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Wednesday, March 17, 2021

Political role under fire in European AstraZeneca vaccine suspensions

 The decision by more than a dozen European countries to suspend AstraZeneca’s COVID-19 shot faced deepening scrutiny on Wednesday, amid concerns the step could undermine public confidence and delay efforts to beat the coronavirus pandemic.

The role of Germany, and in particular Health Minister Jens Spahn, is in the spotlight after a chaotic round of telephone diplomacy at the start of the week ended with the EU’s biggest states agreeing to put AstraZeneca on hold.

Spahn says he acted on expert advice after Germany’s vaccine watchdog reported on what it described as a statistically significant number of cases of a rare brain blood clot.

AstraZeneca says it has found no evidence that the blood clots were caused by the vaccine. The World Health Organization called on countries not to delay lifesaving vaccine programmes.

Germany’s actions have been interpreted as political both at home and abroad, with opposition leaders calling on Chancellor Angela Merkel to sack Spahn. Officials in major European capitals have given mixed accounts over how the joint move to halt AstraZeneca came about.

The stop on AstraZeneca threatens to hobble Europe’s vaccination campaign just as a third wave of infection breaks over the continent, accelerated by more infectious variants.

The bloc has already lagged far behind the United States and former EU member Britain in vaccinating citizens. Hospitals are filling up again, and politicians in several European countries have been forced to consider fresh lockdowns, even as comparable rich countries prepare for normal life to return.

“We need this vaccine,” said Germany’s best-known virologist Christian Drosten, whose regular podcast is widely followed. He cited forecasts of a resurgence in infection by Easter that could endanger Germans over the age of 60 who are next in line for a shot.

Ian Jones, a professor of virology at Britian’s Reading University, said the blood clot issue had “been picked up by politicians who don’t know one side of a virus from another”.

“It’s like falling dominoes. You just need one or two (countries) to state there’s a problem and suspend use, and then a whole lot of others will fall in place. I don’t think there have been any independent decisions,” he told Reuters.

A MATTER OF TRUST

Germany acted after its vaccine oversight body, the Paul Ehrlich Institute, found seven cases of a very rare cerebral vein clot among 1.6 million people given the AstraZeneca shot in the country, including three cases that were fatal.

The EU drug regulator, the European Medicines Agency (EMA) is investigating reports of around 30 cases of blood clots, bleeding and low platelet counts among the 5 million people in the EU that have received the AstraZeneca vaccine.

It will present its findings on Thursday, but meanwhile it has found no causal link to the vaccine, and says the shot’s benefits clearly outweigh any risks.

“We are worried that there may be an effect on the trust of the vaccines,” EMA head Emer Cooke told reporters. “But our job is to make sure that the products that we authorise are safe and can be trusted.”

AstraZeneca Plc said it had conducted a review covering more than 17 million people who had received its shots in the EU and Britain, and had found no evidence of an increased risk of blood clots.

Yet a narrow majority of Germans believe it was right for the government to suspend AstraZeneca, a Forsa opinion poll showed on Wednesday, with 54% backing Spahn’s decision and 39% saying it was excessive.

The willingness of Germans to be vaccinated against COVID, at 71%, meanwhile, has fallen by two percentage points since Forsa’s last poll on March 3. Were AstraZeneca to be reinstated, 63% would be willing to take it.

NO PRESSURE

Officials in European capitals gave conflicting accounts of a round of whirlwind diplomacy on Monday that led Italy, France and Spain to follow Germany in suspending the shot.

Sources said Merkel telephoned Italian Prime Minister Mario Draghi to brief him. One top Italian health official called Italy’s suspension a political decision not to part ways with Germany.

Italian sources said Draghi and French President Emmanuel Macron agreed by phone that the measure was temporary and precautionary.

A senior German government source denied that Berlin had exerted any pressure, noting that smaller EU member states such as Austria and Belgium had already raised the alarm.

“Nobody is being forced to do anything,” said the German source, who spoke on condition of anonymity. “That’s not how the EU works.”

Amid the European controversy, frustration over Spahn’s pandemic management has boiled over among Germany’s ruling conservatives, who have just suffered defeats in two regional elections. Merkel’s Christian Democrats (CDU) are languishing at one-year lows in polls ahead of a general election in September in which she will not seek a record fifth term.

Her successor as CDU chairman, Armin Laschet, a contender to run for chancellor, has criticised the AstraZeneca delay as “bad news”. Rival Markus Soeder, the governor of Bavaria, has called for the shot to be made available to anyone who wants it.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-europe/political-role-under-fire-in-european-astrazeneca-vaccine-suspensions-idUSKBN2B91XQ

AstraZeneca Vax Flops Against South African Variant in Early Trial

 AstraZeneca's COVID-19 vaccine was not protective against mild-to-moderate disease from either the so-called South African variant (B.1.351) or the wild type virus, an interim analysis of phase Ib/II data found.

Overall vaccine efficacy against mild-to-moderate COVID-19 in South Africa was 21.9% (95% CI -49.9 to 59.8), and efficacy against B.1.351 was 10.4% (95% CI -76.8 to 54.8), reported Shabir Madhi, PhD, of University of the Witwatersrand in Gauteng, South Africa, and colleagues, in the New England Journal of Medicine.

Previously, pooled efficacy data on the AstraZeneca vaccine from the U.K., Brazil, and South Africa, prior to B.1.351's emergence, showed overall efficacy of 66.7% (95.8% CI 57.4-74.0), as well as 74.6% efficacy against the so-called U.K. variant, B.1.1.7.

From June 24 to Nov. 9, 2,026 HIV-negative adults, ages 18-65, in South Africa were randomized to receive two standard doses of vaccine or placebo administered 21-35 days apart. Primary endpoint was safety and efficacy against laboratory-confirmed COVID-19 more than 14 days after the second dose, while a secondary endpoint examined vaccine efficacy against the B.1.351 variant.

Participants' median age was 30, about 56% were men, and 71% were Black Africans. Almost 20% of participants had obesity, 42% were smokers, and about 3% apiece had underlying hypertension or chronic respiratory conditions. Median time between doses was 28 days.

Overall, 23 of 717 in the placebo group (3.2%) and 19 of 750 in the vaccine group (2.5%) developed mild-to-moderate disease. Adults with COVID-19 received a nasal swab, and 41 of 42 were sequenced, revealing 39 cases were from the B.1.351 variant.

Regarding the secondary outcome of protecting against COVID-19 disease from the B.1.351 variant, the authors noted, "the trial was powered for the primary objective of a vaccine efficacy of at least 60% in preventing COVID-19 of any severity, regardless of variants."

Madhi's group also noted there were no cases of hospitalization due to severe COVID-19 in either group, but because of participants' demographic and clinical profile, "the trial findings are inconclusive" with regards to whether or not the vaccine protects against severe disease from the B.1.351 variant.

Exploratory analyses found about 33.5% efficacy (95% CI -13.4 to 61.7) against COVID-19 of any severity more than 14 days after the first dose.

Despite these results, the authors said deliberations on the utility of this vaccine "need to be made in the context of ongoing global spread and community transmission of the B.1.351 variant" and other strains with similar mutations.

Disclosures

The study was supported by the South African Medical Research Council, Bill & Melinda Gates Foundation, the National Institute for Health Research (NIHR), and the Department of Health and Social Care.

Madhi disclosed support from Bill & Melinda Gates Foundation, South African Medical Research Council, NIHR, Pfizer, GlaxoSmithKline, and Novavax. Co-authors disclosed support from the South African Medical Research Council, Bill & Melinda Gates Foundation, and Wits Health Consortium, as well as multiple relevant relationships with industry.

Tonix Pharma: Positive COVID-19 Vaccine Efficacy Results in Non-Human Primates

 Vaccine Candidate TNX-1800 Protected Both Upper and Lower Airways After Challenge with SARS-CoV-2, Suggesting an Ability to Block Forward Transmission

TNX-1800 is Based on a Proprietary Vaccine Platform Designed to Stimulate Long Term T cell Immunity

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox virus, live vaccine), a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 (CoV-2) spike protein. Immunogenicity and protective efficacy of single-dose TNX-1800 were assessed at two dose levels (n=4 per group). At Day 41 after the vaccination, animals were challenged with live SARS-CoV-2 through intra-nasal and intra-tracheal routes. Protection was assessed at Day 47, six days after challenge. The research is part of an ongoing collaboration between Southern Research, the University of Alberta and Tonix.

https://finance.yahoo.com/news/tonix-pharmaceuticals-reports-positive-covid-110000971.html

Timber Pharma Development Partner in Euro Licensing Agreement

 Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that its development partner, AFT Pharmaceuticals Limited (“AFT”), has signed an exclusive license and supply agreement with Desitin Arzneimittel GmbH (“Desitin”) for Pascomer® (TMB-002 topical rapamycin) for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in Europe.

In 2019, Timber entered into a licensing and development agreement with AFT for TMB-002 in North America. Under the terms of this agreement, Timber is entitled to receive a significant percentage of the economics (royalties and milestones) in any licensing transaction that AFT executes outside of North America, Australia, New Zealand, and Southeast Asia. The current transaction with Desitin is included in the scope of this provision.

https://www.globenewswire.com/news-release/2021/03/17/2194464/0/en/Timber-Pharmaceuticals-Development-Partner-AFT-Pharmaceuticals-Enters-into-Licensing-Agreement-for-Pascomer-TMB-002-in-Europe.html

FDA extends review period for expanded use of Abbvie's arthritis drug

 The U.S. Food and Drug Administration has extended the review period for expanded use of Abbvie Inc’s rheumatoid arthritis drug Rinvoq by three months, the U.S. drugmaker said on Wednesday.

Abbvie said the U.S. health agency is reviewing the application for the use of Rinvoq in patients with active psoriatic arthritis. Rinvoq was approved for the treatment of rheumatoid arthritis in 2019.

https://www.reuters.com/article/us-abbvie-fda/u-s-fda-extends-review-period-for-expanded-use-of-abbvies-arthritis-drug-idUSKBN2B91S6

Amazon starts offering healthcare service to other employers

 Amazon.com Inc is expanding its virtual healthcare service to other Washington-state employers starting Wednesday and to its own employees nationwide this summer, the company said in a press release.

Piloted in September 2019 for staff near its Seattle headquarters, “Amazon Care” lets employees video-chat with doctors for diagnoses and referrals. It also facilitates housecalls and drug delivery in greater Seattle, a non-virtual benefit that Amazon said would be available in greater Washington, D.C and Baltimore in the coming months.

The news shows how the No. 2 U.S. private employer is diving further into healthcare, the latest industry it has aimed to disrupt after retail, enterprise technology and Hollywood.

Amazon is now delivering prescription medications through an online pharmacy it launched last year and earlier worked with Berkshire Hathaway Inc and JPMorgan Chase & Co on lowering care costs in a now-disbanded venture called Haven.

Its playbook for offering healthcare in-house and then to other employers resembles how Amazon built data centers to satisfy its own web needs, before opening up the same infrastructure to startups in what became its cloud-computing business.

Kristen Helton, director of Amazon Care, said the service has grown during the COVID-19 pandemic and work-from-home period, but the opportunity goes far beyond that.

“Virtual medicine is absolutely part of the future of how healthcare is delivered,” she said in an interview.

Enterprises can contract with Amazon Care, offer that as a workplace benefit and subsidize healthcare costs for employees, Amazon said. It did not disclose financial terms, and Helton did not specify how big a business Amazon anticipates this will be.

Helton said Amazon Care was an add-on for some patients, a way to quickly get help after hours. But for others without a regular doctor, it is shaping up to be more.

“We’ve now evolved to offer more services,” she said. “We can do more primary care.”

https://www.reuters.com/article/amazoncom-healthcare/amazon-starts-offering-healthcare-service-to-other-employers-idUSL1N2LF03U

Tuesday, March 16, 2021

WHO-backed COVAX donates first AstraZeneca vaccines to Nicaragua

 Nicaragua received a first batch of AstraZeneca COVID-19 vaccine doses, Vice President Rosario Murillo said on Tuesday, touting the inoculations donated through the World Health Organization's global vaccine-sharing COVAX program.

Murillo said Covax had donated 137,000 doses and that the Nicaragua would receive more shots through the Covax mechanism at the end of March, but did not specify how many.

In late February, Nicaragua received its first batch of vaccine doses from an initial donation of Russia's Sputnik V product and has begun inoculating people with pre-existing conditions such as heart disease, kidney failure and cancer.

India has also already donated 200,000 doses of the AstraZeneca vaccine to Nicaragua, and has agreed to deliver an additional 300,000 doses.

Global health experts are seeking to clear up questions about the safety of the AstraZeneca vaccine as around a dozen European countries have suspended its use over a possible heightened risk of blood clots.

Europe's medicines regulator is investigating and is expected to release its findings on Thursday.

British health minister Matt Hancock said on Tuesday the AstraZeneca vaccine remained safe. 

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-WHO-backed-COVAX-donates-first-AstraZeneca-vaccines-to-Nicaragua-32701113/