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Moderna believes it could update its coronavirus vaccine without a big new trial

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Covid vaccines reprogrammed to aim at new emerging strains of the virus could reach the market quickly, without going through large clinical trials, according to officials at Moderna and the US government.

As researchers identify new, mutated, versions of the coronavirus that causes covid-19, there’s concern they could evade approved vaccines and that new shots could be necessary.

But new shots could come to market in just a few months. The reason: no need for big studies to prove they work.

Moderna Therapeutics chief medical officer, Tal Zaks said that “scientifically” it would be possible to formulate a new vaccine and expect it to work without testing it again in tens thousands of volunteers. He added that bringing a fast updated shot to market would “depend on regulators.”

Zaks made the comments during a question and answer session at the J.P. Morgan healthcare conference on January 11.

Researchers are scrutinizing new versions of the virus that have been appearing as the germ spreads and mutates. There is concern that some mutations, including one seen in cases in South Africa and in Brazil, could allow the pathogen to overcome existing immunity, gained because someone has gotten a vaccine or previously had covid-19.

“With these mutants coming out, you just wonder where it’s going to go now, it keeps me up at night,” Peter Marks, the US Food and Drug Administration official who conceived the US vaccine program, Operation Warp Speed, said in a December broadcast on WebMD.

Moderna says laboratory studies indicate its current vaccine, first authorized in the US in December, should protect against all the major variants now being tracked, including one in the UK that is believed to be more transmissible, so there is no reason to change the inoculation yet.

“From what we have seen so far, the variants being described … don’t alter the ability of neutralizing antibodies elicited by vaccination to neutralize the virus,” Zaks says, adding that he believed protection conferred by vaccination “should last at least a year.”

“Our technology is very well suited to actually rapidly deploy a vaccine based on the new variant. But based on the data we have seen today we don’t see a need for it,” he says.

The company’s novel vaccine, along with one from Pfizer and BioNTech, involves packaging genetic instructions for the “spike” protein of the coronavirus into miniscule fatty nanoparticles. Injected into a person’s arm, cells begin to read that information and make the spike molecule, setting off an immune response that, trials show, leads to protection against severe covid in the large majority of people.

The technology’s flexibility is that the genetic information—messenger RNA—can easily be rewritten and revised, including to reflect the latest mutant forms of the virus. The other ingredients, salts, sugars, and the lipid nanoparticles, would not have to be changed.

Last spring, it took Moderna only six weeks to devise and manufacture initial lots of its vaccine, which it delivered to the National Institutes of Health for initial tests on animals. There is no reason it can’t be done again. “Technically it is possible to make a new vaccine mimicking the new strain in a few weeks,” Uğur Şahin, founder and CEO of BioNTech, said during a press event in December, and whose company uses similar technology.

What took longer was tests in humans, including a huge study by Moderna and the National Institutes of Health involving more than 30,000 volunteers that lasted from July to November. In that study, half of the participants got the vaccine and half got a dummy shot, giving researchers an unbiased view of how well it worked.

“With the mRNA vaccine, we know how they work … it’s not going to have to be another 30,000 patient clinical trial,” Marks said. “We will have a way of evolving here.”

If the big trials can be skipped, that suggests the timeline to bring a new shot to market would be shortened by at least four months, if not more. Several other vaccines, including ones from Johnson & Johnson and Novavax, have not yet completed their large Phase III trials needed to win the nod from regulators, in part because they began later.

The idea of updating a vaccine to keep up with a changing pathogen isn’t new. Influenza vaccines are also changed each year, to match changes in the virus. Each updated vaccine undergoes more limited tests on people to assess whether they cause the expected immune responses. Flu vaccines are not always very effective, however, especially if there is a mismatch between the strain used in the vaccine and the one which ends up circulating that year.

The fear the public and vaccine companies are grappling with now is the growing evidence that the covid-19 virus will keep mutating and changing its shape, a phenomenon called “antigenic drift.” That could lead to evolved forms which today’s vaccines don’t protect against as well.

“Unfortunately, this virus is starting to look like it wants to become like, Flu Two, or Son-of-Flu,” Marks said in December. “What is good about flu, is it set up a very nice paradigm” for updating vaccines.

On January 12, Brazilian researchers described a new variant circulating in Manaus, the capital of Brazil’s Amazonas state. That city has had among the world’s highest rates of covid-19. Estimates are that two-thirds of the population was infected by summer and so researchers expected the virus to burn out, without many new people to infect.

Instead, though, cases in Manaus are rising again, leading the Brazilian researchers to wonder if their new strain has an “increased propensity for re-infection of individuals” something they say “is essential to rapidly investigate.”

Moderna says it is also looking to real-world events outside the laboratory where countless trillions of copies of the virus are at this moment reproducing in the bodies of millions of people.

“My definition of when to get worried is when we see real clinical data that suggests people who have been sick or immunized are getting reinfected with new variants,” says Zaks. “We are keeping our fingers on the pulse, just like many others.”

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Elon Musk says Tesla Semi is ready for production, but limited by battery cell output

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Tesla CEO Elon Musk said on the company’s 2020 Q4 earnings call that all engineering work is now complete on the Tesla Semi, the freight-hauling semi truck that the company is building with an all-electric powertrain. The company expects to begin deliveries of Tesla Semi this year, the company said in its Q4 earnings release, and Musk said the only thing limiting their ability to produce them now is the availability of battery cells.

“The main reason we have not accelerated new products – like for example Tesla Semi – is that we simply don’t have enough cells for it,” Musk said. “If we were to make the Semi right now, and we could easily go into production with the Semi right now, but we would not have enough cells for it.”

Musk added that the company does expect to have sufficient cell volume to meet its needs once it goes into production on its 4680 battery pack, which is a new custom cell design it created with a so-called ‘tables’ design that allows for greater energy density and therefore range.

“A Semi would use typically five times the number of cells that a car would use, but it would not sell for five times what a car would sell for, so it kind of would not make sense for us to do the Semi right now,” Musk said. “But it will absolutely make sense for us to do it as soon as we can address the cell production constraint.”

That constraint points to the same conclusion for the possibility of Tesla developing a van, Musk added, and the lifting of the constraint will likewise make it possible for Tesla to pursue the development of that category of vehicle, he said.

Tesla has big plans for “exponentially” ramping cell production, with a goal of having production capacity infrastructure in place for a Toal of 200 gigawatt hours per year by 2022, and a target of being able to actually produce around 40% of that by that year (with future process improvements generating additional gigawatt hours of cell capacity  in gradual improvements thereafter).

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Pro-Trump Twitter figure arrested for spreading vote-by-text disinformation in 2016

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The man behind a once-influential pro-Trump account is facing charges of election interference for allegedly disseminating voting disinformation on Twitter in 2016.

Federal prosecutors allege that Douglass Mackey, who used the name “Ricky Vaughn” on Twitter, encouraged people to cast their ballot via text or on social media, effectively tricking others into throwing away those votes.

According to the Justice Department, 4,900 unique phone numbers texted a phone number Mackey promoted in order to “vote by text.” BuzzFeed reported the vote-by-text scam at the time, noting that many of the images were photoshopped to look like official graphics from Hillary Clinton’s presidential campaign.

Some of those images appeared to specifically target Black and Spanish-speaking Clinton supporters, a motive that tracks with the account’s track record of white supremacist and anti-Semitic content. The account was suspended in November 2016.

At the time, the mysterious account quickly gained traction in the political disinformation ecosystem. HuffPost revealed that the account was run by Mackey, the son of a lobbyist, two years later.

“… His talent for blending far-right propaganda with conservative messages on Twitter made him a key disseminator of extremist views to Republican voters and a central figure in the alt-right’ white supremacist movement that attached itself to Trump’s coattails,” HuffPost’s Luke O’Brien reported.

Mackey, a West Palm Beach resident, was taken into custody Wednesday in Florida.

“There is no place in public discourse for lies and misinformation to defraud citizens of their right to vote,” Acting U.S. Attorney for the Eastern District of New York Seth D. DuCharme said.

“With Mackey’s arrest, we serve notice that those who would subvert the democratic process in this manner cannot rely on the cloak of Internet anonymity to evade responsibility for their crimes.”

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Tesla is willing to license Autopilot and has already had “preliminary discussions” about it with other automakers

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Tesla is open to licensing its software, including its Autopilot highly-automated driving technology, and the neural network training it has built to improve its autonomous driving technology. Tesla CEO Elon Musk revealed those considerations on the company’s Q4 earnings call on Wednesday, adding that the company has in fact already “had some preliminary discussions about licensing Autopilot to other OEMs.”

The company began rolling out its beta version of the so-called ‘full self-driving’ or FSD version of Autopilot late last year. The standard Autopilot features available in general release provide advanced driver assistance (ADAS) which provide essentially advanced cruise control capabilities designed primarily for use in highway commutes. Musk said on the call that he expects the company will seek to prove out its FSD capabilities before entering into any licensing agreements, if it does end up pursuing that path.

Musk noted that Tesla’s “philosophy is definitely not to create walled gardens” overall, and pointed out that the company is planning to allow other automakers to use its Supercharger networks, as well as its autonomy software. He characterized Tesla as “more than happy to license” those autonomous technologies to “other car companies,” in fact.

One key technical hurdle required to get to a point where Tesla’s technology is able to demonstrate true reliability far surpassing that of a standard human driver is transition the neural networks operating in the cars and providing them with the analysis that powers their perception engines is to transition those to video. That’s a full-stack transition across the system away from basing it around neural nets trained on single cameras and single frames.

To this end, the company has developed video labelling software that has had “a huge effect on the efficiency of labeling,” with the ultimate aim being enabling automatic labeling. Musk (who isn’t known for modesty around his company’s achievements, it should be said) noted that Tesla believes “it may be the best neural net training computer in the world by possibly an order of magnitude,” adding that it’s also “something we can offer potentially as a service.”

Training huge quantities of video data will help Tesla push the reliability of its software from 100% that of a human driver, to 200% and eventually to “2,000% better than the average human,” Musk said, while again suggesting that it won’t be a technological achievement the company is interested into keeping to themselves.

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