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.
Goldman Sachs Agrees To Largest Penalty Ever Of $2.9 Billion In 1MDB Scandal – NDTV
Global financial titan Goldman Sachs agreed to pay $2.9 billion in penalties to settle criminal charges in the 1MDB Malaysian bribery scandal, the largest US fine ever in a corruption case, the Justice Department announced Thursday.
Acting US Assistant Attorney General Brian C. Rabbitt said Goldman “accepted responsibility” in the case that involved $1.6 billion in bribes, the largest ever recorded, and massive gains laundered through the US financial system.
Goldman Sachs helped raise $6.5 billion for the Malaysian government’s sovereign wealth fund. The US Justice Department has said more than $4.5 billion was stolen from 1MDB by high-level officials at the fund and their associates between 2009 and 2015.
The investment fund “was looted by corrupt officials and their co-conspirators, including senior Goldman bankers” turning it “into a piggy bank for corrupt public officials and their cronies,” Rabbitt said at a press briefing.
In a first for Goldman Sachs, the company’s Malaysian unit pleaded guilty in a US court Thursday for violations of American bribery law as part of a deal to end the criminal probe in the sweeping case that involved authorities in nine countries.
The guilty plea could curtail activities of Goldman Sachs Malaysia but allows the parent company to avoid admitting wrongdoing in court — which would have damaged its ability to do business.
The parent company pleaded not guilty in US court and agreed to “deferred prosecution” for three-and-a-half years, during which time the firm will face increased monitoring by regulators.
But Rabbitt stressed that despite the deal, the company has been charged in the bribery scandal, “so there has been a significant amount of criminal liability” for Goldman and “imposes meaningful consequences” in the cases.
The Justice Department has charged three individuals in the case including two former Goldman executives. Tim Leissner, the former Southeast Asia Chairman, has pleaded guilty, while Ng Chong Hwa, also known as “Roger Ng,” former head of investment banking for GS Malaysia, is awaiting trial, and Low Taek Jho remains a fugitive.
“Goldman admitted today that, in order to effectuate the scheme, Leissner, Ng, Employee 1, and others conspired with Low Taek Jho” to pay the bribes and ignored red flags, the statement said.
In another stunning turn, the company said it will demand repayment of $174 million in salary and bonuses paid to current and former executives including Chief Executive David Solomon and his predecessor Lloyd Blankfein.
These so-called clawbacks are almost unheard of in corporate cases.
Solomon said in a statement “it is abundantly clear that certain former employees broke the law, lied to our colleagues and circumvented firm controls,” adding, “we recognize that we did not adequately address red flags.”
Included in the total penalty amount, Goldman will pay a $400 fine to the SEC and repay $600 million in earnings, and pay a $154 million fine to the Federal Reserve, which also will require the company to improve its risk management and internal oversight.
The Malaysian government dropped the charges against Goldman in July after reaching a $3.9 billion settlement with the financial giant.
The firm, which posted profits of $3.5 billion in the latest quarter, had set aside more than $3.1 billion as of September 30 “for litigation and regulatory proceedings.”
Goldman shares closed US trading 1.2 percent higher after settling the uncertainty.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
Moderna gets 30000 patients for final stage of vaccine trial – BNN
Moderna Inc. has completed enrollment of its 30,000 participants in its final-stage COVID-19 trial, while more than 25,000 volunteers have received their second shot.
The announcement on Thursday is another indication that vaccine trials are moving into their home stretch. Moderna has said it could get an initial readout on whether the vaccine works by late November. The drugmaker is only slightly behind Pfizer Inc., which is working with German biotech BioNTech SE and expects results from its 44,000-person trial as soon as the end of this month.
Moderna shares rose as much as 4.4 per cent on Thursday morning in New York. This year, the stock has more than tripled in value.
Moderna had slowed trial enrollment in September in order to recruit more minorities, a key goal of U.S. health officials. Overall, 37 per cent of volunteers in the trial come from communities of color, the company said. Also, 42 per cent of are at high risk of developing severe cases of Covid-19, either because they are 65 or older or have pre-existing conditions.
Both Moderna and Pfizer say they won’t submit for an emergency-use authorization until they have collected two months of safety data on the participants. That means that even if Pfizer gets positive initial results this month, it won’t submit for an emergency authorization until after it gets the safety results in the third week of November.
Exxon Expected To Announce North America Redundancies Soon – OilPrice.com
Most of Western Canada’s oil production has been restored, according to the Canada Energy Regulator, but U.S. oil producers haven’t had as much luck.
Both countries had to curtail oil production in May due to low oil prices amid the coronavirus pandemic and the oil price war waged by Saudi Arabia and Russia.
The Canada Energy Regulator (CER) now says that about 700,000 barrels of oil production per day has been brought back online after it was forced to cut nearly 1 million barrels per day back in May. The total curtailments as of October now stand at 270,000 bpd.
Last year, Western Canada produced an average of 4.4 million barrels per day.
The oil production rebound tracks oil prices. Western Canadian Select prices were trading around $14 per barrel at the beginning of May but have since more than doubled to $32 per barrel.
Elsewhere in the world, oil production is not rebounding at the same rate. In the United States, oil production fell to 11.5 million bpd in mid-May, down from 13.1 million bpd in March prior to the pandemic and oil price war that tanked prices. U.S. oil production has not yet rebounded, however, and the latest data for the week ending October 16 pegs U.S. oil production at an average of 9.9 million bpd.
In the beginning of May, WTI traded around $22 per barrel. Today, prices have recovered to about $40 per barrel. Still, production is stubbornly low.
There is hope on the horizon, however. Baker Hughes has shown for the last several weeks an increase in the number of new drilling rigs in the United States. The number of rigs actively drilling new wells in the United States rose from 179 in mid-September to 205 in mid-October. That’s the largest four-week increase since the rigs began to drop off.
This rig count movement is a good indication that an increase in production in the United States is in our future.
By Julianne Geiger for Oilprice.com
More Top Reads From Oilprice.com:
Julianne Geiger is a veteran editor, writer and researcher for Oilprice.com, and a member of the Creative Professionals Networking Group.
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