Virus fallout forces U.S. cities to cut budgets, projects

U.S. cities are laying off workers, shelving infrastructure projects and delaying or canceling equipment purchases as the economic fallout from the cornonavirus outbreak ravages their budgets and federal funds remain elusive, a survey released on Tuesday showed.
With cities facing a projected $360 billion revenue loss over the next three years, the National League of Cities’ survey of more than 1,100 municipalities found that 74% have started to cut their budgets, with 20% reporting across-the-board reductions.
“American cities, towns and villages are facing a double whammy,” Matt Zone, a Cleveland City Council member, told reporters in a conference call. “We have mounting expenses related to the pandemic while tax revenues are declining.”

Nearly two-thirds of the survey respondents said they are delaying or canceling infrastructure projects as well as equipment purchases like police cars and garbage trucks.
“What we need now is certainty, especially given that local economies are what drives the national economy. There’s definitely a ripple effect,” said Joe Buscaino, Los Angeles Council president pro tempore and National League of Cities president.
League officials said nearly 70% of cities have not received any of the $150 billion earmarked for state and local government virus-related expenses in the federal CARES Act, which only provided direct funding to the nation’s 36 largest municipalities, leaving the rest relying on allocations from their states or counties. The group is pushing for $500 billion in direct and flexible federal funding for all cities, although the outlook for passage in a divided Congress is unclear.

On the jobs front, 32% of cities are eyeing furloughs or layoffs, while 41% have or will institute a hiring freeze, the survey found.
Local government employment, excluding education, fell by just over 500,000 jobs in April and May, according to the U.S. Labor Department.
https://www.reuters.com/article/us-health-coronavirus-usa-cities/virus-fallout-forces-u-s-cities-to-cut-budgets-projects-survey-idUSKBN23U31D

Inovio moves COVID-19 shot, scores DOD deal to scale up needleless vax devices

Way back in January, Invoio was among the first groups to get involved in COVID-19 vaccine research under a $9 million grant from the Coalition for Epidemic Preparedness Innovations. Now that the company has advanced to human testing, it’s also scored a much larger contract from the U.S. government for delivery devices.

The U.S. Department of Defense (DOD) inked a $71 million supply deal with the Pennsylvania biotech to manufacture devices that use electrical pulses to deliver the company’s vaccines into the skin. The biotech’s vaccine candidate entered human testing in April, and the company plans to report results from that study this month.

The DOD deal will support manufacturing of Inovio’s next-gen Cellectra 3PSP and purchase of its older Cellectra 2000. The new device runs on AA batteries and can “function reliably in challenging environments,” the biotech says, which can be beneficial during pandemics when vaccine demand is extremely high, and in some countries where health systems and supply chains are underdeveloped.

The contract “further supports Inovio’s large-scale production of devices and arrays to deliver potentially hundreds of millions of doses of INO-4800 next year to combat the global COVID-19 pandemic,” Inovio CEO Joseph Kim said in a statement

Inovio is among dozens of companies advancing COVID-19 vaccines, with many of pharma’s biggest players also involved. The company has jumped into emerging disease vaccine research during past outbreaks, but its work has yet to deliver an approved vaccine. After reporting phase 1, the company hopes to start a phase 2/3 trial in July, Kim previously told Fierce Biotech.

That company expects that study will take about a year, and Inovio may file for an emergency approval before the trial wraps up, Kim added.

Even as the company moves forward with its COVID-19 vaccine, it’s also engaged in a legal fight with a manufacturing partner. In a lawsuit this month, the company accused VGXI, a subsidiary of South Korean Geneone Life Sciences, of hindering the ramp-up by refusing to pass technical know-how to CDMOs so those companies could make doses. In a statement, the biotech said it expected the dispute to be “resolved shortly.”

Inovio’s candidate, a DNA vaccine, is one of 13 COVID-19 programs worldwide in human testing, according to a Monday update from the World Health Organization. Aside from those programs, another 130 are in preclinical stages. Moderna and AstraZeneca are in midstage testing, with phase 3 studies planned to kick off this summer.

As the candidates race forward, one group of analysts recently predicted that “at least one” vaccine could be authorized by the FDA by this November.

https://www.fiercepharma.com/pharma/inovio-scores-71m-department-defense-deal-to-scale-up-vaccine-delivery-devices

Oregon county issues face mask order that exempts non-white people

Lincoln County, Oregon, has exempted non-white people from a new order requiring that face coverings be worn in public — to prevent racial profiling.
Health officials announced last week residents must wear face coverings in public settings where they may come within six feet of another individual who is not from the same household.
But people of color do not have to follow the new rule if they have “heightened concerns about racial profiling and harassment” over wearing the masks, officials said.
“No person shall intimidate or harass people who do not comply,” health officials said.
With mask requirements becoming more common, activists have raised concerns that the directives could put non-white people in danger.
“For many black people, deciding whether or not to wear a bandanna in public to protect themselves and others from contracting coronavirus is a lose-lose situation that can result in life-threatening consequences either way,” ReNika Moore, director of the ACLU’s Racial Justice Program, told CNN.
Trevon Logan, who is black, said orders to wear face coverings are “basically telling people to look dangerous given racial stereotypes that are out there.”
“This is in the larger context of black men fitting the description of a suspect who has a hood on, who has a face covering on,” Logan, an economics professor at Ohio State University, told the outlet.
“It looks like almost every criminal sketch of any garden-variety black suspect.”
https://nypost.com/2020/06/23/oregon-county-issues-face-mask-order-exempting-non-white-people/

Exporters say China soy buyers want guarantee of coronavirus-free cargoes

China’s soybean buyers are asking exporters to sign a letter guaranteeing their cargoes are not contaminated with the novel coronavirus, U.S., Brazilian and Canadian soy industry officials said on Tuesday.
China is trying to prevent any risk of new COVID-19 infections from imported goods as it takes aggressive measures to contain a recent spike in coronavirus infections linked to a sprawling wholesale food market in Beijing.
Two grain export traders told Reuters that their companies have not responded to the request and are looking to federal agriculture officials or broader industry groups for a unified response.
The U.S., Brazilian and Canadian departments of agriculture did not immediately respond to requests for comment.
Last week, overseas suppliers of meat and fruit reported that China’s General Administration of Customs asked them to sign declarations ensuring the safety of their shipments to China. Customs did not reply to a Reuters request for comment on Friday about the declarations.
The U.S. Department of Agriculture and trade representatives are telling meat exporters to make their own decisions about whether to sign the declarations, a source who has been in contact with the USDA said. The source said the USDA on Friday advised shippers against signing the letters.
Efforts to ensure soybean cargoes are free from the coronavirus are coming from local customs authorities, not Beijing, said Zhang Xiaoping, China director of the U.S. Soybean Export Council.
“Seems ripe for false positives,” a U.S. soybean export trader said, who asked not to be identified in order to speak candidly. “How in the world do you argue that you verified it to be coronavirus free? We have not responded to it.”
Sergio Mendes, director general of Brazil’s export grain association Anec, said the group is preparing its response and did not expect the Brazilian government to interfere. Contamination is virtually impossible as the ship loading process is almost entirely automated, he said.
“We would be guaranteeing the unimaginable,” Mendes said.
The Canadian government views the situation as a private sector matter and is not recommending whether exporters should provide such guarantees, Soy Canada executive director Ron Davidson said.
Port workers unloading beans present a greater risk for contamination than the beans themselves as bulk shipments spend at least three weeks at sea, longer than the virus can survive without a host, said Iowa State University grain quality expert Charles Hurburgh, a professor of agricultural engineering.
“No one will certify to that risk, I am sure,” he said.
China is the world’s top soybean buyer and is expected to import about 94 million tonnes in the 2019/20 crop year, mostly from Brazil and the United States. Imported soybeans are crushed to produce soymeal to feed livestock.
Multinational traders Bunge Ltd and and Louis Dreyfus Co [AKIRAU.UL] did not immediately respond to a request for comment. Archer Daniels Midland Co and Cargill Inc [CARG.UL] declined to comment.
Most international authorities say there is no evidence that the coronavirus can be transmitted from food to people.
https://www.marketscreener.com/SOY-4272016/news/Exporters-say-China-soy-buyers-want-guarantee-of-coronavirus-free-cargoes-30809970/

Brazil nears deal to produce Oxford coronavirus vaccine

Brazil is likely to sign a contract this week to produce a trial vaccine developed by Oxford University to guard against the novel coronavirus, the country’s interim health minister Eduardo Pazuello said on Tuesday.

Human clinical trials in Brazil for the potential vaccine started this weekend with 3,000 people in Sao Paulo and Rio de Janeiro.

Interim health minister Eduardo Pazuello said in a hearing with lawmakers that a deal could be signed tomorrow and that other partnerships with vaccines developers could also be forged soon.
This month, Brazil’s health regulator Anvisa approved human clinical trials for the potential vaccine, developed by Oxford and supported by AstraZeneca Plc.

Brazil, where the disease is still rife, is the first country outside the United Kingdom to start testing the Oxford vaccine.
Researchers expect to launch the vaccine by year-end.
Brazil’s government plans to roll out a mass test reaching 24% of the country’s population, a health ministry official said during the hearing. Further details on the plan are expected to be released on Wednesday.
Brazil has more than 1 million cases of COVID-19 and 51,000 deaths caused by the virus.
https://www.reuters.com/article/us-health-coronavirus-brazil-vaccine/brazil-nears-deal-to-produce-oxford-coronavirus-vaccine-idUSKBN23U1R3

China to run human coronavirus vaccine trial in UAE

China National Biotec Group (CNBG) has won approval to run a large-scale “Phase 3” clinical trial of its novel coronavirus vaccine candidate in the United Arab Emirates (UAE), the company said on Tuesday.
China is seeking to trial potential vaccines overseas because of a lack of new patients at home.
Over a dozen experimental vaccines are being trialled around the world. None of them has yet successfully completed a late-stage “Phase 3” test to determine efficacy in shielding healthy people from the virus, which has killed over 470,000 people around the world.
Such trials involve thousands of participants and normally take place in countries where the virus is widespread, so that the vaccine can be observed in a real-life environment.
However, China, the origin of the global pandemic, reported fewer than 10 new local cases a day on average last month, and its researchers are now looking abroad.
CNBG announced the move in a Weibo social media post, without naming the vaccine to be tested in the UAE.

Units of CNBG, an affiliate of the state-owned China National Pharmaceutical Group (Sinopharm), have developed two potential vaccines, which have together been given to over 2,000 people in previous tests in China.
Other Chinese companies seeking to trial vaccines overseas include Clover Biopharmaceuticals, whose shots have been given to participants in Australia in an early study, and Sinovac Biotech (SVA.O), which is expected to begin a Phase 3 trial in Brazil with 9,000 volunteers.
https://www.reuters.com/article/us-health-coronavirus-china-vaccine/china-to-run-human-coronavirus-vaccine-trial-in-uae-idUSKBN23U2H8

Merck and Pfizer square up for pneumococcal vaccine fight

The rivals have taken different strategies with next-gen pneumococcal vaccines, which will be fighting for a blockbuster market that is Pfizer’s to lose.

Pneumococcal vaccines are hugely successful products – global sales reached $7.5bn last year – and the market for now is controlled by Pfizer with Prevnar 13. But the company might be facing its first real challenge in the coming years, from a new project being developed by Merck & Co.
V114 adds two more serotypes on top of Prevnar’s 13, strains of the Streptococcus pneumoniae bacterium that Merck says are associated with more serious, invasive infections. Pfizer is not sitting still, however, and has 20vPnC, a 20-valent project, in late-stage development.
The broader the better in one shot is the thinking here: Pfizer has claimed that the five additional serotypes in 20vPnC can provide coverage against around 33% more strains in adults and 42% more strains in infants than V114.
Merck, meanwhile, is going for a more targeted approach, noting that, while broader is important, maintaining efficacy is also vital. As vaccination programmes moved from the older Prevnar 7 to the 13-valent product, breakthrough infections have been seen in certain serotypes. Perhaps the company thinks it can more effectively maintain durability with a tighter focus.
As well as V114, Merck has two other projects. V116 is being developed to target residual pneumococcal disease in adults, while V117 is described as a “next-generation” paediatric vaccine. The latter is not yet in the clinic, and V116 has only just arrived, so V114 is the project to watch for now.
It is also worth remembering that Merck already sells Pneumovax, a 23-valent vaccine; uniquely, this is a polysaccharide vaccine, and is therefore less immunogenic than conjugate vaccines like Prevnar 13 and V114. Polysaccharide vaccines give shorter protection and are less useful in infants or older people, who have weaker immune systems, so Pneumovax’s commercial potential has been limited.

Little phase III data have been released on either V114 or 20vPnC, so it is hard to say yet which strategy might be more successful. Both need to prove non-inferiority to Prevnar 13, as well as responses to new strains – and that they confer lasting protection.
In March Pfizer said 20vPnC had shown itself non-inferior to Prevnar 13, and to Pneumovax on six of seven serotypes that are included in that product, in adults. One of the new seven serotypes missed non-inferiority criteria by a small margin. Results from two further pivotal trials are due in the coming months.
Merck meanwhile has a huge phase III programme under way, with 16 studies on the go. The company revealed this week that V114 elicited immune responses to all serotypes in HIV-positive patients, although nothing was said about non-inferiority. Further readouts are also expected this year.
Phase II data in healthy infants last year showed the jab to be non-inferior to Prevnar 13 on all serotypes included in that vaccine, and that it produced immune responses to the two additional strains.
Merck does have one clear advantage here: it is ahead in the infant population. The childhood vaccine market makes up around 80% of pneumococcal vaccine sales. Pfizer has only just begun pivotal development of 20vPnC in children, announcing the start of two trials this week.
Both companies plan to seek for approvals for their respective projects by the end of this year, in adults. However, analysts believe that Merck is around 1.5 years ahead in the crucial infant setting. Assuming that the project convinces clinically, this is a substantial time advantage, and one of which Merck will be highly motivated to make the most.
https://www.evaluate.com/vantage/articles/news/merck-and-pfizer-square-pneumococcal-vaccine-fight