UK scientists to immunize hundreds with coronavirus vaccine

Scientists at Imperial College London say they are immunizing hundreds of people with an experimental coronavirus vaccine in an early trial after seeing no worrying safety problems in a small number vaccinated so far.

Dr. Robin Shattock, a professor at the college, told The Associated Press that he and colleagues had just finished a very slow and arduous process of testing the vaccine at a low dose in the initial participants and would now expand the trial to about 300 people, including some over age 75.

“It’s well tolerated. There aren’t any side effects,” he said, adding it was still very early in the study. Shattock, who is leading the vaccine research at Imperial, said he hopes to have enough safety data to start inoculating several thousand people in October.

Since COVID-19 infections have dropped dramatically in Britain, making it difficult to determine whether or not the vaccine works, Shattock said he and his colleagues are also looking to test their vaccine elsewhere.

“We’re looking very carefully at the pandemic, at the numbers where the hot spots are and talking to collaborators that have the facilities to do these kinds of studies,” he said.

The Imperial vaccine uses synthetic strands of genetic code based on the virus. Once injected into a muscle, the body’s own cells are instructed to make copies of a spiky protein on the coronavirus. That should in turn trigger an immune response so the body can fight off any future COVID-19 infection.

Earlier this week, the world’s biggest coronavirus vaccine study started in the United States, with the first of 30,000 planned volunteers getting immunized with shots created by the U.S. National Institutes of Health and Moderna Inc.

Several other vaccines made by China and by Britain’s Oxford University, based on different vaccine technologies, began smaller final-stage tests in Brazil and other hard-hit countries earlier this month.

The World Health Organization has said multiple vaccine approaches are necessary for COVID-19, noting that the usual success rate for vaccine development is about 10%.

Shattock said there were numerous coronavirus vaccines now in clinical trials, and he predicted that at least some of them would prove to be effective.

“We have 20 vaccines in clinical trials, (so) we can be pretty confident that at least two of those will work,” he said. “It really depends on how strong the immune response needs to be to provide protection.”

Shattock said he was optimistic the Imperial vaccine would work, but must await the scientific data from the trial.

“I’m just going to hold my breath and wait to see,” he said.

https://medicalxpress.com/news/2020-07-uk-scientists-immunize-hundreds-coronavirus.html

FDA OKs Incyte/Morphosys’ tafasitamab for treatment-resistant lymphoma

Morphosys AG (NASDAQ:MOR) and collaboration partner/licensee Incyte (NASDAQ:INCY) announce the FDA nod for Monjuvi (tafasitamab-cxix), combined with lenalidomide, for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

Under the terms of their January 2020 agreement, the companies will co-commercialize the the humanized Fc-modified cytolytic anti-CD19 monoclonal antibody in the U.S. while INCY will exclusively commercialize ex-U.S.

U.S. commercial launch will commence shortly.

https://seekingalpha.com/news/3598655-fda-oks-incyte-morphosys-tafasitamab-for-treatment-resistant-lymphoma

FDA OKs new use of GW Pharma’s Epidiolex

GW Pharmaceuticals (NASDAQ:GWPH) unit Greenwich Biosciences announces the FDA nod for the use of Epidiolex (cannabidiol) oral solution to treat seizures associated with tuberous sclerosis complex (TSC) in patients at least one year old.

TSC is an inherited disorder characterized by the growth of benign tumors in many parts of the body. Sufferers may experience seizures when they form in the brain.

The agency reviewed the application under Priority Review status.

Epidiolex was first approved in the U.S. in June 2018 for the treatment of seizures associated with two rare and severe types of childhood epilepsy called Dravet syndrome and Lennox-Gastaut syndrome.

https://seekingalpha.com/news/3598672-fda-oks-new-use-of-gw-pharmas-epidiolex

FDA OKs first semi-quantitative blood tests for COVID-19 antibodies

The FDA approves two blood tests developed at Siemens (OTCPK:SIEGY), the ADVIA Centaur COV2G and Attelica COV2G, that estimate the quantity of a patient’s antibodies against the SARS-CoV-2 virus. The semi-quantitative assays are the first such tests approved in the U.S.

Being able to estimate the quantity of antibodies may be useful in determining the degree of immunity against subsequent infection.

All the serology tests approved to date are qualitative, meaning that they detect the presence of antibodies (a “yes/no” result) but not the specific quantities.

https://seekingalpha.com/news/3598675-fda-oks-first-semi-quantitative-blood-tests-for-covidminus-19-antibodies

Trump administration can cut drug subsidies to hospitals: U.S. court

A divided U.S. appeals court on Friday ruled the Trump administration had the authority to reduce subsidies Medicare pays certain hospitals to obtain discounted pharmaceutical medications.

The U.S. Court of Appeals for the District of Columbia Circuit by a 2-1 vote overturned a judge’s decision that the administration lacked authority to cut such payments by $1.6 billion in 2018.

The cuts reduced subsidies for purchases by nonprofit hospitals of outpatient drugs bought through the 340B Drug Pricing Program, which allows them to buy medications at steep discounts and seek reimbursement.

A 2017 rule by the U.S. Department of Health and Human Services sought to address a gap between the discounted drug prices and the reimbursement rate that gave hospitals a substantial profit margin.

The American Hospital Association and hospitals sued, arguing HHS’ 28.5% rate cut rested on an impermissible interpretation of the statute governing Medicare, the government healthcare program for people aged 65 and older.

U.S. Circuit Judge Sri Srinivasan, writing for the majority, said “HHS’s decision to lower drug reimbursement rates for 340B hospitals rests on a reasonable interpretation of the Medicare statute.”

U.S. Circuit Judge Cornelia Pillard dissented, saying the statute did not allow HHS to “take a major bite” out of funding for “financially strapped, public and nonprofit safety-net hospitals serving vulnerable populations.”

HHS Secretary Alex Azar called the ruling a “major victory for President Trump’s agenda of lower drug prices and better healthcare for all Americans.”

The American Hospital Association called on the administration to reverse the “harmful policy.”

Trump’s administration has argued the payment system in place before the rate cuts led to unnecessarily high Medicare spending on prescription drugs.

It again cut the reimbursement rate for 2019, though U.S. District Judge Rudolph Contreras last year held that the change, like the 2018 ones, was unlawful.

https://www.reuters.com/article/us-usa-court-hospitals-lawsuit/trump-administration-can-cut-drug-subsidies-to-hospitals-u-s-court-idUSKCN24W2RJ

Russia preparing mass vaccination against coronavirus for October

Russia’s health minister is preparing a mass vaccination campaign against the novel coronavirus for October, local news agencies reported on Saturday, after a vaccine completed clinical trials.

Health Minister Mikhail Murashko said the Gamaleya Institute, a state research facility in Moscow, had completed clinical trials of the vaccine and paperwork is being prepared to register it, Interfax news agency reported.

He said doctors and teachers would be the first to be vaccinated.

“We plan wider vaccinations for October,” Murashko was quoted as saying.

A source told Reuters this week that Russia’s first potential COVID-19 vaccine would secure local regulatory approval in August and be administered to health workers soon thereafter.

The Gamaleya Institute has been working on an adenovirus-based vaccine.

Yet the speed at which Russia is moving to roll it out has prompted some Western media to question whether Moscow is putting national prestige before science and safety.

The head of the Russian Direct Investment Fund, Kirill Dmitriev, has likened what he said was Russia’s success in developing a vaccine to the Soviet Union’s 1957 launch of Sputnik 1, the world’s first satellite.

On Saturday, Russia reported 95 additional deaths from the novel coronavirus, taking its total to 14,058.

Officials reported 5,462 new cases, raising the total to 845,443.

More than 100 possible vaccines are being developed around the world to try to stop the COVID-19 pandemic.

At least four are in final Phase III human trials, according to World Health Organization (WHO) data, including three developed in China and another in Britain.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russia-preparing-mass-vaccination-against-coronavirus-for-october-idUSKBN24X3KO

Congressional Democrats, White House set for Saturday talks on coronavirus bill

The top Democrats in Congress were to meet Saturday with two top Trump aides to try to reach a deal to pump more money into the U.S. economy to ease the coronavirus’ heavy toll, after an essential lifeline for millions of unemployed Americans expired.

Congress for the past several months has been unable to reach an accord for a next round of coronavirus relief, in a pandemic that has killed more than 150,000 Americans and brought on the sharpest economic collapse since the Great Depression.

U.S. House of Representatives Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer were to meet with Treasury Secretary Steven Mnuchin and White House Chief of Staff Mark Meadows beginning at about 9 a.m. EDT (1300 GMT) at the Capitol, according to an aide familiar with the planning.

Congress has so far agreed on about $3 trillion in coronavirus relief.

Pelosi on Friday said she rejected an offer by Republican President Donald Trump’s administration to continue the $600 payments for another week, saying such a move would only make sense “if you are on a path” toward a deal.

“We’re not,” Pelosi told a news conference.

White House officials took their own hard line, accusing Democrats of refusing Trump’s proposals to extend the jobless benefit and a moratorium on home evictions that expired last week.

“What we’re seeing is politics as usual from Democrats on Capitol Hill,” Meadows – a former Republican House member – told reporters.

The House in May passed a $3 trillion deal that addressed a wide range of coronavirus responses, including more money for testing, for elections and support to financially strapped state and local governments.

Senate Majority Leader Mitch McConnell on Monday unveiled his own $1 trillion package, which met immediate resistance both from Democrats, who called it too small, and from members of his own party, who said it was too costly.

Trump, scrambling to prop up a struggling U.S. economy as he runs for re-election in November, has been pushing for another bill.

In a meeting on Thursday night between top White House officials and congressional Democratic leaders, negotiations focused on an extension of the $600 per week in federal unemployment benefits, which Americans who lost jobs because of the health crisis have been receiving in addition to state jobless payments.

According to a person familiar with the closed-door negotiations, the White House proposed continuing the $600 weekly unemployment payment for one week, which Pelosi and Schumer rejected. The White House then proposed reducing the $600 weekly payment to $400 for the next four months. While that was a move toward Democrats’ demands, the source said they rejected it as insufficient.

The source, who asked not to be identified, said the White House also hinted it could embrace a deal without the legal protections from lawsuits for companies and schools that McConnell has said must be included.

On Thursday, Senate Republicans tried, without success, to pass a bill reducing the jobless benefit to $200 per week.

https://www.reuters.com/article/us-health-coronavirus-usa-congress/congressional-democrats-white-house-set-for-saturday-talks-on-coronavirus-bill-idUSKBN24X3OT