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Moderna claims 94% efficacy for COVID-19 vaccine, will ask FDA for emergency use authorization today

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Drugmaker Moderna has completed its initial efficacy analysis of its COVID-19 vaccine from the drug’s Phase 3 clinical study, and determined that it was 94.1% effective in preventing people from contracting COVID-19 across 196 confirmed cases from among 30,000 participants in the study. Moderna also found that it was 100% effective in preventing severe cases (such as those that would require hospitalization) and says it hasn’t found any significant safety concerns during the trial. On the basis of these results, the company will file an application for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) on Monday.

Seeking an EUA is the next step towards actually beginning to distribute and administer Moderna’s COVID-19 vaccine, and if granted the authorization, it will be able to provide it to high-risk individuals in settings where it could help prevent more deaths, such as with front-line healthcare workers, ahead of receiving a full and final regulatory approval from the U.S. healthcare monitoring agency. Moderna will also seek conditional approval from the European Medicines Agency, which will enable similar use ing the EU.

Moderna’s vaccine is an mRNA vaccine, which provides genetic instructions to a person’s body that prompts them to create their own powerful antibodies to block the receptor sites that allows COVID-19 to infect a patient. It’s a relatively new therapeutic approach for human use, but has the potential to provide potentially even more resistance to COVID-19 than do natural antibodies, and without the risk associated with introducing any actual virus, active or otherwise, to an inoculated individual in order to prompt their immune response.

In mid-November, Moderna announced that its COVID-19 vaccine showed 94.5% efficacy in its preliminary results. This final analysis of that same data hews very close to the original, which is promising news for anyone hoping for an effective solution to be available soon. This data has yet to be peer reviewed, though Moderna says that it will now be submitting data from the Phase 3 study to a scientific publication specifically for that purpose.

Moderna’s vaccine candidate is part of the U.S’s Operation Warp Speed program to expedite the development, production and distribution of a COVID-19 vaccine, initiated earlier this year as a response to the unprecedented global pandemic. Other vaccines, including one created by Pfizer working with partner BioNTech, as well as an Oxford University/AstraZeneca-developed candidate, are also far along in their Phase 3 testing and readying for emergency approval and use. Pfizer has already applied with the FDA for its own EUA, while the Oxford vaccine likely won’t be taking that step in the U.S. until it completes another round of final testing after discovering an error in the dosage of its first trial – which led to surprising efficacy results.

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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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