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Thursday, December 3, 2020

Inovio adds new member to manufacturing group for COVID-19 vaccine

 

WHO looks at possible 'e-vaccination certificates' for travel

 The World Health Organization does not recommend countries issuing “immunity passports” for those who have recovered from COVID-19, but is investigating the prospects of using e-vaccination certificates, a WHO medical expert said on Thursday.

“We are looking very closely into the use of technology in this COVID-19 response, one of them how we can work with member states toward an e-vaccination certificate,” he told a virtual briefing in Copenhagen.

https://www.reuters.com/article/us-health-coronavirus-who-passports/who-looks-at-possible-e-vaccination-certificates-for-travel-idUSKBN28D1J4

IBM warns hackers targeting COVID vaccine 'cold chain' supply process

 IBM is sounding the alarm over hackers targeting companies critical to the distribution of COVID-19 vaccines, a sign that digital spies are turning their attention to the complex logistical work involved in inoculating the world’s population against the novel coronavirus.

The information technology company said in a blog post published on Thursday that it had uncovered “a global phishing campaign” focused on organizations associated with the COVID-19 vaccine “cold chain” - the process needed to keep vaccine doses at extremely cold temperatures as they travel from manufacturers to people’s arms.

The U.S. Cybersecurity and Infrastructure Security Agency reposted the report, warning members of Operation Warp Speed - the U.S. government’s national vaccine mission - to be on the lookout. Understanding how to build a secure cold chain is fundamental to distributing vaccines developed by the likes of Pfizer Inc and BioNTech SE because the shots need to be stored at minus 70 degrees Celsius (-94 F) or below to avoid spoiling.

IBM’s cybersecurity unit said it had detected an advanced group of hackers working to gather information about different aspects of the cold chain, using meticulously crafted booby-trapped emails sent in the name of an executive with Haier Biomedical, a Chinese cold chain provider that specializes in vaccine transport and biological sample storage.

The hackers went through “an exceptional amount of effort,” said IBM analyst Claire Zaboeva, who helped draft the report. Hackers researched the correct make, model, and pricing of various Haier refrigeration units, Zaboeva said.

“Whoever put together this campaign was intimately aware of whatever products were involved in the supply chain to deliver a vaccine for a global pandemic,” she said.

Haier Medical did not return messages seeking comment.

Messages sent to the email addresses used by the hackers were not returned.

IBM said the bogus Haier emails were sent to around 10 different organizations but only identified one target by name: the European Commission’s Directorate-General for Taxation and Customs Union, which handles tax and customs issues across the EU and has helped set rules on the import of vaccines.

Representatives for the directorate-general could not immediately be reached for comment.

IBM said other targets included companies involved in the manufacture of solar panels, which are used to power vaccine refrigerators in warm countries, and petrochemical products that could be used to derive dry ice.

Who is behind the vaccine supply chain espionage campaign isn’t clear.

Reuters has previously documented how hackers linked to Iran, Vietnam, North Korea, South Korea, China, and Russia have on separate occasions been accused by cybersecurity experts or government officials of trying to steal information about the virus and its potential treatments.

IBM’s Zaboeva said there was no shortage of potential suspects. Figuring out how to swiftly distribute an economy-saving vaccine “should be topping the lists of nation states across the world,” she said.

https://www.reuters.com/article/us-health-coronavirus-vaccines-cyber/ibm-warns-hackers-targeting-covid-vaccine-cold-chain-supply-process-idUSKBN28D191

'No guarantee Pfizer vaccine will be distributed direct to English care homes'

 There is no guarantee that Pfizer/BioNTech’s COVID-19 vaccine will be distributed in English care homes but the health service and regulator are working to make it possible, deputy Chief Medical Officer Jonathan Van-Tam said on Thursday.

Britain became the first country to approve the vaccine candidate developed by Germany’s BioNTech and Pfizer, jumping ahead of the rest of the world in the race to begin a crucial mass inoculation programme.

Prime Minister Boris Johnson warned of logistical challenges in distributing the vaccine, which has to be stored at -70C (-94F), across the National Health Service (NHS).

Following the emergency approval, roll-out will initially be focussed on hospitals rather than community settings.

Although it can be kept for five days in a regular fridge, Van-Tam said there was a limit to how often it can be taken out of a fridge and put back, with implications for its distribution to care homes.

“The NHS, the (medicine regulator) MHRA are working really hard, right now, to try and find a solution, so that we can get this into care homes if we possibly can... at this point, there is no absolute assurance of that,” he told ITV’s “This Morning” programme.

“One thing we can’t do is... end up with a vaccine that’s been handled incorrectly, and then isn’t properly viable at the end of the distribution chain.”

Britain has said that care home residents and their carers are the highest priority to get the vaccine, along with those over 80, although the doctor who chairs the vaccine committee that drew up the list has said operational practicalities will influence the roll-out.

NHS England Chief Executive Simon Stevens said on Wednesday that the phased programme of roll-out would see 50 hospital hubs begin to vaccinate those in the highest priority groups.

But he added that there needed to be regulatory approval to split up the 975 dose packs that the Pfizer/BioNTech vaccine arrives in before they could be delivered to care home directly.

“If the MHRA... as we expect they will, give approval for a safe way of splitting these packs of 975 doses, then, the good news is that we will be able to start distributing those to care homes,” he said.

Pfizer UK country manager Ben Osborn said the firm had experience in delivering around 1 billion sterile injectables a year to 165 countries and territories.

“I sincerely hope that this gives the people of the UK confidence that we’re ready now to deliver the vaccine to all four corners of our nation,” he told journalists on Wednesday.

Philipp Rosenbaum, Senior Infectious Diseases Analyst at data and analytics firm GlobalData, said that Britain was an “ideal test bed for the delivery of Pfizer’s vaccine.”

“The country’s small size, dense population and strong healthcare infrastructure should mean distribution of the vaccine with cold chain should go smoothly,” he said in a note.

“If problems do arise, this will not bode well for distribution in countries with longer distances to vaccine distribution centers (or) less developed infrastructure.”

https://www.reuters.com/article/us-health-coronavirus-britain-vaccine/no-guarantee-pfizer-vaccine-will-be-distributed-direct-to-english-care-homes-official-says-idUSKBN28D1CE

J&J files U.S. application for bispecific antibody for type of lung cancer

 

  • Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals has submitted a marketing application to the FDA seeking approval of amivantamab, a fully-human epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET) bispecific antibody, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemo, a Breakthrough Therapy-tagged indication.
  • Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
  • https://seekingalpha.com/news/3641279-j-and-j-files-u-s-application-for-bispecific-antibody-for-type-of-lung-cancer

Karyopharm/Antengene submits applications for Xpovio in Asia-Pac for blood cancer

 

  • Antengene has submitted new drug applications (NDA) for XPOVIO (selinexor, ATG-010) being co-developed by Karyopharm Therapeutics (NASDAQ:KPTI) to the regulatory authorities in Singapore and Australia for the treatment of adult patients with relapsed or refractory multiple myeloma ("rrMM") and refractory diffuse large B-cell lymphoma ("rrDLBCL"), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
  • The NDA of Antengene has already been accepted in Australia on December 2, 2020. NDA for XPOVIO (selinexor) has also been submitted in Hong Kong for the treatment of adult patients with rrMM.
  • Antengene is conducting two registrational Phase 2 clinical trials of XPOVIO in China for rrMM (MARCH) and for rrDLBCL (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).
  • https://seekingalpha.com/news/3641293-karyopharm-therapeutics-antengene-submits-applications-for-xpovio-in-asia-pacific-region-for

JD Health raises $3.5B in Hong Kong IPO amid U.S. crackdown on Chinese shares

 

  • JD Health, the healthcare unit of Chinese e-commerce giant JD.com (NASDAQ:JD), has raised $3.5B in a Hong Kong initial public offering, as the U.S. passed a law to kick Chinese companies off U.S. stock exchanges if they do not fully comply with U.S. auditing rules.
  • The company issued 381.9M shares priced at 70.58 Hong Kong dollars ($9.11) per share, sources told CNBC, valuing the listing at the top end of of the 62.8 Hong Kong dollars to 70.58 Hong Kong dollars marketed to investors.
  • JD Health is focused on online health-care services such as consultations with doctors as well as its online pharmacy. Shares are expected to start trading on Dec. 8.
  • JD.com itself carried out a secondary listing in Hong Kong in June and another Chinese internet firm, NetEase, pulled off a secondary listing in Hong Kong the same month.
  • https://seekingalpha.com/news/3641220-jd-health-raises-3_5b-in-hong-kong-ipo-amid-u-s-crackdown-on-chinese-shares