Search This Blog

Friday, March 5, 2021

Sinovac vaccine may not trigger sufficient antibody response to Brazil variant

 Sinovac Biotech’s COVID-19 vaccine may not trigger sufficient antibody responses against a new variant identified in Brazil, a small-sample lab study showed.

The emergence of variants of the new coronavirus has raised concern that vaccines and treatments that were developed based on previous strains may not work as robustly.

Plasma samples taken from eight people vaccinated with Sinovac’s CoronaVac failed to efficiently neutralize the P.1 lineage variant, or 20J/501Y.V3, researchers said in a paper published on Monday ahead of peer-review.

“These results suggest that P.1 virus might escape from neutralizing antibodies induced by... CoronaVac,” researchers at the University of São Paulo in Brazil, Washington University School of Medicine in the United States, and a few other institutions said in the paper.

CoronaVac is being used in mass vaccination drives in countries including China, Brazil, Indonesia and Turkey.

Although the study suggests re-infection may occur in vaccinated individuals, the protection given by CoronaVac against severe COVID-19 may indicate other mechanisms in the human immune system, aside from antibodies, may also contribute to reducing disease severity, researchers said.

A Sinovac spokesman was not immediately available for comment. Chief executive Yin Weidong said in a programme aired by state-backed broadcaster CGTN on Thursday the company is “fully capable” of using current research and manufacturing capacity to develop a new vaccine against variants if necessary.

He also said the process would take much less time than it took to develop CoronaVac.

https://www.reuters.com/article/us-health-coronavirus-vaccine-sinovac/sinovac-vaccine-may-not-trigger-sufficient-antibody-response-to-brazil-variant-study-idUSKBN2AX0KK

B117 coronavirus variant might soon become dominant in Germany

 A more contagious variant of the coronavirus first detected in Britain might soon become the predominant strain in Germany, making it hard to stop its spread, the head of the Robert Koch Institute said on Friday.

Lothar Wieler said the B117 variant now made up more than 40% of coronavirus cases in Germany, compared to about 6% of cases four weeks ago.

“It is foreseeable that B117 will soon be the predominant variant in Germany and then it will be even more difficult to keep the virus in check because B117 is more contagious and even more dangerous in all age groups,” he said.

https://www.reuters.com/article/us-health-coronavirus-germany-variants/b117-coronavirus-variant-might-soon-become-dominant-in-germany-rki-head-idUSKBN2AX0RV

Japan's Takeda seeks government approval for Moderna COVID-19 vaccine

 Takeda Pharmaceutical Co. asked regulators Friday to approve the use of Moderna Inc.’s COVID-19 vaccine, which would allow it to become the third vaccine to figure in a national inoculation effort begun last month.

Takeda, which is handling domestic approval and imports of about 50 million Moderna doses, announced the filing. It has earlier said approval could be given in May.

“Takeda commits to delivering Moderna’s COVID-19 vaccine candidate in Japan as soon as possible,” Masayuki Imagawa, the head of the firm’s Japan vaccines business unit, said in a statement.

Japan kicked off its inoculations in the middle of February using Pfizer Inc.’s vaccine, the first to be approved for domestic use. But Pfizer doses, imported from European factories, are in short supply.

AstraZeneca PLC applied for Japanese approval of its COVID-19 vaccine candidate early in February, and that decision is still pending.

Takeda is also handling the approval process and domestic production of about 250 million doses of Novavax Inc.’s vaccine, which entered clinical trials in Japan late last month.

While awaiting regulatory approval, Takeda plans to start distributing the Moderna vaccine in the first half of this year, while that of Novavax is expected in late 2021.

Japan has secured rights to at least 564 million doses of COVID-19 vaccines from several overseas makers, the largest volume in Asia and more than enough for its population of 126 million.

Prime Minister Yoshihide Suga has pledged to have enough vaccine doses for the population by June before the July 23 start of the Summer Olympics in Tokyo, postponed from last year because of the virus.

https://www.japantimes.co.jp/news/2021/03/05/national/takeda-seeks-approval-moderna/

ARK adds Schrodinger on weakness

 Cathie Wood's ARK Investment was a buyer of weakness in Schrodinger Inc. (NASDAQ: SDGR), Butterfly Network (NYSE: BFLY), CM Life Sciences (NASDAQ: CMLF), Workhorse Group (NASDAQ: WKHS), and Skillz (NYSE: SKLZ), on Thursday.

The firm also added to its stakes in favorites Square (NYSE: SQ), Roku (NASDAQ: ROKU), Shopify (NASDAQ: SHOP), and Teledoc (NASDAQ: TDOC).

ARK discloses its trades daily M-F. The daily trades are not comprehensive lists of a day's trades for the ARK ETFs and exclude initial/secondary public offering transactions and ETF Creation/Redemption Unit activity. Wood is famous for her ultra-bullish call on Tesla and is regarded as having the hottest hand on the Street currently.

https://www.streetinsider.com/Hedge+Funds/Cathie+Woods+ARK+Adds+to+Favorites+SQ%2C+ROKU%2C+SHOP%2C+TDOC+on+Dip/18086444.html

Thursday, March 4, 2021

J&J CEO: Merck Partnership Goal To Exceed 100M Covid-19 Vaccine Doses By June

 Johnson & Johnson chief executive Alex Gorsky said the company’s new partnership with Merck to produce Covid-19 vaccines could exceed a goal to produce 100 million doses by June for the U.S.

“That’s our goal,” Gorsky told the Washington Post’s David Ignatius in a live interview Wednesday morning regarding the company’s plan to accelerate production with its new partner Merck of its one-shot Janssen Covid-19 vaccine, which was granted emergency use authorization from the U.S. Food and Drug Administration over the weekend.

“Our engineers and our scientists are working hand in hand with the Merck supply chain as we speak to make this possible,” Gorsky said. “We’re very confident that… in the coming months we’ll be able to accelerate.” 

Gorsky’s comments come a day after the Biden White House announced rival drug maker Merck, which has a long history of vaccine development, would collaborate with Johnson & Johnson to expand production of J & J’s Covid-19 vaccine. The Biden administration Tuesday said “the collaboration will increase manufacture of vaccine drug substance, as well as its fill-finish capacity – two of the biggest bottlenecks facing J&J in the production of its vaccine.”

By exceeding the goal of 100 million doses of its Covid-19 vaccine by June, the Johnson & Johnson partnership with Merck would be critical to President Biden’s accelerated timeline for the U.S. to have enough Covid-19 vaccine doses for every adult American by the end of May.

Even without Merck as a partner, Johnson & Johnson has already “distributed almost 4 million vaccines,” Gorsky said.

Johnson and Johnson is committed to 20 million dosages to the U.S. by the end of March and 100 million doses by June. “This is helping to reinforce that in a significant way,” Gorsky said of the Merck partnership.

Johnson & Johnson’s Covid-19 vaccine joins vaccines made by Moderna and Pfizer that are already being given to millions of Americans and tens of millions more people around the world.

Johnson & Johnson’s vaccine only requires one dosage and can be stored in most standard refrigerators, which the company says could help reach medically-underserved areas of the U.S. and globally. Moderna’s and Pfizer’s vaccines require two shots three or four weeks apart and specialized freezers.

Though there are worries the vaccines won’t be as effective against new variants that have emerged in the United Kingdom and South Africa and have begun to spread in the U.S., Johnson & Johnson has said the vaccine will help people from getting sick and hospitalized.

Gorsky said the production of a vaccine against the Coronavirus has come a long way, dating back “13 months ago when we started on this with the genomic sequencing information.”

“When we started, some of the manufacturing facilities were literally parking lots,” Gorsky told the Washington Post Wednesday. “The complexity of bringing up this kind of scale or scope has never been done before.”

Under the partnership with Merck brokered by the Biden administration, the U.S. Department of Health and Human Services “will collaborate with Merck to repurpose some of its existing Merck facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies including the current pandemic,” HHS said Tuesday.

“The facilities will be available to private sector partners working with the federal government on the Covid-19 response or to produce Merck products against COVID-19,” HHS said in a statement. “Janssen Pharmaceuticals, part of Johnson & Johnson, will be the first federal partner to use repurposed Merck facilities to manufacture COVID-19 vaccine. Merck will use two of its facilities to produce drug substance, formulate and fill vials of J&J’s vaccine.”

https://www.forbes.com/sites/brucejapsen/2021/03/03/johnson--johnson-ceo-merck-partnership-goal-to-exceed-100-million-doses-by-june/

Permira Bid $85/Share for LivaNova PLC (LIVN)

Seen as Too Low

 https://www.streetinsider.com/Hot+M+and+A/Permira+Bid+%2485Share+for+LivaNova+PLC+%28LIVN%29%2C+Which+is+Seen+as+Too+Low+-+Source/18080152.html

Drugmakers study how to administer COVID-19 vaccines without needle

 Pharmaceutical companies are exploring ways to deliver vaccines without a needle by investigating new delivery methods such as patches, dissolving implants, electrical-pulse systems, nasal sprays and pills, according to a March 3 report from The Wall Street Journal.

The companies are exploring the possibility of needleless vaccine delivery to mitigate the challenges the current vaccine delivery system poses, such as long waits, ultracold freezing logistics and training personnel to perform needle injections. If these efforts are successful, they could create a reality in which patients can administer vaccines from their own homes, according to the Journal.

Cambridge, Mass.-based Vaxess Technologies told the Journal it is developing a combination COVID-19 and influenza vaccine patch designed so that patients can administer it yearly from their own homes. Vaxxas, also based in Cambridge, Mass., said it is developing vaccine patch technology as well. 

Oxfordshire, England-based Enesi Pharma is working on a device that painlessly implants vaccines under patients' skin. Another approach is being pioneered by global health nonprofit PATH in which vaccines are freeze-dried and turned into lozenges that can dissolve under patients' tongues, according to the Journal.

Codagenix, a Farmingdale, N.Y.-based company, is developing its own single-dose COVID-19 vaccine designed to squirt up the nose. The vaccine candidate is being studied in a small, phase 1 clinical trial in London, according to the Journal.

https://www.beckershospitalreview.com/pharmacy/drugmakers-studying-how-to-administer-covid-19-vaccines-without-a-needle.html