September 1 coronavirus news

Schools are reopening -- and the virus is spreading across US college campuses.

At least 37 states are reporting positive Covid-19 cases at colleges or universities, making a total of more than 25,000 cases among students and campus staff.

Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Washington and Wisconsin.

Lenzilumab, an antibody therapy, reduced the relative risk of death or need for ventilation by 80% for Covid-19 patients, according to a new study.

California-based biopharmaceutical company Humanigen said Tuesday it has been evaluating the drug in an ongoing late stage drug trial. 

Patients who got the therapy had an 8% risk of death or needing a ventilator, compared to 41% for the standard care group.

The antibody therapy patients took one day (on median) to recover from the cytokine storm -- which is when the body's overactive immune response begins to attack its own cells rather than just the virus. For the standard care group, that median recovery time was eight days.

It was originally developed to treat certain forms of leukemia, but because it tamps down the inflammatory response, researchers have been trying it out in coronavirus patients.

A larger randomized, placebo controlled clinical trial is underway at multiple sites across the US. The company expects the trial to be complete sometime in September. 

Maryland Gov. Larry Hogan said on Tuesday that the State Board of Elections had finally mailed out ballot applications to every voter in his state, after he had asked them to do so immediately nearly eight weeks ago.

He urged Maryland voters to take advantage of voting by absentee ballot, to participate in early voting, or to vote at off-peak times on Election Day to reduce crowds at the polls amid the coronavirus pandemic.

“I’m still concerned about whether or not they’re going to be able to pull it off,” Hogan said, concerning the efforts of the Maryland State Board of Elections, adding that he had urged the board to open more polling places, which they did.

“I’m concerned about crowded polls and them not responding fast enough, and I think we’re going to work with the legislature to continue to stay on top of the Board of Elections, because I’m not completely confident that everything is going to go smoothly,” the governor added.

The phased reopening includes opening outdoor performance venues, indoor theaters, and retail and religious facilities -- all with varying caps on the maximum number of people allowed inside.

There are now 30 coronavirus cases in Canada linked to Bar Le Kirouac, a karaoke bar in Quebec City, according to the province's regional public health department.

“We are in the process of figuring out with public security whether this is a criminal matter,” Quebec Health Minister Christian Dubé said during a news conference on Tuesday. 

Dubé said Quebec is considering imposing fines in the case.

“We are talking about karaoke, where people who think that because they are with friends, they know well that they can relax, take off the mask, pass the microphone, get close to each other to sing together. These are enjoyable things, but we can’t do that anymore,” the minister added.

The United States has reported 42,284 new Covid-19 cases and 1,032 virus-related deaths so far on Tuesday, according to data from Johns Hopkins University.

That raises the national total to at least 6,072,871 cases and 184,629 deaths.

The totals include cases from all 50 states, the District of Columbia and other US territories, as well as repatriated cases. 

Colombia’s coronavirus lockdown was partially lifted on Tuesday, even as the country reported 389 new coronavirus deaths, taking the death toll there to 20,052.

The Health Ministry also reported 8,901 new cases of Covid-19 on Tuesday, Colombia’s sixth consecutive day reporting fewer than 10,000 new infections. In total, Colombia has reported 624,069 cases of coronavirus.

Only Brazil and Peru lead Colombia in terms of the highest numbers of coronavirus infections in Latin America, according to data from Johns Hopkins University.

Starting Tuesday, restrictions on activities such as air travel, intercity transport and non-essential businesses were partially lifted in Colombia.

Bars and restaurants are to remain closed until at least the end of September, with limited exceptions allowing for open-air dining.

The US Food and Drug Administration issued a warning letter to a Montana-based company for selling an amniotic fluid product as a coronavirus treatment and for advertising for a nonexistent Covid-19 study.

Lattice Biologics, Ltd. was warned after federal regulators investigated its website and social media sites and learned the company was selling a product called AmnioBoost, a stem cell product that it touted as a treatment for lung damage from Covid-19, the FDA said in a news release.

“Based on our review, this product is an unapproved new drug under section 505 of the Federal Food, Drug, and Cosmetic Act,” the agency said in the warning letter. “Furthermore, this product is a misbranded drug,” it added.

The FDA cited a YouTube video posted on April 2 that the company made called “Stem Cells For Covid-19” where the CEO of Lattice Biologics injects himself with what he says are 1 million stem cells to test safety and efficacy of the amniotic fluid product.

It quoted the post verbatim. “The YouTube video marketing your amniotic fluid product, in which you state that you ‘hop[e] that the stem cells can go in and repair’ [severe lung damage] … even if you are at the hospital … you have this lung damage this is a reasonable treatment to try and repair that,” it said.

“We request that you take immediate action to cease marketing such unlicensed, unapproved, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of SARS or ARDS related to COVID-19,” the agency wrote in the warning letter.

The FDA also warned the company about its recruitment efforts for a “free clinical trial” of its amniotic product looking for Covid-19 patients with “a laboratory confirmed infection with COVID-19 and evidence of lung involvement requiring supplemental oxygen or mechanical ventilation” to be administered “5 million [stem cells] on the first day of enrollment and will receive another 5 million stem cells on the second day of enrollment.”

“We advise you to review your website, social media websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product as safe and effective for a COVID-19-related use for which it has not been licensed by FDA and that you do not make claims that misbrand the product in violation of the FD&C Act,” the regulator said.

The company has 48 hours to respond or face potential legal action.

There are no FDA-approved products to prevent, treat or cure Covid-19, although the FDA has granted emergency use authorization to very few therapies.

Maryland Gov. Larry Hogan today announced that Maryland will begin to move into stage three of the "Maryland Strong: Roadmap to Recovery," with additional gradual reopenings starting Friday.

As part of the state’s initial entry into this stage, indoor theaters for live performances or movies, will be allowed to reopen to the general public at 50% capacity, or 100 people per auditorium, whichever is less, along with appropriate health and safety protocols, a release from Hogan’s office said.

Outdoor venues for live performances and outdoor movie theaters will also be able to reopen to the general public at 50% capacity, or 250 people, whichever is less, Hogan said.

Capacity for retail establishments and religious facilities will be allowed to increase from 50 to 75%, according to the release.

In an extraordinary move, the Centers for Disease Control and Prevention is moving to temporarily halt most evictions for Americans struggling to pay their rent due to the pandemic, in a step that’s broader than eviction protections already in place.

But senior administration officials say renters will have to prove a number of things before qualifying, and will still have to pay back any missed rent payments.

The move comes after negotiations on further coronavirus aid have been stalled on Capitol Hill as Republicans and Democrats refuse to budge on topline numbers for what a new relief package would cost.

In a phone call with reporters on Tuesday, officials, speaking on background, said the order will apply to Americans who qualified for direct payments under the CARES Act.

People will also have to prove that they’ve taken “best efforts possible to seek government assistance to make their rental payments,” they will have to “declare that they are unable to pay rent due to Covid financial hardship,” and must show they “will likely become homeless or move into congregate housing settings if they are evicted.”

Landlords will still be able to remove tenants for “committing criminal acts, threatening the health and safety of other residents, damaging property or other health and safety considerations,” an official added.

Renters will have to fill out several forms, found on the CDC’s website, and give them directly to their landlords to qualify for the program.

“This will be a declaration presented to the landlord, if that landlord approaches a tenant with an intent to evict,” an official said. Because the move is federally mandated, it “would become a criminal offence” if the landlord chose to ignore the declaration. But it could still end up in courts, possibly leading to legal actions that could show up on background checks or credit reports.

“To the extent that there is a dispute between the landlord and the renter about whether or not an eviction protection is in place here, it can be filed, and that would be for the local courts, which are not federal to adjudicate,” an official said.

Officials did not answer questions about how that legal action could impact credit or future housing options. 

Under the CARES Act, only renters in federally-backed rental units were protected from eviction. “This covers any rental unit in United States, so long as the renter meets those requirements, where they've demonstrated that they are at risk of becoming evicted,” an official said. There’s also currently a moratorium on evictions for federally-backed, single family home mortgages.

But, “it is not an invitation to stop paying rent,” another official cautioned. “The order makes clear that a renter who cannot pay his or her full rent should pay an amount that is not unduly burdensome, and as close to payment as possible.”

“We want to be clear that those who benefit from this assistance, are still obligated to pay any accrued rent or housing payments in accordance with their lease or contract,” a senior administration official said.

As for why the move is being made by the CDC, an official says “the CDC director has authority to take measures that he's reasonably necessary to mitigate the spread of communicable disease.”

“Congress has delegated broad authority to HHS, the Surgeon General and CDC, to take reasonable efforts to combat the spread of communicable diseases, and frankly I think it makes sense for those authorities abroad because we don't know for any given situation or scenario what steps will be needed to stop the spread,” an administration official said. “I think, in this particular order, the CDC has made a very compelling case that it is quite problematic at this particular time. It's focused on this particular pandemic, which is obviously the uniquely powerful grasp in the nation's entire history in terms of the effect it's had that for a bunch of reasons in particular, that the home has been sort of the focal point of people social distancing and building, sort of a safe space themselves over the past few months, and also the fact that if people get kicked out, they may end up in overcrowded congregated living facilities or homeless shelters, and that is a potential recipe for a big spread of COVID-19.”

Asked why that authority wasn’t being used to enact a federal mask mandate, officials refused to answer because the question didn’t “have to do with the call at hand.”

Deputy press secretary Brian Morgenstern said the action “means that people struggling to pay rent due to the coronavirus will not have to worry about being evicted and risk further spreading of or exposure to the disease due to economic hardship,” and attacked Democrats on the hill.