Japan, eyeing Olympics, lines up half-billion doses of COVID-19 vaccine

Japan is making an aggressive move to grab enough coronavirus vaccine to inoculate its population four times over, a push the government hopes will instil confidence that it can host a delayed Summer Olympics next year.

Like other rich countries, Japan is signing multiple deals because some of the vaccines could fail in clinical trials or require more than one dose.

But Japan has something else riding on a successful mass rollout of a vaccine: outgoing Prime Minister Shinzo Abe’s aim to bring thousands of athletes and fans to Tokyo for the Games, postponed from this year due to the pandemic.

On the day he announced his resignation as premier, Abe sought to reassure domestic and foreign audiences that the coronavirus was under control. He pledged there would be enough vaccine for Japan by the middle of 2021 and said the nation would relax its travel ban from Sept. 1.

Chief Cabinet Secretary Yoshihide Suga earlier had said Japan was working with Olympic organisers on how to go ahead with the Games, tying the effort to the need to secure a vaccine.

The various companies “will probably be able to produce a vaccine between the end of this year and next March”, Suga told Reuters in an interview this week. “There are a lot of considerations, but we want to hold the Olympics at all costs.”

Japan is on track to have 521 million doses of five different vaccines in 2021, compared with a population of 126 million. Recent deals include global arrangements with such drugmakers as Pfizer Inc (PFE.N) and AstraZeneca PLC (AZN.L), as well as local deals with the likes of Shionogi & Co. (4507.T). “You have to bet evenly to avoid getting nothing,” said Tomoya Saito, director at Japan’s National Institute of Public Health.

‘HOPE FOR A MIRACLE’

Some critics contend that Japan’s rush to secure supplies is driven largely by a political desire to show the world it is fully committed to the Games. “The plan is, hope for a miracle and then capitalise on that miracle,” said Michael Cucek, a political science professor at Temple University Japan. “But the timeframe for that is getting narrower and narrower.” Health ministry and cabinet Office officials did not respond to queries about whether Japan’s drive to secure coronavirus vaccines was connected to the Olympics.

Abe pledged to increase testing capacity to 200,000 per day along with securing vaccine supplies. He also said Japan’s travel ban, one of the strictest in the world, would ease on Sept. 1.

From that date, non-citizen residents of Japan and visa holders can leave and reenter the country, with prior authorisation. They must also demonstrate a negative coronavirus test result within 72 hours of returning to Japan, cabinet officials said at a briefing on Friday.Japanese officials have discussed putting on a “simplified” Games, originally expected to attract 600,000 visitors. But the event would still involve some 11,000 athletes.

Holding the Olympics requires “mass quantities of an effective vaccine”, said Kenji Shibuya, director of the Institute of Population Health at King’s College, London. Staging an Olympics in a pandemic will be a huge logistical challenge, as athletes will have to train and travel to events and many more thousands of fans will have to be accommodated at a time when many countries may still be in lockdown. Japan still has a travel ban in place covering more than 140 countries.

Even with a viable vaccine, the additional challenge of immunising athletes and visitors before or after landing in Japan will be enormous.

A “very, very essential factor” will be when an effective vaccine will be ready and how it will be distributed, Tokyo Governor Yuriko Koike told Reuters.

“We will do our best to prevent coronavirus infections here in Japan and also to welcome the athletes from all over the world.”

https://www.reuters.com/article/us-health-coronavirus-vaccine-japan/japan-eyeing-olympics-lines-up-half-billion-doses-of-covid-19-vaccine-idUSKBN25O0EW

UK moves to fast-track coronavirus vaccine if safety tests passed

Britain’s medical regulator will be able to grant temporary authorisation for any coronavirus vaccine that meets safety and quality standards but before it has received a full licence, under new plans set out on Friday.

The government said that under its proposals the Medicines and Healthcare products Regulatory Agency (MHRA) would be able to grant this status to a vaccine while it underwent the full licensing process, with reinforced conditions to ensure safety.

The move, described as a last resort in the case of a strong public health justification, means the national regulator will be able to act this year if a vaccine arrives, before Britain has fully left the European Union on Dec. 31.

Normally the European Medicines Agency grants a licence for members of the bloc. The MHRA will have a licensing system in place from 2021.

“The proposals consulted on today suggest ways to improve access and ensure as many people are protected from COVID-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective,” England’s Deputy Chief Medical Officer Professor Jonathan Van-Tam said.

The government said it had launched a consultation to discuss the proposals and that it could be in force by October, ahead of the winter flu season. The proposals will also allow more healthcare workers to administer vaccines.

Britain has one of the highest death tolls in the world from COVID-19 and one of the worst economic contractions of any major country.

Like many others, it is pinning its hopes on a vaccine to help bring the pandemic to an end. One of the leading candidates is from the University of Oxford and AstraZeneca, which believes that trial data could go to a regulator this year.

https://www.reuters.com/article/us-health-coronavirus-britain-regulator/uk-moves-to-fast-track-coronavirus-vaccine-if-safety-tests-passed-idUSKBN25O2FX

Phase 2/3 neurodegeneration biotech Athira Pharma files for a $100 million IPO

Athira Pharma, a Phase 2/3 biotech developing therapies for neurodegeneration, filed on Wednesday with the SEC to raise up to $100 million in an initial public offering.

The company is developing small molecule therapies to restore neuronal health and stop neurodegeneration through its ATH platform. Athira’s lead candidate, ATH-1017, demonstrated improvements in brain network activity indicating potentially positive effects on brain function in nonclinical studies and Phase 1 clinical trials. The company plans to initiate a Phase 2/3 clinical trial for ATH-1017 by the end of 2020.

The Seattle, WA-based company was founded in 2011 and plans to list on the Nasdaq under the symbol ATHA. Athira Pharma filed confidentially on July 24, 2020. Goldman Sachs, Jefferies and Stifel are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: ATHA

https://www.renaissancecapital.com/IPO-Center/News/70612/Phase-23-neurodegeneration-biotech-Athira-Pharma-files-for-a-$100-million-I

Moderna, Pfizer Covid vax candidates need ultra-low temps, raise storage issue

The COVID-19 vaccine candidates being developed by Moderna Inc. and BioNTech and Pfizer Inc. will require stringent standards for refrigeration, and that may hamper how they are distributed to the hundreds of millions of Americans expecting to receive them.

Shares of Moderna MRNA, -0.75% fell 3.5% in trading on Thursday, following a rally on Wednesday after the company’s disclosure that people older than 55 years old who participated in the Phase 1 trial had demonstrated neutralizing antibody titers. Pfizer’s PFE, -1.00% stock was down 0.5% in Thursday trading, while BioNTech BNTX, -1.34% tumbled 3.4%.

Executives from Moderna and Pfizer on Wednesday separately told the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practice on Wednesday that mRNA-1273, which is Moderna’s coronavirus vaccine candidate, requires a storage temperature of negative 4 degrees Fahrenheit. BioNTech and Pfizer’s candidates, BN1162b2 and BNT162b2, need to be stored in negative 94 degrees Fahrenheit.

“These storage conditions would make traditional office or pharmacy administration very difficult,” SVB Leerink analysts wrote in a note to investors on Thursday. “These conditions could be met at tertiary hospitals and laboratories and could be accommodated in intensive one-day vaccination events at such sites, but this would still only cover a fraction of the healthy population.”

Officials at the Centers for Disease Control and Prevention said they are aware of the issue.

Dr. Kathleen Dooling, a medical officer for the agency’s division of viral diseases, said Wednesday that storage, distribution, and handling requirements of these vaccines “will make it very difficult for community clinics and local pharmacies to store and administer.” She also noted that most vaccines will have to be “administered at centralized sites with adequate equipment and high throughput.”

Pfizer will need to use ultralow temperature freezers and thermal shipper storage for its COVID-19 vaccine candidates, according to comments made by Dr. Nicholas Kitchin, senior director of Pfizer’s vaccine clinical research and development group.

The vaccines being developed by Moderna, BioNTech, and Pfizer are mRNA vaccines; however, other types of vaccines require less intense rules around storage. Concern about the difficulties of storing and shipping mMRNA COVID-19 vaccines to hundreds of millions of people could put the makers of these candidates at a competitive disadvantage, analysts say. It may also separate Moderna’s vaccine from the ones being developed by BioNTech and Pfizer.

There are about half a dozen COVID-19 vaccine candidates in clinical trials in the U.S. However, not all of them are mRNA vaccines. The vaccine being developed by AstraZeneca AZN, -0.32% AZN, -0.82% and the University of Oxford is a recombinant viral vector vaccine, for example, while Inovio Pharmaceutical Inc.’s INO, 1.10% candidate is DNA-based.

“Investors are increasingly looking to storage and delivery conditions across vaccine candidates as they consider competitive positioning,” SVB Leerink’s Mani Faroohor said in a separate note to investors.

Since the start of the year, Moderna’s stock has soared 244.5%, shares of BioNTech have gained 91.9%, and Pfizer’s stock is down 3.3%. The S&P 500 SPX, 0.17% is up 7.7% for the year.

https://www.marketwatch.com/story/moderna-and-pfizers-covid-19-vaccine-candidates-require-ultra-low-temperatures-raising-questions-about-storage-distribution-2020-08-27

Herbalife down on criminal charges, trading suspended

The NYSE has suspended trading Herbalife Nutrition (HLF -12.0%) due to volatility on reports that U.S. prosecutors have charged it in a criminal case related to bribery in China.

Developing….

Update: In May, the company disclosed that it reached an understanding in principle with the SEC and U.S. Department of Justice (DOJ) to settle their investigation into its compliance with the Foreign Corrupt Practices Act in China during the period of 2006 – 2016.

In September 2019, it agreed to pay $20M to settle SEC charges over false and misleading statements related to its business model in China.

https://seekingalpha.com/news/3609784-herbalife-down-12-on-criminal-charges-trading-suspended

Humana lawsuit exposes fraud risk in high-growth telehealth market

Health insurer Humana has filed a lawsuit against telemedicine company QuivvyTech that it says resulted in fraudulent prescriptions worth millions of dollars being written for duped customers.

According to the complaint, QuivvyTech hired telemarketers to cold-call Humana members, whose details were obtained using “illegal means,” and encouraged them to talk about common ailments, claiming to be calling from Humana.

The script used by the telemarketers was designed to prompt members into describing medical conditions such as “pain and inflammation, acne breakouts, eczema or psoriasis episodes, cold sores, or conditions commonly treated with antifungal medications such as athlete’s foot,” it adds.

The company is accused of then passing on the call recordings and other information to physicians – some of whom are also named in the suit – who then prescribed medicines to the Humana patients without informing them “and never having met or spoken to them.”

“They designed pre-printed prescription forms with multiple options of pre-determined categories of medical conditions with the physician marking boxes for medications, often high-dollar cost topical creams and ointments,” claims Humana and its legal counsel.

The suit also mentions “co-conspirator pharmacies” which it claims were also in on the scam and billed, dispensed and shipped the medicines to patients, often numerous times via automatic refills.

The pharmacies aren’t named as defendants in the lawsuit because of “contractual arbitration provisions” between them and Humana, but are identified in the complaint.

Humana says it paid out between $590,000 and $2.3 million to reimburse drugs prescribed by the six doctors named in the lawsuit, for a total of almost $10 million.

The suit exposes the potential for fraud with telemedicine, which has come to the fore during the COVID-19 crisis at the same time as use of digital health approaches has skyrocketed, fuelled by increased reimbursement of virtual healthcare consultations though Medicaid and Medicare.

Some of the scams identified by a recent article in Fraud magazine include “fraudulent claims using false diagnoses, phantom patients, fake telemedicine appointments and insurance reimbursement for non-essential drugs and fictitious treatments.”

Needless to say, this type of activity undermines the benefits that can accrue from greater use of telehealth services, including reduced burden on healthcare practitioners and easier access to care for people living in remote areas or those who have mobility difficulties.

Humana lawsuit exposes fraud risk in high-growth telehealth market

J&J to start mid-stage coronavirus vaccine trials in 3 European countries

Johnson & Johnson’s (JNJ.N) Janssen unit will begin mid-stage trials for its coronavirus vaccine in Spain, the Netherlands and Germany next week, Spain’s health minister said on Friday, as the U.S. drugmaker expands testing for its experimental shot.

The Phase II trial will last two months and include 550 participants across the three countries, including 190 people in Spain, Salvador Illa told a news conference in Madrid.

“It’s a vote of confidence in our health system,” Illa said, adding it was the first human trial for a coronavirus vaccine to be approved in Spain.

The study will focus on healthy people between the ages of 18 and 55 as well as people over 65.

Johnson & Johnson said the study will evaluate the safety and the ability to induce an immune response from single dose and two-dose regimens of the vaccine candidate, the company said in a statement.

Spain, which has western Europe’s highest tally of coronavirus cases, is also working with AstraZeneca (AZN.L) via the European Union’s vaccine procurement programme to secure sufficient doses.

J&J’s website says if the latest trials are successful, it will begin final Phase III studies, in which even more volunteers will receive the experimental vaccine.

More than 150 potential vaccines are being developed and tested globally to combat the COVID-19 pandemic, with 30 in human trials.

There is so far no approved vaccine, except one authorised in Russia before large-scale trials.

J&J is carrying out tests in the United States and Belgium, and this week added Chile, Argentina and Peru to the list of Latin American nations where it plans to conduct Phase III trials on 60,000 volunteers, in a study that will also cover Brazil, Colombia and Mexico.

The company’s potential vaccine uses “viral vectors” to generate immune responses, similar to the approach taken by the University of Oxford and AstraZeneca in their experimental vaccine, as well as China’s CanSino.

https://www.reuters.com/article/us-health-coronavirus-johnson-johnson/jj-to-start-mid-stage-coronavirus-vaccine-trials-in-three-european-countries-idUSKBN25O1E5