Tag Archives: Food and Drug Administration

How to Completely Wipe out Colon Cancer in Anybody Who Gets Screened

Michael Wallace has performed hundreds of colonoscopies in his 20 years as a gastroenterologist. He thinks he’s pretty good at recognizing the growths, or polyps, that can spring up along the ridges of the colon and potentially turn into cancer. But he isn’t always perfect. Sometimes the polyps are flat and hard to see. Other times, doctors just miss them. “We’re all humans,” says Wallace, who works at the Mayo Clinic. After a morning of back-to-back procedures that require attention to minute details, he says, “we get tired.”

Colonoscopies, if unpleasant, are highly effective at sussing out pre-cancerous polyps and preventing colon cancer. But the effectiveness of the procedure rests heavily on the abilities of the physician performing it. Now, the Food and Drug Administration has approved a new tool that promises to help doctors recognize precancerous growths during a colonoscopy: an artificial intelligence system made by Medtronic. Doctors say that alongside other measures, the tool could help improve diagnoses.

 

We really have the opportunity to completely wipe out colon cancer in anybody who gets screened,” says Wallace, who consulted with Medtronic on the project.

The Medtronic system, called GI Genius, has seen the inside of more colons than most doctors. Medtronic and partner Cosmo Pharmaceuticals trained the algorithm to recognize polyps by reviewing more than 13 million videos of colonoscopies conducted in Europe and the US that Cosmo had collected while running drug trials. To “teach” the AI to distinguish potentially dangerous growths, the images were labeled by gastroenterologists as either normal or unhealthy tissue. Then the AI was tested on progressively harder-to-recognize polyps, starting with colonoscopies that were performed under perfect conditions and moving to more difficult challenges, like distinguishing a polyp that was very small, only in range of the camera briefly, or hidden in a dark spot. The system, which can be added to the scopes that doctors already use to perform a colonoscopy, follows along as the doctor probes the colon, highlighting potential polyps with a green box. GI Genius was approved in Europe in October 2019 and is the first AI cleared by the FDA for helping detect colorectal polyps. “It found things that even I missed,” says Wallace, who co-authored the first validation study of GI Genius. “It’s an impressive system.”

Source: https://www.wired.com/

Johnson & Johnson One-Shot Coronavirus Vaccine Approved in the U.S.

A Centers for Disease Control advisory panel on Sunday recommended Johnson & Johnson’s one-shot COVID-19 vaccine for people 18 and over, clearing the way for inoculations to begin as soon as this week. The recommendation comes one day after the Food and Drug Administration (FDA) on Saturday authorized Johnson & Johnson‘s COVID-19 vaccine for emergency use.

The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said Saturday.

The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The vaccine is the third to be approved for use in the U.S., and the first that requires only one shot. The FDA‘s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend authorizing the vaccine by Janssen, a division of Johnson & Johnson, on Friday. The committee provides expert advice to the FDA, but does not have final say on approval.

https://www.cbsnews.com/

Amazon is now selling COVID-19 tests for customers to use at home

The DxTerity COVID-19 Saliva at-Home Collection Kit detects the presence of the virus but does not confirm immunity or detect antibodies. DxTerity‘s molecular-based PCR test received approval from the Food and Drug Administration last month. The test differs from the quicker and less expensive antigen tests, which use a nasal swab or throat swab to detect the virus.

A single COVID-19 testing kit is listed for $110, and a 10-pack bundle is available for $1,000.

Test takers must spit into a tube provided by the kit. The saliva sample is then inserted into a plastic bag and packed back into the box for shipment to one of DxTerity‘s laboratories certified by the Clinical Laboratory Improvement Amendments. Customers are also granted prepaid express return shipping with the test and should expect to receive results within 24 to 72 hours of sample receipt at the laboratory. DxTerity’s test is currently the only COVID-19 testing kit on Amazon.

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We have demonstrated the reliability and quality of our COVID-19 testing solution with big business and now we want to expand access to customers at home and small businesses,” said Bob Terbrueggen, founder and CEO of DxTerity, when he first announced the collaboration with the company last month. “Amazon is the perfect partner for expanding access to millions of U.S. customers.”

The test may not be valid for all travel purposes because sample collection is unsupervised, according to the product description. The Centers for Disease Control and Prevention recommends saliva specimens should be collected under supervision.

Amazon joins other retail giants in offering at-home COVID-19 saliva tests. Costco offers both regular and those approved for travel requirements to Hawaii, Bermuda and some other destinations for $129.99 and $139.99, respectively. However, the test has several dozen one-star reviews, with most complaining about delayed shipping and poor customer service from provider AZOVA.

Source: https://eu.usatoday.com/

1st Long-acting HIV Drug Combo

U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus. The approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals.

That will enhance quality of life” to need treatment just once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s makers. “People don’t want those daily reminders that they’re HIV infected.”

Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.

The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva. The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shots to be sure the drugs are well toleratedViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things. Studies found that patients greatly preferred the shots.

Even people who are taking one pill once a day just reported improvement in their quality of life to switch to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults for ViiV and wrote a commentary accompanying one study of the drug in the New England Journal of Medicine. Deeks said long-acting shots also give hope of reaching groups that have a hard time sticking to treatment, including people with mental illness or substance abuse problems. “There’s a great unmet need” that the shots may fill, he said.

Source: https://www.pbs.org/

How Does an mRNA Vaccine Work?

The COVID-19 pandemic has brought unusual attention to everything from handwashing to polymerase chain reaction (PCR) tests. As we move into the later stages of this pandemic, though, a different scientific concept has dominated the national conversation: vaccines. The study of the human immune system and how vaccines influence it is complex and sometimes counterintuitive, and the deployment of a new method for immunization based on mRNA has made it all the more confusing.

The two vaccines that have received Emergency Use Authorizations (EUAs) from the Food and Drug Administration are both mRNA vaccines. And since they’re our only hope for ending this pandemic, it’s crucial to understand how they work—and why you should get one.

Vaccines come in a few main forms, but they share the same central goal: equip our immune systems with the tools to handily defeat a pathogen we might encounter in the future. Think of it like a practice round before your body sees the real thing.

The exact way our bodies develop this preemptive immunity depends on the kind of vaccine we’re given. Live-attenuated vaccines provide our cells with a weakened version of a pathogen; protein subunit vaccines give just one part of a bad guy, so immune cells know how to recognize that part of a virus or bacterium. But mRNA (short for messenger RNA) vaccines actually provide our cells with the instructions for making a protein from the pathogen, in essence creating their own practice dummy. Our own cells produce the viral protein specific to, say, SARS-CoV-2, and then our immune system learns to recognize the proteins.

Source: https://www.popsci.com/

Pfizer Says Its COVID-19 Vaccine Is 95% Effective

Pfizer and BioNTech said Wednesday that a final data analysis found their coronavirus vaccine was 95% effective in preventing COVID-19 and, in addition, appeared to fend off severe disease.

Vaccine, called BNT162b2, was highly effective against the virus 28 days after the first dose, and its effectiveness was consistent across all ages, races and ethnicities, the drugmakers said. Additionally, the elderly, who are seen as at high risk of severe illness from COVID-19, saw vaccine effectiveness of more than 94%, they added.

The final analysis underlines the results of the positive interim efficacy analysis announced on November 9,” BioNTech CEO Ugur Sahin said in a statement. “The data indicates that our vaccine … is able to induce a high rate of protection against COVID-19 only 29 days after the first dose. In addition, the vaccine was observed to be well-tolerated in all age groups with mostly mild to moderate side effects, which may be due in part to the relatively low dose.”

The vaccine also appeared to prevent severe disease in volunteers. There were 10 cases of severe cases of COVID-19 observed in the phase three trial, with nine of the cases occurring in the placebo group, the companies said. There were also no “serious” safety concerns, they said, with most adverse events resolving shortly after vaccination. The company’s shares jumped 3% in premarket trading.

The final analysis evaluated 170 confirmed COVID-19 infections among the late-stage trial’s more than 43,000 participants. The companies said 162 cases of COVID-19 were observed in the placebo group versus eight cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 95%, they said.

The news comes more than a week after the companies announced that their vaccine was more than 90% effective and two days after Moderna said preliminary phase three trial data showed its vaccine was 94.5%. Both vaccines use messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response.

A safe and effective vaccine is seen by investors and policymakers as a solution to get the global economy back on track after the pandemic wreaked havoc on nearly every country across the globe and upended businesses. The virus continues to spread rapidly, with more than 55.6 million cases worldwide and at least 1.33 million deaths as of Wednesday, according to data compiled by Johns Hopkins University.

Pfizer and BioNTech‘s initial results on Nov. 9 were based on the first interim efficacy analysis conducted by an external and independent Data Monitoring Committee from the phase three clinical trial. The independent group of experts oversees U.S. clinical trials to ensure the safety of participants. Medical experts note it remains unclear how long the vaccines will provide immunity and whether or how often people may need periodic booster shots.

These vaccines are going to be approved and then rolled out with basically a few months’ worth of data. You’re not going to do a two-year study to see whether it’s effective for two years with more than 200,000 people dying this year” in the U.S., Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said in a recent interview.

Pfizer said it plans to submit an application for emergency use authorization to the Food and Drug Administrationwithin days.” Pfizer CEO Albert Bourla said at Tuesday’s New York Times Dealbook conference that the company had accumulated enough safety data needed to submit the vaccine for review.

The companies reiterated that they expect to produce up to 50 million doses this year and up to 1.3 billion doses in 2021. They also said they are “confident” in their ability to distribute the vaccine, which requires a storage temperature of minus 94 degrees Fahrenheit. By comparison, Moderna‘s vaccine can be stored for up to six months at negative 4 degrees Fahrenheit.

Source: https://www.nbcdfw.com/

Moderna’s coronavirus vaccine is 94.5% effective

The Moderna vaccine is 94.5% effective against coronavirus, according to early data released Monday by the company, making it the second vaccine in the United States to have a stunningly high success rate.”These are obviously very exciting results,” said Dr. Anthony Fauci, the nation’s top infectious disease doctor. “It’s just as good as it gets — 94.5% is truly outstanding.”

Moderna heard its results on a call Sunday afternoon with members of the Data Safety and Monitoring Board, an independent panel analyzing Moderna‘s clinical trial data.
It was one of the greatest moments in my life and my career. It is absolutely amazing to be able to develop this vaccine and see the ability to prevent symptomatic disease with such high efficacy,” said Dr. Tal Zacks, Moderna‘s chief medical officer.

Vaccinations could begin in the second half of December, Fauci said. Vaccinations are expected to begin with high-risk groups and to be available for the rest of the population next spring.

The company says its vaccine did not have any serious side effects. A small percentage of those who received it experienced symptoms such as body aches and headaches.
Moderna plans to apply to the US Food and Drug Administration for authorization of its vaccine soon after it accumulates more safety data later this month.

Fauci says he expects the first Covid-19 vaccinations to begin “towards the latter part of December, rather than the early part of December.”

Pfizer And Biontech Announce Vaccine Against COVID-19

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

After discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after thed second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns. 

Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

Source: https://www.pfizer.com/

Coronavirus Vaccine: Moderna and Pfizer Final Test Results Imminent

Moderna should have enough data from its late-stage trial to know whether its coronavirus vaccine works in November, CEO Stephane Bancel said Thursday. The company could have enough data by October, but that’s unlikely, Bancel said during an interview on CNBC’s “Squawk Box.

If the infection rate in the country were to slow down in the next weeks, it could potentially be pushed out in a worst-case scenario in December,” he added.

Moderna is one of three drugmakers backed by the U.S. in late-stage testing for a potential vaccine. The other two are companies Pfizer and AstraZeneca.

Moderna‘s experimental vaccine contains genetic material called messenger RNA, or mRNA, which scientists hope provokes the immune system to fight the virus. In July, the company released early-stage data that showed its potential vaccine generated a promising immune response in a small group of patients.

Bancel’s comment came four days after the CEO of Pfizer said its vaccine could be distributed to Americans before the end of the year. CEO Albert Bourla told CBS’ “Face the Nation” that the company should have key data from its late-stage trial for the Food and Drug Administration by the end of October. If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses,” he said.

Source: https://www.cnbc.com/

Quick And Affordable Saliva-based COVID-19 Test

A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA).

The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA). SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing.

With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks, the researchers said. A key component of SalivaDirect, they note, is that the method has been validated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.

This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.”

Development of SalivaDirect as a means of rapidly expanding SARS-CoV-2 testing was spearheaded this spring by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health. After finding saliva to be a promising sample type for SARS-CoV-2 detection, they wanted to improve the method further.

The preprint on the development and validation of SalivaDirect was recently posted on medRxiv.

Source: https://news.yale.edu/