Novavax Covid-19 vaccine supplies to Australia delayed

 Australians could be forced to wait even longer for a shot in the arm as major delays push back the expected delivery of 51 million Novavax Covid-19 vaccine doses until next year.

Novavax, a biotech company based in the United States, had secured a deal with the federal government to provide 51 million doses of its two-dose protein-based vaccine by early 2021.

However, major delays have forced Novavax to push back the delivery until 2022, quashing plans for the vaccine to be used as part of Australia’s primary rollout, The Guardian reported.

In a Covid committee hearing on Friday, Health Department secretary Brendan Murphy conceded without a clear production timeline, Novavax would no longer be considered a primary vaccine.

“Because we don‘t have full registration yet and we don’t have a clear production timeline, our current plan is not dependent on having Novavax for our primary vaccination course this year,” he said.

“But they are still committing that they will give us some doses in the fourth quarter. If they come, that will be valuable and could help accelerate.

“But our plan is not dependent on having Novavax this year.”

The ordered doses will now serve as part of the government’s booster program.

In January, Health Minister Greg Hunt said the Novavax vaccine would act as a backup in case Australia’s first choice, AstraZeneca, faced problems.

“Novavax … (is) there either as a primary vaccine option, pending any issues that may arise with regards to either the efficacy or the production of our current vaccines, or, as is more likely the case, it’s there as the potential for subsequent vaccination,” he said.

But on Monday his language shifted, refocusing the vaccine as playing a role in Australia’s booster program.

“We’ve always thought of Novavax as the backup if there were an issue with the first three vaccines for this year, and as a foundation stone and platform for the booster program next year,” he said.

A Health Department spokesperson told NCA NewsWire the Therapeutic Goods Administration was assessing preliminary data for the Novavax vaccine, but the company had yet to provide a complete data package for approval.

Novavax has yet to apply to the TGA for approval, and has not yet been approved for use in any other country.

On Friday, TGA deputy secretary John Skerritt said it was “at the mercy” of Novavax but hoped to have a complete set of information by September.

“We’re on the phone to them almost daily, that we will receive a complete set of information in September, but we really are at the mercy of the company for when they’ve sorted out the manufacturing issues,” he told a Covid committee hearing.

https://www.theaustralian.com.au/breaking-news/novavax-covid19-vaccine-supplies-delayed/news-story/d9829a5d1476b1f65399de590fbe7b7b

Sol-Gel Technologies Announces FDA Approval of TWYNEO acne med

 

• TWYNEO®, a once-daily cream treatment for acne vulgaris, is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide
  
  
• TWYNEO utilizes Sol-Gel’s proprietary microencapsulation technology and is patent protected until 2038
• Under a previously announced license, Sol-Gel to receive regulatory milestone payment from U.S. commercialization partner, Galderma, in conjunction with this approval and retains the option to regain commercialization rights five years following first commercialization in the U.S.

https://www.globenewswire.com/news-release/2021/07/27/2269561/0/en/Sol-Gel-Technologies-Announces-FDA-Approval-of-TWYNEO.html

Oragenics Gains on Pact For Rapid Development Of COVID-19 Vaccine

 

• Oragenics Inc OGEN 45.43% has entered into a licensing agreement with the National Research Council of Canada (NRC), allowing Oragenics to develop next-generation vaccines against the SARS-CoV-2 virus and its variants. 
• In combination with the U.S. National Institutes of Health (NIH) elements found in the Company's Terra CoV-2 vaccine, the NRC technologies provide Oragenics with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern. 
• This platform should allow the production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines.
• This license enables the Company to jumpstart IND-enabling animal studies with supplies of spike proteins to address the wild-type Wuhan variant virus and the Beta (B.1.351 or "South African") variant.

https://www.benzinga.com/general/biotech/21/07/22169125/oragenics-stock-is-trading-higher-on-licensing-material-transfer-pact-for-rapid-development-of-co

CDC reversal: Fully vaccinated should wear masks indoors in Covid hot spots

 The Centers for Disease Control and Prevention is expected to recommend Tuesday that fully vaccinated people begin wearing masks indoors again in places with high Covid-19 transmission rates, according to people familiar with the matter.

Federal health officials still believe fully vaccinated individuals represent a very small amount of transmission, according to the sources. Still, some vaccinated people could be carrying higher levels of the virus than previously understood and potentially transmit the virus to others, they said.

The updated guidance comes ahead of the fall season, when the highly contagious delta variant is expected to cause another surge in new coronavirus cases and many large employers plan to bring workers back to the office.

Health experts fear delta, already the dominant form of the disease in the U.S., is hitting states with low vaccination rates and high prevalence of the virus. Those states are now being forced to reintroduce mask rules, capacity limits and other public health measures that they’ve largely rolled back in recent months.

White chief medical advisor Dr. Anthony Fauci said Sunday that the CDC was considering whether to revise mask guidance for vaccinated Americans, saying it was “under active consideration.”

“It’s a dynamic situation. It’s a work in progress, it evolves like in so many other areas of the pandemic,” Fauci, also the director of the National Institute of Allergy and Infectious Diseases, told CNN. “You’ve got to look at the data.”

The CDC’s guidance is only a recommendation, leaving it up to states and local officials on whether to reintroduce their mask rules for certain people. But even before the CDC’s anticipated guidance Tuesday, some regions were reintroducing mask mandates and advisories.

Several counties across California and Nevada are now advising all residents to wear masks in public indoor settings — whether they are vaccinated or not. In Massachusetts, officials in Provincetown advised all individuals to resume wearing masks indoors after Fourth of July celebrations led to an outbreak of new cases.

Dr. Paul Offit, a pediatrician and vaccine advocate who has served on advisory panels for both the CDC and the Food and Drug Administration, told CNBC earlier this month that the U.S. was still “undervaccinated,” with about half of the population not fully vaccinated.

Even people who are fully protected have cause for concern when it comes to Covid variants, Offit said. While the vaccines protect well against severe disease and death, they may not protect as well against mild disease or spreading Covid to others, he said. No vaccine is 100% effective, he noted.

“It is not a bold prediction to believe that SARS-CoV-2 is going to be circulating two or three years from now. I mean there are 195 countries out there, most of which haven’t been given a single dose of vaccine,” Offit said. “Will it still be circulating in the United States? I think that would be very, very likely.”

Israel released preliminary data last week that showed the Pfizer vaccine is just 39% effective against the virus there, which officials attributed to the rapidly spreading delta variant. Its effectiveness against severe disease and death remained high, the data showed. 

https://www.cnbc.com/2021/07/27/cdc-to-reverse-indoor-mask-policy-to-recommend-them-for-fully-vaccinated-people-in-covid-hot-spots.html

S.Korea Begins COVID-19 Vaccination for Chip, Electronics Workers

 South Korea on Tuesday launched COVID-19 vaccinations for workers at key computer chip and electronic businesses to minimise disruptions in the global supply chain amid struggles to keep up with its inoculation schedule.

Major tech companies including Samsung Electronics Co Ltd, Samsung Display Co, SK Hynix Inc and LG Display Co Ltd and their suppliers began in-house vaccination for their employees on Tuesday, the companies' spokesmen told Reuters.

The government approved the companies' internal vaccination plans last month. The vaccination program will target over 303,000 workers in about 40 companies with in-house clinics, the Yonhap News Agency reported.

The move occurs amid a global chip shortage that has affected manufacturers around the world, particularly automakers. Samsung and SK Hynix are the world's top two memory chip makers.

Samsung, SK Hynix and LG Display said they are vaccinating their workers with the Pfizer/BioNTech shot.

Samsung and its affiliates had initially planned to offer Moderna vaccines. However, Yonhap reported that the plan is now to offer Pfizer/BioNTech after supply and shipment issues.

South Korea said on Monday that Moderna informed the government of an unspecified vaccine production issue and consultations are being held to figure out details.

"Moderna has notified there'll be adjustments in supply schedule due to a production issue and we're in discussion with them to confirm detailed plan for delivery and volume," Prime Minister Kim Boo-kyum said on Tuesday.

South Korea, which expanded its inoculation campaign for people in their 50s on Monday, had to switch to the Pfizer vaccine for some people in the group because of the shipment delays.

The country has a contract for 40 million doses of the Moderna vaccine, of which about 1.1 million have arrived so far.

The specific production issue was not immediately clear and it was not certain how much supply was affected and for how long or whether other countries will be impacted.

Moderna did not reply to a Reuters' request for comment.

South Korea reported 1,365 coronavirus cases for Monday. Total infections across the country of 52 million people are at 191,531 cases and 2,079 deaths, official data showed.

It has inoculated nearly 34% of its 52 million population with at least one dose and 13.5% are fully vaccinated.

https://www.usnews.com/news/world/articles/2021-07-27/skorea-begins-covid-19-vaccination-for-chip-electronics-workers

Idorsia announces financial results for the first half 2021 -- Building momentum

 Idorsia Ltd (SIX: IDIA) today announced its financial results for the first half of 2021.

Business highlights

   -- Daridorexant for the treatment of insomnia under review with US FDA, EMA, 
      and Swissmedic 
 
   -- Nine scientific presentations for daridorexant shared at SLEEP 2021 
 
   -- Ponesimod to treat relapsing forms of multiple sclerosis was approved by 
      the US FDA and the European Commission, Idorsia receives first income 
      from the revenue-sharing agreement in respect to ponesimod 
 
   -- Clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal 
      subarachnoid hemorrhage (aSAH) submitted to the Japanese Pharmaceuticals 
      and Medical Devices Agency (PMDA) in March 2021 
 
   -- "SOS-AMI" Phase 3 registration study with selatogrel in suspected acute 
      myocardial infarction (AMI) initiated in June 2021 
 
   -- Phase 2 study with ACT-539313 for binge eating disorder initiated in 
      March 2021 
 
   -- Results for MODIFY Phase 3 study with lucerastat for Fabry disease 
      expected in Q4 2021 
 
   -- Results for PRECISION Phase 3 study with aprocitentan for resistant 
      hypertension expected mid-2022 
 
   -- Results for CARE Phase 2b study with cenerimod for systemic lupus 
      erythematosus expected in Q4 2021 

Financial highlights

   -- US GAAP operating expenses HY 2021 at CHF 265 million 
 
   -- Non-GAAP operating expenses HY 2021 at CHF 248 million 
 
   -- Guidance for 2021: US GAAP operating expenses around CHF 665 million and 
      non-GAAP operating expenses around CHF 620 million (both measures include 
      inventory build of around CHF 35 million and exclude unforeseen events) 

https://www.marketscreener.com/quote/stock/IDORSIA-LTD-35837944/news/Press-Release-Idorsia-announces-financial-results-for-the-first-half-2021-Building-momentum-tow-35949477/

Heart disease likely to remain #1 killer in U.S. indefinitely due to long-term COVID-19 impact

 Heart disease and stroke continue to kill more people in the U.S. than any other cause, despite, and likely even due to, the impact of the deadly COVID-19 pandemic last year, according to new provisional data released today from the U.S Centers for Disease Control and Prevention. That trend is likely to continue for years to come as the long-term impact of the novel coronavirus will directly affect cardiovascular health, according to the American Heart Association, the leading global volunteer organization dedicated to fighting heart disease and stroke for all.

COVID-19 has taken a huge toll worldwide and is now officially ranked as the third leading cause of death in the U.S. in today's report. Heart disease remains at the top spot and stroke remains at #5. However, the influence of COVID-19 will directly and indirectly impact rates of cardiovascular disease prevalence and deaths for years to come, according to Donald M. Lloyd-Jones, M.D., Sc.M., FAHA, president of the American Heart Association

"Research shows that COVID-19 can cause heart and vascular damage directly. But the indirect effects of the pandemic can affect overall cardiovascular health as well, because most heart disease and stroke deaths are preventable with appropriate medical treatment and healthy lifestyle behaviors," said Lloyd-Jones, an epidemiologist and chair of the department of preventive medicine at Northwestern University Feinberg School of Medicine in Chicago. "We'd made tremendous progress in those areas over the last two decades but have seen much of that progress go out the window since COVID-19 hit."

Unhealthy eating habits, increased consumption of alcohol, lack of physical activity and the mental toll of quarantine isolation and even fear of contracting the virus in health care settings, all can adversely impact a person's cardiovascular risk, he emphasized.

• Unhealthy lifestyle behaviors: During extended periods of quarantine, many people developed or returned to behaviors that can elevate risk for heart disease including: poor eating habits and lower quality diets, increased alcohol consumption, changes in work/sleep habits and lack of regular exercise. In addition, the mental stress of social isolation and excessive sedentary screen time could also contribute to heart disease and stroke risk.
• Missed medical visits: Many patients postponed regular doctor visits for the management of their chronic conditions such as hypertension, coronary heart disease, diabetes and high cholesterol, resulting in an epidemic of poorly controlled conditions that can increase the risk of heart attack or stroke, and could persist for years to come if not brought back under control.
• Fear of hospitals: Data from the American Heart Association show that many individuals experienced a heart attack or stroke during the pandemic and did not seek urgent care out of fear of contracting COVID-19 in a hospital setting. Unfortunately, many people may have experienced heart or brain damage with lasting consequences, or even death, that could likely have been avoided with prompt treatment.
• Heart-related risks for COVID-19 patients: Although studies of the impact of COVID-19 on pre-existing medical conditions are ongoing, the data show that individuals with cardiovascular conditions such as high blood pressure, obesity and diabetes are at increased risk for complications—including prolonged hospitalization and death—if they become ill with COVID-19. It's important for every eligible person to get the COVID-19 vaccine.

"Even as we thought the worst may be over, we're again seeing increased numbers of people getting COVID-19 across the country in this fourth wave related to the Delta variant. We urge everyone who is eligible to be vaccinated as soon as possible, because that's the only way to prevent or lessen the severity of this disease," Lloyd-Jones said. "Our messages for preventing heart disease and stroke and their risk factors have never been more important. Watch your diet, get up and move more, get the sleep your body needs and please see your doctor to make sure you're managing any chronic conditions such as high blood pressure or diabetes. We'll need to watch and address these trends as the full ramifications are yet to come."

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Improving heart health may reduce the severity of COVID-19 disease

https://medicalxpress.com/news/2021-07-heart-disease-killer-indefinitely-due.html