Johnson & Johnson’s single-dose COVID vaccine ‘highly effective’
Johnson & Johnson’s one-shot coronavirus vaccine is on track for emergency authorisation due to its efficacy in preventing severe cases of COVID-19 as the EU promises a renewed jab push.
The US Food and Drug Administration has endorsed Johnson & Johnson’s COVID-19 vaccine for emergency use, a critical step in bringing a third shot to the US marketplace.
According to new documents released by the FDA on Wednesday (local time), the single-shot Johnson & Johnson vaccine is highly effective in preventing severe COVID-19, including the South African and Brazil variants, new documents released by the US Food and Drug Administration showed on Wednesday (local time).
In large clinical trials, the vaccine efficacy against severe disease was 85.9 per cent in the United States, 81.7 per cent in South Africa, and 87.6 per cent in Brazil.
An independent panel of the Food and Drug Administration will meet to discuss its merits on Friday and an emergency use authorisation is likely to follow soon after.
That would bring a third vaccine into the fight against the outbreak in the United States, the world’s hardest-hit country where more than 500,000 people have lost their lives.
Experts see the J & J vaccine as a vital tool, even though its efficacy against moderate COVID-19 is lower than that demonstrated by the Pfizer and Moderna shots that have already received authorisation.
“The vaccine was effective in preventing COVID-19 using a less restrictive definition of the disease and for more severe disease, including COVID-19 requiring medical intervention, considering all cases starting 14 days after vaccination,” the new FDA summary said.
“Although a lower efficacy overall was observed in South Africa, where there was a predominance of B.1.3.5 lineage during the time period of this study, vaccine efficacy against severe/critical COVID-19 was similarly high across the United States, South Africa, and Brazil,” it added.
The J & J vaccine uses a common-cold causing adenovirus, which has been modified so that it can’t replicate, to carry the gene for a key protein of the coronavirus into human cells.
This makes those cells produce that protein, which in turn trains the human immune system.
The fact that it requires only one dose, and that it can be stored at fridge temperature rather than in freezers like the Pfizer and Moderna shots, gives it an operational advantage.
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Oxford starts work on potential COVID-19 vaccine pill
The team behind the Oxford jab have launched research on whether the vaccine could be taken as a pill - a medical breakthrough that could make annual coronavirus inoculation programs faster, cheaper and more widespread.
Professor Sarah Gilbert, the lead developer behind the Oxford-AstraZeneca vaccine being rolled out around the world including in Australia, said a product delivered via nasal spray could also be a game changer in the race for “second generation” vaccine products.
“As you know all the vaccines have been given at the moment as intramuscular injections,” Gilbert said on Wednesday local-time.
“That is not necessarily the best way to provide protection against a respiratory virus infection, where we want the immune system to be active in the upper respiratory tract and then in the lower respiratory tract, which is where the virus is causing the infection.
“And we have flu vaccines that are given by nasal spray. This could be a very good approach in the future to use vaccines against coronaviruses.
“It’s also possible to consider oral vaccination where you take a tablet that will give you the immunisation, and that would have a lot of benefits for vaccine rollout if you didn’t have to use the needles and syringes for people.”
Gilbert told British MPs on Wednesday that her team had started to assess both approaches.
Avoiding labour-intensive COVID-19 vaccination programs could be a crucial factor in the world learning to live with the virus, which experts have repeatedly warned could become a seasonal disease similar to the flu.
“But they will take time to develop,” Gilbert said of the pill or nasal spray.
“They will have to be tested for safety and then for efficacy as well because the immune responses that will be generated by both of those approaches will be a little bit different to what we get from an intramuscular injection.
“But they have potentially large advantages, and so that’s where we’re going to be focusing our attention on working out if we could use different delivery rates in the future for these vaccines.”
Any new product would likely take more than a year to eventuate because it would have to be developed and then go through pre-clinical and clinical trials. Regulators would also have to review it for approval.
Small British biotech company IosBio partnered last year with United States-based ImmunityBio to develop oral coronavirus vaccines after promising tests in monkeys. Clinical trials are underway in South Africa and the US.
IosBio had been trying to develop an oral vaccine for the Zika virus - partly through UK government funding - before the pandemic began last year.
The company’s chairman, Wayne Channon, said pills or nasal sprays had the potential to overcome the global challenges of traditional vaccines, including storage temperatures.
“Oral vaccines are more cost effective to produce and can be easily stored and transported around the world,” he said last month. “They also have the potential to be self-administered, reducing health systems’ dependency on trained health professionals to run immunisation programmes and present a future where people could have vaccines delivered straight to their door.”
The former head of the UK’s vaccine taskforce, Kate Bingham, last month said the world would have to develop more efficient ways of making and distributing COVID-19 vaccines.
“Frankly, two injections delivered by health care professionals is not a good way of delivering vaccines,” she told the BBC. “We need to get vaccine formats which are much more scalable and distributable, so whether they are pills or patches or nose sprays.”
Gilbert also told Wednesday’s parliamentary hearing that clinical trials would start over the coming months on a vaccine tweaked to respond to emerging variants. The UK government has flagged a potential autumn ‘booster’ shot program.
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The Return of Operation Choke Point
Nice bank ya got there. It’d be a shame if something happened to it. That’s essentially the message our nation’s worst attorney general began sending back in 2013 to certain banks that had the wrong kinds of customers. He even came up with a fittingly descriptive name for his unconstitutional anti-business program: Operation Choke Point.
As we wrote yesterday, the Biden administration is planning to revive Barack Obama and Eric Holder’s infamous initiative, a 2013 scheme by which the Obama Justice Department’s banking industry regulators forced certain banks to investigate the business they did with firearm and ammunition dealers and other disfavored businesses — such as pawn shops, coin dealers, and short-term loan providers — ostensibly because they were believed to be at a high risk for fraud and money laundering. Thus, through Operation Choke Point, the Obama administration was trying to deny several perfectly legal industries even basic access to the banking system.
This orchestrated denial of goods and services is the very definition of redlining, a system that was originally used to keep blacks out of certain neighborhoods in certain U.S. cities through the denial of mortgages or home improvement loans. Rather than redlining “undesirable” people, the Obama administration was redlining undesirable businesses.
And it worked. Just ask Brian Bookman, a former police officer and Army veteran. As The Daily Signal reported back in 2014, “After researching his case on the Internet, Brookman says he concluded that his banker, JP Morgan Chase, closed the account because two of his business activities — dealing in vintage coins and selling firearms — were labeled ‘high risk’ by federal bureaucrats as part of an Obama administration initiative called Operation Choke Point.”
So selling firearms and thereby facilitating access to our Constitution’s Second Amendment is now considered “high risk”?
Under President Donald Trump, however, Choke Point was rightly considered an unconstitutional infringement on these legal businesses and ended by the Justice Department in 2017. “And by the end of the former president’s term,” writes Jon Dougherty in BizPac Review, “the Office of the Comptroller of the Currency [OCC] issued a ‘Fair Access’ rule instructing large banks to provide financial services to businesses and individuals irrespective of political considerations.”
But like nearly every other good policy work from the Trump administration, Joe Biden and his hard-left handlers are undoing it. Rather than attempt to enact legitimate legislation through Congress, the Biden administration is, as our Nate Jackson put it, carpet-bombing us with executive orders. And so, eight days after taking office, Biden’s OCC announced that it was suspending the Trump administration’s Fair Access rule.
And why might it do that, except to revive Operation Choke Point, even if by another less suspicious name?
All this is part of a larger strategy: the Left’s politicization of the economy. As Kelsey Bolar writes in The Federalist, “For all intents and purposes, Operation Choke Point is happening every day on a massive scale, [including] a stranglehold on information, speech, and the broader marketplace of ideas. Concerningly, the government is now playing an active role. As exemplified by Parler and the recent Twitter purge, Big Tech is choking conservatives off their social media platforms while Democrats cheer it on.”
So much for the promise our 46th president made in his inaugural speech to “work as hard for those who didn’t vote for me as those who did.” But that’s Joe Biden. Promises made, promises broken.
https://patriotpost.us/articles/77962-the-return-of-operation-choke-point-2021-02-24
***************************************IN BRIEF
Senate Republican leader unloads on "radical and underqualified" HHS nominee Xavier Becerra (Daily Wire)
Senate confirms Linda Thomas-Greenfield as UN ambassador, despite her calling Chinese intervention in Africa a "win-win-win situation" in 2019 (Fox)
Senate confirms former Tom Vilsack for return engagement as agriculture secretary (Des Moines Register)
Good move: Federal judge indefinitely blocks 100-day deportation moratorium (Forbes)
$1 billion class-action lawsuit filed against Texas electric company after "catastrophic" bills (Forbes)
Five ERCOT board members who live outside of the state are resigning (Texas Tribune)
Virginia lawmakers vote to abolish the death penalty (AP)
Grand jury votes not to indict Rochester officers in Daniel Prude case (NPR)
Democrats write a bill to start a racism racist center at the CDC (National Pulse)
Americans identifying as LGBTQ more than ever thanks to indoctrination of our youth (NBC)
Identity wars: Campground for homosexuals takes heat for prohibiting women who identify as men (Disrn)
Washington Football Team to spend one more year fumbling for a new name (Disrn)
Nearly 100 Confederate monuments removed in 2020 (NPR)
Biden to visit Texas on Friday following deadly winter storm (CNBC)
Trump appeals Facebook's decision to indefinitely suspend him (CNSNews.com)
MSNBC contributor who encouraged ISIS to bomb Trump Tower will testify on domestic terrorism (Federalist)
Policy: The Cotton-Romney plan to raise the minimum wage without killing jobs (National Review)
Policy: The tax benefits of parenthood: A history and analysis of current proposals (AEI)
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Also see my other blogs. Main ones below:
http://snorphty.blogspot.com (TONGUE-TIED)
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://awesternheart.blogspot.com.au/ (THE PSYCHOLOGIST)
https://heofen.blogspot.com/ (MY OTHER BLOGS)
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