WHO acknowledges ‘evidence emerging’ of airborne Covid-19 spread

The World Health Organization on Tuesday acknowledged “evidence emerging” of the airborne spread of the novel coronavirus, after a group of scientists urged the global body to update its guidance on how the respiratory disease passes between people.

“We have been talking about the possibility of airborne transmission and aerosol transmission as one of the modes of transmission of COVID-19,” Maria Van Kerkhove, technical lead on the COVID-19 pandemic at the WHO, told a news briefing.

The WHO has previously said the virus that causes the COVID-19 respiratory disease spreads primarily through small droplets expelled from the nose and mouth of an infected person that quickly sink to the ground.

But in an open letter to the Geneva-based agency, published on Monday in the Clinical Infectious Diseases journal, 239 scientists in 32 countries outlined evidence that they say shows floating virus particles can infect people who breathe them in.

Because those smaller exhaled particles can linger in the air, the scientists in the group had been urging WHO to update its guidance.

“We wanted them to acknowledge the evidence,” said Jose Jimenez, a chemist at the University of Colorado who signed the paper.

“This is definitely not an attack on the WHO. It’s a scientific debate, but we felt we needed to go public because they were refusing to hear the evidence after many conversations with them,” he said in a telephone interview.

Speaking at Tuesday’s briefing in Geneva, Benedetta Allegranzi, the WHO’s technical lead for infection prevention and control, said there was evidence emerging of airborne transmission of the coronavirus, but that it was not definitive.

“…The possibility of airborne transmission in public settings – especially in very specific conditions, crowded, closed, poorly ventilated settings that have been described, cannot be ruled out,” she said.

“However, the evidence needs to be gathered and interpreted, and we continue to support this.”

Jimenez said historically, there has been a fierce opposition in the medical profession to the notion of aerosol transmission, and the bar for proof has been set very high. A key concern has been a fear of panic.

“If people hear airborne, healthcare workers will refuse to go to the hospital,” he said. Or people will buy up all the highly protective N95 respirator masks, “and there will be none left for developing countries.”

Jimenez said the WHO panel assessing the evidence on airborne transmission was not scientifically diverse, and lacked representation from experts in aerosol transmission.

Any change in the WHO’s assessment of risk of transmission could affect its current advice on keeping 1-metre (3.3 feet) of physical distancing. Governments, which rely on the agency for guidance policy, may also have to adjust public health measures aimed at curbing the spread of the virus.

Van Kerkhove said the WHO would publish a scientific brief summarising the state of knowledge on modes of transmission of the virus in the coming days.

“A comprehensive package of interventions is required to be able to stop transmission,” she said.

“This includes not only physical distancing, it includes the use of masks where appropriate in certain settings, specifically where you can’t do physical distancing and especially for healthcare workers.”

https://www.reuters.com/article/us-health-coronavirus-who-airborne/who-acknowledges-evidence-emerging-of-airborne-spread-of-covid-19-idUSKBN2482AU

GenMark sees 118% jump in Q2 sales

GenMark Diagnostics (NASDAQ:GNMK) expects Q2 sales to be ~$40.1M, up 118% Y/Y, as COVID-19 impacted second quarter placements and revenue.

During the quarter, the company placed net 71 ePlex analyzers (+48%) and expects ePlex revenue to be ~$35.2M (+195%). SARS-CoV-2 consumables accounted for ~48% of total ePlex revenue

The company will release final Q2 results in early August.

https://seekingalpha.com/news/3589266-genmark-sees-118-jump-in-q2-sales

FDA OKs Astex Pharma combo tablet for certain blood cancers

Under Priority Review status, the FDA approves Otsuka Pharmaceutical Co., Ltd. (OTCPK:OTSKF) unit Astex Pharmaceuticals’ Inqovi (decitabine and cedazuridine) tablets for the treatment of adults with myelodysplastic syndromes and chronic myelomonocytic leukemia.

Decitabine and cedazuridine are chemo agents with different mechanisms of action.

https://seekingalpha.com/news/3589232-fda-oks-astex-pharma-combo-tablet-for-certain-blood-cancers

Idorsia claims second insomnia hit, but has it done enough?

Daridorexant can’t reach the heights of its first pivotal study win, but a pooled analysis could still save it.

Idorsia has followed daridorexant’s first pivotal study success in insomnia, reported in April, with what it claims to be a hit in the project’s second pivotal trial. Closer reading of the results, however, reveals a rather mixed dataset.

Not only has the 25mg dose missed the key secondary measure of daytime functioning – an expected setback after its first pivotal study miss – one of the two co-primary endpoints has failed to show a benefit, too. Idorsia must now hope that pooling the results for the 25mg dose passes statistical and regulatory muster.

Both the earlier 301 trial and the 302 study toplined today measured similar efficacy metrics, and enrolled around 900 patients each, but one key difference between them was always apparent: while the first tested 25mg and 50mg, the second looked at 10mg and 25mg.

25mg therefore seemed always to be the dose Idorsia was banking on, with 50mg representing something of a wild card. However, in the 301 study it was only 50mg that aced both primary and both secondary endpoints (Idorsia adds insomnia to its pipeline successes, April 20, 2020).

The 302 trial readout shows 25mg missing the secondary daytime functioning endpoint, as it had in the first, and additionally hitting only one of the primaries – sleep maintenance, but not sleep onset. The lowest, 10mg dose failed to hit any endpoint with statistical significance, though all showed a numerical benefit versus placebo.

On an analyst call Idorsia stressed that numerically the results were consistent across both trials, though it will not reveal any numbers until a scientific conference. Its argument is that it is merely statistical powering that has defeated daridorexant in some aspects of trial 302.

Today, the group revealed that statistical “alpha” had been split in two for the primary analysis, meaning that a p value of 0.025 or better was needed for daridorexant to meet either co-primary endpoint. There was then a sequential analysis for the secondary endpoints.

Thus the company is pinning its hopes on the US FDA accepting the totality of the data, backed by an as yet undisclosed pooled analysis of the 25mg dose’s result in studies 301 and 302 versus placebo. A US filing is to be submitted by the end of 2020.

What dose?

However, the group will still not spell out which dose it wants to see approved, hinting that it might file 25mg as well as 50mg and let the regulator decide. Tellingly, it continues to cite daridorexant’s lack of next-morning residual hangover as a safety advantage, even though 50mg is the only dose to have shown a statistical effect on the IDSIQ patient-reported questionnaire.

Safety is key for insomnia drugs, because of their propensity to cause sleepiness during the day. Daridorexant is a dual orexin receptor antagonist, and approved orexin antagonists, Merck & Co’s Belsomra and Eisai’s Dayvigo, carry warnings of daytime impairment and possible effects on driving performance.

Such considerations perhaps caused Idorsia to put its money on daridorexant’s 25mg dose; ironically, however, 50mg appears to have shown no more propensity for adverse events than 25mg or 10mg, at least in the limited scope of two pivotal studies.

A separate safety and tolerability trial, study 303, should yield results in time for the FDA’s filing review, Idorsia said. Given that overall the data are positive, perhaps leaving the matter of doses in the hands of a lenient regulator is a smart move.

https://www.evaluate.com/vantage/articles/news/trial-results/idorsia-claims-second-insomnia-hit-has-it-done-enough

Novartis’ Enerzair Breezhaler OK’d in Europe for uncontrolled asthma

The European Commission approves Novartis’ (NVS -0.4%) once-daily Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist (LABA) and a high-dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

The nod also includes an optional digital companion with sensor and app that provides inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions.

https://seekingalpha.com/news/3589196-novartis-enerzair-breezhaler-okd-in-europe-for-uncontrolled-asthma

Fla.’s De Santis: ‘No Doubt’ Disney World Will Be Safe After Reopening

The doors to Disney will be back open soon. Two theme parks, Magic Kingdom and Animal Kingdom, are set to reopen Saturday for the first time since coronavirus-related closures in March. The resort’s two other theme parks, Epcot and Hollywood Studios, are opening four days later.

Florida Governor Ron DeSantis was asked Monday during a news conference in The Villages, one of Florida’s largest retirement communities, about the safety of reopening theme parks amid the spike in cases in the Sunshine State.

DeSantis said he was not concerned about the increasing positivity rate in Florida and theme parks welcoming guests again.

“Disney, I have no doubt is going to be a safe environment. I think that where you start to see the spread is just in social situations where people let their guard down. Usually like a private party or something like that,” DeSantis said.

“Theme parks have been doing great, I mean, Universal, look at what they’re doing. And I think that’s the lesson. We have to have society function. You can have society function in a way that keeps people safe, and when you have all the different procedures they have in place … it’s a safe environment.”

DeSantis said he had “no doubt” Disney would be a safe and called the resort’s plan to reopen “very, very thorough.”

All Walt Disney World theme parks will require reservations in addition to an admission ticket to get in. They will also be opening at limited capacity.

Guests going to the parks can expect temperature checks and closures to help people adhere to social distancing.

The Disney Springs shopping and dining complex has been reopening gradually since May 20.

Universal Orlando reopened in June after also being closed since mid-March.

DeSantis comments came on the same day that Miami-Dade Mayor Carlos Gimenez announced an emergency executive order that closes restaurant dining rooms, gyms, and party venues in an effort to curb the spread of COVID-19.

Florida Governor Ron DeSantis Has ‘No Doubt’ Disney World Will Be Safe After Reopening

State orders all Fla. schools to reopen in August

School districts can submit plans to educate students remotely, but they must prove that students learning from home are receiving the same level of education that students in school buildings receive.

Florida Education Commissioner Richard Corcoran issued an emergency order Monday requiring all schools to open in the fall and laying out the requirements that districts must meet to offer any sort of nontraditional remote instruction in addition to their in-person option.

“All school boards and charter school governing boards must open brick-and-mortar schools in August at least five days per week for all students,” the announcement states.

Local health officials can override the commissioner’s directive if it is not safe to open schools because of COVID-19, but Monday’s announcement makes it clear that districts have to prepare to open their doors to all students in August.

And while health officials could deem schools unsafe, as long as there are not widespread shutdowns, it could be a tough call to single out schools.

“Logically, I don’t think they could say schools aren’t safe if they are allowing people to be out in public,” Department of Education spokeswoman Cheryl Etters said.

“If locally they are not able to open, we will work with districts on the continuation of their Instructional Continuity Plan or determining alternative options,” she said in a followup email.

What it means

Under the directive:

‒ School boards must prepare to reopen physical buildings in August for all students, full time.

‒ School districts cannot shift to a hybrid model, where students spend half their time in school and half at home. Every student must have the option of being in school five days per week.

‒ The only option for schools to not be physically open in August is if local Department of Health officials say schools cannot open.

‒ The DOE will not be waiving the minimum number of instructional hours for students, and schools must provide all services they normally do.

Remote learning options

The order significantly raises the bar for remote learning options.

In the spring, as the coronavirus pandemic intensified, the DOE emphasized “grace and compassion” as schools shifted to all online learning in a matter of weeks, and the state removed several requirements districts normally must follow.

In the fall, schools can offer a remote learning option in addition to in-person learning, but those plans must be approved by the state and must be far more robust than they were last spring.

Remote learning options must …

‒ Ensure students receive the same number of instructional hours, the same content and the same level of feedback and interaction that students in a physical setting would receive.

‒ Allow students to transition off of the remote plan and return to the physical setting.

‒ Share monitoring data to demonstrate that students learning remotely are progressing.

The commissioner’s order requires districts to provide the full suite of services to students with disabilities or English Language learners.

https://www.theledger.com/news/20200706/state-orders-all-florida-schools-to-reopen-in-august