EU: Pfizer jabs not linked to death of vaccinated elderly

 

• EU medicines regulator said it had investigated deaths of elderly jab recipients
• It said there was no evidence of a link and no surprise side-effects of the jab
• EU is battling with rival provider AstraZeneca over delayed supplies to the bloc
• Germany said today it expects EU regulator not to approve AZ jab for over-65s 

The EU rollout of the Pfizer/BioNTech vaccine has not been linked to any deaths and has had no unexpected side-effects in its first month, the European Medicines Agency said today. 

The good review of the Pfizer jab comes as the EU battles with rival vaccine provider AstraZeneca about delayed supplies to the bloc - while Germany added to the pressure on the EMA today by saying it expected the agency to limit the Oxford/AstraZeneca vaccine to under-65s. 

The EMA said it had looked at reports of deaths of elderly patients in Norway and other countries after receiving the Pfizer jab, and concluded that 'the data did not show a link to vaccination'.   

It added that sporadic reports of allergic reactions did not go beyond what was already known about occasional side-effects of the vaccine.

EU vaccinations began in late December but are still lagging behind those in Britain, with several governments facing criticism over the sluggish pace of vaccination. 

The Pfizer jab which was the first to be approved in Europe has been delivered to all 27 EU nations, but the bloc has only given out 2.4 vaccine doses per 100 people compared to 11.7 in the UK. 

In its first safety review of the Pfizer product, the Amsterdam-based EMA said the data so far 'is consistent with the known safety profile of the vaccine, and no new side effects were identified.'

'The benefits of [the jab] in preventing Covid-19 continue to outweigh any risks, and there are no recommended changes regarding the use of the vaccine,' it said. 

Norway in particular had attracted attention for registering 33 deaths among 20,000 care home residents who had received the first dose of the vaccine. 

Norwegian health authorities said it was unsurprising that some of the frail and elderly patients who were first in line for the vaccines would have died naturally by chance, given that 400 people typically die in care homes every week. 

But the EMA said it had investigated 'given concerns which arose from Norway', after other deaths were reported in France, Denmark, Finland and Sweden.    

'In many cases concerning individuals above 65 years of age, progression of pre-existing diseases seemed to be a plausible explanation for death,' the EMA said.

Some had already received palliative care, it said. 

The watchdog said it had asked the company to keep 'reviewing all reports of suspected side effects with fatal outcome thoroughly.'

But it also noted that clinical trials of the Pfizer vaccine had included people aged 75 and older.

By contrast, regulators in Germany have raised concerns about the small number of older people who took part in the AstraZeneca trial. 

Results published by German scientists on Thursday showed that among over-65s, one out of 341 was infected after getting the vaccine while one out of 319 was infected after getting a dummy jab - making a comparison essentially meaningless.   

A German vaccine commission said on Thursday that the data was insufficient to recommend using the vaccine for over-65s. 

German health minister Jens Spahn said today that 'we don't expect an unrestricted approval' when the EMA decides on AstraZeneca's vaccine. 

But Britain has approved the jab for all age groups, with AstraZeneca pointing to results published in a medical journal showing that 100 per cent of older people produced antibodies after getting two doses of the vaccine. 

Boris Johnson yesterday defended the jab, saying that UK regulators believe it is 'effective across all age groups'. 

Asked about Germany's decision not to recommend the vaccine for over-65s, he said: 'I don't agree with that.' 

Dr June Raine, the head of UK regulator MHRA, said that 'current evidence does not suggest any lack of protection against Covid-19 in people aged 65 or over'.  

The questions over the effectiveness of the AstraZeneca jab come amid a separate row over supplies of the UK-made vaccine to the EU. 

Brussels said today it would publish a redacted copy of the contract with AstraZeneca which is at the heart of the dispute after the British-Swedish firm said it could not meet all its orders to the EU. 

The firm's CEO, Pascal Soriot, has said there have been production glitches in AstraZeneca's plants operated by subcontractors in the EU, and that the contract only called for it to make 'best efforts' to hit targets. 

But European Commission chief Ursula von der Leyen insisted the contract committed the British-Swedish firm to fixed numbers of vaccines per quarter.

'The 'best effort' applies as long as it was not clear whether they could develop a vaccine. We have passed that time. The vaccine is there,' she said. 

AstraZeneca has continued to fulfil its separate contract with Britain, where the PM says he expects two million doses to keep being supplied every week.   

One of the plants producing the vaccine in Europe, operated by the US company Thermo Fisher in Seneffe, western Belgium, was inspected this week by Belgian health officials at the European Commission's request.

https://www.dailymail.co.uk/news/article-9201199/EU-says-Pfizer-jabs-not-linked-death-vaccinated-patients.html

Dr. Fauci Wrong Again: Novavax Vaccine Only 50% Effective v. 'Mutant' S. Africa COVID

 The latest COVID-19 vaccine news is unequivocally disappointing.

Novavax, one of six US companies that received hundreds of millions of dollars upfront from the US government to develop a COVIID-19 vaccine, has just released preliminary data from its Phase 3 trials. The data showed the vaccine was 89.3% effective in the UK branch of the trial.

Vaccine trials were held in nearly half a dozen countries, but in the UK, 62 people (out of roughly 15K) came down with COVID-19 symptoms after receiving either the vaccine or a placebo. Of these, six had received the vaccine, while 56 had gotten the placebo.

Yet, in a separate, middle-stage study in South Africa, the trial data suggested the vaccine was much less effective. In South Africa, the Novavax shot was about 49.4% effective against Covid-19 in the study. Preliminary results showed that more than 90% of the sick subjects for whom sequencing data were available were infected with the new variant circulating in South Africa.

The news comes at an inopportune time: A few hours ago, the CDC revealed that the first two confirmed cases of the hyper-infectious South African COVID mutation had been confirmed in South Carolina.

In a separate Novavax trial held in South Africa, the efficacy was significantly lower. In a small trial the rate of protection was just 50%. Almost all the cases that scientists have analyzed there so far were caused by the mutated strain, known as B.1.351.

What's even more disturbing: The data also showed that many trial participants were infected with the variant even after they had already had COVID-19.

Novavax tried to put a bright spin on the results.

"We have the first trial — we are the first to conduct an efficacy trial — in the face of a changing virus," said Stanley Erck, the president and chief executive of Novavax. He said that researchers expected the variants could change the trial results, but “the amount of change has been a bit of a surprise to everyone.”

However, there's no denying the fact that scientists like Dr. Anthony Fauci who repeatedly claimed that the vaccines would provide enduring protection despite mutations of the virus were clearly exaggerating their level of certainty. But that's not the first time the data has gone against "the science".

https://www.zerohedge.com/covid-19/dr-fauci-wrong-again-novavax-vaccine-only-50-effective-against-mutant-south-african-covid

Can the US Keep COVID Variants in Check? Here's What It Takes

 The COVID-19 variants that have emerged in the United Kingdom, Brazil, South Africa, and now Southern California are eliciting two notably distinct responses from US public health officials.

First, broad concern. A variant that wreaked havoc in the UK, leading to a spike in cases and hospitalizations, is surfacing in a growing number of places in the US. This week, another worrisome variant seen in Brazil surfaced in Minnesota. If these or other strains significantly change the way the virus transmits and attacks the body, as scientists fear they might, they could cause yet another prolonged surge in illness and death in the US, even as cases have begun to plateau and vaccines are rolling out.

On the other hand, variants aren't novel or even uncommon in viral illnesses. The viruses that trigger common colds and flus regularly evolve. Even if a mutated strain of SARS-CoV-2, the virus that causes COVID, makes it more contagious or makes people sicker, the basic public health response stays the same: Monitor the virus, and any mutations, as it moves across communities. Use masking, testing, physical distancing, and quarantine to contain the spread.

The problem is that the US has struggled with every step of its public health response in its first year of battle against COVID-19. And that raises the question of whether the nation will devote the attention and resources needed to outflank the virus as it evolves.

Researchers are quick to stress that a coronavirus mutation in itself is no cause for alarm. In the course of making millions and billions of copies as part of the infection process, small changes to a virus's genome happen all the time as a function of evolutionary biology.

"The word 'variant' and the word 'mutation' have these scary connotations, and they aren't necessarily scary," said Kelly Wroblewski, director of infectious disease programs for the Association of Public Health Laboratories.

When a mutation rings public health alarms, it's typically because it has combined with other mutations and, collectively, changed how the virus behaves. At that point, it may be named a variant. A variant can make a virus spread faster, or more easily jump between species. It can make a virus more successful at making people sicker, or change how our immune systems respond.

SARS-CoV-2 has been mutating for as long as we've known about it; mutations were identified by scientists throughout 2020. Though relevant scientifically — mutations can actually be helpful, acting like a fingerprint that allows scientists to track a virus's spread — the identified strains mostly carried little concern for public health.

Then came the end of the year, when several variants began drawing scrutiny. One of the most concerning, first detected in the United Kingdom, appears to make the virus more transmissible. Emerging evidence suggests it also could be deadlier, though scientists are still debating that.

We know more about the UK variant than others not because it's necessarily worse, but because the British have one of the best virus surveillance programs in the world, said William Hanage, an epidemiologist and a professor at Harvard University.

By contrast, the US has one of the weakest genomic surveillance programs of any rich country, Hanage said. "As it is, people like me cobble together partnerships with places and try and beg them" for samples, he said on a recent call with reporters.

Other variant strains were identified in South Africa and Brazil, and they share some mutations with the UK variant. That those changes evolved independently in several parts of the world suggests they might present an evolutionary advantage for the virus. Yet another strain was recently identified in Southern California and flagged due to its increasing presence in hard-hit cities like Los Angeles.

The Southern California strain was detected because a team of researchers at Cedars-Sinai, a hospital and research center in Los Angeles, has unfettered access to patient samples. They were able to see that the strain made up a growing share of cases at the hospital in recent weeks, as well as among the limited number of other samples haphazardly collected at a network of labs in the region.

Not only does the US do less genomic sequencing than most wealthy countries, but it also does its surveillance by happenstance. That means it takes longer to detect new strains and draw conclusions about them. It's not yet clear, for example, whether that Southern California strain was truly worthy of a press release.

Vast swaths of America's privatized and decentralized system of healthcare aren't set up to send samples to public health or academic labs. "I'm more concerned about the systems to detect variants than I am these particular variants," said Mark Pandori, director of Nevada's public health laboratory and an associate professor at the University of Nevada-Reno School of Medicine.

Limited genomic surveillance of viruses is yet another side effect of a fragmented and underfunded public health system that's struggled to test, track contacts, and get COVID under control throughout the pandemic, Wroblewski said.

The nation's public health infrastructure, generally funded on a disease-by-disease basis, has decent systems set up to sequence flu, foodborne illnesses, and tuberculosis, but there has been no national strategy on COVID. "To look for variants, it needs to be a national picture if it's going to be done well," Wroblewski said.

Last week, the Biden administration outlined a strategy for a national response to COVID, which included expanded surveillance for variants.

So far, vaccines for COVID appear to protect against the known variants. Moderna has said its vaccine is effective against the UK and South African strains, though it yields fewer antibodies in the face of the latter. The company is working to develop a revised dose of the vaccine that could be added to the current two-shot regimen as a precaution.

But a lot of damage can be done in the time it will take to roll out the current vaccine, let alone an update.

Even with limited sampling, the UK variant has been detected in more than two dozen US states, and the Centers for Disease Control and Prevention has warned it could be the predominant strain in the US by March. When it took off in the United Kingdom at the end of last year, it caused a swell in cases, overwhelmed hospitals, and led to a holiday lockdown. Whether the US faces the same fate could depend on which strains it is competing against, and how the public behaves in the weeks ahead.

Already risky interactions among people could, on average, get a little riskier. Many researchers are calling for better masks and better indoor ventilation. But any updates on recommendations likely would play at the margins. Even if variants spread more easily, the same recommendations public health experts have been espousing for months — masking, physical distancing and limiting time indoors with others — will be the best way to ward them off, said Dr Kirsten Bibbins-Domingo, a physician and professor at the University of California-San Francisco.

"It's very unsexy what the solutions are," Bibbins-Domingo said. "But we need everyone to do them."

That doesn't make the task simple. Masking remains controversial in many states, and the public's patience for maintaining physical distance has worn thin.

Adding to the concerns: Though case numbers have stabilized in many parts of the US in recent weeks, they have stabilized at rates many times what they were during previous periods in the pandemic or in other parts of the world. Having all that virus in so many bodies creates more opportunities for new mutations and new variants to emerge.

"If we keep letting this thing sneak around, it's going to get around all the measures we take against it, and that's the worst possible thing," said Nevada's Pandori.

Compared with less virulent strains, a more contagious variant likely will require that more people be vaccinated before a community can see the benefits of widespread immunity. It's a bleak outlook for a nation already falling behind in the race to vaccinate enough people to bring the pandemic under control.

"When your best solution is to ask people to do the things that they don't like to do anyway, that's very scary," said Bibbins-Domingo.

https://www.medscape.com/viewarticle/944875

Bellicum: FDA Lifted Clinical Hold on BPX-601 Phase 1/2 Clinical Trial

 Bellicum Pharmaceuticals, Inc. (NASDAQ: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.

Bellicum worked diligently with the FDA over the past two months to respond to the clinical hold and has been informed by FDA that the company has satisfactorily addressed all clinical hold issues. Bellicum may now resume enrollment without modification to the current study protocol. The company plans to work with clinical investigators to resume patient enrollment.

https://www.streetinsider.com/Corporate+News/Bellicum+Pharma+%28BLCM%29+Reports+FDA+Lifted+Clinical+Hold+on+BPX-601+Phase+12+Clinical+Trial/17881371.html

Novavax: COVID-19 Vaccine 89.3% Efficacy in UK Phase 3

 First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants

• Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
• Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
• Company to host investor conference call today at 4:30pm ET

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”

NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate. The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 – 72.8).

Novavax will host a conference call today at 4:30pm ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 7470222. A replay of the conference call will be available starting at 7:30 p.m. ET on January 28, 2021 until 7:30 p.m. ET on February 4, 2021. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 7470222.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until April 28, 2021.

https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

Vertex Cleared on Application for Novel Cell Therapy for Type 1 Diabetes

 - Vertex will initiate a Phase 1/2 clinical trial in first half of 2021 -

- VX-880 is the first stem cell-derived therapy evaluating fully differentiated pancreatic islet cells for the treatment of T1D -

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND, enabling the company to proceed with initiating a clinical trial for VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell therapy to treat T1D. Vertex plans to initiate a Phase 1/2 clinical trial in the first half of 2021 in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia.

"As we celebrate the 100th anniversary of the discovery of insulin this year, we are excited to bring a first-in-class cell therapy to the clinic with the potential to meaningfully impact people living with T1D," said Bastiano Sanna, Ph.D., Executive Vice President and Chief of Cell and Genetic Therapies at Vertex. "We look forward to getting our clinical program underway and testing our unique approach of replacing pancreatic islet cells, which are destroyed in people with type 1 diabetes, with our stem cell-derived fully differentiated insulin-producing pancreatic islet cells."

About VX-880
VX-880, formerly known as STx-02, is an investigational allogeneic human stem cell-derived islet cell therapy that is being evaluated for patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. VX-880 has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.

https://finance.yahoo.com/news/vertex-announces-fda-clearance-investigational-211100000.html

Sana Biotechnology Sets Terms for $323 Million IPO

 Fresh on the heels of filing with the U.S. Securities and Exchange Commission to raise up to $150 million in an initial public offering (IPO), preclinical biotech company Sana Biotechnology announced Thursday terms for its IPO to raise $323 million.

The Seattle, Wash.-based biotech company says it will raise the funds by offering 15 million shares at $20 to $23 per share. Michelle Seitz, Chairman and CEO of Russell Investments, was recently appointed the company’s chief financial advisor and will assist in the company’s financial planning and decision-making. BioSpace’s NextGen Bio “Class of 2021” recently named Sana Biotechnology as its top new life sciences companies to watch out for in 2021.

Under the terms of the newly announced IPO, Sana Biotechnology would command a market value of $4.0 billion at the midpoint of the proposed range. The recent filing of the $150 million IPO from Sana Biotechnology may not reflect the company’s likely market valuation, which experts expect to range between $9 billion and $12 billion.

The company plans to list itself on the Nasdaq under SANA. Joint bookrunners on the deal include Morgan Stanley, Goldman Sachs, J.P. Morgan and BofA Securities. Sana Biotechnology expects to price during the week of February 1, 2021.

Prime focuses of startup company Sana Biotechnology include the development of in vivo and ex vivo cell engineering platforms licensed from Harvard University to discover novel treatments across several therapeutic areas that currently have unmet treatment needs. Therapeutic areas of particular interest to the company include oncology, diabetes, central nervous system (CNS) disorders, cardiovascular diseases and genetic disorders.

Currently, all of Sana Biotechnology’s candidates are in preclinical development, and Investigation New Drug (IND) applications are expected to be submitted to the U.S. Food and Drug Administration some time in 2022 and 2023.

“We are excited to have placed this important technology with Sana, a startup which has assembled a world-class team to advance the development of allogeneic (off-the-shelf) cell therapies,” said Harvard OTD’s Vivian Berlin, Managing Director, Strategic Partnerships, in a statement. “The company’s leadership, vision, and focus on scaled solutions give us confidence that this groundbreaking technology can be developed and deployed to the fullest extent possible for patients.”

In summer 2020, Sana Biotechnology raised up to $700 million in initial financing to advance its discovery and development initiatives. This financing round saw funds from several investors, including Canada Pension Plan Investment Board, Baillie Gifford, Alaska Permanent Fund, the Public Sector Pension Investment Board, Bezos Expeditions, GV, Omega Funds and Altitude Life Science Ventures, among other unnamed institutions.

Sana Biotechnology said that the initial $700 million funding went into a pool to support both IND-enabling and initial clinical studies for different treatment candidates, in addition to further expanding the company’s manufacturing capabilities and helping to buildout of its enabling technologies portfolio.

Back in October 2020, Sana Biotechnology acquired Oscine, a company focused on the development of disease-modifying or potentially curative cell therapies for brain and CNS diseases. The acquisition integrated Oscine’s glial progenitor cell program, in addition to other technologies, to expand on Sana Biotechnology’s broader technology platform and initiatives. Detailed financial terms of the merger were not initially described in the announcement of the deal.

https://www.biospace.com/article/sana-biotechnology-sets-terms-for-323-million-ipo/