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Tuesday, November 30, 2021

India's Serum Institute delivers first Novavax shot through COVAX

 Serum Institute of India has sent doses of COVID-19 vaccine to Indonesia, in its first export of the Novavax shot through the COVAX network, the Indian government said on Wednesday.

The world's biggest vaccine maker exported 137,500 doses of Covovax, as it calls the shot, to the Southeast Asian country last week.

Indonesia has approved the vaccine but India and the World Health Organization, which co-leads the COVAX vaccine-sharing network, have not.

Sanofi to buy Origimm Biotechnology to boost vaccines business

 French healthcare company Sanofi has agreed to buy Austrian group Origimm Biotechnology in a move that Sanofi said would boost its vaccines business.

"The acquisition of Origimm further broadens our vaccines research and development pipeline with a first vaccine candidate against acne, a high medical need for millions of teenagers and adults," said Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, on Wednesday.

Why Wainwright Beefed Up Vir Biotech's Target Price


  • H.C. Wainwright has raised the Vir Biotechnology Inc  price target to $200 from $135, suggesting an upside of 330%. Analyst Patrick Trucchio reiterates a Buy rating on the stock. 
  • The analyst expects a "robust" COVID-19 antiviral market, with Vir as a leader. 
  • Recent updates suggest that Vir and its collaboration partner GlaxoSmithKline Plc  are likely to maintain a top-tier COVID-19 antiviral franchise, led at first by sotrovimab, "for the foreseeable future," Trucchio tells investors.  
  • He believes that as investors better appreciate the potential for a robust prophylaxis mAb market, potentially more significant post-infection antiviral market as more SARS-CoV-2 variants emerge, and the differentiated approach by Vir and GSK, Vir shares "should increase substantially."

Wainwright Sees 'Buying Opportunity' For This COVID-19 Antibody Stock After Sell-Off

 H.C. Wainwright recommends using the selloff today for Regeneron Pharmaceuticals Inc 

 as a buying opportunity. The analyst keeps a Buy rating on Regeneron with an $844 price target.

  • While the company stated the possibility exists that its COVID-19 antibody, REGEN-COV, may lose its potency against the omicron strain, there is limited knowledge about the latest in a series of variants that naturally arise in the environment, analyst Michael King says.
  • Regeneron has already been studying other antibodies, and there are small molecule and other antibody preparations available, says the analyst. 
  • According to Michael, it is too early to determine what negative effect, if any, there will be on sales of the drug. 
  • Earlier today, Regeneron's COVID-19 antibody drug could be less effective against Omicron, it said.
  • Based on its study of Omicron's individual mutations, "there may be reduced neutralization activity of both vaccine-induced, and monoclonal antibody conveyed immunity," Regeneron said.

Healthcare Companies Raising Capital From Retail Investor Crowdfunding

 These startups are providing some exciting innovations in the healthcare industry while trying to become one of the next big names in this multi-trillion dollar industry with a little help from retail investors. 

These three healthcare companies have active startup crowdfunding campaigns that are open to non-accredited investors. 


DeoBioSciences' goal is to reverse-engineer a treatment for advanced metastatic cancer in humans and pets using anecdotal data and human efficiency and safety reports obtained from bioprospecting sources.

The Company: DeoBioSciences (DBS) is a virtual biotech startup in stealth mode that aims to develop a cancer treatment created on a naturally occurring molecule that selectively kills early and advanced-stage cancer cells in humans, dogs and cats.

DeoBioSciences has created an experimental cancer medication (DBX-31) that is a potent natural anticancer molecule. The company also says it verifies research studies using molecular homologues in humans and animals that confirm the drug's safety and efficacy projections.

Furthermore, pre-clinical lab results have validated and met all of DeoBioSciences' predictions for safety and performance.

Investment Highlights: The primary objectives of this offering are to develop a synthetic form of DBX-31 for clinical usage and to test the next set of projections.

If the next trial also goes well, the company reports that its drug has a 90 percent accurate chance of eliminating 4 of the most deadly cancer forms, regardless of stage. It should also be safer, more powerful and more affordable than other cancer treatments now on the market.

  • Minimum Investment: $100
  • Valuation Cap: $15,600.000
  • Type of Security Offered: Common stock
  • Price per Share: $50
  • Platform: Netcapital


NowRx is transforming healthcare to make it more accessible, convenient and inexpensive to everyone. The company provides patients with an end-to-end resolution for acquiring the prescriptions they need, when they need them, with same-day pharmacy delivery and telemedicine services.

The Company: NowRx is a local pharmacy that provides free same-day delivery. The firm aspires to restore healthcare to the way it should be: accessible, convenient and affordable.

NowRx provides many significant benefits to clients by leveraging a plethora of technologies, including tailored robotic dispensing, industry-leading consumer and driver apps, a proprietary pharmacy administration and logistics system.

Besides same-day delivery, the company plans to offer customers online prescribing for various conditions, automatic discount search and application, as well as insurance approval and payment assistance.

Investment Highlights: All pharmaceutical services are delivered by DEA-licensed micro fulfillment centers that use proprietary pharmacy technology and superior end-to-end robotic dispensing. These services eliminate overhead and lower dispensing costs in comparison to industry averages.

All telehealth services are delivered entirely digitally via the NowRx Telehealth app. Physicians can also use existing processes to deliver new prescriptions to NowRx.

  • Minimum Investment: $998
  • Valuation Cap: $275 million
  • Type of Security Offered: Preferred equity
  • Price per Share: $10.50
  • Platform: SeedInvest

Monogram Orthopedics

Monogram is developing an innovative surgical robot to reduce the risks of implant misplacement, fracture and subsidence, giving surgeons confidence that they can install implants that correctly suit every patient.

The Company: Monogram Orthopaedics is a medical technology business paving the way for joint reconstruction in the future. The startup is working on a product solution design that will combine 3D printing and robotics using automated digital image analysis algorithms to enable mass customization of orthopedic implants.

Monogram aims to make orthopedic care more personal by incorporating the newest discoveries of robotic, AI and 3-D printing technologies. The company's ultimate goal is to be at the forefront of the future of joint rehabilitation.

Investment Highlights: Monogram creates implants for active people who wish to improve their quality of life. The startup's integrated solution can reduce operating room costs and boost productivity by minimizing instrumentation and enhancing the cut path execution.

With the help of a robot, the startup’s been perfecting the next-generation 3D joint replacement solution. Although the underlying technologies are considered to be intricate and complex, the workflow is simple and cost-effective.

  • Minimum Investment: $250.80
  • Valuation Cap: $89.9 million
  • Offering Type: Equity
  • Type of Security Offered: Common stock
  • Price per Share: $7.50
  • Platform: StartEngine

De Blasio opening first legal shooting galleries for drug users in the US

 With just four weeks left in office, Mayor Bill de Blasio launched the country’s first legal shooting galleries Tuesday morning, calling them safe havens for addicts — shortly before five people overdosed at just one of the clinics on opening day.

“Overdose Prevention Centers are a safe and effective way to address the opioid crisis. I’m proud to show cities in this country that after decades of failure, a smarter approach is possible,” de Blasio said in a statement.

The nonprofit-run centers, New York Harm Reduction Educators on E. 126th Street in Harlem and Washington Heights’ CORNER Project on W. 180th Street, opened Tuesday.

There were five overdoses at the East Harlem site that saw 85 users inject drugs laced with fentanyl including heroin on Tuesday. 

“We have had some overdoses today,” Kailin See, senior director of programs at New York Harm Reduction Educators, told The Post. 

A kit of supplies containing syringes, adhesive bandages and antiseptic pads waits to be used by a drug addict inside a safe injection site known as Insite on Vancouver, British Columbia's eastside
A kit of supplies is seen inside a safe injection site in Vancouver, British Columbia, which has been at the forefront of the centers in North America.

“They survived,” she said.  

The Washington Heights CORNER Project barred press from visiting the site or speaking to staff. A rep for the nonprofit did not respond to questions, but the owner of a nearby business said he saw someone taken away in an ambulance. 

“I think what they’re doing is they’re promoting this which is awful,” said the business owner, who declined to be named citing concerns that his shop would be vandalized.

In this June 26, 2017 photo, booths line the Cactus "safe injection site," where drug addicts can shoot up using clean needles, get medical supervision and freedom from arrest, in Montreal. More than a dozen other potential sites are being considered across Canada federal officials say.
Booths inside a “safe injection site” in Montreal.
APThe two Manhattan locations were chosen based on “health need and depth of program experience,” according to the Health Department. The sites will provide clean needles and social services, but users must bring their own drugs.

Last year, over 2,000 New Yorkers died of drug overdoses, the highest since the city started tracking the figures in 2000. The most common drug involved in the fatalities is opioids. Between January and March this year, another 596 people lost their lives due to addiction. A city Health Department study found that the sites could save up to 130 people a year.

The mayor tried to push the controversial proposal to open a total of four sites before, but was blocked by Gov. Andrew Cuomo and President Donald Trump, who both opposed the plan.

People hang out in a plaza on East 149th street and Bergen Avenue in the South Bronx
Between January and March this year, another 596 people lost their lives due to addiction.
Stephen Yang

City Council Minority Leader Joe Borelli (R-Staten Island) was skeptical about the program’s effectiveness.

“British Columbia has led North America in safe injection sites, all while crossing overdose death milestones every month. How anyone can see this as a solution to a serious problem is beyond me, never mind the concerns of the neighbors,” Borelli told The Post Tuesday.

Rep. Nicole Malliotakis (R-NY), whose district includes Staten Island and parts of southern Brooklyn, called on the Department of Justice to block the sites, noting that under former President Trump the DOJ said such sites would violate the federal Controlled Substances Act.

Malliotakis wrote US Attorney General Merrick Garland Tuesday urging him to “take swift action to enforce federal law.”

drug use NYC
A city Health Department study found that the supervised injection sites could save up to 130 people a year.
Stephen Yang

The congresswoman cited a Jan. 2021 Third Circuit Court of Appeals ruling that determined it was a federal crime for a supervised injection site run by a Philadelphia nonprofit to allow consumption of illegal drug use at its location.

“Instead of focusing on the root cause of the drug epidemic, Mayor de Blasio is enabling drug cartels that continue to break our laws, smuggle illegal drugs over our border, and prey on our children,” Malliotakis said.

“Crime and fentanyl use are at record highs because of open borders, botched bail reform, and anti-police policies that keep releasing criminal drug dealers back onto our streets. Opening taxpayer-funded heroin shooting galleries is not a proper solution. These centers not only encourage drug use but they will further deteriorate our quality of life,” she said.

De Blasio has largely turned a blind eye to daytime drug sprees in major city hubs like the Garment District and the Triangle Plaza Hub in the Bronx.

Omicron was in Netherlands days before South Africa flights

 The Omicron variant was already in the Netherlands when South Africa alerted the World Health Organization about it last week, Dutch health authorities said Tuesday, adding to fear and confusion over the new version of the coronavirus in a weary world hoping it had left the worst of the pandemic behind.

The Netherlands' RIVM health institute found omicron in samples dating from November 19 and 23. The WHO said South Africa first reported the variant to the UN healthy agency on November 24. It remains unclear where or when the variant first emerged — but that hasn't stopped wary nations from rushing to impose travel restrictions, especially on visitors coming from southern Africa. Those moves have been criticized by South Africa and the WHO has urged against them, noting their limited effect.

Much is still not known about the variant — though the WHO warned that the global risk from the variant is “very high” and early evidence suggests it could be more contagious.

The Dutch announcement Tuesday further muddies the timeline on when the new variant actually emerged. Previously, the Dutch had said they found the variant among passengers who came from South Africa on Friday — but these new cases predate that.

Israel prelim data: Vaccine protects highly effectively against omicron

  The information received in Israel about the Omicron - the good andbad news: After Bennett's declaration of "state of emergency", in Israel tonight received preliminary data - both from South Africa and Europe - on the new variant that is causing concern around the world. The data revealed tonight (Tuesday) in the "main edition", shortly after being received in Israel, are preliminary - but indicate that the vaccine is still effective against the newly discovered mutations .

The data were collected in both South Africa and European countries where verifications were found in the new variant. It should be emphasized that these are preliminary data that the whole world is waiting for, and at this point they become the working assumption. According to these data, the effectiveness of the vaccine (for those who received three doses, ie also the booster), decreases only slightly: 90% protection, compared to 95% protection against the Delta strain. These are impressive and somewhat reassuring figures. The effectiveness of the vaccine in preventing serious illness, for those who have been vaccinated three times, is the same as the effectiveness against the Delta strain - the strain that has been the most dominant in Israel so far. 

But not everything is rosy: the problems start with the risk of recovering from being infected. The data show that the risk of recovering from infection is twice as high as in Delta, and the rate of infection is 1.3 times higher than in Delta. This rate of infection is very high: in South Africa there is talk that in 15 days the number of patients has increased 15 times. Although the numbers are low, the rate is problematic and worrying: in Israel there are many Israelis who are not vaccinated. 

Another worrying statistic has been revealed regarding the unvaccinated: their risk of becoming seriously ill is 2.4 times that of the original strain of the corona, the one that arrived in Israel nearly two years ago. In "unvaccinated" the reference is also to those vaccinated in two doses who are entitled to a booster and have not yet been vaccinated and therefore their protection is insufficient. Despite this news, the data is a reassuring siren when it comes to protecting vaccinated people from both serious illness and infection.

The test of the effectiveness of existing vaccines against the new variant was in its infancy, but Modern CEO Stefan Bensel managed to arouse global concern today when he said in an interview with the Financial Times that he expects a significant decline in vaccine efficacy.

But Bensel spoke of a decline in benefit from a disease with symptoms rather than a serious illness - a difference that is known to be dramatic in corona contexts as Pfizer CEO Albert Burla was apt to describe: Defense compared to Delta but that would be the limit. In both cases, the booster vaccines are expected to reduce the gap dramatically. "

Burla, who promised to know more about the benefits of the vaccine against the variant in about a week and a half, said Pfizer had already started developing a specific vaccine against the variant a few days ago. "We know the genetic linkage of the virus, we have it - that's how it starts," he explained. "We started, at risk, to produce a vaccine. We actually started on Friday to produce a vaccine based on the flooring, the DNA template, that would allow us to make RNA that would eventually women within that vaccine."

Israel, meanwhile, is waiting for a more categorical statement from the two CEOs, and meanwhile relies on data coming from South Africa - where the variant was first discovered - and from which it appears that the omicron is more contagious but is no more violent.

"Data on the benefits of the vaccine - there may be some partial data from South Africa," Dr. Sharon Elrai-Price, head of public health services, said today during a debate in the Knesset. "I hope we will have the answer to that in today's conversation. I know they are doing the lab tests as I described to see how useful the vaccine against this variant is. "

At the same time, the government is today approving a memorandum of law that will allow it to extend the decision to allow the GSS to verify the cellular devices of those infected with Omicron or the suspects who were infected with it with high probability - in order to interrupt the transmission chains as quickly as possible.

But just before the move reaches the Knesset, the coalition itself is sharply critical of the law. Prime Minister Bennett - who saw for himself how in the ministers' WhatsApp groups Ministers Saar, Shasha-Bitton, Barbibai and Avidar voted against - told today why Israel decided to include the GSS in the campaign despite, and perhaps because it is a low number of infected.

"There is a lot of uncertainty and that is why we are taking these extreme measures," he said in a video call with Austrian Chancellor Alexander Schlenberg. "But our advantage, as leaders, is that once we know more, when there is more information - we can let go of those measures, gradually." As for the restrictions at Ben Gurion Airport, the prime minister has already decided that these will last about two weeks from the date of their decision - and only if the final proof does come that the variant does not endanger the population's immunity or the omicron is already spread in the community - these restrictions will be removed.

What Doctors Need to Know About Omicron

 Public health and infectious disease experts warn that there's still much to be learned about the new SARS-CoV-2 variant, Omicron (or B.1.1.529), but here's what we do know so far, broken down by key questions.

The new variant was first detected in Botswana on November 11, and then identified in South Africa 3 days later. It was also detected on November 13 in Hong Kong in a national returning from South Africa.

The World Health Organization (WHO) labeled it a "variant of concern" last Friday.

A total of 168 samples of the variant from 11 countries have been uploaded to GISAID as of 3 p.m. ET on Monday.

Is Omicron More Transmissible?

It's not yet clear whether Omicron is more transmissible than previous versions of SARS-CoV-2, but South African health officials have noted that the rapid increase in cases in Gauteng province is concerning.

During a press briefing last week, Tulio de Oliveira, PhD, director of the Centre for Epidemic Response & Innovation in South Africa, said that test positivity rates in the Tshwane region (which is in Gauteng province) jumped from 1% to over 30% in the last 3 weeks alone, and almost all recent samples from the province have been the Omicron variant.

Experts cautioned that the spike could be due to the "founder effect," wherein a single case in an area of low prevalence is responsible for thousands of cases there. It's not yet clear whether that's what happened in South Africa, and a better answer is expected in the next few weeks.

Does Omicron Cause More Severe Disease?

There's no evidence yet that Omicron causes more severe disease, but again, researchers will have a clearer picture in a few weeks.

There was some excitement late last week when a South African physician who'd first raised the alarm over the new strain said most cases she'd treated were "extremely mild." Angelique Coetzee, MD, chair of the South African Medical Association, told the BBC that the symptoms were "unusual" and differed from the Delta variant, focusing on fatigue and body aches.

Yet this small sample may only include younger patients who may be less likely to suffer severe disease from infection, experts warned. More data need to be gathered before drawing any conclusions about severity.

Can Omicron Evade Immunity?

The WHO said it has preliminary evidence of increased re-infection risk with Omicron, but the agency has not shared the supporting data, noted Jeremy Faust, MD, of Brigham and Women's Hospital in Boston, in his newsletter, Inside Medicine.

When it comes to vaccinated immunity, Faust said that it's "possible, and perhaps even likely, that Omicron partially lowers our vaccines' effectiveness against infection."

That's because it has 32 mutations in the spike protein alone, some of which were associated with immune escape for previous variants.

Still, Faust added that it's possible that vaccines will hold up against severe disease in the face of this new variant.

What Mutations Are Concerning?

Omicron has multiple mutations in the receptor-binding domain (RBD) and the N-terminal domain (NTD) that are associated with resistance to neutralizing antibodies and monoclonal antibody treatments, de Oliveira said during the South African press briefing.

Richard Lessells, MD, an infectious diseases physician at the University of KwaZulu-Natal in Durban, South Africa, highlighted a few of the most concerning mutations for a South African health journalism center. This includes a cluster of mutations adjacent to the S1/S2 furin cleavage site, which are associated with more efficient cell entry (H655Y, N679K, and P681H).

It also has the nsp6 deletion (similar to one seen with Alpha, Beta, Gamma, and Lambda) that has been associated with immune evasion. Additionally, there are the R203K and G204R mutations in the nucleocapsid protein (seen in Alpha, Gamma, and Lambda) that have been associated with increased infectivity.

Jeffrey Barrett, head of the COVID-19 genomics initiative at the Wellcome Sanger Institute in England, created a color-coded key of the 32 spike protein mutations. Nine of them are red, the most concerning level.

Faust noted that the high number of mutations suggests the variant emerged in a single patient whose body couldn't clear the infection.

Edward Nirenberg, a COVID-19 blogger, cautioned on Twitter that it's "hard to know what the effect of all of these mutations together [will be]. Different mutations interact with each other in complex ways."

Where Has the Variant Been Detected?

So far, 11 countries have reported detecting Omicron to GISAID: South Africa (114), Botswana (19), The Netherlands (12), Australia (5), Hong Kong (5), Italy (4), the U.K. (4), Canada (2), Germany (1), Belgium (1), and Israel (1).

The variant has not yet been detected in the U.S., though experts say it is only a matter of time, as it is likely already here.

Punishing South Africa?

Some South African researchers have raised concerns that they should not be punished for alerting the world to the existence of the variant.

"The world should provide support to South Africa and Africa and not discriminate or isolate it! By protecting and supporting it, we will protect the world!" de Oliveira wrote on Twitter.

Ingrid Katz, MD, of Harvard University, tweeted, "We know what we know BECAUSE South Africa has invested in advanced genomic sequencing. We owe them a debt of gratitude -- not punishment."

The Biden administration issued a travel ban for South Africa and several other African nations late last week. South African president Cyril Ramaphosa has called for the U.S. and other nations, including the U.K. and European Union, to lift their travel bans against his country.

Global authorities have also noted that the emergence of the variant speaks strongly of the urgency to help get vaccine doses to nations in need.

During a WHO meeting on Monday, Richard Hatchett, MD, head of the Coalition for Epidemic Preparedness Innovations (a founder of the global vaccine-sharing initiative COVAX), said the emergence of Omicron "has fulfilled, in a precise way, the predictions of the scientists who warned that the elevated transmission of the virus in areas with limited access to vaccine would speed its evolution."

What's the Bottom Line Right Now?

Bob Wachter, MD, of the University of California San Francisco, summed it up aptly in four steps on Twitter: get vaccinated, get boosted, "get prepared mentally to act more cautiously if Omicron proves to be more infectious, immune-evasive, or both," and "follow the news & science -- will be much clearer in 2-3 weeks."

Indeed, the CDC updated its booster guidance on Monday, now advising that all adults ages 18 and up should get a booster 6 months after their initial mRNA series or 2 months after their Johnson & Johnson shot.

"The recent emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of vaccination, boosters, and prevention efforts needed to protect against COVID-19," the agency said in a statement.