NYC’s COVID vaccine supply could run out in a day, de Blasio warns

 New York City’s COVID vaccine supply could run out within the next day due to nationwide shortages and supply chain disruptions caused by storms, Mayor de Blasio said Wednesday.

“We’ve got fewer than 30,000 first doses on hand right now. That means we’re going to run out today or tomorrow. We’re going to run out of what we’ve got now,” he said at a City Hall press briefing Wednesday. “We’re not getting what we need.”

De Blasio said he learned Wednesday morning that storms in other parts of the country are causing delays to vaccine shipments and that shipments expected to arrive by Tuesday and Wednesday had to be pushed back.

“That means we’re going to have to hold back appointments that New Yorkers need,” he said, noting that as many as 35,000 vaccination appointments “might not be scheduled.”

“We have to hold them back because the vaccine hasn’t arrived,” he said. “This is going to be so frustrating for so many New Yorkers.”

De Blasio’s renewed concern comes a day after President Biden’s COVID czar, Jeff Zients, indicated that the weekly vaccine supply being shipped to states will increase by at least 20% to 13.5 million doses this week.

On Wednesday, Zients acknowledged that severe winter weather is affecting vaccine deliveries and urged states to extend vaccination site hours when possible to make up for the current shortages.

A winter storm that’s expected to drop up to 7 inches of snow on the Big Apple on Thursday and Friday could also complicate matters in the days ahead.

accine resupply in the city is tentatively expected to arrive Thursday or Friday, according to a city official, who added that the situation is fluid and could still change.

During a call with reporters Wednesday, Gov. Cuomo blamed the Trump administration for confusing directives on distribution.

“You have a multiplicity of distribution outlets run by federal, state and local governments,” said Cuomo, who himself has weathered criticism for circumventing local governments. “That is now creating confusion. This was a system set up originally by the Trump administration and it does create confusion.”

The state so far has administered 3.3 million COVID-19 vaccine doses in all. The city has given more than 1.3 million shots.

De Blasio praised the Biden administration’s efforts to up supply, but said the city would need “a helluva lot more support” to reach its goal of vaccinating 5 million New Yorkers by June.

“We’ve had these disagreements with the state where they say this center should be only for one type of worker, and another center for another — no, we need lots of grassroots locations where we can reach everyday people, particularly in the communities hardest hit,” de Blasio said.

Spokesmen for Cuomo did not immediately return messages seeking a response to the mayor’s remarks.

https://www.nydailynews.com/news/politics/new-york-elections-government/ny-nyc-covid-vaccine-supply-snowstorm-de-blasio-20210217-gld2762bjbghhbihxjw3rtfrqq-story.html

Immunome Discovers Antibodies That Neutralize Multiple SARS-CoV-2 Variants

 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced today that its discovery engine has isolated potent antibodies capable of neutralizing several SARS-CoV-2 variants, including the South African Variant (B.1.351), in pseudovirus testing.

This effort is part of the company’s ongoing program to develop a cocktail of antibodies targeting spike and non-spike proteins that can serve as a prophylaxis or a treatment for COVID-19. Immunome’s COVID-19 antibody research demonstrates that SARS-CoV-2 "super-responders" who recover from SARS-CoV-2 mount a robust immune response to a broad range of viral targets, including spike and non-spike proteins (https://www.biorxiv.org/content/10.1101/2021.01.27.428534v1).

As part of developing our antibody cocktail (IMM-BCP-001), Immunome has identified antibodies that bind to non-overlapping regions of the spike protein, including those regions containing the critical mutational variants. Immunome’s research shows that certain of our antibodies neutralize pseudoviruses expressing the spike protein of the South African Variant (B.1.351). Recent literature suggests that this South African Variant reduces the effectiveness of certain vaccines and antibody therapies (https://www.biorxiv.org/content/10.1101/2021.01.25.427948v1, https://www.biorxiv.org/content/10.1101/2021.01.25.428137v2).

Purnanand Sarma, PhD, CEO of Immunome, said, "Our findings underscore the power of Immunome’s discovery engine to quickly identify antibodies that are broadly effective against SARS-CoV-2 and its variants. Of note, Immunome’s discovery engine has identified antibodies that bind to conserved epitopes of SARS-CoV-1 and SARS-CoV-2 spike, as well as to other non-spike targets. We believe that our comprehensive strategy could combat the negative impact of escape mutants. We are encouraged by these results and plan to continue development efforts on these antibodies."

Jeffrey P Henderson, MD, PhD, Associate Professor of Medicine and of Molecular Microbiology at Washington University School of Medicine in St. Louis, and a member of Immunome’s COVID-19 Advisory Board, said, "Interrogating the overall immune responses in recovered COVID-19 patients allows Immunome to identify not only broadly neutralizing anti-spike antibodies but also promising non-spike antibodies that have the potential to enhance viral clearance. Broadly targeting multiple viral proteins in this way may provide alternative approaches to combat future SARS-CoV-2 variants."

In July 2020, Immunome was awarded a $13.3 million technology award from the U.S. Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Health Agency, to support Immunome’s COVID program. The research discussed in this press release and the article is part of that program.

https://finance.yahoo.com/news/immunome-discovers-antibodies-capable-neutralizing-120000174.html

Morgan Stanley Sees the Moderna (MRNA) Booster Opportunity as More Sustainable

 

Raising Dose Estimates and Price Target to $215

https://www.streetinsider.com/Analyst+Comments/Morgan+Stanley+Sees+the+Moderna+%28MRNA%29+Booster+Opportunity+as+More+Sustainable%2C+Raising+Dose+Ests+and+PT+to+%24215/17993503.html

Irish firm behind world's first study to deliberately expose people to Covid-19

 The world’s first study which will deliberately expose volunteers to coronavirus to establish the smallest amount of virus needed to cause infection will take place in the UK.

hVIVO, a subsidiary of Dublin-based Open Orphan, is an industry-leading clinical company that will carry out the Covid-19 “human challenge” research backed by the UK government.

Starting in the next few weeks, the trial will involve up to 90 carefully selected, healthy adult volunteers being deliberately exposed to Covid-19 in a safe and controlled environment.

The first-of-its-kind study has been approved by the UK’s clinical trials ethics body.

It will give doctors a greater understanding of Covid-19 and help support the pandemic response by aiding vaccine and treatment development.

Because the safety of volunteers is paramount, this virus characterisation study will initially use the version of the virus that has been circulating in the UK and Ireland since March 2020.

This variant has been shown to be of low risk in young healthy adults.

Medics and scientists will closely monitor the effect of the virus on volunteers and will be on hand to look after them 24 hours a day.

The researchers are working closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not affect the British health service’s ability to care for patients during the pandemic.

The study will not begin without their go-ahead, the UK's Department for Business, Energy and Industrial Strategy (Beis) has announced.

Important role

hVIVO’s chief scientific officer Dr Andrew Catchpole, said Covid-19 “human challenge” studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic.

Dr Catchpole said the challenge model can answer “a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.”

Interim chairman of the UK Vaccines Taskforce, Clive Dix, said: “We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19.

“We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.”

After the initial study has taken place, vaccine candidates proven to be safe in clinical trials could be given to small numbers of volunteers who are then exposed to coronavirus.

This will help identify the most effective vaccines and accelerate their development.

People aged between 18 and 30 years old, who are at the lowest risk of complications resulting from coronavirus, are being encouraged to volunteer for this vital study.

Volunteers will be compensated for the time they spend in the study.

Accelerate new treatments

In the past, human challenge studies have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and flu.

The trials have also helped researchers establish which possible vaccine is most likely to succeed in phase three clinical trials that would follow, usually involving thousands of volunteers.

This study, backed by a £33.6 million (€38.6 million) UK government investment, will also help doctors understand how the immune system reacts to coronavirus and identify factors that influence how the virus is transmitted.

This includes how a person who is infected with Covid-19 virus transmits infectious virus particles into the environment.

The human challenge study is being delivered by a partnership between the UK government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and hVIVO.

The Royal Free Hospital’s specialist and secure clinical research facilities in London are specifically designed to contain the virus.

Highly trained medics and scientists will be on hand to carefully examine how the virus behaves in the body and to ensure the safety of volunteers.

The virus being used in the characterisation study has been produced by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, in collaboration with hVIVO with support from virologists at Imperial College London.

If you live in Northern Ireland or Britain you can express an interest in taking part in this research at ukcovidchallenge.com

https://www.breakingnews.ie/ireland/worlds-first-study-to-deliberately-expose-people-to-covid-19-to-begin-in-uk-1082499.html

Sinovac vaccine works on UK, South African variants - Brazil institute

 The COVID-19 vaccine developed by China’s Sinovac Biotech is effective against the UK and South African variants, the vaccine’s Brazilian partner said on Wednesday, citing test results in Chinese trials.

“We have tested this vaccine in China against the English and the South African variants, with good results,” said Dimas Covas, head of the Butantan biomedical center in Sao Paulo which lead domestic trials of the Chinese vaccine and is supplying doses to Brazil’s Health Ministry.

Covas did not give any more details on exactly how effective the vaccine proved against these strains.

Butantan is also testing the vaccine, known as CoronaVac, against the Brazilian variant of the virus which appeared in the city of Manaus, he said.

“Soon we will have the results and we are very positive it will do the job,” Covas said.

Covas was speaking at a news conference in the small city of Serrana, in the interior of Sao Paulo state, where Butantan began on Wednesday a mass vaccination campaign aimed at inoculating the entire adult population against COVID-19 to test whether it lowers the infection rate.

Covas said he expects CoronaVac to have an advantage over other vaccines due to the technology it uses - an inactivated version of a coronavirus strain.

The efficacy of the Chinese vaccine against the Brazilian strain in particular will be vital to Brazil. The government has secured 100 million doses and made the vaccine a centerpiece of its inoculation campaign.

Covas’ comments come as several cities in Brazil, including state capitals of Rio, Salvador and Cuiaba have suspended new vaccinations as they ran out of doses.

https://www.reuters.com/article/us-health-coronavirus-brazil/sinovac-vaccine-works-on-uk-south-african-variants-brazil-institute-idUSKBN2AH2H0

Pfizer: South African variant could significantly reduce vaccine protection

 A laboratory study suggests that the South African variant of the coronavirus may reduce antibody protection from the Pfizer Inc/BioNTech SE vaccine by two-thirds, and it is not clear if the shot will be effective against the mutation, the companies said on Wednesday.

The study found the vaccine was still able to neutralize the virus and there is not yet evidence from trials in people that the variant reduces vaccine protection, the companies said.

Still, they are making investments and talking to regulators about developing an updated version of their mRNA vaccine or a booster shot, if needed.

For the study, scientists from the companies and the University of Texas Medical Branch (UTMB) developed an engineered virus that contained the same mutations carried on the spike portion of the highly contagious coronavirus variant first discovered in South Africa, known as B.1.351. The spike, used by the virus to enter human cells, is the primary target of many COVID-19 vaccines.

Researchers tested the engineered virus against blood taken from people who had been given the vaccine, and found a two- thirds reduction in the level of neutralizing antibodies compared with its effect on the most common version of the virus prevalent in U.S. trials.

Their findings were published in the New England Journal of Medicine (NEJM).

Because there is no established benchmark yet to determine what level of antibodies are needed to protect against the virus, it is unclear whether that two-thirds reduction will render the vaccine ineffective against the variant spreading around the world.

However, UTMB professor and study co-author Pei-Yong Shi said he believes the Pfizer vaccine will likely be protective against the variant.

“We don’t know what the minimum neutralizing number is. We don’t have that cutoff line,” he said, adding that he suspects the immune response observed is likely to be significantly above where it needs to be to provide protection.

That is because in clinical trials, both the Pfizer/BioNTech vaccine and a similar shot from Moderna Inc conferred some protection after a single dose with an antibody response lower than the reduced levels caused by the South African variant in the laboratory study.

Even if the concerning variant significantly reduces effectiveness, the vaccine should still help protect against severe disease and death, he noted. Health experts have said that is the most important factor in keeping stretched healthcare systems from becoming overwhelmed.

More work is needed to understand whether the vaccine works against the South African variant, Shi said, including clinical trials and the development of correlates of protection - the benchmarks to determine what antibody levels are protective.

Pfizer and BioNTech said they were doing similar lab work to understand whether their vaccine is effective against another variant first found in Brazil.

Moderna published a correspondence in NEJM on Wednesday with similar data previously disclosed elsewhere that showed a sixfold drop antibody levels versus the South African variant.

https://www.reuters.com/article/us-health-coronavirus-vaccines-variants/pfizer-says-south-african-variant-could-significantly-reduce-vaccine-protection-idUSKBN2AH2VG

Medtronic recalls aortic graft implant after stent fractures, patient death

 Medtronic has launched a global recall of its Valiant Navion thoracic stent graft system, used to reinforce large blood vessels at risk of rupturing from an aneurysm or other injuries.

The medtech giant notified physicians to cease using the implant until further notice, following reports of three stent fractures and the death of one patient in an international clinical trial of the device.

The Valiant system is designed to fortify a weakened aorta from the inside and relieve the pressure on the vessel’s walls. The device is threaded through the body’s arteries via a minimally invasive catheter procedure to avoid open surgery and deploys a synthetic fabric tube supported by a metal stent scaffold.

According to Medtronic, two of the three stent fractures resulted in confirmed tears in the fabric tube, leaking blood out of the implant’s channel.

In addition, patient imaging scans found that the stents in seven of the study’s 87 participants had widened to a diameter beyond the implant’s design specifications. The company said those cases need further evaluation to determine potential clinical effects, and it is currently conducting technical root cause investigations and reviewing follow-up trial imaging and commercial complaints.

“There is nothing more important than the safety and well-being of patients,” Nina Goodheart, president of Medtronic’s structural heart and aortic business, said in a statement. “We treat matters of product safety with the highest priority and urgency. Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies.”

https://www.fiercebiotech.com/medtech/medtronic-recalls-aortic-graft-implant-after-stent-fractures-patient-death