Researchers Warn of Heightened Risk of HIV With Certain COVID-19 Vaccines

As the race to approval of a safe and effective vaccine for coronavirus disease 2019 (COVID-19) continues, a group of researchers is warning some of these vaccines could make patients more susceptible to contracting HIV.

Writing in The Lancet, the researchers are urging caution when it comes to the use of adenovirus type-5 (Ad5) vectored vaccines for COVID-19, recalling their research from a decade ago on an Ad5 vectored vaccine in 2 HIV vaccine trials.

“On the basis of these findings, we are concerned that use of an Ad5 vector for immunisation against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could similarly increase the risk of HIV-1 acquisition among men who receive the vaccine,” wrote the researchers. “Both the HIV and COVID-19 pandemics disproportionately affect vulnerable populations globally. Roll-out of an effective SARS-CoV-2 vaccine globally could be given to populations at risk of HIV infection, which could potentially increase their risk of HIV-1 acquisition.”

There are several clinical trials assessing Ad5 vectored vaccine candidates underway, including by China’s CanSino Biologics and California-based ImmunityBio.

The group’s ”cautionary tale” stems from the Step and Phambili phase 2b trials that studied the efficacy of an Ad5 vectored HIV-1 vaccine in preventing HIV infection. Across both international studies, they found that the vaccine actually increased the risk of HIV among the vaccinated men.

The findings from the Phambili study, in particular, have important implications for the use of the vaccines in COVID-19, according to the researchers, as findings from this study showed that heterosexual men receiving the Ad5 vectored vaccine faced a consistently increased risk of HIV infection. Notably, this increased risk appeared to be limited to men, with women not having an observed increase of infection in the study.

In the Step trial, the risk of acquiring HIV was particularly high among men who were uncircumcised and Ad5 seropositive men who reported having unprotected anal sex with a partner who was HIV seropositive or who had unknown serostatus as baseline.

Of note, the vaccine in both studies did not have the HIV envelope. Meanwhile, in another study that used a DNA prime and an Ad5 vector, both of which had the HIV envelope, there was no observed increase in HIV infection.

The reason for the observed increase in HIV risk remains uncertain, although several follow-up studies have suggested a potential explanation, according to the researchers.

“The vaccine was highly immunogenic in the induction of HIV-specific CD4 and CD8 T cells; however, there was no difference in the frequency of T-cell responses after vaccination in men who did and did not later become infected with HIV in the Step Study,” they wrote. “These findings suggest that immune responses induced by the HIV-specific vaccine were not the mechanism of increased acquisition.

Participants with high frequencies of preimmunisation Ad5-specific T cells were associated with a decreased magnitude of HIV-specific CD4 responses and recipients of the vaccine had a decreased breadth of HIV-specific CD8 responses, suggesting that pre-existing Ad5 immunity might dampen desired vaccine-induced responses.”

Other exploratory studies have indicated that the vaccine enhances HIV replication in CD4 T cells or that Ad5-specific CD4 T cells could be more susceptible to HIV infection.

Jaime Rosenberg

Reference

Buchbinder SP, McElrath MJ, Dieffenback C, Corey L. Use of adenovirus type-5 vectored vaccines: a cautionary tale. Lancet. Published online October 19, 2020.doi:10.1016/S0140-6736(20)32156-5

Source: http://ajmc.com

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ENewsTrends

A new paper warns the link between COVID-19 vaccines and HIV risk.

Mayo Clinic

Nearly half of people in the U.S. diagnosed with HIV, the virus that causes AIDS, are over 50, according to the Centers for Disease Control and Prevention (CDC). HIV damages the body’s immune system, and interferes with the body’s ability to fight infection and disease. Does that make it more difficult to fight off COVID-19? Dr. Stacey Rizza, an infectious diseases specialist at Mayo Clinic, says, “We know that anybody who has a suppressed immune system may have an altered response to the virus that causes COVID-19. We know that older people whose immune systems are a little weaker, and people who have medical issues or organ diseases, are going to generally do worse with the infection.

If somebody has HIV and their immune system is weaker, meaning they’re not on therapy, or they’re earlier on in their therapy and their CD4 count is still low, they may be at risk of having a worse reaction to the virus. We will learn more about SARS-CoV-2 on people living with HIV over time.” Read more: https://newsnetwork.mayoclinic.org/di… More health and medical news on the Mayo Clinic News Network. https://newsnetwork.mayoclinic.org/ Journalists: Clean and nat sound versions of this pkg available for download at https://newsnetwork.mayoclinic.org/ Register (free) at https://newsnetwork.mayoclinic.org/re…

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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.

Gilead Testing Inhaled Form Of Remdesivir That Could Be Used To Treat Covid-19 Outside Hospital

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Gilead is launching a phase 1 clinical trial of an inhaled version of remdesivir, a drug used to treat Covid-19, that could be administered to patients outside of the hospital, it said in a statement released Wednesday.

KEY FACTS

Though there are no drugs approved by the FDA to treat Covid-19, Remdesivir is one of the more promising candidates and was granted an Emergency Use Authorization in May to treat patients with severe cases of the disease.

In the hospital remdesivir is given intravenously, but the new trial will test whether it is effective if breathed directly into the lungs.

The medication would be given to patients through a nebulizer, a device commonly used to treat asthma that turns liquid medication into a breathable mist.

 

If inhaled remdesivir is successful, it could be an at-home or doctor’s office treatment for patients who are not sick enough to need hospitalization, but still could benefit from medication.

The new trial will include approximately 60 adults, and will test first for safety and tolerability of the inhaled medication.

 

Key Quote

“Based on current scientific understanding, the upper respiratory tract is the most prevalent site of SARSCoV-2 infection early in disease,”  said Gilead’s Chief Medical Officer Merdad Parsey in a statement. “Delivering remdesivir directly to the primary site of infection with a nebulized, inhaled solution may enable more targeted and accessible administration in non-hospitalized patients.”

Background

While many medications have been tested to see if they can treat Covid-19, almost none have been successful so far. Some studies have shown that remdesivir, an antiviral medication developed by Gilead, can help patients recover faster from severe Covid-19 in the hospital — but more research still needs to be done. One study found that patients treated with remdesivir recovered from Covid-19 about four days faster than those treated with a placebo, and had a 7.1% risk of mortality compared to 11.9%. In early June, the U.S. received criticism for buying the world’s supply of the drug, leaving some to wonder what other countries would do if they need it for Covid-19 treatment. Late last month the pricing of remdesivir was revealed: private insurance companies in the U.S. will be charged $3,120 for a course of treatment, or $520 per vial.

Full coverage and live updates on the Coronavirus

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I am the assistant editor of healthcare and science at Forbes. I recently graduated from UC Berkeley with a Master’s of Journalism and a Master’s of Public Health, with a specialty in infectious disease. Before that, I was at Johns Hopkins University where I double-majored in writing and public health. I’ve written articles for STAT, Vice, Science News, HealthNewsReview and other publications. At Forbes, I cover all aspects of health, from disease outbreaks to biotech startups.

Source: http://www.forbes.com

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