Fauci says rushing out a vaccine could jeopardize testing of others

The top U.S. infectious diseases expert is warning that distributing a COVID-19 vaccine under special emergency use guidelines before it has been proved safe and effective in large trials is a bad idea that could have a chilling effect on the testing of other vaccines.

Scientists and health experts have expressed concern that President Donald Trump will apply pressure on the U.S. Food and Drug Administration to deliver a vaccine before November to boost his chances of re-election.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, declined to comment on the president, but said there are risks in rushing out a vaccine despite the urgent need.

“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci told Reuters in a phone interview.

“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci said.

Large-scale clinical trials of the leading vaccine candidates from Moderna Inc (MRNA.O), Pfizer Inc (PFE.N) andAstraZeneca Plc (AZN.L), which aim to enroll tens of thousands of volunteers, were launched in recent weeks. Johnson & Johnson (JNJ.N) last week said it hopes to include 60,000 subjects in its Phase III vaccine trial.

Trump stoked concerns of politicizing the regulatory approval process with an announcement on Sunday of an emergency use authorization for plasma from recovered COVID-19 patients to treat current patients before its benefits have been assessed in randomized, placebo-controlled clinical trials.

Trump had tweeted on Saturday that “deep state” elements at the FDA were delaying progress on drugs and vaccines until after the Nov. 3 election in order to hurt his reelection bid.

Safe and effective vaccines are seen as essential to ending the pandemic that has claimed the lives of more than 800,000 people worldwide, over 177,000 of them in the United States.

But vaccine experts worry that the White House may apply pressure on the FDA to push out a vaccine via an EUA before it has been fully tested – a pathway that has never been used to approve a vaccine intended for widespread use.

“I would be very worried about using an EUA mechanism for something like a vaccine. It’s very different from plasma therapy,” said Dr. Peter Hotez, an infectious disease expert and vaccine researcher at Baylor College of Medicine.

Fauci said the FDA’s guidance on vaccines – both for full approval and for an EUA – explicitly requires a demonstration that it is both safe and effective.

An EUA is typically used for products to “diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product,” Fauci said.

An EUA might be appropriate once studies have shown safety and effectiveness, but before the FDA has completed its formal review of the company’s marketing application, he said.

“To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both,” Fauci said. “We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”

https://www.reuters.com/article/us-health-coronavirus-vaccine-approval-e/exclusive-fauci-says-rushing-out-a-vaccine-could-jeopardize-testing-of-others-idUSKBN25K2M0

DJI shakeup: Salesforce, Amgen, Honeywell in; Exxon Mobil, Pfizer, Raytheon out

In a major shakeup for the Dow Jones Industrial Average, Salesforce.com (NYSE:CRM), Amgen (NASDAQ:AMGN) and Honeywell International (NYSE:HON) are joining the venerable index, S&P Dow Jones Indices says.

Exiting the index are Exxon Mobil (NYSE:XOM), Pfizer (NYSE:PFE) and Raytheon Technologies (NYSE:RTX).

The moves were spurred by Apple’s decision to split its stock, which cuts the Dow’s weight in the Information Technology sector (a change offset in part by the new shifts, which S&P says also help diversify the index).

The moves are effective before the open next Monday, Aug. 31; the divisor used to calculate the index from the constituents will be changed before then, preventing any distortions from the change.

After hours: CRM +1.2%; AMGN +0.7%; HON +0.5%; XOM -2.2%; PFE -0.3%; RTX -0.1%.

https://seekingalpha.com/news/3608387-dow-jones-index-shakeup-salesforce-amgen-honeywell-in-exxon-mobil-pfizer-raytheon-out

Outdoor learning plan unveiled for students in New York City

Mayor Bill de Blasio and Schools Chancellor Richard Carranza unveiled their new plan for outdoor learning in New York City Monday.

The mayor said that New York City has the strongest schools reopening plan in the country and improves on plans shown to work across the world.

“The focus has been on health and safety,” he said. “We’ve created a new gold standard. We’ve combined them into one strategy for safety for all.”

The mayor pointed to the city’s 3% infection threshold for reopening and said it’s stricter than the WHO’s 5% reopening threshold.

He also said masks requirements for all grades of students and teachers is as stringent as in Japan and South Korea, free testing for staff surpasses Europe’s plan except Luxembourg, the contact tracing program matches Japan and Germany, and the new option for outdoor learning is similar to Italy, Denmark, and Norway.

The outdoor learning plan will apply to all public, charter, and even private schools in the city.
–Principals can set up classrooms in their schoolyards and request additional space
–Any school that applies by Friday 8/28 will have a response next week.
–The plan prioritizes the 27 hardest-hit neighborhoods and schools with no usable outdoor space.

Schools must provide barriers and staffing to close any street. When submitting a street location, schools are strongly encouraged to select streets with the following criteria:
–Is a quiet, non-commercial street
–Is a one-way street; if two-way, not more than one lane of traffic in each direction
–Is not an MTA bus route or truck route
–Is not used by a police/fire station, parking garage, or hospital

Sister agencies will review the schools requesting space and make sure that the spaces are safe and secure for students and staff, Chancellor Carranza said.

“I’m excited about outdoor learning as a supplement to the school day,” Carranza said. “Before COVID, I always knew how important it was for my scholars to get some time outdoors, and now, in partnership with our sister agencies, that will be possible for more schools – even if that school doesn’t have a yard.”

Reaction was mixed.

“The mayor’s reopening plan continues to fall short, particularly in terms of necessary testing,” United Federation of Teachers President Michael Mulgrew said.

The city’s current reopening plan calls for a mix of in-person and remote learning, with students taking turns in classrooms when they return in the fall. But more than a quarter of students have decided to go with the all-remote option instead.

“Any teacher, any staff member – whatever they need, they’ll get with PPEs, there’ll be plenty available for each school,” de Blasio said last week. “We want kids to come to school already wearing a face covering. We want kids wearing a face covering wherever they go. In school, out of school – any kid who needs one will get one.”

https://abc7ny.com/nyc-schools-reopen-teachers-union-uft-united-federation-of/6385936/

Telehealth platform Amwell files for a $100 million IPO

American Well, which provides a telehealth platform for insurers and patients, filed on Monday with the SEC to raise up to $100 million in an initial public offering.

The Amwell Platform is a complete digital care delivery solution that equips its health system, health plan, and innovator clients with the tools to enable new models of care for their patients and members. Its scalable technology enables care delivery across a wide variety of clinical, retail, school, and home settings.

The Boston, MA-based company was founded in 2006 and booked $202 million in revenue for the 12 months ended June 30, 2020. It plans to list on the NYSE under the symbol AMWL. American Well filed confidentially on June 1, 2020. Morgan Stanley, Goldman Sachs, Piper Sandler, UBS Investment Bank, Credit Suisse, Cowen and Berenberg are the joint bookrunners on the deal. No pricing terms were disclosed.
Relevant Profile: AMWL

https://www.renaissancecapital.com/IPO-Center/News/70531/Telehealth-platform-Amwell-files-for-a-$100-million-IPO

NASH biotech Metacrine files for a $100 million IPO

Metacrine, a Phase 1 biotech developing FXR agonist therapies for NASH, filed on Monday with the SEC to raise up to $100 million in an initial public offering.

The company’s pipeline contains lead candidate MET409, a potent and sustained FXR agonist with the ability to be dosed orally once daily. MET409 demonstrated notable reductions in liver fat and improvements in other NASH biomarkers and was generally well tolerated in its Phase 1b trial as a monotherapy. The company plans to submit an IND in the 4Q20 and initiate a Phase 2a combination trial in the 1H21, with topline data expected in the 1H22.

The San Diego, CA-based company was founded in 2014 and plans to list on the Nasdaq under the symbol MTCR. Metacrine filed confidentially on July 12, 2018. Jefferies, Evercore ISI and RBC Capital Markets are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: MTCR

https://www.renaissancecapital.com/IPO-Center/News/70527/NASH-biotech-Metacrine-files-for-a-$100-million-IPO

AmerisourceBergen board to face investor lawsuit over cancer unit malfeasance

A Delaware court has ruled against a motion by the board of directors of drug wholesaler AmerisourceBergen (NYSE:ABC) to dismiss an investor lawsuit regarding alleged illegal behavior by its Oncology Supply Pharmacy Services unit that used overfill quantities of cancer medicines to fill up additional syringes in an unsterile process leading to contaminated drugs.

The plaintiffs claim that the board allowed the subsidiary to be run like a “criminal organization” by ignoring red flags and permitting a “woefully inadequate” reporting system.

ABC representatives have yet to comment on the litigation.

https://seekingalpha.com/news/3608366-amerisourcebergen-board-to-face-investor-lawsuit-over-cancer-unit-malfeasance

FDA OKs Teva’s generic pemetrexed for lung cancer

The FDA approves Teva Pharmaceutical Industries (TEVA -2.6%) unit Actavis’ generic pemetrexed for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has not progressed after four cycles of first-line platinum-based chemo.

https://seekingalpha.com/news/3608341-fda-oks-tevas-generic-pemetrexed-for-lung-cancer