Lonza: production for Moderna at two new Swiss lines to start 'soon'

 

Lonza will "soon" start production at two more Swiss manufacturing lines for Moderna's COVID-19 vaccine, CEO Pierre-Alain Ruffieux said, after the first line began production and is due to deliver a first batch this month.

"We expect that within a couple of months, we will reach cruising speed," Ruffieux told reporters on a conference call on Wednesday, without giving a firm timeline for when all three new production lines supplying Moderna will be at their full capacity and making ingredients for roughly 300 million vaccine doses annually.

https://www.marketscreener.com/quote/stock/LONZA-GROUP-AG-2956013/news/Lonza-says-production-for-Moderna-at-two-new-Swiss-lines-to-start-soon-32285390/

Dr.Reddy's ends study of COVID-19 drug Avigan in Kuwait

 Indian drugmaker Dr.Reddy’s Laboratories said on Wednesday it had terminated its clinical study of Fujifilm Holdings’ COVID-19 treatment Avigan in patients with moderate to severe symptoms in Kuwait.

Data from the Kuwait trial, conducted in partnership with United Arab Emirates-based medical alliance Global Response Aid FZCO (GRA), showed that the difference in time taken by Avigan and placebo to resolve a sustained absence of oxygen in the tissues was not significant enough to continue the trial. (bit.ly/3onNbij)

Fujifilm, Dr.Reddy’s and GRA had entered into a deal in July to sell Avigan globally excluding Japan, China and Russia.

Avigan was approved as an anti-flu drug in Japan in 2014, and Fujifilm has been seeking approval for the drug as a treatment for COVID-19 since October.

The Japanese Health Ministry’s medical review board last month concluded that clinical trial data to determine Avigan’s efficacy for COVID-19 was inconclusive.

Dr.Reddy’s, in partnership with GRA and Canada’s Appili Therapeutics, will continue a late-stage North American trial of Avigan in patients with mild to moderate COVID-19 symptoms.

Several Indian drugmakers, such as Cipla, Lupin and Glenmark Pharmaceuticals, offer their own generic versions of Avigan to treat COVID-19.

India, which has the second-highest number of coronavirus infections in the world, is in the middle of its first phase of COVID-19 vaccinations and has vaccinated nearly 2 million healthcare workers as of Monday.

https://www.reuters.com/article/us-health-coronavirus-dr-reddys/indias-dr-reddys-ends-study-of-covid-19-drug-avigan-in-kuwait-idUSKBN29W0RT

India's COVAXIN likely effective against UK variant

 A vaccine developed by India’s Bharat Biotech and a government research institute is likely to be effective against the UK strain of the coronavirus, according to a study on 26 participants shared by the company on Wednesday.

The findings on COVAXIN, which is in use in India after receiving emergency-use authorisation early this month, have been published here on the website bioRxiv that carries research not certified by peer review.

“Sera from the vaccine recipients could neutralise the UK-variant strains discounting the uncertainty around potential escape,” wrote scientists from the company and its partner, the state-run Indian Council of Medical Research.

“It is unlikely that the mutation 501Y would be able to dampen the potential benefits of the vaccine in concern.”

Another study published here on bioRxiv last week said a vaccine developed by U.S. company Pfizer Inc and its German partner BioNTech was also likely to protect against the more infectious variant that has now spread around the world, with 150 cases in India.

While approving COVAXIN without any efficacy data from an ongoing late-stage trial, India’s drug regulator had touted its ability to act against the whole body of a virus instead of just its “spike-protein” tip, potentially making it more effective in case of mutations.

India has already expanded the use of the vaccine in its massive immunisation programme that began on Jan. 16 and has so far covered more than 2 million people on the frontline such as sanitation workers, nurses and doctors.

The world’s second most populous country, which has reported the most number of COVID-19 infections after the United States, has also approved the Oxford University-AstraZeneca shot for emergency use.

India on Wednesday reported 12,689 new infections, taking the total to 10.69 million. Deaths rose by 137 to 153,724.

Bharat Biotech has sought emergency-use authorisation for its vaccine in the Philippines and is also in talks with Brazil to sell shots.

https://www.reuters.com/article/us-health-coronavirus-india-vaccine/indias-covaxin-likely-effective-against-uk-variant-study-idUSKBN29W0SV

CMS withdraws 3 proposed health rules, implements others

 CMS has withdrawn three proposed healthcare rules developed under the administration of former President Donald Trump.

The withdrawn rules include a revision to Medicare Part A enrollment requirements, altered dialysis coverage requirements for third party-payment programs and increased oversight of accrediting organizations. 

The withdrawn rules come after President Joe Biden's Chief of Staff Ronald Klain ordered a freeze on new or pending rules issued by the Trump administration. The freeze prevents the departments and agencies from implementing the rules until the Biden administration has had a chance to review them. 

The White House Office of Management and Budget had been reviewing the rules. 

The budget office has finished reviewing several other Trump administration healthcare rules, including a rule to simplify prior authorizations, Medicare coverage changes for breakthrough technologies and an update to the definition of "reasonable and necessary medical coverage. Those rules will be implemented.

https://www.beckershospitalreview.com/finance/cms-withdraws-3-proposed-health-rules.html

Last-mile delivery issues slowing vaccine rollout

 The global COVID-19 vaccination effort is being slowed by logistical problems with last-mile delivery, industry leaders told CNBC Jan. 26. 

"I said from the beginning it will not be a problem of global logistics, it will be a problem of last-mile [delivery] from our warehouses to doctors, or whoever, because it is difficult to transport minus-70 degrees products," Frank Appel, CEO of Deutsche Post, a logistics company, told CNBC. 

Dorothea von Boxberg, chief commercial officer of Lufthansa Cargo, an air freight and logistics company, told CNBC: "You don’t only need the vaccine, but you also have to have the patient, the doctor, additional material like syringes. So, it is a big, big logistical effort to get everything in place, and also keeping the cold chain at the same time for the vaccines."

She added that the air freight industry is prepared to deliver vaccines, and there should be no bottlenecks in that section of the vaccine supply chain, saying that "every freighter is in the air every time it can be" to deliver vaccines. 

The United Nations last week said it is working with airlines, freight and logistics companies to "ensure safe and timely delivery" of COVID-19 vaccines to all corners of the world, according to CNBC. 

https://www.beckershospitalreview.com/supply-chain/last-mile-delivery-issues-slowing-vaccine-rollout.html

Some states reallocate COVID vaccines meant for long-term care facilities

 Some states say the federal government has given CVS and Walgreens an excess supply of COVID-19 vaccines through their partnership to vaccinate residents and staff of long-term care facilities, so the states are reallocating doses away from those facilities to vaccinate a broader population, Politico reports. 

State officials told Politico that tens of thousands of vaccines designated for long-term care facilities through the partnership with CVS and Walgreens have gone unused. Meanwhile, state health officials say they are using up their weekly allocated supply of vaccines. 

Utah halted new vaccine shipments to long-term care facilities this week and is redistributing 8,775 shots to local health departments and other providers, a health department spokesperson told Politico. Minnesota is redistributing 30,000 shots from long-term care facilities to teachers and childcare providers. Maine has redistributed about 3,400 shots from CVS and Walgreens to hospitals and independent pharmacies, according to Politico, and Michigan is redistributing 120,000 shots to other providers. 

State officials told Politico the redistribution won't slow CVS and Walgreens' initiative to vaccinate long-term care facilities and said the CDC is helping with the reallocation. 

CVS said Jan. 25 that it finished giving all first-round shots to skilled nursing facilities and will complete giving first-round doses to all long-term care facilities in the program by mid-February. Walgreens said Jan. 22 that it has administered more than 1 million vaccine doses to long-term care facilities and was on track to finish giving first doses by Jan. 25. 

Spokespeople for CVS and Walgreens told Politico that in some cases, they received more vaccine doses than they needed and are working with states to figure out how to reallocate them. 

https://www.beckershospitalreview.com/pharmacy/some-states-reallocating-covid-19-vaccines-meant-for-long-term-care-facilities.html

SARS-CoV-2 reacts to antibodies of virus from 2003 SARS outbreak: study

 A new study demonstrates that antibodies generated by the novel coronavirus react to other strains of coronavirus and vice versa, according to research published today by scientists from Oregon Health & Science University.

However, antibodies generated by the SARS outbreak of 2003 had only limited effectiveness in neutralizing the SARS-CoV-2 virus. Antibodies are blood proteins that are made by the immune system to protect against infection, in this case by a coronavirus.

The study published today in the journal Cell Reports.

"Our finding has some important implications concerning immunity toward different strains of coronavirus infections, especially as these viruses continue to mutate," said senior author Fikadu Tafesse, Ph.D., assistant professor of molecular microbiology and immunology in the OHSU School of Medicine.

Given the speed of mutations—estimated at one to two per month—it's not surprising that an antibody generated from a virus 18 years ago provides a meager defense against the new coronavirus. Nonetheless, Tafesse said the findings suggest more work needs to be done to determine the lasting effectiveness of COVID-19 vaccines.

"I don't think there is any one size-fits-all vaccine," he said. "Although the vaccines coming out now may break the momentum of the virus and end the pandemic, they may not be the end game."

Tafesse noted that researchers used individual antibody clones to test cross-reactivity, and that a body's normal immune system will generate many antibodies that are more likely to neutralize a wider series of targets on the mutating virus.

"I'm not personally terribly concerned," said lead author Timothy Bates, a fourth-year molecular microbiology and immunology graduate student in the OHSU School of Medicine. "Emerging mutant viruses may have some propensity to escape certain antibodies raised by previous infection or vaccine.

"Every individual has a different immune system that will make a unique repertoire of different antibodies that bind to different places on the virus, so the chance of any one SARS-CoV-2 variant escaping from all of them is quite low."

The study also suggests that efforts to accurately discern a previous COVID-19 infection, by analyzing antibodies in blood, may be confounded by the presence of antibodies reacting to other strains of coronavirus including the common cold. Although this complicates diagnosis of older infections, researchers say the finding actually expands scientists' ability to study the biology and disease-causing effects of the SARS-CoV-2 virus since they know it reacts to antibodies of multiple strains of coronaviruses.

"It provides more tools to study the biology of this virus because we have very limited reagents available right now for SARS-CoV-2," Tafesse said.

More information: Cell Reports (2021). DOI: 10.1016/j.celrep.2021.108737

https://medicalxpress.com/news/2021-01-sars-cov-reacts-antibodies-virus-sars.html