'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

Silverback Therapeutics upsizes IPO, seeks to raise up to $200M

 

• The Seattle-based biopharma Silverback Therapeutics (SBTX) has upsized its IPO of 10M shares of common stock, to be priced between $19-$20 per share.
• The company initially planned to offer 6.95M shares at a price range of $17-$19 per share.
• Underwriters' over-allotment is an additional 1.5M shares.
• Goldman Sachs, SVB Leerink and Stifel are the lead underwriters.
• Below is the current status of the company’s drug development pipeline:
• • Financials (9 months): Net loss: $20M vs. $17M in 2019; Cash used in operations: $20M vs. $13M in 2019; Cash and equivalents: $142M.
  • https://seekingalpha.com/news/3641302-silverback-therapeutics-upsizes-ipo-seeks-to-raise-up-to-200m

$38B pie: Pfizer, Moderna COVID-19 vaccines set for lion's share of 2021 sales

 With the first COVID-19 vaccinations expected to start in the coming weeks, 2021 is shaping up to be quite a year for the companies leading the vaccine race, with major blockbuster revenues on the line.

In fact, the top five players are set to divvy up about $38.5 billion in sales, Bernstein analysts figure, with the first-to-market companies reaping more than half of that. Pfizer, which just won U.K. approval Wednesday, is in line for $14.3 billion in COVID-19 vaccine sales next year, followed by $10.9 billion for Moderna, $6.4 billion for AstraZeneca, $3.9 billion for Novavax and $3 billion for Johnson & Johnson, according to the projections.

After a huge haul in 2021, the analysts predict the market will dwindle to around $6 billion in 2025, assuming vaccine recipients need a booster every three years. Along the way, the team of analysts project $23.1 billion in total COVID-19 vaccine sales in 2022, $12.6 billion in 2023 and $8.5 billion in 2024. But their model only accounts for those leading players right now.

Assuming “supply will flow to developed markets first with emerging markets given supply as demand ebbs in developed ones,” the analysts wrote, they expect the U.S. to reach herd immunity in June. Other developed markets such as the U.K., Canada, Japan and Europe should reach herd immunity in August or September, the Bernstein analysts wrote. 

The latest figures are an update to the team's model based on Pfizer and Moderna’s recent success plus "lower confidence” in adeno-associated virus vaccines. That's due to a comparatively lower efficacy number for AstraZeneca’s vaccine and the company’s CEO Pascal Soriot recently commenting that it’ll need to conduct an “additional study” to win a U.S. nod. 

The team is further factoring in expectations for December launches and the most recent company commentary around prices and dose availability. 

The financial projections come at a time of remarkable success for COVID-19 vaccine research. On Wednesday, partners Pfizer and BioNTech scored the world’s first approval for a fully researched vaccine as the U.K. endorsed their shot. The partners plan to make around 800,000 doses available in the U.K. next week, The Guardian reports. The U.K. has placed an order for 40 million doses total. 

Meanwhile, the partners are gearing up for a Dec. 10 meeting with independent FDA experts, and an FDA decision is expected to follow. The next closest player, Moderna, is set for a Dec. 17 meeting with the panel. The first vaccinations in the U.S. could start this month, officials have said.

While the Bernstein team expects U.S. herd immunity sometime next summer, Operation Warp Speed head Moncef Slaoui recently voiced even more ambitious expectations. Speaking with CNN last month, he said the U.S. could reach herd immunity by May based on the expected rate of vaccinations.

https://www.fiercepharma.com/pharma/as-first-covid-19-vaccinations-near-leading-developers-set-to-reap-tens-billions-analysts

Asymptomatic Covid-19 cases 'may not be infectious' - Wuhan study

 Shaun Griffin

doi: https://doi.org/10.1136/bmj.m4695

PDF: https://www.bmj.com/content/371/bmj.m4695.full.pdf

A mass screening programme of more than 10 million residents of Wuhan, China, performed after SARS-CoV-2 was brought under control, has identified 300 asymptomatic cases of covid-19, none of which was infectious.

The findings cannot be extrapolated to countries where outbreaks have not been brought under control successfully, said the authors of the report, which was published in Nature Communications.1

The researchers conducted a screening programme using PCR testing for viral RNA among the 10 million participants who were aged between 10 and 89. Trained staff interviewed participants on their history of covid-19. Asymptomatic positive cases were those who had a positive result on screening with neither a history of covid-19 diagnosis nor any clinical symptoms at the time of the nucleic acid testing. The researchers found no “viable virus” in cultures from asymptomatic samples.

The asymptomatic positive rate was lowest in participants aged under 17 and highest in those over 60. Further swab testing of 1174 close contacts of the 300 asymptomatic positive cases were all negative. The study population included 34 424 people with a history of covid-19, 107 of whom (0.310%) had been re-infected.

Findings not generally applicable

The researchers said that their findings did not show that the virus couldn’t be passed on by asymptomatic carriers, and they didn’t suggest that their findings were generalisable.

They said that strict measures—such as mask wearing, hand washing, social distancing, and lockdown—were successful in reducing the virulence of SARS-CoV-2 in Wuhan and that asymptomatic people in Wuhan may have low viral loads. This means that the finding cannot be applied to countries where outbreaks have not been successfully brought under control.

Fujian Song, from UEA’s Norwich Medical School, who collaborated with colleagues in Wuhan on the research, said: “The asymptomatic cases identified in the screening programme were truly asymptomatic, as none of them showed clinical symptoms before or during their follow-up isolation.” But, he added, “there is plenty of evidence elsewhere showing that people infected with covid-19 may be temporarily asymptomatic and infectious, before going on to develop symptoms.”

Using antibody testing, the researchers found that almost two thirds of the asymptomatic cases had previously had covid-19. “With the centralised isolation and treatment of all covid-19 cases during the lockdown period in Wuhan, the risk of residents being infected in the community has been greatly reduced. When susceptible residents are exposed to a low dose of virus, they may tend to be asymptomatic as a result of their own immunity,” wrote the authors.

Song said, “It is very important to say that these asymptomatic cases were identified shortly after the relaxation of a very stringent lockdown in Wuhan that lasted more than 70 days. By then, the epidemic in Wuhan had been effectively brought under control. It is too early to be complacent, because of the existence of asymptomatic positive cases and high level of susceptibility in residents in Wuhan.”

Noting that mask wearing remains common in public places, he added that this and other public health measures, such as safe social distancing, should be sustained in Wuhan to control transmission, noting that “vulnerable populations with weakened immunity or comorbidities, or both, should continue to be appropriately shielded.”

References

1. ↵
   1. Cao S, 
   2. Gan Y, 
   3. Wang C, 
   4. et al

   . Post-lockdown SARS-CoV-2 nucleic acid screening in nearly ten million residents of Wuhan, China. Nat Commun2020;11:5917. doi:10.1038/s41467-020-19802-w. pmid:33219229

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https://www.bmj.com/content/371/bmj.m4695