Johnson & Johnson begins giant trial testing one-dose COVID shot – BNN
Johnson & Johnson has begun dosing up to 60,000 volunteers in a study of its COVID-19 vaccine, marking the first big U.S. trial of an inoculation that may work after just one shot.
J&J became the fourth vaccine maker to move its candidate into late-stage human studies in the U.S. If enrollment goes as expected, the trial could yield results as soon as year-end, allowing the company to seek emergency authorization early next year, should it prove effective, according to Chief Scientific Officer Paul Stoffels.
“A single dose could be a very efficient tool to combat the pandemic as it is faster acting,” he said Wednesday in an interview. Animal models and early human studies showed that one shot of its vaccine generated a strong immune response in just 15 days, he said.
The final-stage study will pit the vaccine against a placebo injection, with a goal of showing whether it reduces cases of moderate to severe COVID-19, “the most important part of the disease to prevent,” Stoffels said. J&J is also looking at whether the shot curbs the virus’s spread.
The company’s shares rose as much as 2.3 per cent in New York.
The New Brunswick, New Jersey-based company published detailed trial plans on Wednesday. Frontrunners Pfizer Inc., Moderna Inc. and AstraZeneca Plc have already done the same in a broader transparency push.
“It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a statement. J&J’s vaccine “may be especially useful in controlling the pandemic if shown to be protective after a single dose.”
The study is nearly two months behind those of Moderna, working with NIAID, and Pfizer, partnered with BioNTech SE, whose final-stage trials started in late July. Pfizer has said it could get efficacy results by the end of October. Those vaccines use two-dose regimens.
J&J’s vaccine could offer an advantage in distribution over those inoculations, which require vaccination sites to ensure recipients return for their second dose. The company also said its vaccine can be stored at refrigerator temperatures for three months, far longer than the Pfizer vaccine that requires deep freezing for long-term storage.
“In countries where there is less health-care infrastructure, it can be much better used at a very large scale,” Stoffels told Bloomberg. “Single dose, easy to use in the field are the main characteristics that make it different.”
Years in the Making
The J&J product is made from a cold virus, called an adenovirus, that’s modified to make copies of the coronavirus’s spike protein, which the pathogen uses to enter cells. The altered virus can’t replicate in humans, but it induces an immune response that prepares the body for an actual COVID-19 infection. The vaccine was developed with researchers at Harvard University who have spent years working on the adenovirus vaccine platform, which is also used in J&J’s Ebola vaccine.
The health-care behemoth is running the study in conjunction with NIAID and the Biomedical Advanced Research and Development Authority at sites in the U.S., Brazil, Mexico, South Africa and other countries. It will include significant representation among those over the age of 60, as well as minorities at disproportionate risk of becoming infected, including Black, Hispanic, American Indian and Alaskan Native peoples, according to a statement.
J&J has also agreed to collaborate with the U.K. on a separate phase 3 clinical trial that will test a two-dose regimen of the vaccine in multiple countries, with two months between each dose, according to Stoffels. That booster could be critical to providing long-term protection, he said.
The decision to begin the final-stage trial was based on data from an earlier human study that showed a single shot was safe and stimulated a strong immune response, Stoffels said.
Like other final-stage vaccine trials, J&J’s study is monitored by an independent board of doctors and statisticians who wait for a certain number of coronavirus cases to accumulate before looking at the data.
The trial aims to accumulate 154 cases for a final analysis. If the vaccine turns out to be more than 90% effective, the study could produce results after just 20 cases, Stoffels said. He said that scenario is unlikely, though.
J&J’s trial appears to have stringent criteria for declaring early success that prevent a readout based on very short-term results in patients with relatively moderate symptoms. Based on discussions with U.S. regulators, the data won’t undergo its first analysis until at least half of participants have been vaccinated for two months or more.
The study will also have to accrue at least 5 severe cases for an early readout. And to be considered a success, the absolute number of severe cases needs to be half of that in the placebo group, along with other benchmarks, according to documents posted on J&J’s website.
Still, the study will take less time to complete than it would with two doses. Scientists will start counting cases just 15 days after patients get their inoculations or placebo shots.
Despite accelerated timelines, Operation Warp Speed won’t cut corners in confirming vaccine safety or efficacy, National Institutes of Health director Francis Collins said on the Tuesday media call. “That absolutely will not be allowed to happen,” he said.
Stoffels said J&J will continue to clinch new manufacturing partnerships to meet its 1 billion dose production goal for 2021. The company has already kick-started at-risk manufacturing in hopes the shot will prove successful in the clinic.
The 6 Big Takeaways From Tesla’s Battery Day – CleanTechnica
The overall content of the Tesla Battery Day presentation might have been overwhelming for those who do not have a technical background in battery development. The level of abstraction that Elon Musk and Drew Baglino presented relative to Tesla’s battery tech was surprisingly low, even though I’m sure they thought their presentation was just an overview.
|Elon Musk talks batteries (Source: Tesla)|
Given that, it might be a good idea to “pull the lens back” just a bit and discuss the major takeaways:
1. The holy grail of battery tech — a cost of less than $100 per kWh — will be achieved and production-ready in less three years. That means a significant reduction in vehicle cost and the real likelihood that a mass-market, $25,000 Tesla will be available in three years.
2. The technical breakthroughs and improvements presented during the battery day presentation mean that a transition away from fossil fuels for most, if not all, energy needs is no longer a pipe dream. If Tesla can achieve (and it’s likely that it will) a 3 TWh battery production capability within the next decade, the entire face of the energy and power delivery system will be transformed.
3. The new paradigm that Tesla uses for building the “machine that builds the machine” is groundbreaking, representing substantial improvement that will increase production capacity and lower production costs. Tesla used vertical integration, avoids sub-optimization, and makes the entire production process more efficient. This paradigm will bode well for Tesla’s ability to produce cars and trucks in great volume. The capital investment (CapEx) in production facilities will be less costly than originally assumed, making the company more profitable.
4. Tesla is building an increasingly bigger “moat” that will enable it to keep even the most able competitors at bay. Batteries are the pivotal element for long range, high performance and low cost EVs. From what we’ve seen, there’s no other company that’s even close to the battery tech that was previewed during Battery Day.
5. Tesla and Musk care more about the stuff that really matters — the underlying tech infrastructure for building EVs — than they do about the “bling” of new vehicle designs every n years. It’s the tech infrastructure that really matters for long-term success.
6. Tesla is not resting on its laurels. It appears that they’re working to jettison existing methods and approaches to EV design and production, replacing them with new and better ideas.
And finally … it’s hard to imagine any other CEO at a major auto company that can drive technical effort in the manner that Elon Musk has accomplished to date. Much like SpaceX, this rate of progress could accelerate in the coming years. As Musk says, Tesla is a “hardcore engineering” company … and it shows in their relentless pursuit of improvement.
Source: – Alberni Valley News
Kitchener drive-thru COVID-19 testing site to reopen by appointment only on Thursday – CTV Toronto
Kitchener’s drive-thru COVID-19 testing site will reopen on Thursday, but people will need to book an appointment to get a test.
Anyone who needs a test should go online, pick a time slot and register with their name and health card.
The site was closed down early on Wednesday morning after staff reportedly faced verbal abuse and threats of violence.
A spokesperson for Grand River Hospital, which runs the site, said that the issue was compounded by traffic issues along the streets around the testing site.
Long wait times and lineups have created tension around COVID-19 testing as more people look to get tested amid fears of a second wave.
Some people arrived at the drive-thru site as early as 2 a.m. in order to secure a place there. Dozens of cars lined up Wednesday morning, and the line’s capacity was full by 7 a.m. Staff don’t start testing until 15 minutes after then.
By around 8:30 a.m., the site had closed for the day. Waterloo regional police posted about the closure on Twitter, asking for people to be patient and avoid the area.
Police said there were no arrests, but they did assist with setting up barricades.
Thirty minutes later, the hospital tweeted about the closure as well, citing “safety concerns.”
Everyone signing up for a COVID-19 test starting Thursday will need to fill out a separate pre-registration form, the Grand River Hospital said in a tweet. Only people who have pre-registered will be able to get a test.
Those who were still in line would still be tested, Grand River Hospital said. By 11 a.m., the site, normally backed up for hours at a time, was completely empty.
The difficulties of getting tested are not unique to Waterloo Region, as thousands of people face the same hurdles daily around Ontario. The calls for more accessible testing has led Premier Doug Ford to partner with pharmacies in order to allow more people to get tested.
On Wednesday, Ford announced that 60 pharmacies would be offering testing soon. None of them are in Waterloo Region.
The tests will be by appointment only for people without symptoms.
St. Mary’s General Hospital said Wednesday that people should only self-refer to the assessment centre if they have COVID-19 symptoms or if they’ve been directed to get a test because they’re a high-risk contact of someone else with the disease.
They said people can also come if they’ve been referred by a medical health professional to meet a ministry guideline, like visiting a long-term care home or having a medical procedure done.
Lee Fairclough, head of the region’s COVID-19 assessment centres and president of St. Mary’s General Hospital, said she’d like to see pharmacies doing tests at local pharmacies.
“We will certainly be open to how we do that within our region,” she said.
Fairclough said the region is also seeking out new locations for additional testing sites, but the main priority is to beef up the existing sites.
“The decision we are making right now is to move nurses, move physicians from other clinical services and practices, to do this testing,” she said. “That’s probably the biggest thing we are sorting through.”
The walk-in centres are busy, but sites offering appointments are also swamped.
“The numbers have gone through the roof,” said Dr. Joseph Lee from KW4 COVID Assessment Centre.
The clinic’s next available appointment isn’t until early October. Lee said he’s proposing turning his other two walk-in clinics into COVID-19 assessment centres as well.
Cambridge Memorial Hospital’s COVID-19 assessment launched a new phone number on Wednesday to help manage calls for appointments. The new number is 519.740.4975, but the centre said it’s best to reach through email at email@example.com.
Anyone calling can register for a booked appointment when arriving at the centre, schedule an appointment and cancel an appointment.
The centre said it’s prioritizing people with symptoms and anyone who’s been instructed to get a test by a public health official.
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