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Russians to Approve COVID-19 Vaccine Aug 10th – Before Completing Assessment of Safety and Efficacy

Russian COVID-19 vaccine approval imminent, source says



This article was originally published by PharmaLive.

MOSCOW (Reuters) – Russia’s first potential COVID-19 vaccine will win local regulatory approval in the first half of August and be administered to frontline health workers soon afterwards, a development source close to the matter told Reuters. A state research facility in Moscow – the Gamaleya Institute – completed early human trials of the adenovirus-based vaccine this month and expects to begin large-scale trials in August. The vaccine will win regulatory approval from authorities in Russia while that large-scale trial continues, the source said, highlighting Moscow’s determination to be the first country in the world to approve a vaccine.

FILE PHOTO: Chief Executive of the Russian Direct Investment Fund, Kirill Dmitriev, attends a session of the St. Petersburg International Economic Forum (SPIEF), Russia, June 7, 2019. REUTERS/Maxim Shemetov

The speed at which Russia is moving to roll out the vaccine has prompted some Western media to question whether Moscow is putting national prestige before solid science and safety. “(Regulatory) approval will be in the first two weeks of August,” the development source said. “August 10 is the expected date, but it will definitely be before August 15. All (trial) results so far are highly positive.” The source added that Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated soon after the vaccine receives the regulatory approval. Separately, Russia’s Interfax news agency cited “an informed source” as saying the vaccine would be registered from Aug. 10-12 and be administered from Aug. 15 onwards. The press service of the Russian Direct Investment Fund (RDIF), which is coordinating and funding Russia’s vaccine development efforts, declined to comment, but its head, Kirill Dmitriev, has denied that Russia’s vaccine push is compromising safety. “The Ministry of Health in Russia is following all necessary strict procedures. No corners are being cut,” Dmitriev said on Tuesday. Dmitriev likened what he said was Russia’s success in developing a vaccine to the Soviet Union’s 1957 launch of Sputnik 1, the world’s first satellite. “Just as Sputnik was the result of very talented Russian scientists … our vaccine research is based on the work of great Russian scientists,” he said. Britain’s National Cyber Security Centre said this month that hackers backed by the Russian state were trying to steal COVID-19 vaccine and treatment research from academic and pharmaceutical institutions around the world. The allegations have been denied by Moscow. More than 100 possible vaccines are being developed around the world to try to stop the COVID-19 pandemic. At least four are in final Phase III human trials, according to WHO data, including three developed in China and another in Britain.

Reporting by Andrew Osborn; Editing by David Goodman

Reuters source:

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CDC Announces Overhaul After Botching Pandemic

CDC Announces Overhaul After Botching Pandemic

After more than two years of missteps and backpedaling over Covid-19 guidance that had a profound…



CDC Announces Overhaul After Botching Pandemic

After more than two years of missteps and backpedaling over Covid-19 guidance that had a profound effect on Americans' lives, the Centers for Disease Control (CDC) announced on Wednesday that the agency would undergo a complete overhaul - and will revamp everything from its operations to its culture after failing to meet expectations during the pandemic, Bloomberg reports.

Director Rochelle Walensky began telling CDC’s staff Wednesday that the changes are aimed at replacing the agency’s insular, academic culture with one that’s quicker to respond to emergencies. That will mean more rapidly turning research into health recommendations, working better with other parts of government and improving how the CDC communicates with the public. -Bloomberg

"For 75 years, CDC and public health have been preparing for Covid-19, and in our big moment, our performance did not reliably meet expectations," said Director Rochelle Walensky. "I want us all to do better and it starts with CDC leading the way.  My goal is a new, public health action-oriented culture at CDC that emphasizes accountability, collaboration, communication and timeliness."

As Bloomberg further notes, The agency has been faulted for an inadequate testing and surveillance program, for not collecting important data on how the virus was spreading and how vaccines were performing, for being too under the influence of the White House during the Trump administration and for repeated challenges communicating to a politically divided and sometimes skeptical public."

A few examples:

Walensky made the announcement in a Wednesday morning video message to CDC staff, where she said that the US has 'significant work to do' in order to improve the country's public health defenses.

"Prior to this pandemic, our infrastructure within the agency and around the country was too frail to tackle what we confronted with Covid-19," she said. "To be frank, we are responsible for some pretty dramatic, pretty public mistakes — from testing, to data, to communications."

The CDC overhaul comes on the heels of the agency admitting that "unvaccinated people now have the same guidance as vaccinated people" - and that those exposed to COVID-19 are no longer required to quarantine.

Tyler Durden Wed, 08/17/2022 - 12:22

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The Las Vegas Strip Gets a Major New Innovation

It’s not just Caesars and MGM innovating on the Strip. Elon Musk has been tunneling under Las Vegas to solve a big problem, and now he has a rival.



It's not just Caesars and MGM innovating on the Strip. Elon Musk has been tunneling under Las Vegas to solve a big problem, and now he has a rival.

Las Vegas has quietly become a hotbed for innovation. Some of that has been driven by the major casino operators -- Caesars Entertainment (CZR) - Get Caesars Entertainment Inc. Report, MGM Resorts International (MGM) - Get MGM Resorts International Report, Resorts World Las Vegas, and Wynn Resorts (WYNN) - Get Wynn Resorts Limited Report -- trying to outdo each other to win over customers.

Some innovations are ostentatious and hard to miss, like the MSG (MSGE) - Get Madison Square Garden Entertainment Corp. Class A Report Sphere being built at the Venetian. That first-of-its-kind concert venue looks as if it dropped to Earth from a technologically advanced civilization, and it has raised the bar for performance venues.

Many innovations, however, aren't as obvious. Caesars, for example, uses an artificial intelligence text-based concierge that's surprisingly effective. "Ivy," as it goes by, can answer questions, help with mundane tasks like getting clean towels delivered, or advance your issue to a human where needed.

Innovations big and small are happening up, down, and under the Las Vegas Strip. Elon Musk's Boring Co. has been building a network of tunnels under the city that will eventually use driverless Tesla  (TSLA) - Get Tesla Inc. Report electric vehicles to ferry people all over the city. 

That's a revolutionary idea -- but now a rival has emerged.  

Image source: Daniel Kline/TheStreet

Musk Goes Low, Lyft Goes High?

Musk's Boring Co. has a bold plan for more than 50 stations connecting the Las Vegas Strip to the airport, the Convention Center, Allegiant Stadium, and Fremont Street using driverless Teslas. 

Currently, only a small portion of that network has been built -- a section connecting the two halves of the Las Vegas Convention Center (and one connecting Resorts World Las Vegas to that same location.

For Musk and Boring Co., it's all about taking traffic off the city's busy streets and bringing it underground.

"During typical peak hours, driving from the Las Vegas Convention Center to Mandalay Bay, for example, can take up to 30 minutes. The same trip on Vegas Loop will take approximately 3 minutes," the company says on its website.

If Musk's plan is fully built, it'll effectively give Las Vegas a modern subway, helping alleviate road congestion. It will not, however, stop tourists from using ride-share and taxi cabs.

Now, ride-share company Lyft  (LYFT) - Get Lyft Inc. Report has brought a solution to Sin City that may ultimately help it solve another problem: a shortage of taxi and ride-share drivers. 

Lyft Brings Driverless Cars (Sort of) to Las Vegas

Labor in Las Vegas has been in short supply since the pandemic hit. Some people left the city and others found work outside the service-industry jobs that fuel the Las Vegas economy. At times, that has made the wait for a cab, or a ride-share from Uber (UBER) - Get Uber Technologies Inc. Report and Lyft, longer than usual.

Lyft plans to fix that by partnering with Motional to bring Motional's "Ioniq-5-based robotaxi, an autonomous vehicle designed for fully driverless ride-hail operation, to the Lyft network in Las Vegas," the ride-share company shared in a news release.

The Ioniq 5 is Hyundai's  (HYMTF)  prominent EV. Motional is the Boston joint venture between Hyundai and automotive-technology specialist Aptiv.  (APTV) - Get Aptiv PLC Report

"Launching Motional’s all-electric Ioniq 5 on Lyft’s network in Las Vegas represents tremendous progress in our vision to make an electric, autonomous, and shared future a reality for people everywhere," said  Lyft CEO Logan Green.

An Important Caveat

There is, however, a pretty big catch.

"Each vehicle arrives with not one but two backup drivers standing by to take control of the car should anything go wrong"'s Corey Levitan reported.

Lyft has promised a truly driverless system at some point in 2023, but current laws and the state of driverless technology make the backups necessary.

Motional and Lyft have quietly been testing driverless vehicles in Las Vegas since 2018. In the news release, Lyft explained how the system works.

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"This means riders are able to easily control their ride without assistance from a driver. The enhanced experience includes unlocking the doors through the Lyft app and starting the ride or contacting customer support from the new in-car Lyft AV app, an intuitive in-ride display tailored to autonomous ride-sharing," the company said.

Lyft and Boring Co. are not working together. But if Musk's plan takes vehicles off Las Vegas's streets, the new program makes the experience better for any that remain. 

Ride sharing and taxis will continue to cost significantly more than using Boring Co's subway-like system, so it's easy to see how the two options will work well together.   .



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COVID vaccine: how the new ‘bivalent’ booster will target Omicron

The UK has become the first country to approve the shot, which targets omicron alongside the original strain of SARS-CoV-2.




The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a bivalent COVID booster vaccine, making it the first country in the world to do so.

Developed by Moderna, this vaccine has been approved for use in adults, and is set to form part of the upcoming autumn booster campaign in the UK.

But what actually is a bivalent vaccine, and what impact might this booster have on the trajectory of the pandemic? Let’s take a look.

Read more: COVID vaccines: our current shots could soon be updated to target new variants – an immunology expert explains

The COVID vaccines and boosters we currently have, or the first generation, are “monovalent” vaccines. This means they only target the original strain of SARS-CoV-2 (the virus that causes COVID-19).

A recent study suggested that first generation COVID vaccines prevented up to 20 million deaths around the world in their first year of use.

The emergence of the new variants of SARS-CoV-2, including Omicron variants, has been very concerning. Omicron variants are better than earlier non-Omicron variants at evading our immunity from prior infections and vaccines.

Although the vaccines continue to offer protection against deaths and hospital admissions, recent research has shown the initial course of COVID vaccination provides limited protection against symptomatic disease caused by the Omicron variant.

So this second-generation bivalent or dual-variant vaccine targets both the ancestral strain of SARS-CoV-2 and the Omicron variant BA.1. It contains 25 micrograms of original coronavirus vaccine and 25 micrograms of vaccine that specifically targets the Omicron variant.

Likewise, “multivalent” vaccines can protect against even more than two strains of a microbe – though we don’t have any multivalent shots for COVID yet.

Bivalent and multivalent vaccines aren’t new in healthcare. For example, all influenza vaccines available in the UK and the US are quadrivalent, targeting four different strains of flu.

The Gardasil-9 vaccine targets nine strains of the human papillomavirus, a common sexually transmitted infection. Meanwhile, the pneumococcal polysaccharide vaccine, PPSV23, targets an impressive 23 different strains of bacteria that cause pneumococcal diseases, protecting against pneumonia and meningitis, among others.

Safety and efficacy

No serious safety concerns have been identified for this new bivalent vaccine. Any side effects observed during safety monitoring were broadly the same as those seen with the original Moderna booster dose. These are typically mild and get better on their own, such as fever, headache, fatigue or pain at the injection site.

The MHRA’s approval of Moderna’s new bivalent vaccine is based on data from a clinical trial involving more than 400 participants. The results showed that a booster of the bivalent vaccine triggers a strong immune response against both the original Wuhan strain and Omicron BA.1.

Specifically, Moderna reported that in a combined phase 2 and 3 trial, a booster dose of the new bivalent vaccine increased neutralising antibody levels against Omicron BA.1 roughly eight-fold above baseline levels. This was a superior neutralising antibody response when compared with the company’s current monovalent booster.

Notably, Omicron BA.1 was the first Omicron subvariant, but BA.5 is now the dominant variant in the UK and globally. While this vaccine was designed to target BA.1, Moderna have stated the booster also elicited potent neutralising antibody responses against BA.4 and BA.5 compared with the company’s current booster.

These results are promising, but we will need to watch closely for confirmation that they translate beyond clinical trials, and that the vaccine is effective against BA.5 and potentially any new variants in the real word.

An illustration of SARS-CoV-2, the coronavirus that causes COVID-19.
The new bivalent vaccine targets Omicron as well as the ancestral strain of SARS-CoV-2. creativeneko/Shutterstock

In the meantime, Moderna has completed regulatory submissions for its bivalent vaccine in other countries including Canada, Australia and the European Union. Pending authorisation, the vaccine is likely to be available in the US starting in autumn too.

Other pharmaceutical companies including Pfizer and BioNTech are also developing and trialling bivalent boosters to target Omicron.

Read more: COVID vaccines: why second boosters are being offered to vulnerable people in the UK – but not young and healthy people yet

Boosters are a vital weapon against COVID

When immunity from initial vaccine doses wanes, boosters are an important way to increase our immunity. And there’s little doubt that introducing this new Moderna bivalent vaccine will provide substantial protection to many people against COVID, including the newer variants, as we enter the winter months.

At the same time, first-generation boosters are still highly valuable, alongside other precautions we can continue taking to prevent the spread of the virus and new variants. These might include wearing a mask in crowded places, staying away from others when ill, and maintaining good hand hygiene.

COVID remains a threat and we can’t anticipate how the virus will evolve. We may well see the emergence of new variants, creating a need for multivalent vaccines in the future.

Manal Mohammed does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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