech—neither of which have been linked to these unusual cases—US officials took the cautious route of pausing Johnson & Johnson’s vaccine while they investigate the cases further and inform clinicians about how to spot and treat any others that may arise. This latter point is critical because if doctors try to use standard blood clot treatments in these vaccine-linked cases, the outcomes can be fatal.

Read 27 remaining paragraphs | Comments

#adenovirus, #astrazeneca, #cdc, #covid-19, #fda, #features, #infectious-disease, #johnson-johnson, #science, #vaccine-development, #vaccines, #viral-vector

0

J&J COVID vaccine use paused due to one-in-a-million complication

Image of a woman receiving a vaccine.

Enlarge / A nurse practitioner named Heidi Johnson administers a vaccine from Johnson & Johnson. (credit: Tom Williams / Getty Images)

On Tuesday morning, the US Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.

Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.

This is not the first vaccine to create extremely rare clotting issues. They’ve also been seen following use of the AstraZeneca vaccine. The problem appears to be caused by the harmless virus (an Adenovirus) that carries a single gene from SARS-CoV-2 in order to elicit an immune response.

Read 7 remaining paragraphs | Comments

#astrazeneca, #cdc, #clotting, #covid-19, #fda, #johnson-johnson, #medicine, #science, #vaccine

0

AstraZeneca vaccine linked to rare blood clots, EU regulators conclude

Extreme close-up photo of small, clear vials.

Enlarge / Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination center in Cyprus on March 22, 2021. (credit: Getty | Etienne Torbey)

European medical regulators on Wednesday concluded that there is a strong link between AstraZeneca’s COVID-19 vaccine and life-threatening conditions involving the unusual combination of blood clots and low levels of blood platelets.

As such, the conditions should be listed as a “very rare side effects” of the vaccine, according to the European Medicines Agency, a regulatory agency of the European Union.

The conclusion was based on the EMA’s in-depth review of 86 blood-clotting events among around 25 million people vaccinated with the AstraZeneca vaccine in Europe and the UK. Of the 86 blood-clotting events, 18 people died. Most—but not all—of the cases occurred in women under the age of 60.

Read 19 remaining paragraphs | Comments

#adenovirus, #astrazeneca, #clotting, #covid-19, #ema, #heparin, #immune-response, #johnson-johnson, #platelets, #science, #side-effects, #vaccine

0

After dramatic rebuke, AstraZeneca lowers vaccine efficacy estimate—a little

A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021.

Enlarge / A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021. (credit: Getty | Gabriel Bouys)

Brushing aside a dramatic rebuke from government researchers and independent experts, AstraZeneca on Wednesday night announced that a new analysis found its COVID-19 vaccine to be 76 percent effective at preventing symptomatic COVID-19—down from the 79 percent efficacy estimate it announced in a press release Monday.

The new estimate is still high, according to an independent board of experts tasked with overseeing the vaccine’s trial and data analysis. The trial’s Data and Safety Monitoring Board (DSMB) sent a highly unusual letter to AstraZeneca soon after the Monday press release, noting that trial data it had seen during February and March meetings suggested that the vaccine’s efficacy was actually between 69 percent and 74 percent.

“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter stated. “The point that is clear to the board is that the [vaccine efficacy number]… they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”

Read 8 remaining paragraphs | Comments

#astrazeneca, #clinical-trial, #covid-19, #fda, #infectious-disease, #science, #vaccine

0

Authorities raise red flags about AstraZeneca’s vaccine press release

Authorities raise red flags about AstraZeneca’s vaccine press release

Enlarge (credit: Getty| NurPhoto)

A board of independent experts tasked with monitoring the data and safety of AstraZeneca’s COVID-19 vaccine trial has raised a red flag about the company’s Monday press release, which trumpeted that the vaccine was 79 percent effective at preventing symptomatic COVID-19.

In the wee hours of Tuesday, the National Institute of Allergy and Infectious Diseases released an unusual statement indicating that the trial’s Data and Safety Monitoring Board (DSMB) had been in touch with the federal agency as well as the company. The statement read:

The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

In an interview with Good Morning America Tuesday morning, NIAID director and top infectious disease expert Anthony Fauci tried to add more context to the situation. He noted that the DSMB, which has access to all of the data from the AstraZeneca trial, was left surprised by what the company said in its press release.

Read 5 remaining paragraphs | Comments

#astrazeneca, #clinical-trial, #covid-19-vaccine, #infectious-disease, #niaid, #nih, #pandemic, #public-health, #science, #vaccine

0

AstraZeneca vaccine: 79% effective and no rare blood clots in US trial

Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination centre in Cyprus, on March 22, 2021.

Enlarge / Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination centre in Cyprus, on March 22, 2021. (credit: Getty | Etienne Torbey)

Exceeding expectations, AstraZeneca’s two-dose COVID-19 vaccine appeared highly effective against symptomatic and severe disease in a new late-stage trial conducted partly in the US. The company said it is now seeking emergency use authorization from the Food and Drug Administration. However, the vaccine may still be dogged by doubts.

The Phase III trial conducted in the US, Peru, and Chili found that the vaccine was 79 percent effective at preventing symptomatic disease, the company reported early Monday. Previous trial results suggests efficacy could be as low as 62 percent.

In the new 32,449-person trial, two-thirds of participants were dosed with the vaccine while the remaining third was given a placebo. There were five cases of severe disease in the trial, all in the placebo group. None of the vaccinated participants required hospitalization.

Read 10 remaining paragraphs | Comments

#astrazeneca, #blood-clotting, #covid-19, #cvst, #efficacy, #infectious-disease, #public-health, #science, #university-of-oxford, #vaccine

0

Scary 22% vaccine efficacy in South Africa comes with heaps of caveats

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

Dismal preliminary data on AstraZeneca’s COVID-19 vaccine in South Africa—where the B.1.351/ 501Y.V2 coronavirus variant is spreading widely—lead the government there to rethink its vaccination rollout and raised further international concern about the variant.

But the small study has so many limitations and caveats, experts caution that drawing any conclusions from it is difficult.

The study, which has not been published or peer-reviewed but presented in a press conference Sunday, began in June and enrolled only around 2,000 participants, about half of which received a placebo. Early in the study—before B.1.351 emerged—the vaccine appeared over 70 percent effective at preventing mild-to-moderate cases of COVID-19. That is largely in line with the conclusion of an international Phase III trial released by AstraZeneca and vaccine co-developer Oxford University, which showed mixed results for the replication-deficient adenovirus-based vaccine but an overall efficacy of around 70 percent.

Read 6 remaining paragraphs | Comments

#astrazeneca, #clinical-trial, #coronavirus, #covid-19, #pandemic, #science, #south-africa, #vaccine, #variants, #who

0

Experts debate fiddling with vaccine doses as virus rages out of control

Vials of undiluted Pfizer COVID-19 vaccine are prepared to administer to staff and residents at the Goodwin House Bailey's Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020.

Enlarge / Vials of undiluted Pfizer COVID-19 vaccine are prepared to administer to staff and residents at the Goodwin House Bailey’s Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020. (credit: Getty | BRENDAN SMIALOWSKI )

With the pandemic continuing to surge to new heights, debate has erupted among experts about how to get the most protection as quickly as possible from the limited supply of COVID-19 vaccines currently available.

Suggestions floated so far include delaying the second of a two-dose regimen for maybe three to four months rather than doling them out in the planned three-to-four-week intervals evaluated in large clinical trials. With this change, more people can get a first dose now, offering ­some protection. Another possibility is simply cutting doses by half, which would immediately double the number of people who can be vaccinated now. And regulators in the United Kingdom have introduced the idea of mixing regimens—with some people getting their first dose of a vaccine by one manufacturer and then getting a second dose of vaccine from a different manufacturer based on availability at the time.

Evidence supporting these suggested tweaks in the vaccine rollout are shaky at best. But some experts argue that the dire state of the pandemic warrants a new, perhaps riskier approach.

Read 13 remaining paragraphs | Comments

#astrazeneca, #covid-19, #fauci, #fda, #immunity, #moderna, #pfizer, #science, #vaccine

0

FDA authorizes Moderna’s COVID-19 vaccine for emergency use

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, as expected after an independent panel commissioned by the administration recommended its approval earlier this week. This is the second vaccine now authorized for use in the U.S. under EUA, after the Pfizer -BioNTech vaccine was approved last week.

Moderna’s vaccine could begin being administered to Americans by “Monday or Tuesday” next week, according to Dr. Anthony Fauci speaking to NBC’s Today show in a new interview. That’s in keeping with the timelines between the Pfizer EUA and the first patients actually receiving the vaccine last week.

Like Pfizer’s vaccine, Moderna’s is an mRNA therapy. That means that it contains no actual virus — just genetic instructions that tell a person’s body to create a specific protein. That protein is more or less identical to the one that SARS-CoV-2, the virus which causes COVID-19, uses to attach to a host’s cells and replicate. Moderna’s vaccine causes a person to create just the protein, which on its own is harmless, and then their natural defenses via their immune system react to that and develop a method for fighting it off. That defense system is “remembered” by the body, while the vaccine itself naturally dissolves after a brief time, leaving a person with immunity but nothing else.

The Oxford-AstraZeneca vaccine, which has yet to be approved for use in the U.S., uses a weakened and modified common cold virus that doesn’t spread in humans to create the spike protein in recipients, resulting in the body generating its own immune response. That’s a much more tried-and-tested method for creating a vaccine, but both Moderna and Pfizer’s mRNA therapies have shown to be very effective in preliminary data from their large Phase 3 clinical trials.

#astrazeneca, #biontech, #biotech, #health, #medical-research, #medicine, #moderna, #oxford, #pfizer, #science, #tc, #united-states, #vaccine

0

AWS expands on SageMaker capabilities with end-to-end features for machine learning

Nearly three years after it was first launched, Amazon Web Services’ SageMaker platform has gotten a significant upgrade in the form of new features making it easier for developers to automate and scale each step of the process to build new automation and machine learning capabilities, the company said.

As machine learning moves into the mainstream, business units across organizations will find applications for automation,  and AWS is trying to make the development of those bespoke applications easier for its customers.

“One of the best parts of having such a widely-adopted service like SageMaker is that we get lots of customer suggestions which fuel our next set of deliverables,” said AWS vice president of machine learning, Swami Sivasubramanian. “Today, we are announcing a set of tools for Amazon SageMaker that makes it much easier for developers to build end-to-end machine learning pipelines to prepare, build, train, explain, inspect, monitor, debug and run custom machine learning models with greater visibility, explainability, and automation at scale.”

Already companies like 3M, ADP, AstraZeneca, Avis, Bayer, Capital One, Cerner, Domino’s Pizza, Fidelity Investments, Lenovo, Lyft, T-Mobile, and Thomson Reuters are using SageMaker tools in their own operations, according to AWS.

The company’s new products include Amazon SageMaker Data Wrangler, which the company said was providing a way to normalize data from disparate sources so the data is consistently easy to use. Data Wrangler can also ease the process of grouping disparate data sources into features to highlight certain types of data. The Data Wrangler tool contains over 300 built-in data transformers that can help customers normalize, transform and combine features without having to write any code.

Amazon also unveiled the Feature Store, which allows customers to create repositories that make it easier to store, update, retrieve and share machine learning features for training and inference.

Another new tool that Amazon Web Services touted was its workflow management and automation toolkit, Pipelines. The Pipelines tech is designed to provide orchestration and automation features not dissimilar from traditional programming. Using pipelines, developers can define each step of an end-to-end machine learning workflow, the company said in a statement. Developers can use the tools to re-run an end-to-end workflow from SageMaker Studio using the same settings to get the same model every time, or they can re-run the workflow with new data to update their models.

To address the longstanding issues with data bias in artificial intelligence and machine learning models, Amazon launched SageMaker Clarify. First announced today, this tool allegedly provides bias detection across the machine learning workflow, so developers can build with an eye towards better transparency on how models were set up. There are open source tools that can do these tests, Amazon acknowledged, but the tools are manual and require a lot of lifting from developers, according to the company.

Other products designed to simplify the machine learning application development process include SageMaker Debugger, which enables to developers to train models faster by monitoring system resource utilization and alerting developers to potential bottlenecks; Distributed Training, which makes it possible to train large, complex, deep learning models faster than current approaches by automatically splitting data cross multiple GPUs to accelerate training times; and SageMaker Edge Manager, a machine learning model management tool for edge devices, which allows developers to optimize, secure, monitor and manage models deployed on fleets of edge devices.

Last but not least, Amazon unveiled SageMaker JumpStart, which provides developers with a searchable interface to find algorithms and sample notebooks so they can get started on their machine learning journey. The company said it would give developers new to machine learning the option to select several pre-built machine learning solutions and deploy them into SageMaker environments.

#3m, #adp, #amazon, #amazon-sagemaker, #amazon-web-services, #artificial-intelligence, #astrazeneca, #avis, #aws-reinvent-2020, #bayer, #capital-one, #cerner, #cloud, #cloud-computing, #cloud-infrastructure, #computing, #deep-learning, #dominos-pizza, #enterprise, #fidelity-investments, #lenovo, #lyft, #machine-learning, #sagemaker-studio, #t-mobile, #tc, #workflow-management

0

Moderna claims 94% efficacy for COVID-19 vaccine, will ask FDA for emergency use authorization today

Drugmaker Moderna has completed its initial efficacy analysis of its COVID-19 vaccine from the drug’s Phase 3 clinical study, and determined that it was 94.1% effective in preventing people from contracting COVID-19 across 196 confirmed cases from among 30,000 participants in the study. Moderna also found that it was 100% effective in preventing severe cases (such as those that would require hospitalization) and says it hasn’t found any significant safety concerns during the trial. On the basis of these results, the company will file an application for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) on Monday.

Seeking an EUA is the next step towards actually beginning to distribute and administer Moderna’s COVID-19 vaccine, and if granted the authorization, it will be able to provide it to high-risk individuals in settings where it could help prevent more deaths, such as with front-line healthcare workers, ahead of receiving a full and final regulatory approval from the U.S. healthcare monitoring agency. Moderna will also seek conditional approval from the European Medicines Agency, which will enable similar use ing the EU.

Moderna’s vaccine is an mRNA vaccine, which provides genetic instructions to a person’s body that prompts them to create their own powerful antibodies to block the receptor sites that allows COVID-19 to infect a patient. It’s a relatively new therapeutic approach for human use, but has the potential to provide potentially even more resistance to COVID-19 than do natural antibodies, and without the risk associated with introducing any actual virus, active or otherwise, to an inoculated individual in order to prompt their immune response.

In mid-November, Moderna announced that its COVID-19 vaccine showed 94.5% efficacy in its preliminary results. This final analysis of that same data hews very close to the original, which is promising news for anyone hoping for an effective solution to be available soon. This data has yet to be peer reviewed, though Moderna says that it will now be submitting data from the Phase 3 study to a scientific publication specifically for that purpose.

Moderna’s vaccine candidate is part of the U.S’s Operation Warp Speed program to expedite the development, production and distribution of a COVID-19 vaccine, initiated earlier this year as a response to the unprecedented global pandemic. Other vaccines, including one created by Pfizer working with partner BioNTech, as well as an Oxford University/AstraZeneca-developed candidate, are also far along in their Phase 3 testing and readying for emergency approval and use. Pfizer has already applied with the FDA for its own EUA, while the Oxford vaccine likely won’t be taking that step in the U.S. until it completes another round of final testing after discovering an error in the dosage of its first trial – which led to surprising efficacy results.

#astrazeneca, #biontech, #biotech, #coronavirus, #covid-19, #european-union, #health, #healthcare, #medical-research, #medicine, #moderna, #oxford-university, #pfizer, #tc, #united-states, #vaccine

0

AstraZeneca says it will likely do another study of COVID-19 vaccine after accidental lower dose shows higher efficacy

AstraZeneca’s CEO told Bloomberg that the pharmaceutical company will likely conduct another global trial of the effectiveness of its COVID-19 vaccine trial, following the disclosure that the more effective dosage in the existing Phase 3 clinical trial was actually administered by accident. AstraZeneca and its partner the University of Oxford reported interim results that showed 62% efficacy for a full two-dose regimen, and a 90% efficacy rate for a half-dose followed by a full dose – which the scientists developing the drug later acknowledged was actually just an accidental administration of what was supposed to be two full doses.

To be clear, this shouldn’t dampen anyone’s optimism about the Oxford/AstraZeneca vaccine. The results are still very promising, and an additional trial is being done only to ensure that what was seen as a result of the accidental half-dosage is actually borne out when the vaccine is administered that way intentionally. That said, this could extend the amount of time that it takes for the Oxford vaccine to be approved in the U.S., since this will proceed ahead of a planned U.S. trial that would be required for the FDA to approve it for use domestically.

The Oxford vaccine’s rollout to the rest of the world likely won’t be affected, according to AstraZeneca’s CEO, since the studies that have been conducted, including safety data, are already in place from participants around the world outside of the U.S.

While vaccine candidates from Moderna and Pfizer have also shown very strong efficacy in early Phase 3 data, hopes are riding high on the AstraZeneca version because it relies on a different technology, can be stored and transported at standard refrigerator temperatures rather than frozen, and costs just a fraction per dose compared to the other two leading vaccines in development.

That makes it an incredibly valuable resource for global inoculation programs, including distribution where cost and transportation infrastructures are major concerns.

#astrazeneca, #biotech, #ceo, #coronavirus, #covid-19, #fda, #health, #medical-research, #moderna, #oxford, #pfizer, #pharmaceutical, #tc, #united-states, #vaccine, #vaccines

0

AstraZeneca’s best COVID vaccine result was a fluke. Experts have questions

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

Pharmaceutical giant AstraZeneca and the University of Oxford made an exciting announcement Monday: the COVID-19 vaccine they developed together appeared up to 90 percent effective at preventing disease. But in the days since, that exciting news melted into a pool of confusion after it became clear that the 90 percent figure came about from a complete accident. Now, experts are scratching their heads over what actually happened in the trial and what it means for the vaccine’s future.

The questions all swirl around the vaccine’s dosage regimen. In initial press releases, AstraZeneca and Oxford explained that researchers had used two different dosage regimens to test their experimental vaccine, AZD1222. In one regimen, trial participants received two “full” vaccine doses, 28 days apart. In the other, participants received a half dose of vaccine followed by a full dose 28 days later.

Pooling results from trials in the United Kingdom and another in Brazil, the researchers found the two-full-dose regimen was 62 percent effective at preventing COVID-19—a good, but not great result. The half-dose/full-dose regimen, on the other hand, appeared 90 percent effective—a rather impressive result.

Read 13 remaining paragraphs | Comments

#astrazeneca, #covid-19, #operation-warp-speed, #oxford, #sars-cov-2, #science, #vaccine

0

AstraZeneca’s COVID-19 vaccine shows success: Here’s how it stacks up to others

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

AstraZeneca announced in a press release on Monday that its COVID-19 vaccine showed positive results in an interim analysis of clinical trial data.

The announcement marks the third vaccine to show strong efficacy in late-stage trials against the pandemic coronavirus, SARS-CoV-2. Though AstraZeneca’s vaccine efficacy numbers are not as impressively high as those for the vaccines before it—mRNA vaccines from Pfizer/BioNTech and Moderna—AstraZeneca’s does offer some advantages over those vaccines.

In all, the news adds to ballooning optimism that effective vaccines could bring an end to the global crisis in the coming year.

Read 21 remaining paragraphs | Comments

#adenovirus, #astrazeneca, #clinical-trial, #covid-19, #infectious-disease, #oxford, #public-health, #sars-cov-2, #science, #vaccine

0

Oxford University’s COVID-19 vaccine shows high efficacy, and is cheaper to make and easier to store

Oxford University’s COVID-19 vaccine, being developed in partnership with drugmaker AstraZeneca, has shown to be 70.4% effective in preliminary results from its Phase 3 clinical trial. That rate actually includes data from two different approaches to dosing, including one where two full strength does were applied, which was 62% effective, and a much more promising dosage trial which used one half-dose and one full strength dose to follow – that one was 90% effective.

Oxford’s results may not have the eye-catching high efficacy headline totals of the recent announcements from Pfizer and Moderna, but they could actually represent some of the most promising yet for a few different reasons. First, if that second dosage strategy holds true across later results and further analysis, it means that the Oxford vaccine can be administered in lower amounts and provide stronger efficacy (there’s no reason to use the full two-dose method if it’s that much less effective).

Second, the Oxford vaccine can be stored and transported at standard refrigerator temperatures – between 35° and 45°F – whereas the other two vaccine candidates require storage at lower temperatures. That helps obviate the need for more specialized equipment during transportation and on-site at clinics and hospitals where it will be administered.

Oxford’s COVID-19 vaccine also uses a different approach to either Moderna’s or Pfizer’s, which are both mRNA vaccines. That’s a relatively unproven technology when it comes to human therapeutics, which involves using messenger RNA to provide blueprints to a person’s body to build proteins effective at blocking a virus, without any virus present. The Oxford University candidate is an adenovirus vaccine, which is a much more established technology that’s already been in use for decades, and which involves genetically altering a weekend common cold virus and using that to trigger a person’s own natural immune response.

Finally, it’s also cheaper – in part because it uses tried and tested technology for which there’s already a robust and mature supply chain, and in part because it’s easier to transport and store.

The Phase 3 trial for the Oxford vaccine included 24,000 participants, and it’s expected to grow to 60,000 by the end of the year. Safety data so far shows no significant risks, and among the 131 confirmed cases in the interim analysis that produced these results, none of those who received either vaccine dosage developed a severe case, or one requiring hospitalization.

This is great news for potential vaccination programs, since it introduces variety of supply chain into an apparently effective vaccine treatment for COVID-19. We’re much better off if we have not only multiple effective vaccines, but multiple different types of effective vaccines, in terms of being able to inoculate widely as quickly as possible.

#astrazeneca, #biotech, #health, #medical-research, #medicine, #messenger, #moderna, #oxford-university, #pfizer, #tc, #unproven-technology, #vaccination, #vaccine, #vaccines

0

The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another private Chinese company, CanSino Biologics developed a vaccine that was already being distributed to members of the Chinese military in late July,

A collaboration in the U.K. between the University of Oxford and European pharmaceutical company AstraZeneca is also recruiting volunteers in Brazil, India, the United Kingdom, the US and South Africa. And, in Australia, the Murdoch Children’s Research Institute is trying to see whether a vaccine used to prevent tuberculosis could be used to vaccinate against the coronavirus.

Finally in Russia, the Gamaleya National Center of Epidemiology and Microbiology in partnership with the state-run Russian Direct Investment Fund have claimed to have developed a vaccine that the country has registered as the first one on the market cleared for widespread use. Russia has not published any data from the clinical trials it claims to have conducted to prove the efficacy of the vaccine and the World Health Organization still considers the treatment to be in the first phase of development.

Therapies in phase three clinical trials

If vaccines can prevent against infection, a slew of companies are also working on ways to limit the severity of the disease should someone become infected with Sars-Cov-2, the novel coronavirus that causes COVID-19.

The Milken Institute lists 41 different therapies that have made it through to phase three of their clinical trials (the last phase before approval for widespread delivery).

These therapies come in one of five primary categories: antibody therapies, antivirals, cell-based therapies, RNA-based treatments, and repurposing existing treatments that may be in pharmaceutical purgatory.

Antibody therapies use the body’s natural defense systems either taken from the blood of people who have recovered from an infection or manufactured in a lab to neutralize the spread of a virus or bacteria. Antivirals, by contrast, stop a virus from spreading by attacking the viruses’ ability to replicate. Cell-based therapies are designed to boost the immune system’s ability to fight pathogens like viruses or bacteria. Meanwhile RNA-based treatments are another method to stop the virus from replicating by blocking the construction of viral proteins. Finally, several companies are mining their libraries of old drug compounds to see if any might be candidates for COVID-19 treatments.

So far, only three therapeutics have been approved to treat COVID-19. In the U.K. and Japan dexamethasone has received approvals, while favilavir is being used in China, Italy and Russia; and — famously thanks to its use by the President — remdesivir has been approved in the United States, Japan and Australia.

The US is also using convalescent plasma to treat hospitalized patients under emergency use authorizations. And special cases, like the President’s, have had access to other experimental treatments like Regeneron’s cell therapy under emergency use authorizations.

And there are several US-based startups developing potential COVID-19 therapies in each of these areas.

Adaptive Biotechnologies, Cytovia Therapeutics, and SAB Biotherapeutics are all developing antibody treatments. Applied Therapeutics is using an understanding of existing compounds to develop treatments for specific conditions associated with COVID-19. Cellularity has a cell-therapy that could reduce a patient’s viral load by stimulating so-called natural killer cells to attack infected cells. Humanigen has developed a new drug that could reduce fatalities in high-risk COVID-19 patients with severe pneumonia. Meanwhile Partner Therapeutics is working on a drug that could improve lung function in COVID-19 patients — and potentially boost antibody production against the virus and restore damaged lung cells. Finally, Sarepta Therapeutics has been working with the United States Army Medical Research Institute of Infectious Diseases to find ways for its RNA-based treatment to stop the spread of coronaviruses by attacking the ability for the virus to replicate.

Beyond therapies, startups are finding other ways to play a role in helping the nation address the COVID-19 epidemic.

“At this point the U.S. doesn’t have the best public health system, but at the same time we have best-in-class private companies who can sometimes operate a lot more efficiently than governments can,” Carbon Health chief executive Eran Bali told the audience at TechCrunch’s Disrupt 2020 conference. “We also just recently launched a program to help COVID-positive patients get back to health quickly, a rehabilitation program. Because as you know even if you survive it doesn’t mean your body was not affected, there are permanent effects.”

Indeed the drive for more effective at-home tests and remote treatments for consumers are arguably more important when the federal government refuses to make the prevention of viral spread a priority, because consumers may voluntarily lock down if the government won’t.

“This is an opportunity to take a technology that naturally is all about detecting viruses — that’s what CRISPR does in [its native environment] bacteria — and repurposing it to use it as a rapid diagnostic for coronavirus,” said the Nobel Prize-winning co-inventor of some foundational CRISPR gene-editing technology, Jennifer Doudna. “We’re finding in the laboratory that that means that you can get a signal faster, and you can also get a signal that is more directly correlated to the level of the virus.”

#astrazeneca, #covid-19, #jake-tapper, #jennifer-doudna, #johnson-johnson, #moderna-therapeutics, #pfizer, #pharmaceutical, #tc, #vaccine, #world-health-organization

0

“Not uncommon at all”: AstraZeneca pauses COVID-19 vaccine trial

A double-masked health care worker jabs a needle into the arm of a seated woman in a mask.

Enlarge / A volunteer receives an injection of AZD1222 from a medical worker during the country’s first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020, in Soweto, South Africa. It is reported that Africa’s first COVID-19 vaccine trial began on June 24 in South Africa. (credit: Getty Images | Felix Dlangamandla)

With the coronavirus crisis gripping the globe, all eyes are on every bump and dip on the path to the pandemic’s end. So, of course, news that researchers triggered a common pause to the clinical trials of a leading COVID-19 vaccine candidate made swift and alarming headlines late Tuesday.

The global phase III trials for the vaccine AZD1222 (formerly ChAdOx1)—developed by the University of Oxford and pharmaceutical giant AstraZeneca—were put on a “temporary” and “voluntary” pause for a “standard review process,” AstraZeneca said in a statement Wednesday.

According the company, the pause was triggered by a “potentially unexplained illness” in one of thousands of participants involved in its trials. Per standard protocol, researchers must pause the trial to investigate whether the illness is related to exposure to the experimental vaccine or not.

Read 15 remaining paragraphs | Comments

#adverse-event, #astrazeneca, #clinical-trial, #covid-19, #oxford-university, #pandemic, #sars-cov-2, #science, #vaccine

0

COVID vaccine makers vow science—not Trump—will dictate release timing

Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial.

Enlarge / Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial. (credit: Getty | Boston Globe)

In an extraordinary move Tuesday, nine top pharmaceutical executives made a public pledge that they will not prematurely release a COVID-19 vaccine and that they will only seek federal approval to distribute a vaccine after rigorous ethical and scientific standards are met.

The pledge was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi. All of the represented companies are working on a vaccine against COVID-19 and four—AstraZeneca, Moderna, and a joint venture between BioNTech and Pfizer—have vaccines in phase 3 clinical trials.

The vow appears to be a coordinated resistance to pressure from the Trump administration, which is pushing for a rollout of a vaccine by November 1, just before the presidential election. Last week, the Centers for Disease Control and Prevention told states to be ready to start distributing vaccines by November 1.

Read 10 remaining paragraphs | Comments

#astrazeneca, #cdc, #covid-19, #fda, #gsk, #infectious-diseases, #moderna, #pfizer, #public-health, #sars-cov-2, #science, #trump, #vaccine

0

Meet the 4 frontrunners in the COVID-19 vaccine race

A volunteer receives an injection from a medical worker during the country's first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa's first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University's (UK) Jenner Institute, will inoculate 2,000 South Africans.

Enlarge / A volunteer receives an injection from a medical worker during the country’s first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa’s first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University’s (UK) Jenner Institute, will inoculate 2,000 South Africans. (credit: Getty | Felix Dlangamandla)

Researchers have now reported data from early (and small) clinical trials of four candidate COVID-19 vaccines.

So far, the data is positive. The vaccines appear to be generally safe, and they spur immune responses against the novel coronavirus, SARS-CoV-2. But whether these immune responses are enough to protect people from infection and disease remains an important unknown.

The four candidates are now headed to larger trials—phase III trials—that will put them to the ultimate test: can they protect people from COVID-19 and end this pandemic?

Read 35 remaining paragraphs | Comments

#antibodieis, #astrazeneca, #cansino, #china, #covid-19, #features, #immune-system, #immune-system-response, #immunity, #immunology, #moderna, #mrna, #pfizer, #public-health, #sars-cov-2, #science, #vaccines

0

Moderna set to start final-stage trial of its coronavirus vaccine by July

Pharmaceutical company Moderna told Bloomberg on Thursday that it’s on pace to begin the final-stage clinical trial of its vaccine for the novel coronavirus that causes COVID-19 by July. Moderna was the first company to begin human clinical trials of its vaccine candidate in the U.S., and the last stage of its study will include 30,000 people and be conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the study will be to show definitive clinical proof that Moderna’s vaccine actually does prevent people from developing COVID-19, and, secondarily, that it prevents at least severe symptoms and cases that require hospitalization from materializing. Moderna’s second-stage clinical trial kicked off last month, and the company has previously said that it could potentially begin offering experimental doses available to healthcare workers in limited capacities as early as this fall.

The pace of development of a number of leading vaccine candidates is actually moving just as quickly, if not more quickly. Johnson & Johnson said early this week that it would start trials of its vaccine later in July, while AstraZeneca and its research and development partner the University of Oxford will be entering its own final-stage clinical trials as of this month.

Moderna’s vaccine candidate is an mRNA vaccine, which is a technology that essentially provides instructions to healthy cells to produce antibodies to the coronavirus, without having to actually introduce any of the active or inactive virus itself. mRNA vaccines, while used in veterinary medicines, are relatively new technology and have not yet been approved for use in human patients, but they represent a number of the early vaccine attempts, because of their advantages in terms of speed of development and the lessened theoretical health risk they pose to people, including early trial participants.

#astrazeneca, #coronavirus, #covid-19, #drugs, #health, #johnson-johnson, #medicine, #moderna, #tc, #united-states, #vaccines

0