We’ve seen the Alpha, Kappa and Delta variants cross our borders, but it turns out another strain of the virus that causes COVID-19 has reached our shores.
The Lambda variant is one of 11 official SARS-CoV-2 variants recognised by the World Health Organization
It was first detected in Peru and has spread to 29 countries, including Australia
A new study that has yet to be peer-reviewed found signs that the variant could be more infectious and harder to tackle with vaccination, but it’s early days
The variant, named Lambda by the World Health Organization (WHO) last month, was detected in an overseas traveller who was in hotel quarantine in New South Wales in April, according to national genomics database AusTrakka.
Some reports suggest the new variant could be fast spreading and difficult to tackle with vaccines. So what sets this variant apart from others and should we be concerned?
A Chilean team of scientists analysed blood samples from health workers in Santiago who had received two doses of the CoronaVac vaccine developed by Sinovac Biotech in China.
They found the Lambda variant has a mutation called L452Q, which is similar to the L452R mutation seen in the Delta and Epsilon variants.
As the L452R mutation is thought to make Delta and Epsilon more infectious and resilient against vaccination, the team concluded that Lambda’s L452Q mutation might also help it spread far and wide.
While it’s possible that Lambda is indeed more infectious than other variants, it’s too early to know for sure, said Kirsty Short, a virologist at the University of Queensland.
“It’s very preliminary,” said Dr Short, who was not involved in the study.
“It’s a good starting point, but I certainly wouldn’t infer anything from that into the clinic.”
Are vaccines still effective against the Lambda variant?
The study also found signs that Lambda’s unique spike mutations could help it slip past the body’s immune response.
The results of the study suggested that the CoronaVac vaccine produces fewer neutralising antibodies — proteins that defend cells against infections — in response to the Lambda variant.
But according to Paul Griffin, who specialises in infectious diseases and vaccines at the University of Queensland, it’s important to remember that these antibodies are just one aspect of immunity.
“We know that [neutralizing antibodies] only tell a part of the story,” said Dr Griffin, who was not involved in the study.
“If that further immunity remains intact, then even with a reduction in neutralizing antibodies, sometimes that protection can still be enough.”
It’s also worth remembering that different vaccines work in different ways to respond to the virus and its variants.
“You can’t really extrapolate from one vaccine,” Dr Short said.
CoronaVac uses inactive versions of SARS-CoV-2 to kick the immune system into gear.
On the other hand, Pfizer contains a single strand of the genetic code that builds the virus’s spike proteins, while AstraZeneca contains a double-strand.
Dr Griffin said that more traditional inactivated vaccines like CoronaVac have proven to be less effective overall than others.
“As a broad category, the inactivated ones have been a little bit underwhelming, particularly compared to others that have such high rates of efficacy,” said Dr Griffin, who was not involved in the study.
While not much is known about how effective the Pfizer and AstraZeneca vaccines are against Lambda, their response to the Delta variant can offer clues.
A recent study from the UK found that two doses of either Pfizer or AstraZeneca are over 90 per cent effective at preventing hospitalisation due to the Delta variant.
Should Australia be worried?
While there has only been one case of Lambda recorded in hotel quarantine in Australia so far, it’s worth keeping an eye on the emergence and spread of SARS-CoV-2 variants around the world, Dr Short said.
“There’s a reason why it’s a variant that we’re watching and looking into more, but it’s certainly not at a point of panic or anything like that.”
Dr Griffin added that Lambda would need to out-compete Delta to become a major concern. “That’s certainly not what we’re seeing,” he said. But as more people get infected, the more chance the virus has to evolve into new variants, Dr Short said.
The best way to tackle this is to focus on getting more people vaccinated, not just in Australia, but globally. “What this should emphasise to everyone is that we need global effort in the vaccination campaign,” Dr Short said.
Pharma giant AstraZeneca could face strict new export rules from the European Union that could restrict supply of its Covid-19 vaccine outside the bloc, as officials pressure the company to explain production shortfalls, while the company denies claims in German media that its vaccine is mostly ineffective in seniors.
Citing government sources, two German papers reported Monday that the efficacy of the vaccine AstraZeneca developed with the University of Oxford was “less than 10%” and 8% in those over 65.
AstraZeneca said the claims are “completely incorrect” and go against published data from its clinical trials which showed a significant response in over-65s..
Oxford University , which developed the vaccine with AstraZeneca, told the Financial Times there is “no basis for the claims of very low efficacy.”
The German health ministry also rejected the reports Tuesday, suggesting that the newspapers had got confused with the statistics.
The confusion comes as tensions between AstraZeneca and the European Union soar to new levels, with the bloc furious at the company’s apparent inability or refusal to explain why it cannot honor its agreements and threatening to introduce new export rules for vaccines leaving the Union.
Forbes has contacted AstraZeneca to find out whether its supply chain issues and export rules could threaten vaccine supply to other parts of the world.
On Friday, AstraZeneca informed Brussels that production issues meant it would be unable to honor its contractual commitments to provide doses to the EU. The vaccine is expected to be approved shortly and the delays mark another setback for the bloc’s vaccination efforts, which are already being hampered by a temporary reduction in deliveries from Pfizer while it makes changes to its production site.
The EU stopped short of directly accusing AstraZeneca of reneging on its contracts in order to sell doses elsewhere, but said: “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered,” Stella Kyriakides, the European Commissioner for Health and Food Safety, said in a statement.
Later, Kyriakides tweeted that discussions with the pharma giant “resulted in dissatisfaction” and there was a “lack of clarity and insufficient explanations.
What To Watch For
The EU may follow through on its threat to implement new vaccine export rules. This would require companies to seek permission before exporting internationally.
31 million. This is how many doses the bloc is now expecting before the end of March, an EU official told Reuters. That amounts to a 60% cut.
I am a London-based reporter for Forbes covering breaking news. Previously, I have worked as a reporter for a specialist legal publication covering big data and as a freelance journalist and policy analyst covering science, tech and health. I have a master’s degree in Biological Natural Sciences and a master’s degree in the History and Philosophy of Science from the University of Cambridge. Follow me on Twitter @theroberthart or email me at email@example.com
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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.
“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.
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.
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.
AstraZeneca scientist Mene Pangalos says ‘serendipity,’ led to a break through
‘Mistake’ helped scientists discover half-dose was more effective than a full one
More analysis needed to explain why an initial lower dose was more effective
A dosing error by researchers on the AstraZeneca-Oxford University Covid vaccine trial led to a huge boost in the jab’s success rate, the pharmaceutical company’s vice president has revealed.
Dr Mene Pangalos, head of AstraZeneca’s biopharmaceutical research, said the discovery that giving a half-dose at the start worked better was a lucky accident. He said: ‘The reason we had the half dose is serendipity.’
Volunteers were expected to receive two full doses of the vaccine. What happened with these participants would then be compared with the other half of the study group, who received a placebo.
Dr Pangalos said researchers were confused when they noticed volunteers in the vaccine group were reporting much milder side effects, such as fatigue, headaches and arm aches, than they originally predicted.
He said: ‘So we went back and checked … and we found out that they had underpredicted the dose of the vaccine by half.’
Study results published yesterday showed that Oxford’s vaccine appeared to be up to 90 per cent effective in people who received the vaccine as a half-dose followed up by a full dose weeks later, compared to a lower 62 per cent when they were given two full doses.
Scientists explained this could be because the first smaller dose effectively prepared the immune system by showing it a small sample of the coronavirus, and then the full dose later on triggered a full-blown immune response.
Dr Pangalos said that despite the error the team decided to press ahead with the half-dose group, and to administer the second, full dose booster shot at the scheduled time.
The results showed the vaccine was 90 per cent effective among this group, while a larger group who had received two full doses produced an efficacy read-out of 62 per cent, leading to an average efficacy of 70 per cent across both dosing patterns, Dr Pangalos said.
‘That, in essence, is how we stumbled upon doing half dose-full dose (group),’ he told Reuters. ‘Yes, it was a mistake.’
It is now likely that doctors will be advised to use the 1.5 dose regimen of the vaccine rather than the full two doses because it appears to be more effective.
This will also mean that the jab, expected to cost around £2 per dose, will stretch further.
The 100million doses pre-ordered by the UK, for example, would have covered 50million people using a full two-dose system, but could now stretch to the entire population of 66million.
Although the clinical trial’s early results were published yesterday, the study is not completed.
Oxford researchers said they intend to publish the full results of the trial in a medical journal in the coming weeks and will then submit an application to the drugs regulator, the MHRA, for a licence to use the vaccine on members of the public.
This process could then take days or weeks for the MHRA to decide whether the jab is good enough to use before it can start to be given out – this is currently expected to be completed in December.
The vaccine uses a harmless adenovirus to deliver genetic material that tricks the human body into producing proteins known as antigens that are normally found on the coronavirus’s surface, helping the immune system develop an arsenal against infection.
Dr Pangalos said more analysis was needed to explain why an initial lower dose bolstered protection.
One possible explanation was that lower antigen levels to begin with triggered an overall better immune system build-up, he added.
Oxford University confirmed its cheap, easy to store and simple to deliver jab could be approved by regulators in as little as a fortnight and start to be administered next month.
Britain has ordered 100million doses, with almost 20million due by Christmas.
Professor Andrew Pollard, head of the Oxford Vaccine Group and a professor who has spent two decades running clinical trials, said that while speed of the Covid-19 vaccine’s development was in some ways extraordinary, 2020 had ‘been a very long year’ since the team started work on the vaccine in January.
That culminated this past weekend, Pollard said, in having ‘an enormous mountain to climb to pull all of the information together’ to be able to issue the early phase three trial results.
He added: ‘The last few weeks have been pretty exhausting. The feeling is absolutely one of extreme fatigue and tiredness at this point.
‘If the results have not met those regulatory requirements, they would have told us just to carry on with the trial. So it was a great relief.’
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.
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.
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.
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.
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.
It was the Chinese philosopher Sun Tzu, and not Al Pacino in The Godfather Part 2, who first said, “Keep your friends close, and your enemies closer.” Yin Weidong, the CEO of Chinese biotech firm SinoVac, seems to have taken that advice to heart.
On the desk in his office in Beijing are two plastic models of a virus—each blue core surrounded by red protein spikes. From the time it started spreading in the central Chinese city of Wuhan in late December, containing that virus has occupied virtually every waking moment for the scientist.
The pandemic we now know as COVID-19 is rampaging across every continent. On the dozens of daily infection charts, broken down by nation and pasted floor to ceiling on Yin’s office wall, the numbers tell a horrifying story: 16 million infections and 640,000 deaths worldwide, including 146,000 American lives lost as of Monday.
But if the enemy is close, so is a possible new friend. Yin’s desk is now also home to several small glass vials of SinoVac’s COVID-19 vaccine—dubbed CoronaVac—that began phase 3 trials involving 9,000 volunteers in Brazil last week. (A phase 1 trial involves small groups of patients to check a vaccine for negative side effects, and a phase two trial usually tests for a combination of safety and efficacy, while a phase 3 trial is like a phase 2 but involving many more participants.)
Normally, getting from pathogen identification through phase 3 trials in about 10 years is considered quick. The mumps vaccine is generally considered the fastest ever developed at four years. But if all goes well, CoronaVac might be ready for regulatory approval early next year. Not that Yin is satisfied.
“Do you really think this is fast? Compared with the spread of the virus, it’s not fast enough,” he says, holding his plastic nemesis aloft with grudging respect. “That is how we should measure our progress.”
During the 2002 to 2003 SARS outbreak, which claimed over 774 lives worldwide, SinoVac was the only firm to go into phase 1 vaccine trials, but the pandemic suddenly disappeared. That meant that research was discontinued at a huge loss for the firm. It wasn’t entirely wasted, however. Now, 17 years later, SinoVac is able to build on that earlier work, given that COVID-19 is very similar to SARS. It and coronavirus are “like brothers,” says Yin.
Still, creating an effective vaccine is just a third of the battle. The other two prongs of vaccine development are production capacity and getting regulatory approval. At present, every nation’s FDA equivalent would need to approve CoronaVac independently, though given the unprecedented need, there are conversations about streamlining.
“The virus doesn’t require a passport but the vaccine needs to be licensed by every country,” says Yin.
SinoVac CEO Yin Weidong in his Beijing office on Tuesday, July 21, 2020.
SinoVac is aiming to triple current capacity to produce 300 million doses per year. That might sound impressive, but accessibility is likely to be a big issue. Given that at least two doses will be required to immunize one person, it would still take almost a decade to vaccinate every person in China alone, never mind sharing the vaccine with the world’s 7.6 billion people.
“If only one or two countries get protected this won’t solve the problem and get economic activity back to normal” Yin says.
SinoVac isn’t the only company with a potential vaccine in clinical evaluation. There are over 20 companies around the world engaged in the task with more than 130 vaccines in development, according to the WHO. But given the scale of the need, there’s going to be no quick fix to the pandemic.
Another vaccine candidate, developed by U.S. biotech firm Moderna with the National Institutes of Health, provoked the desired immune response in a test of 45 individuals, and is about to enter phase 3 trials. It functions by introducing an mRNA sequence—a molecule that tells cells what to build—coded for a disease-specific antigen. Once produced within the body, the antigen is logged by the immune system, empowering it to fight the real virus.
But while such RNA vaccines, as they’re known, have multiple benefits—including speed of production—they must be stored at sub-zero temperatures. That means their distribution to far-flung populations is problematic. While SinoVac initially experimented with RNA and other vaccine prototypes, they found that a traditional inactivated virus vaccine produced the best results. Under normal conditions, Yin believes CoronaVac has a shelf life of three years.
“The purpose of this work is not to discover which technology is better,” says Yin. “The purpose is to control the disease.”
In principle, SinoVac is a private company that owns CoronaVac as its licensed intellectual property, meaning where the vaccine is distributed should be a purely commercial decision. However, the Chinese government has contributed to the estimated one billion renminbi (about $140 million) the firm is investing in CoronaVac. This and other contributions from international NGOs currently under negotiation all come with distribution commitments attached.
In a speech to the World Health Assembly on May 18, Chinese President Xi Jinping promised to make a COVID-19 vaccine produced in China a “global public good.” In reality, of course, every queue has someone at the back, meaning there will be much jostling for priority—and potentially boosting Beijing’s global clout.
According to Benjamin N. Gedan, a former regional director on the White House’s National Security Council now with the Wilson Center, “If China produces the first coronavirus vaccine at scale, it would be an extraordinary diplomatic tool anywhere in the world.”
SinoVac has already committed to sharing 60-100 million doses in Brazil through a collaboration with São Paulo-based Instituto Butantan, which is performing the phase 3 study. In Asia, the firm is “actively in discussion with several countries,” says Yin, including Indonesia and Turkey, and is exploring options in Europe. It has also had more than 30 meetings with the WHO to update the global health body on its progress.
“We will share our vaccine with the world,” says Yin.