White House gets set for cautious pivot on pandemic

 The White House is preparing to pivot on the pandemic — but with a different approach than the July 4 celebration last summer that some have subsequently criticized as premature.   

“No one wants a repeat of last July,” said one Democratic strategist.   

At the Independence Day event, President Biden declared near “independence” from COVID-19.   

What followed were the delta and omicron variants, which caused spikes in cases and hospitalizations, contributing to the COVID fatigue that has been a factor in declining approval numbers for Biden.   

New evidence is now emerging that gives the White House and plenty of others hope that the nation is veering out of the pandemic.   

The omicron variant is showing signs of fading: coronavirus cases are on the decline across the country. The White House is signaling that the new phase is about being able to live with the virus.   

But there is caution in Democratic circles after the bad turns from last summer and fall.  

“We can’t spike the football when we’re dealing with a huge unknown,” the strategist said.   

Biden administration officials haven’t said much publicly about their plans and have made clear they’re still focused on ushering the country through the current surge of the pandemic.  

“Our progress over the last year and the tools we now have certainly allow us to get closer to a time when COVID doesn’t disrupt our daily lives but is something we protect against and treat,” White House COVID-19 response director Jeff Zients said Wednesday during a briefing with reporters. “As we make more progress against omicron, we’ll, you know, get closer to that point.”  

Political observers say the White House needs to hammer home the new approach in the coming months and beyond.   

“It’s like when you’re preaching: You gotta tell them what you’re gonna tell them. Then you gotta tell them. And then you gotta tell them what you just told them,” said Michael Eric Dyson, the renowned professor and author who is also an ordained minister. “You gotta keep telling the story.   

“Repetition is our friend,” added Dyson, who met with Biden as part of a conversation with a group of academics last year.   

Mark McClellan, a former FDA commissioner under George W. Bush, said there are some steps the administration is already taking to prepare for a more endemic phase of the virus. Officials are in touch with vaccine makers working on omicron-specific vaccines, for instance. And they’ve made surplus purchases of tests that are being distributed to Americans free of charge.  

“It’s definitely time to move towards a more ongoing, robust, resilient strategy to prevent a surge from ever happening again while enabling people to get back to more normal life,” McClellan said. “The public needs some more straight talk and guidance on what to do in this new phase.”  

It’s unclear whether or when Biden himself plans to outline the way forward in the pandemic. White House officials and health experts say the country still has some time before reaching some kind of “new normal.”  

“COVID as it is today is not COVID forever and we’re actively working towards that and what that will look like,” an administration official said, emphasizing that the tools the U.S. has to fight the virus are working. 

Biden on Friday touted a strong jobs report that showed the U.S. economy added 467,000 jobs during the month of December despite the omicron wave. He also sounded a bit of a positive note on the pandemic.  

“The COVID crisis has been cut in half, down in half in just three weeks,” Biden said during a speech on the jobs report. “Still too many cases, still we have to be on the alert, but to be clear, this is a dramatic decline.”  

A group of outside health experts are preparing a detailed plan on a forward-looking COVID-19 strategy that they hope to have completed by early March and are planning to send to the White House, according to one former member of the Biden transition advisory team who is involved with the development of the plan.   

The person described a shift in the White House strategy on COVID-19 as “critical” but said that the administration and the public health community need to handle the pivot carefully, given the unknowns of future variants and the large pool of unvaccinated people in the nation. 

“We all have to be careful,” the person said. “Everyone.”  

Democrats largely agree that the White House shouldn’t rush to move away from the issue. Instead, Biden and his team need to realistically portray the realities of an elusive virus, they say.   

“It’s time to have a serious conversation with the American people and say that we are going to be living with this for a long time,” said Democratic strategist Rodell Mollineau. “We’ve been looking at this in a very binary way. Things are likely to never go back to normal, but it doesn’t mean we have to live in fear.”   

Some Democrats and health experts do not fault Biden for the July 4 speech, which was an address to frontline workers at the White House that celebrated a large segment of the eligible population getting vaccinated against COVID-19.   

The administration official said that the White House has always been clear about the unpredictability of the virus, noting that Biden included a warning about the more contagious delta variant in his address last summer.  

Lawrence Gostin, a public health law professor at Georgetown University, said the U.S. is in a far different place than last summer due to an overwhelming segment of the population having protection against the virus due to the vaccines or recovery from COVID-19.   

“We need to assure the public that, unless some really serious variant causes another emergency, that we’re going to soon stop our emergency response and start with a ‘living with COVID’ response,” Gostin said.  

https://thehill.com/homenews/administration/592906-white-house-gets-set-for-cautious-pivot-on-pandemic

Europe Could Soon Enter COVID-19 'Ceasefire', Long Period Of Tranquility: WHO Europe Director

 by Katabella Roberts via The Epoch Times,

The World Health Organization’s (WHO) Europe director said on Thursday that the continent could soon enter a “cease-fire” and a “long period of tranquillity” in the CCP (Chinese Communist Party) virus pandemic.

Dr. Hans Kluge cited increased immunity to Omicron either through vaccines or natural immunity, a “favorable seasonality pause” as Europe nears the end of winter, and the less severe nature of the Omicron variant as reasons for the more tranquil period.

Speaking to reporters from Geneva, he said:

“This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace.”

“This context, that we have not experienced so far in this pandemic, leaves us with the possibility for a long period of tranquility and a much higher level of population defense against any resurgence in transmission, even with a more virulent variant.”

Despite the more optimistic view, Kluge warned European nations to continue with their vaccination and boosting campaigns to preserve immunity and to maintain surveillance of strains to detect new variants of the CCP virus, which causes COVID-19.

He also urged European governments to continue promoting “self-protecting behavior and individual responsibility” such as social distancing and hand sanitizing to limit unnecessary socio-economic impacts of the virus.

If new variants of COVID were to emerge, Kluge said he believes that it is possible for European governments to respond in a manner that does not require the kind of “disruptive measures” that were needed before.

However, Kluge also warned that this was “not to say that (the pandemic) is now all over,” but “there is a singular opportunity to take control of the transmission.”

The WHO Europe director’s comments come as the continent recorded 12 million new COVID-19 cases in the past week, the highest weekly number of cases since the start of the pandemic.

Those figures are being largely driven by the highly transmissible Omicron variant, which is sweeping from west to east, Kluge said, adding that 30 percent of all COVID-19 cases since the pandemic began have been reported this year alone.

The EU health agency, the European Center for Disease Prevention and Control (ECDC) says that the overall level of risk to public health in Europe is “very high.”

But while hospitalizations continue to rise, particularly in those countries with lower vaccination rates, the less severe nature of Omicron means that officials have not seen a significant spike in those needing critical hospital care.

As such, multiple countries across Europe have started to relax COVID-19 rules and restrictions in recent weeks as they learn to live with the virus.

At the end of January, England lifted multiple restrictions that were put in place in December after Omicron cases were found in the country.

Brits are no longer required to wear masks in enclosed places and the NHS COVID pass which was previously required to enter nightclubs and large events is no longer needed, although organizations can still choose to use the vaccine passport if they wish to do so.

Elsewhere in the Netherlands, which has been under a hard lockdown since mid-December, the Dutch government last month announced a lifting of restrictions on Jan. 26, to allow the hospitality industry to again welcome back customers.

The Danish government has also decided that “COVID-19 should no longer be categorized as a socially critical disease after 31 January 2022” and has lifted virtually all of the restrictions previously put in place.

France last week eased some restrictions for vaccinated residents but unvaccinated people who are over 16 are barred from domestic flights and interregional trains, restaurants and bars, sports events, cinemas, theaters, and other venues.

On Thursday, Sweden’s government announced it will end all COVID-19 restrictions in place as of Feb. 9.

“It is time to open up Sweden again,” Prime Minister Magdalena Andersson said during a press briefing. “While the pandemic is not over, it has entered an entirely new phase.”

https://www.zerohedge.com/covid-19/europe-could-soon-enter-covid-19-ceasefire-long-period-tranquility-who-europe-director

J&J tried to get federal judge to block publication of Reuters story

 Johnson & Johnson tried to get a U.S. judge to block Reuters from publishing a story based on what it said were confidential company documents about the healthcare giant's legal maneuvers to fight lawsuits claiming its Baby Powder caused cancer.

"The First Amendment is not a license to knowingly violate the law," said the company in a filing late Thursday in U.S. Bankruptcy Court in New Jersey, where a unit of J&J had sought bankruptcy protection while defending the Baby Powder lawsuits. The First Amendment of the U.S. Constitution protects freedom of the press.

On Friday, Reuters reported that J&J secretly launched "Project Plato" last year to shift liability from about 38,000 pending Baby Powder talc lawsuits to a newly created subsidiary, which was then to be put into bankruptcy. By doing so, J&J could limit its financial exposure to the lawsuits.

After the publication of the story, Reuters asked U.S. Bankruptcy Judge Michael Kaplan to deny J&J's motion, claiming it was moot. Less than an hour after Reuters submitted its letter, J&J said in a filing that it was withdrawing a request for an immediate hearing on the matter but was "not prepared to agree" that its request regarding the documents was moot.

J&J said in its filing after the publication of the story that it intends to continue discussions with Reuters and said it was "heartened that publication of confidential documents may no longer be imminent."

J&J's request to block publication was "among the most extraordinary remedies a litigant can request under the law," attorneys for Reuters, a unit of Thomson Reuters, said in a Friday court filing. The news agency's lawyers called J&J's request a "prior restraint of speech on a matter of public interest."

J&J said Reuters had obtained documents that were protected from public disclosure by an order from Kaplan. The company demanded that Reuters return the documents and refrain from publishing information gleaned from the documents.

"This is a complex matter that should be heard by the court – in a forum where both sides present their cases in an appropriate setting – and not argued through the media," a J&J spokesperson said in a statement on Friday.

Reuters denied that it has confidential information, saying in court papers that the confidentiality of one of the documents was lifted in January and that the second is not in the possession of Reuters.

J&J's LTL unit filed for bankruptcy in October to resolve the claims alleging J&J's talc-based products contained asbestos and caused mesothelioma and ovarian cancer.

J&J maintains that its consumer talc products are safe and have been confirmed to be asbestos-free.

The company has said it placed LTL into bankruptcy to settle those claims rather than litigating them individually. It has said resolving these claims through Chapter 11 is a legitimate use of the restructuring process.

Talc plaintiff committees argue that J&J should not be permitted to use bankruptcy to address the talc litigation and that by doing so, it is depriving plaintiffs their day in court.

https://finance.yahoo.com/news/j-j-tried-federal-judge-235514656.html

Alnylam upped to Buy from Neutral by Guggenheim

 Target $170

https://finviz.com/quote.ashx?t=ALNY

HIV vaccine research moves forward with immunogen that produces tier-2 antibodies

 Nearly four decades after its discovery, HIV has killed 36.3 million people, with no vaccine in sight. However, a new study by researchers at The Wistar Institute, an international biomedical research leader in cancer, immunology, infectious disease, and vaccine development, takes a promising step in the direction of developing an HIV vaccine.

The findings, published in Nature Communications, demonstrate the promise of using a unique native-like trimer to develop Tier-2 neutralizing antibodies -- the kind that matter for combating HIV -- in mice for the first time.

Previously, eliciting these types of antibodies using candidate vaccines required long and expensive experiments in large animal models creating a significant bottleneck on HIV-1 vaccine development. "With our new finding, we have opened the door to rapid, iterative vaccinology in a model that can produce Tier-2 neutralizing antibodies, enabling development of more advanced HIV vaccine concepts," said Daniel Kulp, Ph.D., associate professor in the Vaccine & Immunotherapy Center at The Wistar Institute and corresponding author on the paper.

The researchers encoded the native-like trimer into DNA for delivery into the mice. This has the practical advantage of turning the host bodies into "antigen factories" instead of requiring what would otherwise be a complex vaccine manufacturing process. The researchers then compared the results from the mice who received the DNA-encoded native-like trimer to results from mice who received a standard protein immunization. Only those mice that received the DNA-encoded native-like trimer developed Tier-2 neutralizing antibodies.

"We were able to generate strong immune responses with both platforms, but the DNA platform uniquely drove this neutralizing response," said Kulp.

Once they'd verified their immunization regime was producing Tier-2 antibodies, Kulp and his colleagues isolated monoclonal antibodies from the mice and used cryo-electron microscopy to determine the atomic structure of one Tier-2 neutralizing monoclonal antibody. They found that the antibody binds to an epitope (a segment of a protein that sticks out of the antigen, which prompts an immune response) called C3V5. In the gold standard HIV vaccine model (non-human primates), prior research has shown that antibodies binding to C3V5 protect animals from a SHIV infection, which is a close relative of HIV that infects non-human primates.

"The structure gives us incredible insight into how this antibody is able to neutralize the virus," said Kulp. "For the first time, we can strategize about how to design new vaccines that can generate broadly neutralizing antibody responses to the C3V5 epitope."

Coauthor David B. Weiner, Ph.D., executive vice president and director of the Vaccine & Immunotherapy Center and the W.W. Smith Charitable Trust Professor in Cancer Research at The Wistar Institute, emphasized the utility of their findings.

"What we've done is enable direct in vivo self-assembly of structurally designed immunogens, which are engineered and delivered using nucleic acid technology, inside the vaccinated animal. Our data demonstrating induction of autologous Tier 2 neutralization illustrate the value of this approach as a tool to create surgically tailored immunity against a difficult pathogen's vulnerable sites, in this case for HIV."

Work supported by: National Health Institutes (NIH) IPCAVD Grant U19 Al109646-04; W. W. Smith Charitable Trust; and Wistar Monica H.M. Shander Memorial Fellowship.

---

Story Source:

Materials provided by The Wistar Institute. Note: Content may be edited for style and length.

---

Journal Reference:

1. Ziyang Xu, Susanne Walker, Megan C. Wise, Neethu Chokkalingam, Mansi Purwar, Alan Moore, Edgar Tello-Ruiz, Yuanhan Wu, Sonali Majumdar, Kylie M. Konrath, Abhijeet Kulkarni, Nicholas J. Tursi, Faraz I. Zaidi, Emma L. Reuschel, Ishaan Patel, April Obeirne, Jianqiu Du, Katherine Schultheis, Lauren Gites, Trevor Smith, Janess Mendoza, Kate E. Broderick, Laurent Humeau, Jesper Pallesen, David B. Weiner, Daniel W. Kulp. Induction of tier-2 neutralizing antibodies in mice with a DNA-encoded HIV envelope native like trimer. Nature Communications, 2022; 13 (1) DOI: 10.1038/s41467-022-28363-z

https://www.sciencedaily.com/releases/2022/02/220204085437.htm

Approval of COVID vaccine made in South Africa could take 3 years: WHO

 The mRNA-based COVID-19 vaccine produced at the World Health Organization-backed vaccine hub in South Africa could take up to three years to get approval if companies do not share their technology and data, a WHO official said on Friday.

The WHO-backed tech transfer hub in South Africa was set up in June to give poorer nations the know-how to produce COVID-19 vaccines, after market leaders of the mRNA COVID vaccine, Pfizer, BioNTech and Moderna, declined a WHO request to share their technology and expertise.

Martin Friede, coordinator of the WHO Initiative for Vaccine Research, said if companies with approved COVID vaccines or late stage clinical data shared their technology and data with the consortium, the vaccine produced in South Africa could be approved in 12 to 18 months.

“..It could be 12 months if there was a partnership with a company that already has an approved vaccine. Otherwise, it’s more like 24 to 36 months depending on what the approval process is.”

On Thursday, South Africa’s Afrigen Biologics, which was part of WHO’s consortium, said it has used the publicly available sequence of Moderna’s mRNA vaccine to make its own version of the shot.

The WHO has been trying to persuade Moderna and Pfizer-BioNTech to join forces with its African tech transfer hub.

Friede said the vaccine will be going into first clinical trials in fourth quarter of this year.

“Now have the challenge of having to scale this up. And this is of course where we’re going to run into some challenges.”

https://wtvbam.com/2022/02/04/approval-of-covid-vaccine-made-in-south-africa-could-take-3-years-who-says/

Wyden still undecided on FDA pick, presses for plans on accelerated drug approvals

 Biden's  pick to lead the Food and Drug Administration (FDA) pledged to Sen. Ron Wyden (D-Ore.) that he would crack down on companies that take advantage of the agency's accelerated approval pathway.

But in a letter released Friday, the chairman of the Senate Finance Committee said that even though he extracted that promise from Robert Califf, he's still not satisfied.

Under the accelerated approval pathway, the FDA can accept lower quality evidence from manufacturers in order to expedite approval if the drug will address a serious unmet medical need.  

But Wyden said some companies have been taking advantage of the process by not following up with the required studies even after gaining approval, and the FDA has not been holding those companies accountable. 

The accelerated approval process was most notably used to approve Aduhelm, the controversial Alzheimer's drug from Biogen. 

The company gained accelerated approval for Aduhelm last summer, but the decision came despite mixed evidence at best that the drug worked. A committee of outside scientific advisers to FDA said the drug shouldn’t have been approved, and three members resigned.

Wyden said that during his meeting with Califf on Monday, Califf pledged to "take strong action" within his first 30 days to ensure the agency holds companies accountable for providing the necessary follow-up evidence.

But Wyden said he needed to know just how forceful Califf will be. In the letter, he asked Califf a series of questions, including how he will determine a company's failure to comply, and what authorities he will use to hold companies accountable. 

Califf previously led the FDA from Feb. 2016 to Jan. 2017 under former President Obama, but his confirmation this time is uncertain. At least five Democrats have already spoken out against him, and it's not yet clear if enough Republicans will support him to make up the difference.

Sen. Elizabeth Warren (D-Mass.) recently said she would vote to confirm Califf after he made significant ethics concessions, including a pledge not to seek employment or compensation from any drug or medical device companies he interacts with as commissioner.

https://thehill.com/policy/healthcare/592900-wyden-still-undecided-on-fda-pick-presses-for-plans-on-accelerated-drug