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Sunday, November 29, 2020

NYC public schools to begin to reopen with weekly COVID-19 testing

 New York City’s public schools will begin to reopen for in-person learning on Dec. 7, starting with elementary schools for students whose parents agree to a weekly testing regimen for the novel coronavirus, Mayor Bill de Blasio announced on Sunday.

The schools, which make up the country’s largest school system, were closed less than two weeks ago after the citywide rate of coronavirus tests coming back positive exceeded a 3% benchmark agreed to by the mayor and the teachers’ union.

“It’s a new approach because we have so much proof now of how safe schools can be,” de Blasio told reporters, saying the 3% benchmark was being scrapped and pointing to research that shows young children appear to be less vulnerable to COVID-19. On Sunday, the city’s seven-day rolling average of positive tests was 3.9%, de Blasio said.

Schools Chancellor Richard Carranza, who joined the mayor at a news conference, said with the new measures he believed the city could “safely and successfully keep our schools open for the duration of this pandemic.”

Michael Mulgrew, the president of the United Federation of Teachers, said in a statement that the labor union was supportive of the mayor’s phased reopening so long as “stringent testing was in place.”

New York City, which teaches more than 1.1 million students in its public schools, was one of the few jurisdictions in the United States to attempt to reopen schools in the autumn as the country continues to struggle with the world’s deadliest outbreak of the coronavirus, and its efforts are being widely watched. But it closed classrooms back down in mid-November, less than eight weeks after they had begun to offer in-class lessons.

Some New Yorkers were frustrated to see schools close down again while gyms were allowed to operate and restaurants could offer indoor dining in most areas under rules enforced by New York Governor Andrew Cuomo, who has publicly feuded with de Blasio over how best to tamp down the virus’ spread.

“I think that’s the right direction,” Cuomo said of the mayor’s announcement on a later conference call with reporters. Health experts said schools “should be kept open whenever it’s possible to keep them open safely,” he said.

Pre-kindergarten classes will also reopen Dec. 7 alongside elementary schools. Schools that serve children with special educational needs, known as District 75 schools, will reopen Dec. 10. De Blasio said middle schools and high schools would reopen at later dates that had not yet been set.

Many families had opted for remote learning even as classrooms reopened in September, but the city also offered “blended” learning, with students attending in-person classes a few days each week if they agreed to monthly coronavirus tests.

With the reopening of schools next month, to enter a classroom, students must have a signed consent form agreeing to coronavirus testing or a letter of medical exemption from a doctor, de Blasio said. Tests will be soon be carried out in schools on a weekly, not monthly, basis, but only about a fifth of students will be tested in a given week.

The mayor said the plan was to have in-person learning five days a week where possible when schools reopen.

The governor retains the power to override the city and close schools in neighborhoods where the test positivity rate surges, de Blasio noted. The city will also monitor schools’ coronavirus test results, and may close down any individual classrooms or entire schools where multiple cases are reported.

The United States has reported over 4 million new cases so far in November and over 35,000 coronavirus-related deaths, according to a Reuters tally, with more hospitalizations than ever this year and deaths reaching their highest level in six months.

https://www.reuters.com/article/us-health-coronavirus-usa-new-york/new-york-city-public-schools-will-begin-to-reopen-with-weekly-covid-19-testing-idUSKBN2890OO

India regulators probe alleged AstraZeneca shot reaction, trial continues

 The Indian Council of Medical Research (ICMR) is assisting an inquiry into an alleged adverse reaction during AstraZeneca’s COVID-19 vaccine trial, but has found no reason to recommend halting it, a senior official at the regulator said on Sunday.

A 40-year-old man said in a complaint seen by Reuters that he had suffered serious “neurological and psychological” symptoms after receiving the vaccine in a trial being run by the British drugmaker’s partner Serum Institute of India (SII).

“There was no immediate cause of concern at this stage,” Samiran Panda, head of Epidemiology and Communicable Diseases at the ICMR, the research body involved in trials, told Reuters.

“It doesn’t mean that long term assessment will not happen, it is still happening. I am aware of the activity,” Panda said.

AstraZeneca did not respond to a request for comment.

Law firm N.G.R. Prasad & R. Rajaram Advocates sent the complaint by the unnamed volunteer, who is seeking 50 million rupees ($676,288) in compensation and a suspension of testing, manufacturing and distribution of the vaccine, to ICMR, SII, AstraZeneca and the Drugs Controller General of India.

“While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there’s absolutely no correlation with the vaccine trial,” SII said.

“(The) volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent,” it added.

The Drugs Controller General of India, who is responsible for drug and vaccine approval, could not immediately be reached for comment on Sunday.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca/india-regulators-probe-alleged-astrazeneca-shot-reaction-trial-continues-idUSKBN2890QJ

Schumer: $30 billion in federal funds needed to distribute COVID vaccine

 Senate Minority Leader Chuck Schumer said on Sunday that $30 billion in federal funds was needed to distribute the COVID-19 vaccine as legislative negotiations over an economic relief bill remain stalled.

Schumer, a Democrat, said that New York state alone would need “hundreds of millions” for distribution and education work around the distribution of the vaccine.

“This should be a moment of clarity for everyone,” Schumer, who represents New York, told reporters in a brief press conference. “This is a huge crisis and we need big relief.”

https://www.reuters.com/article/us-health-coronavirus-usa-congress/democrat-schumer-says-30-billion-in-federal-funds-needed-to-distribute-covid-vaccine-idUSKBN2890PT

Moderna amends U.K. pact for 2M more doses of COVID-19 vaccine

 

Moderna to Present at Upcoming Investor Conferences in December

 Moderna, Inc.., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced its participation in the following upcoming virtual investor conferences:

  • Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1, 2020 at 12:30 p.m. ET.
  • Piper Sandler 32nd Annual Virtual Healthcare Conference on Wednesday, December 2, 2020 at 9:00 a.m. ET.
  • Nasdaq 43rd Virtual Investor Conference on Friday, December 4, 2020 at 12:00 p.m. ET.
  • BMO 2020 Growth & ESG Conference on Wednesday, December 9, 2020 at 8:00 a.m. ET.

A live webcast of each presentation will be available under “Events and Presentations” in the Investors section of the Moderna website at https://investors.modernatx.com/. A replay of each webcast will be archived on Moderna’s website for 30 days following the presentation.

https://www.biospace.com/article/releases/moderna-to-present-at-upcoming-investor-conferences-in-december-2020/

GRAIL, UK Govt to Make Galleri Multi-Cancer Early Detection Blood Test Available

 

  • GRAIL and NHS Partner to Transform Cancer Outcomes in First-of-Kind Program
  • Agreement Aims to Help UK Meet its Goal of Diagnosing Three-Quarters of All Cancers at an Early Stage by 2028

GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, today announced a partnership with the United Kingdom’s (UK) National Health Service (NHS) to help transform cancer outcomes by making GRAIL’s multi-cancer early detection blood test, Galleri™, available to UK patients starting in 2021.

The commercial partnership program aims to confirm Galleri's clinical and economic performance in the NHS system as a precursor to its routine use by the NHS.

The partnership program will involve approximately 165,000 people in the UK and includes two groups. The first will include 140,000 people over the age of 50 without any suspicion of cancer, and the second will include 25,000 people aged 40 and above with suspicious signs or symptoms of cancer. Based on data from this program, access to the test could be expanded to around one million people across 2024 and 2025 and may roll out to a larger population thereafter.

In a clinical validation study in the U.S., an earlier version of Galleri detected over 50 types of cancer with a low false positive rate of less than 1% through a single blood draw. Modeling data show that adding Galleri to existing standard of care has the potential to decrease the number of cancers diagnosed at late stage by nearly half, which could reduce the total number of cancer deaths in the UK by approximately one-fifth.

“Every year, nearly 200,000 people in the UK die from cancer. Many of these people are diagnosed too late for treatment to be effective,” said Lord David Prior, Chair of NHS England. “This collaboration between the NHS and GRAIL offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer.”

“We are building a world-leading diagnostics industry in the UK -- not just for coronavirus, but for other diseases too,” said Matt Hancock, Health and Social Care Secretary. “This exciting and ground-breaking new blood test from GRAIL will give us another tool to give more people the very best chance of survival, demonstrating how the UK continues to lead the way in using the latest innovative treatments to help patients. Many of us know a loved one who has battled against cancer and have seen first-hand the impact of this deadly disease."

Cancer is projected to soon become the world’s leading cause of death, with more than 1,000 people in the UK receiving a cancer diagnosis every day. The majority of cancers are found too late when outcomes are often fatal, because most deadly cancers have no available screening tests. In the UK, more than 80% of all cancer deaths are from cancers which don’t currently have any available recommended screening.

https://www.biospace.com/article/releases/grail-and-uk-government-to-make-galleri-multi-cancer-early-detection-blood-test-available-to-patients/


CDC panel meets Tuesday to vote on COVID-19 vaccine priority

 A panel of U.S. advisers will meet Tuesday to vote on how scarce, initial supplies of a COVID-19 vaccine will be given out once one has been approved.

Experts have proposed giving the  to  first. High priority also may be given to workers in essential industries, people with certain  and people age 65 and older.

Tuesday's meeting is for the Advisory Committee on Immunization Practices, a group established by the Centers for Disease Control and Prevention. The panel of experts recommends who to vaccinate and when—advice that the government almost always follows. The agenda for next week's emergency meeting was posted Friday.

Pfizer and its German partner BioNTech have asked the Food and Drug Administration to allow emergency use of its COVID-19 vaccine candidate. Moderna Inc. is expected to also seek emergency use of its vaccine soon.

FDA's scientific advisers are holding a public meeting Dec. 10 to review Pfizer's request, and send a recommendation to the FDA.

Manufacturers already have begun stockpiling coronavirus vaccine doses in anticipation of eventual approval, but the first shots will be in short supply and rationed.

https://medicalxpress.com/news/2020-11-cdc-panel-tuesday-vote-covid-.html