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Thursday, July 30, 2020

New protocols for positive COVID-19 cases in NYC schools

The Department of Education released new protocols Thursday for handling any possible confirmed coronavirus cases in schools this upcoming year.
The DOE plan states that if one or more students from the same class test positive their classrooms will close and anyone who had close contact with those students should self-quarantine for 14 days.
If two or more children in the same school test positive for the virus but do not share a classroom, the entire building will close for two weeks.
If at least two cases arise in the same building but the infections occurred outside of school, the DOE will also shutter the whole building while investigating the source of the exposures.
Once the probes into those cases are completed, the school will reopen while the impacted classrooms will remain closed for two weeks. Additional students and staff will be quarantined based on where the exposure took place.
If tracing efforts can’t determine infection origins, schools will be automatically shuttered for 14 days.
Kids who are compelled to leave classrooms because of an exposure will transition to remote learning.
“We are doing everything in our power to keep kids healthy while ensuring they are getting the education they deserve,” Mayor de Blasio said in a statement.
“These rigorous test and trace protocols will keep our students and staff safe as we start off this new school year.”
The DOE said it will encourage all school staffers to get tested in the days prior to the scheduled September 10 start of the new year and will be given priority at 34 testing sites throughout the city.
If clusters emerge, the DOE said it could take more drastic measures based on the circumstances.
The department will also require some form of documentation in order to consider a case confirmed.
“New Yorkers did the incredibly difficult work reducing the risk posed by COVID-19, and as a result we’re in a better position than any other city in the country to safely resume in-person education under the current conditions and with clear, consistent health protocols,” said Schools Chancellor Richard A. Carranza.
Students and teachers who feel sick will be required to stay home and are encouraged to get tested if their symptoms are consistent with the coronavirus.
Kids who feel unwell in school will be isolated and monitored by a staff member until they can be picked up, officials said.
Staffers who exhibit signs of illness will be also asked to leave their buildings.
City Hall’s reopening plan will have students alternate between classroom and remote learning.
The format has been met with stiff resistance from both the city teachers and principals union. Both groups have questioned the DOE’s logistical and safety preparedness.
Mayor de Blasio has lobbied for a blended reopening and has stressed the need to provide some scheduling relief for parents who can’t work remotely.

State won’t collect, release data on coronavirus cases in Tennessee schools

A day after a top official in Gov. Bill Lee’s administration said Tennessee plans to withhold the number of COVID-19 cases in schools from the public, a spokesperson said the information will not even be collected by the state.
When Lee announced guidance for school reopenings on Tuesday, state Department of Health Commissioner Dr. Lisa Piercey said Tennessee had no plans to provide the public with data on the number of coronavirus cases and deaths at schools as many return to in-person classes.
Instead, Piercey said such data sharing would be left up to individual school districts.
On Wednesday, a spokesperson for the state health department elaborated on the commissioner’s comments, saying patient privacy continues to be a priority.
“At this time we do not plan to ask school districts to submit formal reports to us about COVID-19 cases, and do not plan to systematically release school-specific information on cases among students and/or staff members,” spokesperson Shelley Walker said.
Walker said the department will encourage school districts to track COVID-19 cases in an effort to “best understand the burden of disease in their jurisdiction and take appropriate steps to mitigate further spread of illness.”
But Deborah Fisher, executive director of the Tennessee Coalition for Open Government, said the state’s approach is inadequate.
“Whether it’s the Department of Health or the Department of Education, some state agency needs to be paying attention and keeping track of COVID-19 spread in the schools,” she said, noting public school operations are highly regulated. 
“It would seem irresponsible for the state to just look the other way and not track that data.”
The Tennessee Department of Education also said it will not be collecting any data regarding cases, citing federal privacy laws.
“Local school districts must maintain compliance with all state and federal privacy laws, including, the Family Educational Rights and Privacy Act (FERPA) with regard to any records they maintain regarding cases of COVID-19,” an education department spokesperson said in an email.

State has faced past criticism over data collection, release

The issue over COVID-19 data collection and schools comes months after the Tennessee Department of Health twice faced criticism for initially refusing to release certain information.
Days after Tennessee reported its first case of the virus in March, state officials said they would not publicly share county-by-county data. Instead officials said Tennessee would only identify where new cases occurred by each of the state’s three grand divisions.
After facing criticism, the state reversed course and began sharing county-level data.
In April, state officials began to share data it had collected highlighting the number of cases of the virus at long-term care facilities. Prior to the reversal, the health department cited the need to protect patient privacy.
The same reasoning was recently used by Lee’s office when it refused to tell The Tennessean how many employees in the executive branch, including the governor’s staff, had tested positive for COVID-19. The legislative branch has released a total number of people that have tested positive.

Mexican president orders creation of state-run medicine agency

Mexico’s government will create a state-run medicine distribution agency and will sign an agreement with the United Nations to purchase cheaper drugs and vaccines on the international market, the country’s president said on Thursday.
“This means breaking up the monopoly of companies that had control in Mexico. They sold medications that were expensive, of poor quality and there were often shortages,” said President Andres Manuel Lopez Obrador at a regular news conference.
Lopez Obrador said the distribution agency will make sure residents even in the far-flung corners of Mexico have access to medications and vaccines. The current head of Mexico’s civil protection agency, David Leon, will lead the new state-run agency.
Lopez Obrador’s government has been criticized for a shortage of medicines following a procurement shake-up, which centralized drug purchases to reduce corruption and overpricing.
The head of pharmaceutical business chamber Canifarma, Rafael Gual, has estimated that the agreement with the U.N. puts 100,000 direct jobs and half a million indirect jobs at risk.
He added that drug prices have already fallen nearly 19% between 2013 and 2019 due to consolidated purchases.
Opposition congresswoman Martha Gonzalez said the measures will not fix the medicine shortage, which she said was the result of “government inefficiency.”

Chinese-backed hackers targeted COVID-19 vaccine firm Moderna

Chinese government-linked hackers targeted biotech company Moderna Inc, a leading U.S.-based coronavirus vaccine research developer, earlier this year in a bid to steal valuable data, according to a U.S. security official tracking Chinese hacking activity.
Last week, the U.S. Justice Department made public an indictment of two Chinese nationals accused of spying on the United States, including three unnamed U.S.-based targets involved in medical research to fight the COVID-19 pandemic. The indictment states the Chinese hackers “conducted reconnaissance” against the computer network of a Massachusetts biotech firm known to be working on a coronavirus vaccine in January.
Moderna, which is based in Massachusetts and announced its COVID-19 vaccine candidate in January, confirmed to Reuters that the company had been in contact with the FBI and was made aware of the suspected “information reconnaissance activities” by the hacking group mentioned in last week’s indictment.
Reconnaissance activities can include a wide range of actions, including probing public websites for vulnerabilities to scouting out important accounts after entering a network, cybersecurity experts say.
“Moderna remains highly vigilant to potential cybersecurity threats, maintaining an internal team, external support services and good working relationships with outside authorities to continuously assess threats and protect our valuable information,” spokesman Ray Jordan said, declining to provide further detail.
The U.S. security official, who spoke on condition of anonymity, did not provide further details. The FBI and the U.S. Department of Health and Human Services declined to disclose the identities of companies targeted by Chinese hackers.
Moderna’s vaccine candidate is one of the earliest and biggest bets by the Trump administration to fight the pandemic. The federal government is supporting development of the company’s vaccine with nearly half a billion dollars and helping Moderna launch a clinical trial of up to 30,000 people beginning this month.
China is also racing to develop a vaccine, bringing together its state, military and private sectors to combat a disease that has killed over 660,000 people worldwide.
A July 7 indictment released last week alleges that the two Chinese hackers, Li Xiaoyu and Dong Jiazhi, conducted a decade-long hacking spree that most recently included the targeting of COVID-19 medical research groups.
Prosecutors said Li and Dong acted as contractors for China’s Ministry of State Security, a state intelligence agency. Messages left with several accounts registered under Li’s digital alias, oro0lxy, were not returned. Contact details for Dong were not available.
The Chinese Embassy in Washington referred Reuters to recent Chinese Foreign Ministry comments that said: “China has long been a major victim of cyber thefts and attacks” and its officials “firmly oppose and fight” such activities. The Chinese government has consistently denied any role in hacking incidents across the globe. The embassy spokesperson did not address specific questions sent via email.
The two other unnamed medical research companies mentioned in the Justice Department indictment are described as biotech companies based in California and Maryland. Prosecutors said the hackers “searched for vulnerabilities” and “conducted reconnaissance” against them.
The court filing describes the California firm as working on antiviral drug research and suggested the Maryland company had publicly announced efforts to develop a vaccine in January. Two companies that could match those descriptions: Gilead Sciences Inc and Novavax Inc .
Gilead spokesperson Chris Ridley said the firm does not comment on cybersecurity matters. Novavax would not comment on specific cyber security activities but said: “Our cyber security team has been alerted to the alleged foreign threats identified in the news.”
A security consultant familiar with multiple hacking investigations involving premier biotech firms over the last year said Chinese hacking groups believed to be broadly associated with China’s Ministry of State security are one of the primary forces targeting COVID-19 research, globally. This matches the description of the indicted hackers, as MSS contractors.

U.S. to launch ‘overwhelming’ COVID-19 vaccine campaign by November

The Trump administration anticipates launching a far-reaching promotions campaign by November to encourage Americans to get vaccinated against the coronavirus, contingent on evidence that a successful vaccine will be available roughly by year end, a senior administration official said.
The campaign will likely be compressed into a short period of time, around four to six weeks, to eliminate any lag between when Americans are alerted to the vaccine and then they can get vaccinated, the official said during a press conference.
“The fine line we are walking is getting the American people very excited about vaccines and missing expectations versus having a bunch of vaccines in the warehouse and not as many people want to get it,” the official said.
“You may not hear a lot about promoting vaccines over the airwaves in August and September but you’ll be overwhelmed by it come November.”
The official cautioned that there is still uncertainty around the timing of when a vaccine will actually be available. Doses could be available as early as October or as late as January, he said.
He also added that the details of the communications campaign will vary based on which subsets of the population the vaccines prove most likely to benefit, which will be determined as data reads out from ongoing clinical trials.
Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N) launched two 30,000-subject trials of COVID-19 vaccines on Monday that could clear the way for regulatory approval and widespread use by the end of this year.
British drugmaker AstraZeneca Plc (AZN.L) said it will begin large-scale U.S. trials this summer of its vaccine.
The U.S. government has begun preparing to distribute the vaccines, including talking to private companies about developing technology to track their deployment and monitor who has received them.

Gilead raises sales outlook to include COVID-19 treatment remdesivir

Gilead Sciences Inc (GILD.O) on Thursday raised its 2020 sales forecast to include revenue from its antiviral drug remdesivir, one of the only treatments shown to help hospitalized COVID-19 patients.
Gilead said it now expects total 2020 sales of $23 billion to $25 billion, up from a previous range of $21.8 billion to $22.2 billion.
“We think this implies up to $1 billion to $3 billion of remdesivir … a positive that was not expected at the start of the year,” said Jefferies analyst Michael Yee.
Mizuho analyst Salim Sayed said the forecast translates into $1 billion in remdesivir sales in third quarter “and perhaps another $1 billion in the fourth quarter.”
The drugmaker reported worse-than-expected second-quarter results due to weak sales of its hepatitis C drugs and flagship HIV treatments during pandemic lockdowns. The company said it expects a gradual recovery for its HIV drugs and hepatitis C sales to begin regaining momentum in the third quarter.
Adjusted earnings for the quarter of $1.11 per share topped analysts’ average estimate by 34 cents.
Second-quarter sales of Gilead’s HIV drugs fell 1% from a year earlier to $4 billion, while sales of its drugs to cure hepatitis C fell 47% to $448 million due to fewer new patients and competition from rival drugs.
Gilead this month began commercial sales of remdesivir, which is given to hospitalized patients by infusion. The drug was granted emergency use authorization by the U.S. Food and Drug Administration in May after it demonstrated an ability to shorten hospital stays for COVID-19 patients, but does not yet have full U.S. approval. It was approved in Japan.
But demand continues to outstrip supply in many parts of the world.
Gilead Chief Executive Daniel O’Day, on a conference call, said the company expects by the end of September to be producing enough remdesivir to meet real time global demand.
Gilead said it still expects to manufacturer 2 million or more remdesivir treatment courses cumulatively in 2020, and its revenue outlook reflects expected sales of up to 1.5 million courses this year.
So far, only remdesivir and the generic steroid dexamethasone have been shown in rigorous clinical trials to help patients with COVID-19.
Shares of Gilead, which closed up about 1% in regular trading, were down 2% at $70.88 in extended trading.