FDA Offers Tips To Avoid Coronavirus Vaccine Scams

Americans are anxiously anticipating approval and public distribution of a COVID-19 vaccine to inoculate the masses and return to normalcy — and scammers are standing by.

Government agencies like the Federal Trade Commission, Department of Homeland Security, and Food and Drug Administration have issued warnings to Americans to be wary of groups or individuals offering COVID-19 vaccines or cures because a vaccine has yet to be approved by the FDA.

So far, the FDA has only approved the antiviral drug remdesivir as a treatment for COVID-19.

“Unfortunately, some people and companies are trying to profit from the challenge of this pandemic by selling unproven products that make false claims, such as being effective against COVID-19,” according to a public service announcement from the FDA. “These fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family.”

Here are a few tips to keep in mind to avoid falling victim, according to the FDA and the Department of Homeland Security, as reported by the AP:

  • Products marketed for veterinary use, or “for research use only,” or otherwise not for human consumption, have not been evaluated for safety and should never be used by humans.
  • Be suspicious of products that claim to treat a wide range of diseases.
  • Personal testimonials are no substitute for scientific evidence.
  • Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”
  • If it seems too good to be true, it probably is.
  • “Miracle cures,” which claim scientific breakthroughs or contain secret ingredients, are likely a hoax.
  • Always consult a licensed medical professional to obtain a COVID-19 vaccine or treatment.
  • Make sure your doctor has been approved to administer the vaccine.
  • Do not buy COVID-19 vaccines or treatments over the internet or through an online pharmacy.
  • Ignore large, unsolicited offers for vaccinations and miracle treatments or cures.
  • Don’t respond to text messages, emails, or calls about vaccines and treatments.
  • Be wary of ads for vaccines and treatments on social media.

The FDA is working to protect Americans from these “unapproved products with false or misleading claims about COVID-19” by issuing warning letters and pursuing seizures, injunctions, or criminal prosecutions against products, firms, or individuals who violate the law.

Similarly, the U.S. Immigration and Customs Enforcement (ICE) said Monday it’s launching new efforts to find and prevent the production, sale, and distribution of unapproved or unauthorized COVID-19 products and drugs.

AdChoices

“Special agents anticipate that criminal organizations will continue to adapt and capitalize on public demand for access to vaccines and treatments as they are developed and approved,” according to an ICE press statement. “With that, the agency expects a surge in illicit attempts to introduce counterfeit versions of approved vaccines into U.S. and global marketplaces.”

This type of criminal activity is not new during the pandemic.

Shortly after the country went into lockdown this spring to stave off the spread of the coronavirus, fraudsters jumped to action, trying to make a buck off the unwitting and anxious. Scammers then peddled highly-coveted items like PPE, test kits, hand sanitizer, and alleged antidotes, while others intercepted stimulus checks.

Read more: Coronavirus stimulus check scams: How to avoid becoming a victim

Since the pandemic’s outset, over 257,800 fraudulent coronavirus-related reports have been filed, amounting to an estimated $190 million in losses, according to the FTC. The majority of activity comes from online shopping and the FTC has come down on counterfeit websites claiming to sell cleaning products, sending over 300 warning letters to companies profiting off of spurious claims and purported COVID treatments.

The Better Business Bureau also issued a warning last month about text and email messages to enroll in phony clinical COVID-19 studies. The message would advertise compensation of up to $1,000 and more if you click on the link to register. The link would either download malware onto your computer or phone or send you to a registration page asking for your personal information.

“No matter how curious you are — or how much you could use an extra $1,200 — don’t click,” the BBB warned. “It’s a scam!”

Stephanie Asymkos is a reporter for Yahoo Money and Cashay, a new personal finance website. Follow her on Twitter @SJAsymkos.

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CBS This Morning

The Justice Department has filed its first enforcement action against alleged coronavirus fraud. It obtained a temporary restraining order Sunday against the website coronavirusmedicalkit.com. Prosecutors say the site claimed to offer consumers access to vaccine kits from the World Health Organization, but there are currently no vaccines for the disease. Anna Werner joins “CBS This Morning” to explain how to avoid the scam and others like it. Watch “CBS This Morning” HERE: http://bit.ly/1T88yAR Download the CBS News app on iOS HERE: https://apple.co/1tRNnUy Download the CBS News app on Android HERE: https://bit.ly/1IcphuX Like “CBS This Morning” on Facebook HERE: http://on.fb.me/1LhtdvI Follow “CBS This Morning” on Twitter HERE: http://bit.ly/1Xj5W3p Follow “CBS This Morning” on Instagram HERE: http://bit.ly/1Q7NGnY Get new episodes of shows you love across devices the next day, stream local news live, and watch full seasons of CBS fan favorites anytime, anywhere with CBS All Access. Try it free! http://bit.ly/1OQA29B Each weekday morning, “CBS This Morning” co-hosts Gayle King, Anthony Mason and Tony Dokoupil deliver two hours of original reporting, breaking news and top-level newsmaker interviews in an engaging and informative format that challenges the norm in network morning news programs. The broadcast has earned a prestigious Peabody Award, a Polk Award, four News & Documentary Emmys, three Daytime Emmys and the 2017 Edward R. Murrow Award for Best Newscast. The broadcast was also honored with an Alfred I. duPont-Columbia Award as part of CBS News division-wide coverage of the shootings at Sandy Hook Elementary School in Newtown, Connecticut. Check local listings for “CBS This Morning” broadcast times.

Why Scientists & Public Health Officials Need To Address Vaccine Mistrust Instead of Dismissing it

Recent polls indicate that more than a third of the country has concerns about a vaccine that in all likelihood will be the only reliable way to end to the COVID-19 pandemic.

These results reflect a similar public sentiment in the U.S. in the 1950s when a polio vaccine was introduced. There are likely multiple reasons for this suspicion, including safety concerns, lack of transparency from the scientific community, lack of trust in the government and the desire to wait until a longer track record of safety can be established.

We are experts in media literacy, health and political communication and biostatistics and biomedical research for future health care providers, from Washington State University’s Edward R. Murrow Center for Media & Health Promotion Research and the Elson S. Floyd College of Medicine. We also live in the communities we hope to serve with our science.

Based on our research, we believe that officials need to use this testing period to build trust, not to create reasons for diminishing it. Respect and forthrightness can turn the tone from adversarial to collaborative, and from a provider-directed practice to a shared decision-making process. Scientists and public health officials must anticipate and address people’s concerns and not brush aside concerns, a process that has become commonplace across other areas of the provider-patient relationship, but vaccine decisions remain a notable exception.

Vaccines and complications

Vaccines are among the safest, most transformative drugs on Earth, with adverse events so low that very nearly universal vaccination is a reasonable expectation. With such a safety record, and with so much at risk with diseases like COVID-19, measles and influenza, vaccine advocates have good reason to stress the overwhelmingly positive safety record.

History has included some vaccines of questionable quality as well as vaccination tactics of even more concern. Certain minority groups have been targeted with egregious coercion. This included cases of forced vaccination for smallpox of African Americans at gunpoint in the southern United States in the early 1900s. At a tenement house in Manhattan’s Little Italy, over 200 men in 1901 in essence performed a smallpox vaccination raid in the middle of the night, trying to vaccinate as many people as they could.

When the miracle vaccine for polio was widely distributed in 1955, speed took precedent over safety, and many doses were distributed that contained live polio virus. As a result, 70,000 children developed muscle weakness, 164 were paralyzed permanently and 10 children died. This led to direct government intervention that has led to thousands of required tests in order to ensure safety and effectiveness.

Why can’t vaccines bounce back from mistakes?

As medical and public health researchers, we have found it interesting that corporations that have been lax and dishonest have bounced back without lasting damage to their reputations. For example, Volkswagen was caught in 2014 for outright lying to the public about their emissions. By 2019, the company topped its prescandal sales record of 2014.

We accept these occasionally fatal flaws and ethical missteps because cars are essential to our lives. The documented safety record of vaccines is staggering, not unlike the impressive safety record boasted by most automobiles on the road today.

Why do vaccines get special scrutiny? Have scientists and health care providers engaged in scientific snobbery by assuming people should do what we advise, without question or any decision-making process? Can scientists and health care providers communicate the good and positive (and bad) background of vaccines better? Has social media sown doubt in an authority that can be perceived to be overconfident? Personal health care decisions have a lasting impact on our kids and our families, so let’s rise to the occasion and utilize this unique opportunity to reframe the conversation about vaccines.

Embrace shared decision-making

The existence of a little-known but critical government office both acknowledges past problems with some vaccines and also provides a method of recourse for those injured by vaccines. The National Vaccine Injury Compensation Program, launched in the 1980s, is a powerful tool for transparency and accountability that should help shape this important, shared decision-making process. For example, between 2006 and 2018 over 3.7 billion doses of covered vaccines were distributed in the U.S. During this same period, 5,233 filed petitions to this office were compensated out of a total of 7,482 petitions. This means that for every 1 million vaccine doses distributed, one individual received compensation.

Rather than brushing off concerns among parents and others who are concerned about safety, experts should listen. When they do talk, they should explain safety issues and should use metaphors such as the safety of vehicles and other medical breakthroughs (e.g., insulin, heart valve surgery) so often relied upon in an effort to work toward the same goal together as a country, and as health care provider and patient.

Experts should acknowledge that the practice of medicine and public health research is a relatively new field of science to drive public health, medical practice advancement and policies when compared to other, far more established scientific disciplines such as physics or chemistry. Building public support requires more than citing solid evidence in the peer-reviewed scientific literature. Owning up to setbacks in vaccine development that the current administration may be on the brink of repeating – and then making the necessary repairs to move forward again, as the auto manufacturers do – also builds confidence. AstraZeneca’s public announcement about a serious adverse event in one of their trials, which led to a pause of participant enrollment, was a great first step.

Let’s begin by acknowledging that all parties want to achieve the same end goal of a healthy, safe return to daily life. Despite the explosion of misinformation about COVID-19, a clear, consistent and respectful approach can reset the vaccine conversation.

[Deep knowledge, daily. Sign up for The Conversation’s newsletter.]

Next, let’s acknowledge that vaccines are not now and have not been 100% perfect (nor is any medicine or car). We should also note that the same science that produces vaccines also produces myriad breakthroughs in specialties such as cardiology and oncology, along with over-the-counter medications such as ibuprofen that mitigate minor ailments but also have limitations and warning labels.

Finally, invite skeptics to a conversation and acknowledge up front that, like any other scientific advancement of things that now work, there was a time when they didn’t work as well, or at all.

Instances like these undoubtedly fuel people’s concerns. Such occurrences should give us all pause, scientist or not, to do better next time and strive to never repeat such notable grievances.

By: Sterling M. McPherson/ Associate Professor, Director and Assistant Dean for Research, Washington State University

Erica Weintraub Austin/ Professor and Director, Edward R. Murrow Center for Media & Health Promotion Research, Washington State University

Porismita Borah/Associate Professor, health communication, Washington State University

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CBC News: The National

Misinformation about vaccines have public health officials in Canada looking for guidance on how to combat medical mistrust. As CBC’s Katie Nicholson reports, the answers they are looking for might be half a world away. »»» Subscribe to The National to watch more videos here: https://www.youtube.com/user/CBCTheNa… Voice Your Opinion & Connect With Us Online: The National Updates on Facebook: https://www.facebook.com/thenational The National Updates on Twitter: https://twitter.com/CBCTheNational »»» »»» »»» »»» »»» The National is CBC Television’s flagship news program. Airing six days a week, the show delivers news, feature documentaries and analysis from some of Canada’s leading journalists.

Covid Vaccine Frontrunner Moderna Says Vaccine Won’t Be Approved Until Spring 2021

Pharmaceutical company Moderna, one of the companies in the lead pack in the race to develop a coronavirus vaccine, won’t be in a position to widely distribute it until at least next spring, CEO Stéphane Bancel told the Financial Times, echoing public health experts who predict a similar timeline for other vaccine candidates.

Key Facts

“November 25 is the time we will have enough safety data to be able to put into an emergency use authorization file that we would send to the FDA,” Bancel said, adding that an approval wouldn’t be expected until late first quarter or early second quarter of 2021.

The timeline matches up with what public health experts have previously laid out, which is that a vaccine could be found to be safe and effective by the end of the year at the earliest but widespread distribution wouldn’t occur until further into 2021.

One of the frontrunners to develop a safe vaccine first, Moderna earlier in the month said it was slowing its trial enrollment to ensure it was representing disproportionately affected minority groups but later added it could have enough data by November to know if its vaccine candidate works.

The comments follow Trump’s claim during Tuesday’s U.S. presidential debate that, “We’re weeks away from a vaccine,” citing Moderna as well as Pfizer and Johnson & Johnson.

Pfizer is another frontrunner—Johnson & Johnson are further behind their late-stage clinical trials—and while its CEO Albert Bourla said it will have an “answer” by the end of October on its candidate’s efficacy, a spokesperson for the company later told the New York Times that Pfizer wouldn’t be close to the completion of its clinical trial by then.

There are currently 11 vaccines in expansive Phase 3 clinical trials, according to data from the Times.

Chief Critic

Trump has pushed the notion that a vaccine will be ready before the November election, fueling fear in the U.S. that anything approved could have been rushed. Even with wide distribution of a vaccine, the upwards of 60% to 70% will need to be immunized to put an end to the pandemic. That could take until 2022, according to billionaire and philanthropist Bill Gates and Dr. Soumya Swaminathan, the World Health Organization’s chief science officer.

Key Background

A Covid-19 vaccine is being developed at an unprecedented speed, with a typical immunization taking 10 years to develop, test, approve and distribute. The U.S. leads the world in confirmed cases of the coronavirus with 7,221,278, as well as reported deaths with 206,693. In total, there are 33,802,841 global infections and 1,010,477 deaths.

Full coverage and live updates on the Coronavirus…Follow me on Twitter. Send me a secure tip

Matt Perez

Matt Perez

I cover breaking news and also report on the video game industry. I previously wrote for sites like IGN, Polygon, Red Bull eSports, Kill Screen, Playboy and PC Gamer. I also managed a YouTube gaming channel under the name strummerdood. I graduated with a BA in journalism from Rowan University and interned at Philadelphia Magazine. You can follow me on Twitter @mattryanperez.

The Covid Vaccine Will Require Billions of Tiny Glass Vials & This Italian Billionaire Family Is Making Them

At the height of Italy’s lockdown in April factories were shuttered across the country. But in Piombino Dese, a small town about20 miles outside of Venice, the hulking glass-cutting machines at the Stevanato Group kept whirring along, spitting out millions of ampoules and syringes. Hundreds of employees donned face masks to work around the clock in three daily shifts, seven days a week – making everything from insulin pen cartridges to miniature glass barrelsand — most pressingly — millions of tiny sterile vials, each one smaller than a single fluid ounce, that one day will house doses of a Covid-19 vaccine.

“Every Saturday and Sunday, even on Easter, I went to work alongside my employees to show that we were in the trenches as well,” says Franco Stevanato, the 46-year-old CEO of the group and grandson of its founder, Giovanni.

Vaccines, like most injectable drugs, need to be packaged in sterile glass. Glass is essentially impermeable to corrupting gases like oxygen while even high-grade plastic lets some air inside. Making these vials was a big business even before Covid-19 appeared in January. Last year, the global pharmaceutical industry purchased some 12 billion vials. The Stevanato Group, a 71-year-old family-owned firm, provided more than 2 billion of those (The company is also the world’s largest manufacturer of cartridges for insulin pens). A Covid-19 vaccine, which likely will have to be administered in two separate injections, will require billions of additional vials. Stevanato expects the pandemic to drive up demand for its glass vials by 20% over the next two years.

“We proactively started to supply our customers with everything they wanted [to fight] Covid-19,” says Franco. “There was no magic strategy. We tried to move quickly and took enormous risks by anticipating some investments, because it was the right time to do it.”

Other than making the actual glass, which they buy from big outfits like Corning and Schott, Stevanato does it all. They design the vials. They make the machines that craft and sterilize the containers. They work with medical regulators in 150 different markets around the world. And then many of their customers use Stevanato-made machines to package the drugs before shipping them to pharmacies and hospitals.

Those machines are a key differentiator. In 2007, when French pharma giant Sanofi needed a supply of sterile syringes that could quickly hit the market, Stevanato developed a ready-to-use syringe that didn’t require any additional sterilization. Stevanato built its own machines to wash and sterilize the syringes and patented the whole process, creating a product line that is now one of the company’s top earners.

“They really value quality and they really value customers and connecting the customer needs to their products,” says Ron Verkleeren, who manages the life sciences division at Corning and has worked with Stevanato since 2011. “That really sets them apart from the competition.”

It’s a solid, if unspectacular, business. In 2019, Stevanato netted $47 million on $675 million sales. Forbes estimates that Sergio Stevanato, the 77-year old company president and son of the founder, owns a 68% stake worth $1.8 billion. Sergio’s sons, Franco (the CEO) and Marco, the 47-year-old vice chairman, run the place now. Each own 16%, worth more than $400 million apiece.

Big changes are afoot. In June, the group raised $59 million in a private debt placement, the first time the company had ever sought outside funding. They plan to use the money to develop wearable medical devices and machines to automatically assemble them. And the family has plans to take the company public within the next three years.

“The banks we’re working with want us to go public earlier, but I want to do it when I feel sure, regardless of Covid-19,” says Franco.


Stevanato has been ramping up for a Covid-19 vaccine for months. The firm hired more than 580 new workers in the first six months of 2020. In late June, Stevanato signed a deal with Norway’s Coalition for Epidemic Preparedness and Innovations (CEPI), a Gates Foundation-backed group that is assisting with scalingnine different Covid-19 vaccine projects — including efforts by Boston-based biotech Moderna and Oxford University — to supply 100 million borosilicate glass vials for up to 2 billion doses of vaccine.

Borosilicate glass can withstand much higher temperatures than other types of glass and is more resistant to external chemicals, making it the glass of choice for sensitive medicines like vaccines. Stevanato is also supplying several other significant vaccine efforts it can’t currently disclose, along with 30 more in early stages of development. Altogether, that’s more than a fifthof the 176 vaccines in the works around the world.

“We talked with every glass producer and the Stevanato Group was the only group that still had uncommitted glass [vial production] capacity,” says Jim Robinson, deputy chair of CEPI’s scientific advisory committee. “They had the prize that everyone wanted.”

Vaccines face much tougher regulatory barriers than most other medicines and need to be stored in sterile glass vials and syringes, says Verkleeren of Corning. “A lot of drugs degrade in the presence of oxygen. It would take millions of years for one molecule of oxygen to permeate glass, and it would take minutes for it to go through plastic,” he says. “Quality and sterility are really, really important, because if it’s not sterile, or there’s a quality problem, and you’re injecting something into the body, it can be very, very serious.”


The Stevanato Group was founded on the outskirts of Venice, a city with a long tradition of glassblowing, in 1949 to make bottles for wine and perfume. The firm, originally called Soffieria Stella, grew as the postwar Italian economy boomed. By 1959, they needed more space so they relocated to Piombino Dese, an industrial town situated on the confluence of five rivers.

As food producers began to switch to plastic in the 1960s, Giovanni Stevanato took a risk and doubled down on glass, developing a machine capable of rapidly producing containers from glass tubing at scale. The 3BS machine, named after Stevanato and his three co-inventors — Bormioli, Bottaro and Bardelli — enabled the firm to double production and target a new market: the growing pharmaceutical industry. In the early 1970s, the family shut down Soffieria Stella entirely, cementing its pivot to medical glass packaging.

“The first decades were very difficult,” says Franco, particularly because the family shunned outside investment. But they made headway. “By making our own machines, we could produce 50% to 60% more than our competitors. Because my father reinvested all our profits into the company, we could advance our technology faster than the others. [They] would buy their technology in Germany, but we could double their production with the same number of employees.”

Franco and Marco entered the family business in 1998 in their mid-twenties, two years after the death of Giovanni. The first order of business: rebuffing a series of acquisition offers from larger competitors. The second order: Expanding the company abroad. In 2008, the family opened its first overseas plant — in Monterrey, Mexico — to target the North American market. Stevanato now has a network of 12 factories on four continents. In 2016 the group entered the U.S. for the first time, via its acquisition of German plastic packaging firm Balda for $112 million, which has two facilities in southern California.

One advantage of providing complex, specially designed packages is that they are patented and included in the regulatory approval process for new drugs, meaning that pharmaceutical firms must use the company’s packaging for the duration of the product’s lifespan. According to Aaron DeGagne, healthcare analyst at Morningstar, this effectively locks in business for decades, because drug producers often continue to use the same packaging—even after the medicine’s patent expires and it becomes a generic drug.

Spinning a sleek, Stevanato-made insulin pen between his fingers during an interview via video, Franco spells out a future in which his family firm expands into more complex products. “Now we have [insulin] pens, and tomorrow the devices will be more self-medicating, analyzing…and much more evolved,” he explains. For example, a cancer patient may be able to self-administer drug infusions at home. “This is the big challenge we want to dive into over the next 10 to 20 years.”

Giacomo Tognini

Giacomo Tognini

I cover billionaires and their wealth for Forbes. In the past, I’ve covered everything from oil & gas for Bloomberg News to the 2014 Indonesian presidential election for the Jakarta Globe. I’m a graduate of Columbia Journalism School and UC Berkeley, and my work has also appeared in the Houston Chronicle, the Calgary Herald, and more…

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