Suicide halts Brazil trial of Chinese vaccine attacked by Bolsonaro

Brazil’s health regulator suspended a clinical trial of China’s Sinovac coronavirus vaccine due to a severe adverse event, delighting President Jair Bolsonaro, who has repeatedly criticized the vaccine’s credibility and said it would not be purchased by his government.

Brazil’s health regulator, Anvisa, suspended the trials late on Monday saying the event occurred on Oct. 29.

The state government of Sao Paulo, where the trial is being run, said the death of a trial volunteer had been registered as a suicide and was being investigated. A police report of the incident was seen by Reuters.

The suspension further inflamed tensions between Bolsonaro and Sao Paulo Governor Joao Doria, who has pinned his political ambitions on the Chinese vaccine which he aims to roll out in his state as early as January, with or without federal assistance.

On Tuesday, Anvisa said it would maintain the suspension and did not give any indication of how long it might last, adding it required more information on the incident. It dismissed any suggestion the move was politically motivated, saying the decision was purely technical.

The trial’s organizers criticized Anvisa’s decision, saying they had not been notified in advance and that there was no reason to stop the trial.

Although a trial volunteer had died, it had nothing to do with the vaccine, Jean Gorinchteyn, Health Secretary for the state of Sao Paulo told a news conference on Tuesday.

“We had an external event that led to the regulator being notified,” Gorinchteyn said. “This vaccine is safe.”

Dimas Covas, the head of Sao Paulo’s medical research institute Butantan, which is conducting the Sinovac trial, said the vaccine had shown no serious adverse effects. Speaking at the same news conference, he said he hoped the trial would be resumed later on Tuesday or Wednesday.

Anvisa said the initial information it received from Butantan had not specified that the death was a suicide.

“We had no choice but to suspend the trials given the event,” the head of the agency Antônio Barra Torres said.

Brazil’s suspension of the trial, one of Sinovac’s three large late-stage studies, and the resulting fallout underlines the increasingly fraught political atmosphere surrounding the development and distribution of potential vaccines.

The setback to Sinovac’s efforts contrasts with welcome news from Pfizer Inc, which said on Monday its experimental COVID-19 vaccine is more than 90% effective based on initial trial results.

Bolsonaro, a longtime China skeptic, has dismissed the Sinovac vaccine as lacking in credibility. On Tuesday morning, he said on his Facebook page that the suspension was “another victory for Jair Bolsonaro.”

Hu Xijin, editor-in-chief of The Global Times, published by the People’s Daily, the official newspaper of China’s Communist Party, said on social media platform Weibo: “I am very worried that politics and the excessive pursuit of economic interests are deeply involved in the information release on vaccines.”

A World Health Organization spokeswoman sought to play down the politics. “I don’t think you need to try to find reasons or explanations other than the fact that people who are looking for a vaccine ... are very cautious,” Fadela Chaib said.

POLITICAL BATTLE LINE

Sinovac said in a statement on its website on Tuesday it was confident in the safety of its vaccine and will continue to communicate with Brazil on the matter. It has previously said it expects interim results of late-stage trials this year.

It is not uncommon for clinical trials to be suspended temporarily after a subject dies or becomes ill so that independent monitors and trial organizers can check whether it is related to the drug being tested.

Sinovac’s vaccine is among the three experimental COVID-19 vaccines China has been using to inoculate hundreds of thousands of people under an emergency use program. A Chinese health official said on Oct. 20 that no serious side effects had been observed in clinical trials.

Bolsonaro has previously said the federal government will not buy the vaccine, although he had appeared to soften his position before his celebratory social media post on Tuesday.

His stance has set a clear political battle line with the Sao Paulo Governor Doria, who has said his state will both import the vaccine and produce it. Work has even begun on a plant capable of producing 100 million doses a year.

Doria is widely expected to challenge Bolsonaro at the next presidential election in 2022.

Sinovac is also hoping to supply its experimental coronavirus vaccine to more South American countries by outsourcing some manufacturing procedures to Butantan.

Late-stage trials are also being conducted in Indonesia and Turkey. Indonesia’s state-owned Bio Farma said on Tuesday its Sinovac vaccine trials were “going smoothly.”

Four COVID-19 vaccines are being tested in Brazil, including one being developed by Oxford University with AstraZeneca Plc and another from Johnson & Johnson.

Pfizer’s vaccine, developed in partnership with Germany’s BioNTech SE, is undergoing late-stage tests involving 3,100 volunteers in Sao Paulo and Bahia states.

Worldwide, there are at least 10 experimental coronavirus vaccines in late-stage clinical trials, according to the World Health Organization. Four of them are from China.

https://www.reuters.com/article/us-health-coronavirus-brazil-sinovac/suicide-halts-brazil-trial-of-chinese-vaccine-attacked-by-bolsonaro-idUSKBN27Q04C

NYC to try responding to mental health calls without police

Mental health and crisis workers in New York City will respond to emergency mental health calls instead of law enforcement under a pilot program announced on Tuesday, following months of protests around the country over police brutality.

The program, slated to begin in February, will be composed of new mental health teams from the Fire Department’s Emergency Medical Services unit and will target two “high-need” neighborhoods, which were not identified.

“For the first time in our city’s history, health responders will be the default responders for a person in crisis, making sure those struggling with mental illness receive the help they need,” Mayor Bill de Blasio said in a statement.

The move comes as New York and other large cities seek to reform their police departments after the May death of George Floyd in police custody in Minneapolis and other incidents sparked nationwide protests.

The national debate over how to improve policing has in part centered on how to prevent mental health calls from escalating into violent confrontations with police.

Currently, New York police officers and emergency medical technicians respond to nearly all 911 calls involving a mental health issue, regardless of whether there is a risk of violence.

De Blasio and the city’s first lady, Chirlane McCray, said in the statement that the responders would have the expertise to deal with a range of situations, including suicide attempts, drug abuse and physical problems which can mask mental health issues.

The mental health responders will be accompanied by a police officer if there is a weapon involved or “imminent risk of harm,” the statement said.

The city is modeling the trial after programs in other cities, including one in Eugene, Oregon, in which unarmed mental health professionals respond to mental health calls instead of the police.

https://www.reuters.com/article/us-global-race-policing-new-york/new-york-city-to-try-responding-to-mental-health-calls-without-police-idUSKBN27Q33P

U.S. to start distributing Lilly COVID-19 antibody this week

The United States will this week begin distributing Eli Lilly and Co's LLY.N COVID-19 antibody treatment to state health departments, Department of Health and Human Services (HHS) Secretary Alex Azar said on Tuesday.

“Early treatment may help people avoid disease progression and avoid hospitalization,” Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said on a conference call along with Azar.

The FDA on Monday gave emergency use authorization to Lilly’s antibody for anyone over age 65 who is recently diagnosed with mild-to-moderate COVID-19, and for patients age 12 and older who have an underlying health condition putting them at risk for serious illness. The agency said the treatment should not be used in patients already hospitalized with COVID-19.

HHS will distribute the drug, bamlanivimab, using a system developed over the summer to allocate supplies of remdesivir, an antiviral drug developed by Gilead Sciences Inc GILD.O, which is approved for use in hospitalized COVID-19 patients.

Bamlanivimab allocations to states and territories will be based on their number of hospitalized COVID-19 patients and the number of overall cases, government officials said on the HHS call.

Woodcock explained that some states may have more people with underlying risk factors, such as obesity and diabetes. “Those are the people we are trying to target,” she said.

A one-time infusion of bamlanivimab has been shown to reduce the risk of hospitalization and emergency room visits.

The U.S. has purchased 300,000 doses of the treatment for this year and has an option to buy an additional 650,000 doses next year.

Drug distributer AmerisourceBergen Corp ABC.N will initially deliver the biotech drug to hospitals, but the aim is to widen distribution to outpatient infusion centers.

Officials said out-of-pocket costs for patients covered by the government Medicare program but without supplemental insurance would be $60. That represents a 20% co-payment for the $300 infusion fee.

Uninsured patients and those on Medicaid would have no financial responsibility, they said. Commercial insurance plans each have their own coverage terms.

https://www.reuters.com/article/us-health-coronavirus-lilly-antibody/u-s-to-start-distributing-lilly-covid-19-antibody-this-week-idUSKBN27Q2XL

U.S. has plan to start Pfizer vaccine shots in December - Azar

If Pfizer Inc PFE.N submits the positive initial data from its COVID-19 vaccine trial to health regulators as quickly as expected, the U.S. government plans to begin vaccinating Americans in December, Health Secretary Alex Azar said on Tuesday. 

Pfizer on Monday said the vaccine it has been developing with German partner BioNTech SE BNTX.O was 90% effective against COVID-19, based on an early look at results from its large, late-stage trial.

The U.S. drugmaker said it expects to have safety data as soon as next week that it needs to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration.

Upon FDA authorization, the United States would receive about 20 million doses of the Pfizer vaccine per month, Azar said on a call with reporters, noting that HHS could being procuring supplies at the end of this month.

The United States has a $1.95 billion contract for 100 million doses of the Pfizer vaccine - enough to inoculate 50 million people - with an option to acquire 500 million more.

Earlier on Tuesday, Azar said on CNBC that final decisions are subject to a close look at the vaccine efficacy data.

Based on recommendations to the government, it will likely start with inoculations of the elderly in nursing homes and assisted living facilities, healthcare workers and first responders, with a goal to complete those shots by the end of January.

Top U.S. infectious disease expert Anthony Fauci also said in an interview with MSNBC that he expects the doses of the vaccine to be available for certain high priority groups in December.

Azar said he anticipates there will soon be more vaccines to protect against COVID-19 from other companies, including Moderna Inc MRNA.O, which is expected to announce interim results of a large trial of its experimental vaccine at the end of the month.

“By the end of March, early April, we expect to have enough for every American who would like to be vaccinated,” Azar told CBNC.

ANTIBODY DRUG DISTRIBUTION

Azar also said the U.S. government would begin distribution of Eli Lilly and Co's LLY.N antibody treatment this week, starting first in areas with the highest numbers of hospitalized COVID-19 patients and overall cases.

The treatment, which is administered by infusion, received an EUA on Monday.

"We'll ensure equitable distribution, and we'll work tightly with our governors," Azar said. He said the government will use the same process employed to distribute remdesivir, an antiviral drug from Gilead Sciences Inc GILD.O used to treat people hospitalized with COVID-19.

According to the Health and Human Services website, the agency will ship more than 79,000 doses of the antibody therapy this week, with the largest number going to Wisconsin, Texas, California, and Illinois.

The United States has purchased 300,000 doses of the treatment for this year and has an option to buy an additional 650,000 doses next year.

Azar said health officials and Eli Lilly were exploring ways to provide the treatment outside of hospitals, including through outpatient infusion centers.

Fauci described the Lilly treatment as “an important first step in the development and distribution of interventions that are given early in the course of disease.”

https://www.reuters.com/article/us-health-coronavirus-vaccine-azar/u-s-has-a-plan-to-start-pfizer-vaccine-shots-in-december-health-secretary-azar-idUSKBN27Q20J

Covid vaccine hope dampens prospects for corporate stay-at-home darlings

The surge in shares of Netflix, Zoom and other of this year's stay-at-home corporate winners has been brought to a sudden halt by promising vaccine data suggesting a possible way out of the COVID-19 pandemic.

The jury was still out on Tuesday, however, as to whether that reverse, sparked by positive data from trials run by U.S. drugs giant Pfizer and Germany's BioNtech, would last.

Shares in video conferencing network Zoom fell 4% on Tuesday after plunging about 17% a day earlier. But both exercise bike maker Peloton, which sank more than 20% on Monday, and Netflix, actually gained ground on Tuesday.

Tech heavyweights from Google-parent Alphabet to Apple and Amazon also suffered but have still mushroomed hugely in value this year.

"Even if a vaccine proves effective, inoculating a large enough part of the population will take time and leave these segments prone to economic lockdown fallout," said Commerzbank analyst Christoph Rieger.

The shakiness of moves may have reflected both those doubts about the speed at which a vaccine can be produced and distributed as well as the remaining doubts about whether it will work as a solution in the long-run.

But there is also the conviction that the pandemic has fundamentally changed business for many of these companies in ways that will not be reversed.

"Investors are now focused on how the 'new normal' looks ... and how sustainable are the tailwinds for such companies as the direct impact of the pandemic on consumer behavior starts to diminish," MKM Partners analyst Rohit Kulkarni, said.

Peloton, which has seen demand for its at-home fitness systems soar due to gym closures, recently posted a 274% jump in quarterly profit for its unit which sells interactive fitness equipment.

An outstanding beneficiary among tech stocks from the shift to work from home is Zoom, whose shares have jumped over 460% this year as corporate firms, schools, and organizations run countless virtual meetings on its video conferencing app.

Amazon.com Inc and Microsoft Corp have seen a substantial boost to their business but the capital they have available for new investment has soared as a result - potentially giving them more leverage going forward.

Shares of video game and e-sports related companies, which benefited from long cancellations of traditional sports leagues, tumbled after Pfizer's announcement, with game studios such as Activision Blizzard and Take-Two Interactive Software ending Monday's session lower.

Gaming peripheral makers such as Turtle Beach and Corsair Gaming also tumbled on Monday, while U.S. listed shares of game developers and e-sports organizers Bilibili Inc and Sea Limited saw their worst day since March.

All, however, are still up between 50% and 350% since March, while Corsair has risen 57% since its initial public offering in September.

"The market is likely discounting a deceleration of growth for the sector in 2021," said Will Hershey, CEO of Roundhill Investments.

"However, I believe that the growth in gaming due to the pandemic likely increased the trajectory of gaming adoption for years to come."

https://www.marketscreener.com/news/latest/Coronavirus-vaccine-hope-dampens-prospects-for-corporate-stay-at-home-darlings--31739892/