Sunday, September 6, 2020

The Race For a Vaccine

Around the track they come:

"Markets worldwide rallied on rising hopes for a COVID-19 vaccine Wednesday, and the S&P 500 climbed back to where it was a few days after it set its record early this year. Investors see a vaccine as the best way for the economy and human life to get back to normal, and researchers said late Tuesday that one developed by the National Institutes of Health and Moderna revved up people’s immune systems in early testing, as hoped. Several things helped lift the market, including stronger-than-expected reports on the economy and on corporate profits from Goldman Sachs and others, but the vaccine hopes were at the center of the rise, which meant the market’s leaderboard was dominated by companies that would benefit most from a return to normal life. They included cruise-ship operators, airlines, retailers and hotel chains. Stocks of smaller companies also leaped much more than the rest of the market, an indication of rising expectations for the economy. The Russell 2000 index of small-cap stocks jumped 3.5 percent. Winners of the stay-at-home economy created by quarantines and lockdowns, meanwhile, lagged behind. Clorox, Netflix and Amazon all fell. It’s the latest bout of erratic trading for the market, which has been largely churning in place for weeks....."

"A network of more than 100 clinical trial sites at hospitals and medical clinics across the United States will take on the unprecedented challenge of testing COVID-19 vaccines and other preventive treatments, federal officials announced Wednesday. The Covid-19 Prevention Trials Network, which knits together existing federal clinical trial infrastructure developed largely to test HIV vaccines and treatments, launched with a website for volunteers to join the roster of people to be considered when the first trials begin later this month. The scientific effort to develop a COVID-19 vaccine will depend crucially on tens of thousands of volunteers, in a gargantuan scientific, medical, and logistical undertaking, with the aim of providing ‘‘substantial quantities of a safe, effective vaccine by January 2021,’’ Health and Human Services Secretary Alex Azar said in a statement."

We need a new HHS chief, not one bought off by the biotechs (subject to review, of course).


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"Pfizer, BioNTech reach $1.95 billion COVID-19 vaccine deal with US government" by Hannah Denhamand Carolyn Y. Johnson Washington Post, July 22, 2020

Pharmaceutical giant Pfizer and German biotechnology firm BioNTech will supply the federal government with 100 million doses of coronavirus vaccine under a $1.95 billion deal announced Wednesday, the administration’s largest investment yet in a vaccine that has not been proven effective.

The government also has an option to acquire an additional 500 million doses of BNT162, as the vaccine candidate is called. It still must secure regulatory approval or authorization that Pfizer projects it may seek as early as October.

The agreement could allow the US to buy a large portion of the vaccine Pfizer plans to make through the end of 2021, and comes on top of the government’s vaccine contracts with AstraZeneca for 300 million doses, and Novavax for at least 100 million doses.

Related"Novavax, the little-known Maryland company that received a $1.6 billion deal from the federal government for its experimental coronavirus vaccine, announced encouraging results in two preliminary studies on Tuesday. In one study, 56 volunteers produced a high level of antibodies against the virus without any dangerous side effects. In the other, researchers found that the vaccine strongly protected monkeys from coronavirus infections.  John Moore, a virologist at Weill Cornell Medicine who was not involved in the studies, said, “This is the first one I’m looking at and saying, ‘Yeah, I’d take that.’” Novavax’s vaccine is one of more than two dozen products to have entered the first round of safety tests in people, known as Phase 1 trials. Five other coronavirus vaccines are already in Phase 3 trials, in which thousands of people are tested to see if a vaccine works....."

With so much money at stake and the larger plan in view, they are no doubt fudging the side effects like Moderna!

‘‘All of this runs a very high risk of excluding people in the developing world,’’ said Peter Lurie, president of the Center for Science in the Public Interest. ‘‘Basically, certain rich countries are snapping up the candidate vaccines. It may leave people, who by then are at higher risk, with no protection.’’

No, Oxford is going to test theirs in Africa first, per standard protocol.

The US government is effectively paying an implied price of $19.50 per dose for the vaccine under the agreement, although the companies said Americans would receive the shots for free. Bloomberg Intelligence analysts wrote in a note that agreements between the United Kingdom and GlaxoSmithKline imply a price of $10 a dose and a candidate from AstraZeneca appears to be priced at $3 to $4 per dose.

‘‘That’s not profit, it’s profiteering off a public health crisis,’’ Ben Wakana, executive director of Patients For Affordable Drugs, an advocacy group, said in a statement.

During a congressional hearing Tuesday, executives from several major pharmaceutical companies would not commit to providing the vaccines at no profit indefinitely, but several companies did say they would price them at a not-for-profit basis during the pandemic.

‘‘We recognize these are extraordinary times and our pricing will reflect that during the time of the pandemic. We’ll price our potential vaccine consistent with the urgent global health emergency that we’re facing,’’ John Young, chief business officer of Pfizer testified.

Through Operation Warp Speed, an effort to fast-track the development of coronavirus countermeasures, the US is investing billions of dollars to reduce the financial risk to companies of scaling up vaccine production before the products are proved to be safe and effective. Typically, companies wait for data before initiating large-scale manufacturing, but because of the urgent global need, they are making doses so that they can be ready the day they are shown effective.

Meaning if the whole thing falls apart, as it is by the minute, they get to keep the money.

The Pfizer contract is the fifth large vaccine investment by the US government to help support the research and development or pre-purchase of experimental vaccines, which have also gone to Johnson & Johnson, Moderna, AstraZeneca, and Novavax.

Maybe you take a momenta to read this.

Pfizer plans to have 100 million doses of a vaccine available by the end of the year and produce 1.3 billion doses in 2021, suggesting that the US contract could tie up much of the supply the company plans to manufacture in the near future.

That's four doses for every person in the country.

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I guess you won't getting one from these guys then:

"Oxford University, AstraZeneca say their experimental vaccine is yielding promising results" Washington Post, July 20, 2020

LONDON — An Oxford University group and the British-Swedish pharmaceutical company AstraZeneca reported Monday that their coronavirus vaccine candidate, on which the US and European governments have placed substantial bets, was shown in early-stage human trials to be safe and to stimulate an immune response.

I've got a bridge to sell you if interested.

The study, published in the British medical journal the Lancet and involving 1,077 volunteers, was described as promising. A second report in the same medical journal on a Chinese vaccine showed what researchers not involved in the study call modest, positive results.

The two vaccines are among 23 candidates now being tested in human trials, according to a running tally kept by the World Health Organization. Over 130 others are in preclinical trials.

Scientists caution that no one yet knows what level of immune response will be protective against the virus in the real world.

If any at all, and why is it even needed when we have a 99.96% survival rate, 90% of the tests are false positives, and only 6% of the deaths are COVID specific?

Looks like a $windle to me!

Last week, American researchers announced the first COVID-19 vaccine tested in the United States boosted people’s immune systems, and the shots will now enter the final phase of testing. That vaccine, developed by the National Institutes of Health and Cambridge, Mass.-based Moderna, produced the molecules key to blocking infection in volunteers who got it, at levels comparable to those in people who had survived a COVID-19 infection.

Moderna’s stock fell 12.83 percent Monday following news about Oxford’s vaccine candidate.

Much about the virus remains unknown. Last week, British researchers said people infected with it may see antibodies against it fade within months.

Still, researchers are optimistic they can stimulate a permanent guard against infection.

Large-scale, real-world trials of the Oxford vaccine are underway in Britain, Brazil, and South Africa. The United States plans to test it later this summer, along with a handful of other candidates, in clinical trials with about 30,000 volunteers each.

The Oxford vaccine is named ChAdOx1 nCoV-19 and was made from a weakened and nonreplicating version of a common cold virus, an adenovirus.

That's because that is all COVID-19 is, a common cold!

Paul Offit, head of the Vaccine Education Center at Children’s Hospital of Philadelphia, said it’s unclear how protective the immune memory in T cells will be against coronavirus, in part because immune memory is typically more valuable against pathogens that have a longer incubation period than the coronavirus. his biggest concern about the Oxford study was that while the vaccine triggered the immune system best when given with a second shot, that two-dose regimen was tested in only 10 patients.

‘‘I’d want to see in a phase two trial: two doses consistently inducing a neutralizing antibody response — and that it’s relatively long lived, not months, not a few weeks,’’ Offit said.

The injections will never end, folks!

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Of course, it could never be the $ource of your cancer, right?

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Time to check Moderna's $tock price:

"The Swiss federal government has struck a deal with Moderna to supply Switzerland with 4.5 million doses of COVID-19 vaccine if the Cambridge-based biotech firm successfully develops one. The Federal Office of Public Health says the agreement aims “to guarantee Switzerland early access to the vaccine of Moderna” and is one of the first such deals by any government with the company. An office statement on Thursday says the government wants to ensure that the Swiss population has rapid access to a safe and effective COVID-19 vaccine. At the same time, it says Switzerland is supporting multilateral projects for the fair distribution of a future vaccine. The Moderna deal would make it possible to vaccinate 2.25 million people, because expectations are that two doses would be needed, it said. The Swiss government is also in talks with other vaccine companies and has already allocated nearly $330 million for purchases of COVID-19 vaccine. It did not specify the value of the Moderna deal."

Related:


That comes amid concerns over U.S. government COVID-19 contracts and transparency, as Moderna (MRNA) has failed to comply with disclosure requirements and publicly report development costs of a vaccine that is being funded by the Biomedical Advanced Research and Development Authority.

It's enough to give them an up$et $tomach:

"A nearly $21 million government-funded study to see if a popular, over-the-counter heartburn medication could be a COVID-19 remedy has fizzled amid allegations of conflicts of interest and scientific misconduct, according to interviews, a whistleblower complaint, and internal government records obtained by The Associated Press. In mid-April, the Trump administration funded a study of famotidine, the main ingredient in Pepcid, despite a lack of published data or studies to suggest heavy doses would be effective against the novel coronavirus. When government scientists learned of the hastily produced proposal to spend millions in federal funding on the research, they considered it laughable. Now, the Pepcid project faces an uncertain future. Northwell Health, the New York health care provider hired to conduct the testing at its hospitals, put the trial on hold because of a shortage of hospitalized COVID-19 patients in that state. Northwell is partnered with Alchem Laboratories, the Florida-based pharmaceutical company that received the contract. The Pepcid project underscores what critics describe as the Trump administration’s casual disregard for science and anticorruption rules. It was harshly criticized by a government whistleblower, Rick Bright. He filed a complaint accusing a senior administration health official of rushing the deal through without the scientific oversight necessary for such a large federal award."

The latest is a ruling that threatens to upend patents on Moderna’s Covid-19 vaccine, and it's a "game of chicken" between Moderna and Canadian firm Arbutus.

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Time for someone else to develop the vaccine:

"Another big drug maker growing in Cambridge; Bristol Myers Squibb signs lease for new building in Cambridge Crossing megadevelopment" by Tim Logan Globe Staff, August 19, 2020

Despite the COVID-19 pandemic, some things about Boston real estate haven’t changed. One of them is voracious demand from life sciences companies.

It's easier to get a hotel room as well, even if the center of town has been hollowed out. 

The latest is Bristol Myers Squibb, which late Tuesday announced plans to lease 360,000 square feet in a building under construction at Cambridge Crossing, a huge office and housing complex on the Cambridge-Somerville line in East Cambridge.

The drug maker will consolidate its two Cambridge research-and-development facilities — one now on nearby Binney Street in Kendall Square, the other in Alewife — into a new, single, lab building there. The 483,000-square-foot building, at 250 Water St., is on track to open in 2023.

Bristol is the latest big-name company to make its way to Cambridge Crossing, a former rail yard being redeveloped with a slew of office and lab buildings, a new Lechmere station on the extended Green Line, and more than 3,000 condos and apartments planned. Philips North America is moving its headquarters there from Andover, while Sanofi is planning to consolidate several Cambridge locations into two buildings currently under construction. In all, developer DivcoWest has leased 1.7 million square feet of office and lab space in the complex, with about 700,000 square feet left to go.

Looks like part of the Great Re$et, does it not?

“We are thrilled that global leader Bristol Myers Squibb has chosen CX (Cambridge Crossing) as their future home,” said Mark Roopenian, managing director at DivcoWest, in a statement. “CX is designed to be a network of forward-thinking change makers like Bristol Myers Squibb, and we are proud to create a space for them at 250 Water St. so that they can pursue discoveries that positively transform patients’ lives.”

The deal also highlights the ongoing strength of the region’s life-sciences market, despite the pandemic. While deals and expansions in other corners of Boston’s office market have slowed to a trickle, the business of building and leasing lab space roars on.

Despite? 

More like because of!

Last month, gene-editing firm CRISPR Therapeutics leased a full building near the Broadway Red Line station in South Boston, and life-sciences-oriented development projects are pushing ahead in various corners of Greater Boston.

Meanwhile, we are all going backward as a result of this fraud lockdown and $camdemic!

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When you shot is ready you can go right to the corner drug store to be inoculated:

"Aetna helps CVS navigate changing behavior amid pandemic" by Angelica LaVito Bloomberg News, August 5, 2020

CVS Health Corp.’s newly acquired health insurer, Aetna, helped it weather abrupt shifts in consumer behavior during the pandemic, resulting in better-than-expected second-quarter results for CVS and a boost in its full-year forecast.

People have skipped doctor visits and postponed elective surgeries throughout the COVID-19 pandemic, sending Aetna’s medical benefit ratio down to 70.3 percent from 84 percent a year earlier. Revenue for the health care benefits segment jumped 6 percent to $18.5 billion, CVS said in a statement Wednesday. The Woonsocket, R.I.-based company acquired Aetna in 2018 for $68 billion.

Yeah, the teleheath market is flying high these days and doctors will soon be a thing of the past.

Shelter-in-place restrictions kept people at home after the mad dash to stock up on toilet paper and prescriptions in the spring. New business helped CVS’s pharmacy services unit, including CVS’s pharmacy-benefit manager, overcome fewer new prescriptions. Pharmacy same-store sales rose 4.6 percent.

CVS has grown beyond a drugstore to include a pharmacy-benefit manager and a health insurer. Executives touted the quarterly results as evidence that its strategy is paying off.

CVS shares were down Wednesday.

CVS anticipates it will administer 18 million flu shots this season, more than previous years, according to Merlo. Health officials are planning a bigger push than usual in hopes of preventing another crisis. The company is also in talks with the Trump administration about plans for administering a COVID-19 vaccine when one becomes available, said CVS chief executive Larry Merlo.

Earlier this summer, CVS introduced a program called Return Ready to help employers and universities devise testing strategies, as well as other programs like contact tracing. Merlo said CVS has signed more than 40 clients and has more than 1,000 prospects.

In its quarterly filing, CVS outlined several downsides it anticipates related to COVID-19, including less prescription drug use with people skipping visits to their doctors, fewer front-store sales amid shelter-in-place orders, and higher unemployment and a decrease in commercial insurance members due to companies laying workers off or folding entirely, as well as an unwillingness of prospective clients to switch carriers.

So another lockdown is coming, 'eh?

At the same time, CVS reported $27 million of uninsured store damage and inventory losses from ‘‘civil unrest’’ across the United States in the second quarter, which ended June 30. Demonstrations, most of which were peaceful, surged across the United States in May following the killing of George Floyd by police in Minneapolis. Some were accompanied by looting.

CVS operates about 9,900 stores across the country.....

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Think I will start going to Walgreens instead, and there has been very little backlash to what is going on out there.

So what if a drug treatment works, is cheap, and we no longer need a vaccine because of herd immunity?

Race over?