Biotech week ahead, Aug. 9

 Biopharma stocks ended higher for the week ending Aug. 6, as the sector latched on to the optimism that was evident in the broader markets. Earnings continued to flow in, triggering stock-specific moves, while clinical readouts also moved stocks during the week.

BeyondSpring Inc. BYSI 23.82% was among the biggest biopharma gainers of the week, with the stock reacting to a positive late-stage readout for its lung cancer treatment combo. The stock ended the week with a gain of about 128%.

Dicerna Pharmaceuticals, Inc. DRNA 28.14%, however, was not as fortunate, as the stock lost about one-fifth of its market cap following mixed results from a pivotal trial of its RNAi therapeutic candidate nedosiran in primary hyperoxaluria 1.

The market reacted negatively to earnings from vaccine companies Moderna, Inc. 

MRNA 0.61% and Novavax, Inc. NVAX 19.61%. Moderna's results, although outstanding, elicited negative reaction, while a lack of update about U.S. approval of Novavax' vaccine sent its shares tumbling on Friday.

On the approvals front, the Food and Drug Administration cleared Sanofi SNY 0.57%'s Nexviazyme (avalglucosidase alfa-ngpt), an enzyme replacement therapy drug for Pompe disease.

The IPO news flow tapered off, with ABVC BioPharma, Inc. ABVC 0.16%, Indaptus Therapeutics, Inc. INDP 6.31% and Adagio Therapeutics, Inc. Common Stock NASDAQADGI among the companies pricing their offerings and listing during the week.

Here are the key catalytic events for the unfolding week:

Conferences:

BTIG Virtual Biotechnology Conference: Aug. 9-10

2021 Wedbush Pacgrow Healthcare Virtual Conference: Aug. 10-11

PDUFA Dates

The FDA is scheduled to rule on Jazz Pharmaceuticals plc's JAZZ 1.04%'s supplemental new drug application for Xywav (JZP-258) as a treatment option for idiopathic hypersomnia in adults. The PDUFA goal by date is Thursday, Aug. 12.

Clinical Readouts

Pending Mid-2021 Releases

F-star Therapeutics, Inc. FSTX 1.93%: update on the progress of SB 11285 in the phase 1 clinical trial

Crinetics Pharmaceuticals, Inc. CRNX 1.95%: preliminary Phase 1 data for CRN04894 in Cushing's disease and congenital adrenal hyperplasia and CRN04777 in congenital hyperinsulinism

Praxis Precision Medicines, Inc. PRAX 0.2%: Preliminary topline data from the Phase 2a trial of PRAX-944 in essential tremor and safety, tolerability and PK data from the ongoing Phase 1 trial of PRAX-562

Kaleido Biosciences, Inc. KLDO 3.11%: Topline Phase 2 data from a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis

Earnings

Monday

• Dicerna Pharmaceuticals, Inc. DRNA 28.14% (before the market open)
• Intra-Cellular Therapies, Inc. ITCI 2.28% (before the market open)
• Eagle Pharmaceuticals, Inc. EGRX 1.51% (before the market open)
• Epizyme, Inc. EPZM 1.82% (before the market open)
• Syneos Health, Inc. SYNH 0.11% (before the market open)
• ShockWave Medical, Inc. SWAV 1.44% (before the market open)
• Viatris Inc. VTRS 2.3% (before the market open)
• Rubius Therapeutics, Inc. RUBY 2.13% (before the market open)
• Biohaven Pharmaceutical Holding Company Ltd. BHVN 1.5% (before the market open)
• bluebird bio, Inc. BLUE 3.25% (before the market open)
• BioNTech SE BNTX 3.93% (before the market open)
• Avadel Pharmaceuticals plc AVDL 4.22% (before the market open)
• Agenus Inc. AGEN 0.71% (before the market open)
• Amneal Pharmaceuticals, Inc. AMRX 3.18% (before the market open)
• Axsome Therapeutics, Inc. AXSM 0.99% (before the market open)
• Elanco Animal Health Incorporated ELAN 1.2% (before the market open)
• Amphastar Pharmaceuticals, Inc. AMPH 0.2% (after the close)
• Atara Biotherapeutics, Inc. ATRA 1.79% (after the close)
• Aethlon Medical, Inc. AEMD 1.7% (after the close)
• Adamas Pharmaceuticals, Inc. ADMS 1.5% (after the close)
• Athersys, Inc. ATHX 3.9% (after the close)
• Apellis Pharmaceuticals, Inc. APLS 1.92% (after the close)
• Adaptimmune Therapeutics plc ADAP 1.13% (after the close)
• Alpine Immune Sciences, Inc. ALPN 4.24% (after the close)
• Aziyo Biologics, Inc. AZYO 0.89% (after the close)
• Castle Biosciences, Inc. CSTL 2.84% (after the close)
• Gossamer Bio, Inc. GOSS 0.48% (after the close)
• Pulse Biosciences, Inc. PLSE 2% (after the close)
• Recro Pharma, Inc. REPH 2.16% (after the close)
• NexImmune, Inc. NEXI 1.39% (after the close)
• ZIOPHARM Oncology, Inc. ZIOP 1.73% (after the close)
• REGENXBIO Inc. RGNX 2.61% (after the close)
• Reata Pharmaceuticals, Inc. RETA 4.07% (after the close)
• ZIOPHARM Oncology, Inc. ZIOP 1.73% (after the close)
• Ocular Therapeutix, Inc. OCUL 2.86% (after the close)
• Fulgent Genetics, Inc. FLGT 4.61% (after the close)
• FibroGen, Inc. FGEN 0.79% (after the close)
• Organogenesis Holdings Inc. ORGO 2.39% (after the close)
• Halozyme Therapeutics, Inc. HALO 0.2% (after the close)
• Syndax Pharmaceuticals, Inc. SNDX 0.77% (after the close)
• Tricida, Inc. TCDA 1.01% (after the close)
• Rocket Pharmaceuticals, Inc. RCKT 2.93% (after the close)
• Inovio Pharmaceuticals, Inc. INO 1.41% (after the close)
• Penumbra, Inc. PEN 2.33% (after the close)
• Turning Point Therapeutics, Inc. TPTX 1.71% (after the close)
• Precigen, Inc. PGEN 0.36% (after the close)
• Lyra Therapeutics, Inc. LYRA 9.25% (after the close)
• Celcuity Inc. CELC 0.67% (after the close)
• Cara Therapeutics, Inc. CARA 2.24% (after the close)
• Catalyst Pharmaceuticals, Inc. CPRX 1.19% (after the close)
• ChemoCentryx, Inc. CCXI 2.8% (after the close)
• Exagen Inc. XGN 0.48% (after the close)

Tuesday

• Harmony Biosciences Holdings, Inc. HRMY 0.71% (before the market open)
• TransDigm Group Incorporated TDG 0.81% (before the market open)
• Marinus Pharmaceuticals, Inc. MRNS 2.79% (before the market open)
• Fulcrum Therapeutics, Inc. FULC 2.14% (before the market open)
• BioXcel Therapeutics, Inc. BTAI 0.53% (before the market open)
• Matinas BioPharma Holdings, Inc. MTNB 0.71% (before the market open)
• Aptinyx Inc. APTX 0.78% (before the market open)
• aTyr Pharma, Inc. LIFE 0.42% (after the close)
• Akoya Biosciences, Inc. AKYA 0.29% (after the close)
• Talis Biomedical Corporation TLIS 4.06% (after the close)
• Clearside Biomedical, Inc. CLSD 1.33% (after the close)
• Bioventus Inc. BVS 0.46% (after the close)
• ClearPoint Neuro, Inc. CLPT 1.41% (after the close)
• Inari Medical, Inc. NARI 0.94% (after the close)
• Cumberland Pharmaceuticals Inc. CPIX 5.28% (after the close)
• OncoCyte Corporation OCX 6.58% (after the close)
• Maravai LifeSciences Holdings, Inc. MRVI 0.77% (after the close)
• KemPharm, Inc. KMPH 0.92% (after the close)
• Regulus Therapeutics Inc. RGLS 0.91% (after the close)
• Relmada Therapeutics, Inc. RLMD 4.73% (after the close)
• Neovasc Inc. NVCN (after the close)

Wednesday

• Haemonetics Corporation HAE 1.55% (before the market open)
• OptiNose, Inc. OPTN 0.74% (before the market open)
• Royalty Pharma plc RPRX 0.7% (before the market open)
• IMV Inc. IMV 1.71% (before the market open)
• Altimmune, Inc. ALT 0.29% (before the market open)
• Gamida Cell Ltd. GMDA 0.36% (before the market open)
• ADMA Biologics, Inc. ADMA 0.64% (before the market open)
• TELA Bio, Inc. TELA 0.94% (after the close)
• Navidea Biopharmaceuticals, Inc. NAVB 2.41% (after the close)
• Evofem Biosciences, Inc. EVFM 0.25% (after the close)
• Repro Med Systems, Inc. KRMD 1.13% (after the close)
• Xenon Pharmaceuticals Inc. XENE 2.94% (after the close)
• VolitionRx Limited VNRX 1.25% (after the close)
• Cyclacel Pharmaceuticals, Inc. CYCC (after the close)
• MannKind Corporation MNKD 3.81% (after the close)
• DiaMedica Therapeutics Inc. DMAC 0.59% (after the close)
• Eyenovia, Inc. EYEN 0.71% (after the close)
• GeoVax Labs, Inc. GOVX 8.01% (after the close)
• Histogen Inc. HSTO 1.17% (after the close)
• Revolution Medicines, Inc. RVMD 0.92% (after the close)
• Panbela Therapeutics, Inc. PBLA 2.44% (after the close)

Thursday

• F-star Therapeutics (before the market open)
• Entasis Therapeutics Holdings Inc. ETTX 1.71% (before the market open)
• Virios Therapeutics, Inc. VIRI 1.5% (before the market open)
• Synlogic, Inc. SYBX 5.92% (before the market open)
• Ikena Oncology, Inc. IKNA 1.67% (before the market open)
• VYNE Therapeutics Inc. VYNE 0.38% (before the market open)
• Veru Inc. VERU 1.69% (before the market open)
• Celsion Corporation CLSN 1.87% (before the market open)
• Organon & Co. OGN 0.07% (before the market open)
• PDS Biotechnology Corporation PDSB 3.01% (before the market open)
• Selecta Biosciences, Inc. SELB 1.04% (before the market open)
• Precision BioSciences, Inc. DTIL 1.8% (before the market open)
• Apyx Medical Corporation APYX 2.95% (before the market open)
• Evaxion Biotech A/S EVAX 3.28% (before the market open)
• HOOKIPA Pharma Inc. HOOK 2.08% (before the market open)
• CymaBay Therapeutics, Inc. CBAY (after the close)
• Trevi Therapeutics, Inc. TRVI 2.51% (after the close)
• TFF Pharmaceuticals, Inc. TFFP 0.88% (after the close)
• Onconova Therapeutics, Inc. ONTX 0.2% (after the close)
• Achieve Life Sciences, Inc. ACHV 1.09% (after the close)
• AbCellera Biologics Inc. ABCL 4.1% (after the close)
• Acutus Medical, Inc. AFIB 0.32% (after the close)
• Applied DNA Sciences, Inc. APDN 3.66% (after the close)
• Atea Pharmaceuticals, Inc. AVIR 11.68% (after the close)
• Brickell Biotech, Inc. BBI 0.55% (after the close)
• Daré Bioscience, Inc. DARE 4.55% (after the close)
• BIOLASE, Inc. BIOL 4.09% (after the close)
• Co-Diagnostics, Inc. CODX 3.7% (after the close)
• ImmuCell Corporation ICCC 2.8% (after the close)
• CorMedix Inc. CRMD 0.5% (after the close)
• Capricor Therapeutics, Inc. CAPR 2.81% (after the close)
• Lineage Cell Therapeutics, Inc. LCTX 0.78% (after the close)
• OpGen, Inc. OPGN 2.02% (after the close)
• PAVmed Inc. PAVM 1.05% (after the close)
• NeuroPace, Inc. NPCE 3.24% (after the close)
• Spectrum Pharmaceuticals, Inc. SPPI 21.54% (after the close)
• Relay Therapeutics, Inc. RLAY 0.12% (after the close)
• Progenity, Inc. PROG 0.51%
• Viveve Medical, Inc. VIVE 0.4% (after the close)
• PolarityTE, Inc. PTE 3.54% (after the close)
• Dyadic International, Inc. DYAI 2.5% (after the close)
• Eledon Pharmaceuticals, Inc. ELDN 1.84% (after the close)
• Helius Medical Technologies, Inc. HSDT 0.32% (after the close)
• Lucira Health, Inc. LHDX 1.69% (after the close)
• ThermoGenesis Holdings, Inc. THMO 1.27% (after the close)
• Friday
• Medicenna Therapeutics Corp. MDNA 1.74% (before the market open)
• GT Biopharma, Inc. GTBP 1.68% (before the market open)
• Forma Therapeutics Holdings, Inc. FMTX 2.44% (before the market open)
• Bio-Path Holdings, Inc. BPTH 2.89% (before the market open)

IPOs

IPO Pricing

Stamford, Connecticut-based Healthcare Royalty, Inc. has filed a preliminary prospectus with the SEC to offer 46.875 million shares in an initial public offering. Royalty is a mid-market royalty acquisition company and focuses on growth assets and emerging companies driving innovation in the biopharmaceutical industry. The company proposes to price the IPO between $15 and $17 per share. It has applied to list its shares on the Nasdaq under the ticker symbol "HCRX."

WCG Clinical, Inc., a Princeton, New Jersey-based provider of clinical trial solutions, focused on providing solutions that are designed to improve the quality and efficiency of clinical research, stimulate growth and foster compliance, has filed to offer 45 million shares in an IPO. The shares, which are estimated to be priced between $15 and $17, are expected to list on the Nasdaq under the ticker symbol "WCGC."

IPO Quiet Period Expiry

• Sera Prognostics, Inc. SERA 0.31%
• Rapid Micro Biosystems, Inc. RPID 5.85%
• Sight Sciences, Inc. SGHT 1.71%
• Imago BioSciences, Inc. IMGO 0.41%
• TScan Therapeutics, Inc. TCRX 2.7%
• Erasca, Inc. ERAS 1.7%
• Regencell Bioscience Holdings Limited RGC 3.23%
• HCW Biologics Inc. HCWB 4.27%

https://www.benzinga.com/general/biotech/21/08/22388070/the-week-ahead-in-biotech-aug-8-14-jazz-pharma-fda-decision-earnings-deluge-and-ipos-in-the-spotl

NYC Ramps Up Youth Vaccination Ahead Of First Day Of Public School

 This Monday is the last day public school students eligible for the COVID-19 vaccine can start their inoculation series, and be fully vaccinated before they head back to class September 13th. While the shots are not required, officials are encouraging all eligible children 12 and up to get them. 

The de Blasio administration has promised a youth vaccination blitz in the weeks leading back to the start of school. Besides the city offering vaccinations at Summer Rising program sites and launching a $1.4 million ad campaign on subways and buses and in bodegas, the Education Department is promising phone calls to connect families with vaccines, and will set up home visits by request. 

There will also be pop-up vaccination sites at school supply stores and sports practice during pre-season. And Schools Chancellor Meisha Porter announced this week that school PTAs can get $100 for every person they help get vaccinated. 

At an appearance Saturday at the Harlem headquarters of Rev. Al Sharpton’s National Action Network, Porter appealed to families to vaccinate themselves and their kids over the age of 12.

“I know that this is a sensitive conversation for many of us but it’s important. It’s important not only for our school system, it’s important for our city. It’s important for our families, it’s important for us to get back to our new normal,” Porter said.

“We got to get our babies vaccinated. We have to get our families vaccinated. We have to keep each other safe, we have to do it for our communities to thrive in the way that they need to,” Porter said.

So far, officials said nearly 50% of kids 12-17 have gotten at least one dose. Both Mayor Bill de Blasio and Governor Andrew Cuomo have indicated that they won’t mandate vaccines for K-12 students.  

Like all city workers, public school staff must now get vaccinated or be tested weekly. As of late July, the Education Department said 60% of employees who have gotten at least one dose, although the number is likely higher because it does not include staff who got vaccinated outside the city. 

The city’s push comes against the backdrop of a broader federal effort to increase inoculations among young people. The Biden Administration recently announced a similar strategy to get students vaccinated across the country, dubbing this week a “Week of Action” with outreach and text messages to teens. 

The Pfizer-BioNTech vaccine, the only one authorized for children ages 12-17, includes two shots three weeks apart, and people are considered fully vaccinated two weeks after their second shot. 

Information on where to get shots can be found by going to vaccinefinder.nyc.gov.

https://gothamist.com/news/nyc-ramps-youth-vaccination-efforts-ahead-first-day-public-school

Pandemic set off deadly rise in speeding that hasn’t stopped

 Motorists put the pedal to the metal during the pandemic and police are worried as roads get busy with the final stretch of summer travel.

The latest data shows the number of highway deaths in 2020 was the greatest in more than a decade even though cars and trucks drove fewer miles during the pandemic.

“Summer is an incredibly dangerous time. And it culminates with Labor Day, that last hurrah,” said Pam Shadel Fischer of the Governors Highway Safety Association.

Traffic data indicates the higher death toll was related to higher average speeds in conjunction with more of those on the roads driving under the influence of drugs and alcohol and a slight decline in seatbelt use.

Motorists do not seem to be slowing down.

“People are flying down the roads,” Maine State Police Cpl. Doug Cropper said of summer traffic on Interstate 95. “It’s just ridiculous.”

Tickets issued by the California Highway Patrol for speeding in excess of 100 mph from January to June were nearly double pre-pandemic levels, and the number of tickets for reckless driving citations grew, as well, officials said.

In New York state, the percentage of fatalities for which speeding was the primary cause and the total number of speeding tickets grew from January through June, compared to the year before the pandemic, officials said.

“There is continued concern about the rise in speeding and aggressive driving as we enter the heart of the vacation travel season and increased traffic volumes on the highways,” said Beau Duffy, spokesperson for New York State Police.

The extreme speeding dates to the early days of the pandemic.

With police distracted by civil disobedience and scaling back routine stops for safety, the lightly traveled roads quickly turned into the wild west in many places. In New York City, super cars like Ferraris and Lamborghinis blazed down empty streets, with roaring engines disturbing residents trying to sleep. Motorists from coast to coast were ticketed at eye-watering speeds.

Several lead-footed motorists took advantage to set new records on an illegal, nonstop race from coast to coast called the Cannonball Run.

A Mainer used a rented Ford Mustang GT with 130 gallons worth of fuel tanks to set a solo record for racing from New York to Los Angeles in 25 hours, 55 minutes. A team set a new record soon after his record-setting jaunt.

Fred Ashmore said New York was a “ghost town” as he sped away, topping out at 159 mph and averaging about 108 mph over the 2,806-mile trip.

“There’s no person who’s never sped,” he said. “I just sped faster and longer.”

The National Highway Traffic Safety Administration sounded the warning early in the pandemic about speeding and reckless driving.

The agency expected fatalities to decline with fewer miles driven, similar to previous declines during economic downturns. But the fatalities grew throughout the pandemic, and even picked up steam in the latter part of the year.

In the end, traffic deaths nationwide in 2020 grew about 7.2% to 38,680 even though there was a 13.2% reduction in the number of miles traveled, according to the NHTSA estimates. It was the deadliest year on highways since 2007.

Joseph Schwieterman, a transportation expert at DePaul University, said there are a combination of factors at play. Some drivers are emboldened by the lack of enforcement, and others tend to join them in going with the flow.

At the same time, motorists feel safer speeding because they are putting too much faith in air bags, anti-lock brakes and other safety features, he said.

Unfortunately there’s no silver bullet to reversing the trend.

Police and highway safety officials must ensure speed limits take into account all users, and then they must vigorously enforce them with a visible presence, said Joseph Young, spokesperson for the Insurance Institute for Highway Safety.

Some police departments are launching public awareness campaigns.

“Summer holidays should be a time of fun and family, not sorrow and tragedy,” Washington State Police Chief John R. Batiste said as California, Oregon and Washington kicked off a summer travel safety enforcement effort.

In places like California’s Los Angeles County, heavy congestion can slow motorists down naturally.

But those flashing blue lights remain the best antidote for speeding and bad behavior, said Fischer, from the Governors Highway Safety Association.

“High visibility enforcement works,” she said. “When people see police officers, they will think twice about what they’re doing.”

https://apnews.com/article/lifestyle-health-travel-coronavirus-pandemic-30a26b82eeab5880abab5f2b30952725

Cleveland Clinic, UPMC among systems holding off on COVID-19 vaccine mandates

 Dozens of hospitals and health systems have decided to require COVID-19 vaccination for employees since March. However, some health systems have chosen not to mandate vaccines as of Aug. 6.

Pittsburgh-based UPMC told Becker's that it is not mandating vaccines for any of its employees at its hospitals. It said it recognizes that vaccination and targeted mask use are key strategies in quelling the COVID-19 pandemic. 

The $23 billion healthcare provider and insurer said it will continue its vaccine advocacy and outreach efforts, make vaccines easily and readily available for all, and maintain employee, patient and visitor masking requirements in all of its facilities regardless of vaccination status. 

"UPMC continues to evaluate how we can further strengthen our protocols, particularly in settings with highly vulnerable patient populations," said spokesperson Susan Manko.

Cleveland Clinic has not announced a vaccine requirement for its staff at its 24 hospitals either. Alicia Reale Cooney, a spokesperson for the health system, said it's focusing on encouraging "caregivers to receive the COVID-19 vaccine, providing education and making vaccination as accessible as possible."

"As the pandemic evolves, we will continue to monitor the situation," Ms. Cooney told Becker's.

Chicago-based Northwestern Medicine, which has 11 hospitals across Illinois, has decided it will not mandate vaccines for its employees. Chris King, the director of media relations and communications, told Becker's that the response to choosing not to mandate the vaccine for its staff has been overwhelmingly positive. To date, more than three-fourths of its staff are already vaccinated, Mr. King said.

"For our unvaccinated employees, we are trying to get a better understanding of why they have not received the vaccine," Mr. King said. "Is there a medical reason or religious exemption? If those are not the reason, then we want to create an environment where we can provide information and learning opportunities to educate any employee that may have questions or concerns on being vaccinated."

Cincinnati-based Mercy Health, which has six hospitals across the U.S., has also decided not to mandate vaccines, WBKN 27 reported Aug. 6. 

On Aug. 6, the health system said it's encouraging its employees to receive a COVID-19 vaccine and is closely following the local, state and federal guidelines regarding vaccine mandates. Yet, it is still deliberating whether it will require its staff to get inoculated.

The health system said each of its employees is critical for supporting the needs of its patients and that their health and safety remain among its top priorities.

https://www.beckershospitalreview.com/workforce/cleveland-clinic-upmc-among-systems-holding-off-on-covid-19-vaccine-mandates.html

Antibody findings spark ideas for pan-coronavirus vaccine

 Three epidemic or pandemic coronaviruses—SARS-CoV, MERS-CoV, & SARS-CoV-2—have spilled over from animals to cause deadly illness in humans in the past 20 years. Virus researchers are determined to discover a means to broadly safeguard people from the continuing threat of emerging coronaviruses.

Clues for creating such an overarching countermeasure might come from a rare type of human antibody that can neutralize several different coronaviruses. These antibodies have been detected in some people who have recovered from COVID-19.

A paper appearing Aug. 3 in the journal Science describes research on five such human monoclonal antibodies that can cross-react with a number of beta-coronaviruses. These antibodies target a structure, called stem helix, in the spike protein of these viruses. The spike protein is critical to the virus' ability to overtake host cells.

The lead authors on the study were Dora Pinto, Maximilian M. Sauer, Nadine Czudnochowski and Jun Siong Low and the senior scientists were David Veesler, associate professor of biochemistry at the University of Washington School of Medicine in Seattle, and Davide Corti of Humabs Biomed SA, Vir Biotechnology, in Switzerland.

The stem helix in the spike protein has remained conserved during the evolution of certain coronaviruses. That means it is much less prone to genetic changes and is similar in various coronaviruses. These include those originating in bats that have become dangerous pathogens in people, and another subgenus that causes a serious human lung disease transmitted by dromedary camels, as well as a few other subgenera that cause simple common cold symptoms.

The researchers explain in their paper that they were interested in exploring antibodies that target highly conserved regions of the spike protein machinery that enable coronaviruses to fuse with the membrane of host cells. (Other parts of the infective machinery conduct the initial engagement with the cells' receptors; those parts of the coronavirus spike have a tendency to rapidly mutate and form variants under selective pressure from the body's antibody response.) An antibody's ability to bind to the less mutable fusion machinery is what allows it to neutralize distantly related coronaviruses.

To find these sorts of antibodies, the researchers examined certain memory B cells from COVID-19 convalescent donors. Memory B cells are white blood cells that recognize and respond to pathogens that have tried to attack the body during a previous encounter.

Out of five promising antibodies that they isolated, the scientists decided to concentrate on one designated S2P6. Molecular structure analysis and functional studies showed that this human monoclonal antibody had impressive breadth: it was able to neutralize three different subgenera of beta-coronaviruses. The scientists observed that it did so by inhibiting the virus' ability to fuse with cell membranes.

The researchers went on to test if the S2P6 stem helix antibody could protect against SARS-CoV-2 by administering it to hamsters 24 hours before exposure. They found that this antibody reduced the viral load of SARS-CoV-2 by inhibiting entry of the virus and by enhancing additional anti-viral and virus-clearing cellular immune responses.

Studies of the plasma from pre-pandemic human samples, as well as from COVID-vaccinated and COVID-recovered individuals were also analyzed to see how frequently the stem-helix targeting antibodies appeared. They highest frequencies occurred in people who had recovered from COVID-19, then were later vaccinated. Overall, however, the data from this study shows that, while it does occur, it is relatively rare for SARS-CoV-2 to elicit plasma stem-helix antibody responses. The researchers hope that additional studies might reveal whether this is the case for antibodies that target other parts of the coronavirus fusion machinery or only for those that target the stem helix.

The researchers also looked at how the broadly reactive monoclonal antibodies studied in this project might have originated. Their findings suggest that they may have resulted from the priming of B memory cells through one of the common cold-inducing coronaviruses. Then the virus-specific B cells gained cross-reactivity through somatic mutations occurring during the body's immune response to a natural infection with another type of coronavirus.

The results from this study indicate that eliciting a sufficient quantity of stem helix antibodies through a standard vaccination development approach likely would be difficult. However, the researchers propose that recent computational protein-design advances for potential vaccine candidates against respiratory syncytial viruses and multiple influenza viruses might be adapted to try to induce broad beta coronavirus immunity and overcome the pan-coronavirus vaccine challenge.

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Explore further

New 'atlas' charts how antibodies attack spike protein variants

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More information: Dora Pinto et al, Broad betacoronavirus neutralization by a stem helix–specific human antibody, Science (2021). DOI: 10.1126/science.abj3321

https://medicalxpress.com/news/2021-08-antibody-ideas-pan-coronavirus-vaccine.html

Booster shot debate intensifies on global stage

 The debate over booster shots of the COVID-19 vaccine is heating up as some public health experts warn countries against moving forward with plans to offer third doses.

France, Germany and Israel are taking steps to deliver additional shots of the vaccine to vulnerable groups such as the elderly and people with compromised immune systems. Moderna said Thursday that it thinks booster shots will likely be needed before the winter, following a similar statement from Pfizer last month.

But some experts say the broad push for boosters is premature and that while certain small groups such as the immunocompromised need a third jab, there is no evidence that widespread booster shots are needed at this time.

The Biden administration is caught in the middle and faces a balancing act. It does not want hesitant people to think talk of booster shots is an indication that the existing vaccine regimen is insufficient. Administration officials also say they are committed to helping vaccinate the world while being careful not to shortchange the needs of Americans.

The World Health Organization (WHO), meanwhile, is calling on wealthy countries to hold off on giving third doses to allow more people around the world to get their first shots.

Asked about the WHO’s message, White House press secretary Jen Psaki said it was a “false choice” and that the U.S. can provide boosters domestically while also donating doses abroad.

“We believe we can do both, and we don’t need to make that choice,” she said.

Craig Spencer, director of global health in emergency medicine at Columbia University Medical Center, pushed back on Psaki’s comments, saying vaccines are in fact a “zero-sum game at the moment” given that there simply are not enough doses for everyone in the world.

“It’s not a false choice; it’s a deliberate choice by wealthy nations,” he said, adding that most Americans should not be getting third doses before health care workers around the world receive their first.

But Spencer also said it would be reasonable for much smaller groups of particularly vulnerable Americans to get boosters, such as the immunocompromised or people in nursing homes.

There are signs that booster shots could begin soon in the U.S., at least for some groups.

Last month, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) quickly pushed back in a rare joint statement after Pfizer suggested booster shots, saying they were not currently needed.

But since then, health officials have left the door open a little wider.

Anthony Fauci, the government’s top infectious diseases expert, said Thursday that booster shots for immunocompromised people are a “very high priority” and that the administration was working to move forward “as quickly as possible.”

While action for immunocompromised people could come sooner, Peter Marks, a top FDA vaccine official, said this week that the agency could release more general information on booster recommendations in September.

“I suspect again by sometime in September we'll be able to make some more coherent statement about what the recommendation will be,” Marks said at an event hosted by the COVID-19 Vaccine Education and Equity Project.

He emphasized that the possibility of boosters is not evidence the vaccines don’t work properly.

“I don't think that we want to think that these vaccines have somehow failed us,” Marks said. “It may simply be that to get the kind of really good immunity against COVID-19 that we get with some other vaccines, it may take a series of three vaccinations.”

Paul Offit, a leading vaccine expert at the Children’s Hospital of Philadelphia, said he does not think there is evidence yet that boosters are needed, except for immunocompromised people.

“For now, I don’t think we're there,” he said, noting that the number to watch is the percentage of vaccinated people who are hospitalized.

For now, that number remains very small.

“The problem in this country is not boosting those who are already vaccinated,” he said. It’s getting unvaccinated people to take the shots.

Some experts also point out that vaccine makers such as Pfizer and Moderna have a financial incentive to sell more doses to wealthy countries and to say that boosters are needed.

Spencer said most Americans do not need boosters, “regardless of what the pharmaceutical company tries to tell you.”

He said the vaccines have gone through a “credibility crisis” recently, with new announcements from the CDC on masks and scary-sounding headlines. But the reality is that the vaccines are still working very well, he said.

A study released last month showing the efficacy of the Pfizer vaccine dropped to 84 percent after six months raised some eyebrows. But Spencer said other studies have put the efficacy higher; British data put efficacy at 88 percent, even against the delta variant.

Effectiveness is higher still against severe disease and hospitalization, which experts emphasize as the most important factor when it comes to COVID-19 vaccines.

Fauci said this week, however, that the recommendation for a broader swath of the population could change quickly as more data comes in.

“That could change, and that’s the reason why we’re following it really carefully on a week-by-week basis,” he said.

Asked at the event, hosted by the Center for Strategic and International Studies, if the change could come on a “fast trigger,” Fauci responded, “Absolutely.”

https://thehill.com/policy/healthcare/public-global-health/566816-booster-shot-debate-intensifies-on-global-stage

Vaccines less protective in Colorado county with Delta variant surge - CDC study

 COVID-19 infections in a Colorado county with a Delta variant surge this spring were more common among fully vaccinated people than in the state's other counties where it was circulating at lower levels, a U.S. Centers for Disease Control and Prevention study released on Friday showed.

The study also found that the Delta variant caused more severe illness. Cases, hospital intensive care unit admissions and deaths were higher in Mesa County, Colorado, than anywhere else in the state, it said.

The CDC recently said in a leaked report it believed the Delta variant was producing more severe illness among the unvaccinated than other versions of coronavirus, citing studies outside the United States.

In Mesa County, the proportion of Delta variant cases more than doubled from 43% for the week ending May 1 to 88% for the week ending June 5. The study looked at data from April 27 to June 6 in the county, which accounted for half of Delta variant cases in the state.

An estimated "crude efficacy" of COVID-19 vaccines against preventing symptomatic infection among the fully vaccinated people in Mesa County was 78%, versus 89% for other Colorado counties where the variant was less dominant.

The lower estimates may "lend support to previous findings that COVID-19 vaccines provide modestly lower protection against symptomatic infection with the Delta variant," the study found.

In another study also published on Friday, CDC data showed that a person infected with COVID-19 who was fully vaccinated is less likely to be reinfected than someone who has had the virus but is unvaccinated.

The analysis of 246 patients in Kentucky showed that state residents with previous COVID-19 infections who were unvaccinated had 2.34 times the odds of reinfection compared to those who were vaccinated and had been infected previously.

"If you have had COVID-19 before, please still get vaccinated," CDC Director Dr. Rochelle Walensky in a statement. 

https://finance.yahoo.com/news/vaccines-less-protective-colorado-county-184158429.html