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Wednesday, February 10, 2021

SoftBank To Invest $900M In Pacific Biosciences

 

  • SoftBank Group Corp (OTCMKTS: SFTBY) will reportedly invest $900 million into Pacific Biosciences of California Inc (NASDAQ: PACB), according to the Wall Street Journal, which comes on top of around 6% stake in PacBio that Softbank amassed almost a month back, worth over $350 million.
  • Last year, PACB was blocked by U.S. antitrust enforcers from merging with Illumina in a $1.2B deal. Illumina paid PacBio a $98 million breakup fee. But under their arrangement, if PacBio raised more than $100 million subsequently, it would owe Illumina $52 million. PacBio will now have to pay that amount.
  • The company recently announced a multi-year collaboration with Invitae Corp (NYSE: NVTA) to begin developing a production-scale high-throughput sequencing platform leveraging PacBio’s HiFi sequencing to expand Invitae’s whole genome testing capabilities.
  • Both companies committed resources to support the development.

South Korea to approve AstraZeneca as first COVID-19 vaccine, including for elderly

 South Korea on Wednesday said it would grant its first approval for a coronavirus vaccine to AstraZeneca, and will allow use in people 65 years or older, despite advisory panels’ warning of a lack of data on its efficacy for the elderly

Regulators will grant AstraZeneca’s vaccine emergency authorisation under the condition the company must submit its full clinical trial results, Vice Health Minister Kim Gang-lip told a news conference.

“However, we have added a precautionary line for cautious decision for use of the shots the elderly aged 65 and older,” Kim said.

Several European countries have warned that the shot should only be given to those ages 18 to 64, and such concerns had threatened to upend South Korea’s plan to prioritise elderly residents and medical workers in the first round of vaccinations.

On Monday, authorities sought to reassure elderly residents after a panel of advisers urged caution over the use of the AstraZeneca vaccine for people older than 65 because of a lack of data.

AstraZeneca and the chief of clinical trials for Britain’s Oxford University, which co-developed the vaccine, have said it triggers a good immune response in older people.

The approved doses for South Korea are produced by SK bioscience, the drugmaking arm of SK Chemicals, Kim said.

The Korea Disease Control and Prevention Agency (KDCA) had said vaccinations will begin on Feb. 26 with about 1.5 million doses of AstraZeneca vaccines, enough for 750,000 people. It will inoculate about 10 million high-risk people by July and aim to reach herd immunity by November.

The ministry has asked to receive by April final clinical trial results from AstraZeneca’s survey in the United States on about 30,000 people. The study includes around 7,500 elderly people, Kim said.

He added that the KDCA is reviewing the efficacy of the AstraZeneca-Oxford shot on new UK or South African variants, after uncertainty over protection. Oxford had said its vaccine has similar efficacy against the British coronavirus variant as it does to the previously circulating variants.

The KDCA reported 444 new COVID-19 cases by Tuesday, bringing the total number of infections to 81,930, with 1,486 deaths. The daily cases rebounded above 400 ahead of the Lunar New Year holiday, boosted by cluster infections mostly in near the capital Seoul.

https://www.reuters.com/article/us-health-coronavirus-southkorea-astraze/south-korea-to-approve-astrazeneca-as-first-covid-19-vaccine-including-for-elderly-idUSKBN2AA0E8

EMA expected to approve Johnson & Johnson vaccine by March - CEO of Janssen Italy

 The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by Johnson & Johnson by March, the Managing Director of Janssen Italia, part of the J&J group, said on Wednesday.

Massimo Scaccabarozzi, who is also the head of Italy’s pharmaceutical company association Farmindustria, said in an interview with Italian daily Corriere della Sera the vaccine had been tested on almost 44,000 people, “hence shields us from variants”.

He added that, under a European Union agreement, Italy will be allotted 27 million shots, which require only one dose and no booster.

https://www.reuters.com/article/us-health-coronavirus-italy-vaccine/ema-expected-to-approve-johnson-johnson-vaccine-by-march-ceo-of-janssen-italy-to-paper-idUSKBN2AA0JG

India's Biological E looking to make 600 million J&J vaccine shots a year

 Indian pharmaceutical company Biological E Ltd is looking to contract-manufacture roughly 600 million doses of Johnson and Johnson’s COVID-19 vaccine annually, its managing director told Reuters on Wednesday.

The country’s inoculation drive is currently using the Oxford University-AstraZeneca vaccine and another developed at home by Bharat Biotech with the state-run Indian Council of Medical Research.

Several other vaccines, including Russia’s Sputnik V, Cadila Healthcare’s ZyCov-D and a Novavax product are in the queue in the world’s biggest vaccine-making country.

“We are targeting 600 million doses for J&J,” Biological E’s Mahima Datla said, adding it was not clear when they could start production. “This will be in addition to our own product for which we are targeting approximately 1 billion doses.”

She declined to answer if the company could help J&J run a small local safety and immunogenicity study in India for the single-dose shot found to be 66% effective in preventing moderate-to-severe COVID-19 disease. India generally asks for so-called bridging studies for foreign vaccines.

A senior government official said on Tuesday J&J was interested in manufacturing its vaccine in India, which has recorded the highest number of COVID-19 infections after the United States.

Biological E’s own vaccine candidate developed with Baylor College of Medicine in Houston and U.S.-based Dynavax Technologies Corp is undergoing clinical trials in India, with late-stage testing due to begin in April.

India, which manufactures around 60% of vaccines sold in the world, wants COVID-19 vaccine companies to make locally to sell on the domestic market as well as export.

The country has vaccinated more than 6.6 million frontline workers since starting its campaign on Jan. 16, with an aim to reach 300 million people by August. It has reported 10.86 million infections and more than 155,000 deaths.

The Serum Institute of India, the world’s biggest vaccine maker, is making the AstraZeneca and Novavax shots for low- and middle-income countries.

https://www.reuters.com/article/us-health-coronavirus-india-johnson-john/indias-biological-e-looking-to-make-600-million-jj-vaccine-shots-a-year-idUSKBN2AA0IU

South Africa says selling or swapping AstraZeneca doses are options

  South Africa’s health minister said on Wednesday the government may sell or swap its doses of the AstraZeneca COVID-19 vaccine, but it would wait for advice from scientists as it prepares to roll out an alternative U.S. shot next week.

South Africa paused the rollout of the vaccine developed by AstraZeneca and Oxford University following data in a small clinical trial that showed it did not protect against mild to moderate illness from the 501Y.V2 variant of the coronavirus now dominant in the country.

One million doses of the AstraZeneca vaccine, produced by the Serum Institute of India, landed in the country last week, and another 500,000 are due to arrive in the coming weeks. South Africa was also expecting to receive AstraZeneca shots via the COVAX global vaccine distribution scheme co-led by the World Health Organization and an African Union (AU) arrangement.

Health Minister Zweli Mkhize told a news conference the country would start vaccinating health workers with Johnson & Johnson’s vaccine in the form of an “implementation study” with researchers some time next week.

“Why not sell the AstraZeneca to other countries, well it’s an option, ... we will consider it. First our scientists will tell us what we do with it, can we use it within the time that’s available ... before it expires,” Mkhize said.

“If not, can we swap it with anyone else, because we’ve discussed it with COVAX and with AVATT (the AU’s vaccine task team), so we will see what we will do.”

The government’s Ministerial Advisory Committee should be able to give a considered view on how to deal with the AstraZeneca vaccines in the next week or two, Mkhize said, adding that the government had also secured vaccine doses from Pfizer for health workers.

Negotiations with Moderna, China’s Sinopharm and over Russia’s Sputnik V vaccine are ongoing.

Mkhize said the first batch of J&J doses would not be a lot compared to the total the country was hoping to order.

“It’s possible that the first batch would actually be not paid for, because it would be covered more as the research stock. So if we are able to achieve that it’s fine, but if we have got to pay for it we have got no problem,” he said.

Officials previously said the country had secured 9 million J&J doses.

The J&J vaccine was 89% effective at preventing severe disease and 57% against moderate-to-severe disease in the South African leg of a global trial. Ninety-five percent of infections observed in the local study were due to the 501Y.V2 variant first identified late last year.

The 501Y.V2 variant has alarmed health experts who have raised concerns about its ability to potentially evade the immune response generated by prior exposure to the coronavirus or vaccines.

South Africa’s neighbour eSwatini said on Tuesday that it would not be using the AstraZeneca vaccine.

South Africa hopes to vaccinate 40 million people, or two-thirds of its population, to achieve some level of herd immunity.

https://www.reuters.com/article/us-health-coronavirus-safrica/south-africa-says-selling-or-swapping-astrazeneca-doses-are-options-idUSKBN2AA0G2

Vaccine vs variant: Promising data in Israel's race to defeat pandemic

 Israel’s swift vaccination rollout has made it the largest real-world study of Pfizer Inc’s COVID-19 vaccine. Results are trickling in, and they are promising.

More than half of eligible Israelis - about 3.5 million people - have now been fully or partially vaccinated. Older and at-risk groups, the first to be inoculated, are seeing a dramatic drop in illnesses.

Among the first fully-vaccinated group there was a 53% reduction in new cases, a 39% decline in hospitalizations and a 31% drop in severe illnesses from mid-January until Feb. 6, said Eran Segal, data scientist at the Weizmann Institute of Science in Rehovot, Israel.

Reuters Graphic

In the same period, among people under age 60 who became eligible for shots later, new cases dropped 20% but hospitalizations and severe illness rose 15% and 29%, respectively.

Reuters interviewed leading scientists in Israel and abroad, Israeli health officials, hospital heads and two of the country’s largest healthcare providers about what new data shows from the world’s most efficient vaccine rollout.

The vaccine drive has provided a database offering insights into how effective the vaccines are outside of controlled clinical trials, and at what point countries might attain sought-after but elusive herd immunity.

More will be known in two weeks, as teams analyse vaccine effectiveness in younger groups of Israelis, as well as targeted populations such as people with diabetes, cancer and pregnant women, among a patient base at least 10 times larger than those in clinical studies.

“We need to have enough variety of people in that subgroup and enough follow-up time so you can make the right conclusions, and we are getting to that point,” said Ran Balicer, chief innovation officer of HMO Clalit, which covers more than half the Israeli population.

Pfizer is monitoring the Israeli rollout on a weekly basis for insights that can be used around the world.

As a small country with universal healthcare, advanced data capabilities and the promise of a swift rollout, Israel provided Pfizer with a unique opportunity to study the real-world impact of the vaccine developed with Germany’s BioNTech

But the company said it remained “difficult to forecast the precise time when herd protection may start to manifest” because of many variables at play, including social distancing measures and the number of new infections generated by each case, known as the reproduction rate.

Even Israel, in the vanguard of the global vaccine drive, has lowered expectations of emerging quickly from the pandemic because of soaring cases.

A third national lockdown has struggled to contain transmission, attributed to the fast-spreading UK variant of the virus. On a positive note, the Pfizer/BioNTech shot appears to be effective against it.

“We’ve so far identified the same 90% to 95% efficacy against the British strain,” said Hezi Levi, director-general of the Israeli Health Ministry.

“It is still early though, because we have only now finished the first week after the second dose,” he said, adding: “It’s too early to say anything about the South African variant.”

WHICH ARM?

Israel began its vaccination programme Dec. 19 - the day after Hanukkah - after paying a premium for supplies of the Pfizer/BioNTech vaccine.

Four days later, the more contagious UK variant was detected in four people. While the vaccine is preventing illness in older people, the variant now makes up about 80% of new cases.

Finding themselves in a race between the vaccine and the new variant, Israel began giving shots to those over 60 and gradually opened the programme to the rest of the population.

Every detail was digitally tracked, down to in which arm the patient was jabbed and what vial it came from.

One week after receiving the second Pfizer dose - the point at which full protection is expected to kick in - 254 out of 416,900 people were infected, according to Maccabi, a leading Israeli healthcare provider.

Reuters Graphic

Comparing this against an unvaccinated group revealed a vaccine efficacy of 91%, Maccabi said.

By 22 days after full vaccination, no infections were recorded.

Israeli experts are confident the vaccines rather than lockdown measures brought the numbers down, based on studying different cities, age groups and pre-vaccine lockdowns.

The comparisons were “convincing in telling us this is the effect of the vaccination,” said Weizmann Institute’s Segal.

With 80% of senior citizens partially or fully vaccinated, a more complete picture will begin to emerge as soon as this week.

“And we do expect further decline in the overall cases and in the cases of severe morbidity,” said Balicer, of HMO Clalit.

VACCINES AND TRANSMISSION

There may be early signs that vaccinations are tamping down virus transmission in addition to illness

At Israel’s biggest COVID-19 testing centre, run by MyHeritage, researchers have tracked a significant decrease in the amount of virus infected people carry, known as cT value, among the most-vaccinated age groups.

This suggests that even if vaccinated people get infected, they are less likely to infect others, said MyHeritage Chief Science Officer Yaniv Erlich.

“The data so far is probably most clear from Israel. I do believe that these vaccines will reduce onward transmission,” said Stefan Baral, from Johns Hopkins School of Public Health in Maryland.

DIMINISHING RETURNS

It is unclear whether Israel will be able to keep up its world-leading vaccination pace.

“When you vaccinate fast and a lot, you eventually get to the hardcore - those who are less willing or harder to reach,” said Boaz Lev, head of the Health Ministry’s advisory panel.

The vaccination pace is seen even more crucial with the British variant’s rapid transmission.

“In the race between the UK variant spreading and the vaccinations, the end result is that we are seeing a kind of plateau in terms of the severely ill,” said Segal.

The big question is whether vaccines can eradicate the pandemic.

Michal Linial, a professor of molecular biology and bioinformatics at Jerusalem’s Hebrew University, said data from past decades suggests viruses become endemic and seasonal.

She predicted this coronavirus would become far less aggressive, perhaps requiring a booster shot within three years.

“The virus is not going anywhere,” she concluded.

https://www.reuters.com/article/us-health-coronavirus-israel-results-ins/vaccine-vs-variant-promising-data-in-israels-race-to-defeat-pandemic-idUSKBN2AA0MS

Gamida Cell Presents Results of Phase 3 Study of Omidubicel in Hematologic Malignancies

 — Omidubicel represents a potentially transformative cell therapy treatment option for patients in need of a bone marrow transplant —

—Newly presented data support clinical benefit demonstrated by primary and secondary endpoints—

—Company anticipates BLA submission in second half of 2021—

Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced the results of a Phase 3 clinical study of omidubicel presented in an oral session at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR), or the TCT Meetings. Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies.

This clinical data set was from the international, multi-center, randomized Phase 3 study of omidubicel that was designed to evaluate the safety and efficacy of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. This is the first presentation of these data in a peer-reviewed conference. The full presentation is available on the Gamida Cell website.

"The results of this global Phase 3 study of omidubicel in patients with hematologic malignancies show that omidubicel resulted in faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital, all of which are meaningful results and represent potentially important advancements in care when considering the patient experience following transplant," said Mitchell Horwitz, M.D., principal investigator and professor of medicine at the Duke Cancer Institute. "The comparator, a transplant with umbilical cord blood, has been historically shown to result in low incidence of graft versus host disease (GvHD) in relation to other graft sources, and in this study, omidubicel demonstrated a GvHD profile similar to the comparator. Moreover, previous studies have shown that engraftment with omidubicel is durable, with some patients in the Phase 1/2 study receiving their transplant more than 10 years ago. The data presented at this meeting indicate that omidubicel has the potential to be considered a new standard of care for patients who are in need of stem cell transplantation but do not have access to a matched donor."