Well, trades of that magnitude I suspect are done by the likes of a Black Rock or Citadel, and odds are they have folks on their teams with phd's in this stuff. Sooo... who knows. When I saw those trades and wrote the PM's, I had no idea there was even another strain out there. I don't follow it like you do. That's why I came down here just now to ask, because I caught Gottleib on CNBC this AM talking about it. That was the first I'd heard.
The U.S. also extended the Covid public health emergency declaration due to the risk of a winter surge from these new Omicron variants. Biden administration extends COVID-19 public health emergency declaration https://thehill.com/policy/3687408-...ds-covid-public-health-emergency-declaration/
Progress continues to be made on a "universal vaccine" that will address all variants of Covid. Scientists are one step closer to an adaptation-proof COVID-19 vaccine https://medicalxpress.com/news/2022-10-scientists-closer-adaptation-proof-covid-vaccine.html A vaccine design approach that could protect against new variants of SARS-CoV-2 (the virus that causes COVID-19) but also potentially protects against other coronaviruses is one step closer to reality as a result of Penn State College of Medicine research. The scientists used areas of the SARS-CoV-2 virus that are less susceptible to mutation to engineer proteins called immunogens, which can elicit an immune response. SARS-CoV-2's surface spike protein—a major antibody target—allows the virus to enter host cells by engaging with a receptor called angiotensin-converting enzyme 2. Existing vaccines target the receptor binding domain (RBD) of the spike protein, but the susceptibility of RBD to mutations provides escape routes for the virus from neutralizing antibodies. "Variants of concern continue to emerge due to the spike protein's susceptibility to mutations," said Nikolay Dokholyan, G. Thomas Passananti Professor and vice chair for research in the Department of Pharmacology. "We identified areas of the spike protein that are least likely to mutate and used that information to engineer new proteins, which could be used to develop a vaccine that protects more broadly against not only future COVID-19 variants but potentially other related coronaviruses." Just weeks after the Centers for Disease Control and Prevention approved a new bivalent COVID-19 vaccine, the researchers published a study about the design and efficacy of their immunogens, which target the virus in a different way. Unlike current vaccines on the market, these immunogens are designed based on conserved regions of the spike protein, areas that are less susceptible to mutation. The team designed the immunogens by using computational biology to identify three regions of the spike protein that remain conserved in millions of theoretical mutations that could occur. These areas, called epitopes, were then matched and grafted, or attached, to protein scaffolds, which provided stability to the epitopes while in solutions. The immunogens were then structurally optimized through various design modifications, including stabilizing mutations. Computer simulations were used to test the stability of the immunogens. Dokholyan has previously described this computational biology approach. "Proteins are complex structures that are built to withstand a variety of physical and chemical challenges in nature," said Yashavantha Vishweshwaraiah, postdoctoral scholar in the Department of Pharmacology and first author on the paper. "Epitopes, which are small fragments of the protein, are not stable on their own in solution, so they need to be grafted to a larger protein for stability. This is similar to how a flower (epitope) might need its stem (scaffold protein) to survive. The flower may be the part of the interest, but it's not viable without the stem that offers structure and support." The team used recombinant expression, a technique where bacteria are given the genetic instructions to make proteins, to create the virtually designed immunogens. The proteins were then purified and studied in the lab to ensure they closely matched with their virtual counterparts. In the end, the researchers developed four stable immunogen designs which were used to immunize mice, who then produced antibodies against SARS-CoV-2. Each design produced antibodies to varying degrees, but one design, ED2, had a robust immune response. Through further testing, the researchers found these antibodies bound to the SARS-CoV-2 spike protein. They also evaluated how well the ED2 immunogen bound to serum samples from human COVID-19 patients using specialized chemical tests they developed. They found that the antibodies in COVID-19 patient serum samples were able to bind to the ED2 immunogens, demonstrating that they might also be used for diagnostic applications. The methodology and results were published in the journal Advanced Functional Materials on Oct. 3. According to researchers, further studies will be done to optimize the design and immune response of the immunogens. Once perfected, they could someday be used as vaccine candidates in clinical trials. "Our methodology could be used not just for SARS-CoV-2 and other related viruses, but also for other clinically important pathogenic viruses," said Vishweshwaraiah. "To our knowledge, we're the first to design immunogens based on conserved regions of the SARS-CoV-2 spike protein. The designed immunogens show promising results and [we] will plan to further optimize them." Brianna Hnath, Brendan Rackley, Jian Wang and Neil Christensen of Penn State College of Medicine; Abhinay Gontu, Suresh Kuchipudi and Neela Yennawar of Penn State Huck Institutes of the Life Sciences; and Morgan Chandler and Kirill Afonin of the University of North Carolina at Charlotte also contributed to this research.
Moderna says Omicron booster response stays high through 3 months https://www.reuters.com/business/he...ponse-stays-high-through-3-months-2022-10-19/ Moderna Inc (MRNA.O) said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months. Omicron-tailored shots by Pfizer Inc (PFE.N) and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron. "Clinical trial data now indicates that the superior immune response produced by our bivalent booster has durability for at least three months," Moderna Chief Executive Officer Stephane Bancel said in a statement. Moderna said it expects data from human trials of its BA.4/BA.5 targeted vaccine later this year.
An initial study on the bivalent boosters is out. More studies are in progress. New Covid Boosters Aren’t Better Than Old Ones, Study Finds https://www.bloomberg.com/news/arti...fizer-aren-t-better-than-old-ones-study-shows Bivalent booster shots from Moderna Inc. and Pfizer Inc. failed to raise levels of protective proteins called neutralizing antibodies against the dominant omicron strains any more than four doses of the original Covid vaccine, according to an early independent study on a small group of people. Researchers at Columbia University and the University of Michigan compared levels of neutralizing antibodies in blood samples from 21 people who got a fourth shot of the Moderna or Pfizer-BioNTech SE bivalent boosters against antibody levels in 19 people who got four shots of the original vaccines. Three to five weeks after a fourth shot, those people who received the new boosters aimed at BA.4 and BA.5 variants “had similar neutralizing antibody titers as those receiving a fourth monovalent mRNA vaccine,” the authors conclude in a manuscript posted on the preprint server bioRxiv.org. This held true for antibodies that protect against BA.4, BA.5 and older variants such as the original omicron strain, according to the study. Moderna shares rose 2.7% to $136.57 at the close in New York trading. Pfizer stock was little changed. The results don’t mean that getting a bivalent shot has no benefit, and it will need to be confirmed in much larger studies. However, they raise the question of whether the switch to a new version of the vaccine was necessary. The results also contrast sharply with an Oct. 13 press release from Pfizer and BioNTech touting “positive early data” from a clinical trial suggesting that its bivalent vaccine “is anticipated to provide better protection.” The statement was based on data collected from subjects in the first seven days after immunization, and the company has not yet released details. “Little difference in antibody levels is shown between a bivalent booster and the original shots, potentially opening the door to competing vaccines from the likes of Sanofi and GSK.” -Bloomberg Intelligence analyst Sem Fazeli, click here for research “So far we don’t see the benefit” of the bivalent shots over the old ones, said study senior author David Ho, a virologist who heads the Aaron Diamond AIDS Research Center at Columbia University. A clear difference between the boosters could emerge over longer periods of time, he said in a telephone interview. It could also turn out that a second booster shot with the bivalent vaccine may be needed, he said. Ho said that the study has been submitted for publication in a scientific journal. Slow Rollout Rollout of the bivalent vaccines has been slow so far. Only about 20 million Americans have received the latest version of the vaccine, according to the Centers for Disease Control and Prevention. The lackluster results for bivalent boosters could be due to a phenomenon called imprinting, Ho said. That means that the immune system most strongly remembers the first version of a virus it encounters. After it mutates, the response to a vaccine -- even one targeting newer strains -- may still be tilted toward fighting the original pathogen. Ho said he personally has gotten four doses of the original generation of mRNA shots, and that he is waiting for more data to roll in to decide what to do about a fifth dose. Pfizer declined to comment on outside research. A spokesperson said the company would reveal additional 30-day data on its bivalent shot in the coming weeks. Moderna didn’t immediately respond to a request for comment. In early October, Moderna researchers published data from the clinical trial of a different bivalent booster that is tailored to the original omicron strain. That study, in the New England Journal of Medicine, found that a fourth shot of that bivalent vaccine produced higher levels of antibodies compared to four shots of Moderna’s original vaccine. Moderna’s bivalent vaccine against the original omicron strain, called mRNA-1273.214, is not authorized in the U.S., but has been cleared for use in numerous countries including the UK and Canada. Nonetheless, scientists have harbored doubts about the benefit of switching up the shots’ composition. Before the US began rolling out updated boosters in September, John Moore, a professor of microbiology and immunology at Weill Cornell Medical College said the new vaccines would be “little or no better” than earlier formulations.
Pfizer Says New Covid Booster Works Better Than Old One in Study Company’s results contrast with data from Harvard and Columbia In people over 55, new shot made more antibodies than old shot https://www.bloomberg.com/news/arti...r-fought-omicron-better-than-old-one-in-study Pfizer Inc.’s bivalent vaccine bolstered protective antibodies against the dominant omicron strains substantially more than its original booster in people older than 55, according to a company study that suggests the new booster may provide an enhanced level of protection. Pfizer and German vaccine partner BioNTech SE compared blood samples from 36 people older than 55 who had received the bivalent booster with those from a control group of people over 55 who had received a fourth dose of the original shot. One month later, antibody levels against the widespread BA.4 and BA.5 variants were four-fold higher in people who had received the bivalent shot when compared with those who had received another dose of the original vaccine, the companies said Friday in a statement. Those findings contrast sharply with recent results from two independent labs at Columbia University and Harvard University. Both of those teams reported in October that bivalent boosters made by Pfizer and rival Moderna Inc. didn’t appear to provide much incremental benefit when compared with a fourth dose of the original vaccines, according to studies posted on the preprint server bioRxiv.org. Pfizer’s own study, however, suggests that the bivalent shot “may induce a higher level of protection against the omicron BA.4 and BA.5 sublineages than the original vaccine,” the company said in its statement. The drugmaker has shared its results with the US Food and Drug Administration and said it plans to give them to regulators elsewhere soon. Debate Implications Pfizer didn’t release a direct comparison of how the bivalent booster fared in comparison with four doses of the original shot in adults younger than 55. But it did say that the bivalent shot raised antibodies against the BA.4 and BA.5 strains 9.5-fold in the 18- to 55-year-old age group compared to their pre-booster levels. In the over-55s, it raised antibody levels 13.2-fold. By comparison, a fourth shot of the original booster raised antibodies 2.9 times in people over 55. A third academic study from Emory University posted this week was more in line with the Pfizer results, suggesting that the bivalent shot broadens immunity against omicron variants. However, a fourth study from researchers at the University of Texas Medical Branch in Galveston found that the bivalent shot, while generally stimulating more antibodies against omicron than the original vaccine, “does not produce robust neutralization” against the latest omicron strains, including the BQ.1.1. variant that’s rapidly taking hold in the US. Both studies were posted on bioRxiv.org. It isn’t clear why various studies have produced what appear to be divergent results. All of them are small and have not yet been published in scientific journals. The debate over the findings may have important implications. Both the Harvard and Columbia studies hint that the immune system response may become biased toward protecting against the original version of Covid virus. If true, that’s a potential problem that companies developing booster shots against future variants will have to find ways to surmount. Rollout of the new bivalent boosters from Moderna and the Pfizer-BioNTech partnership are off to a slow start in the US. The Centers for Disease Control and Prevention estimates that only about 26 million people have received them so far. Pfizer rose 1.7% as of 10:40 a.m. in New York, while BioNTech’s American depositary receipts gained 6.3%. Moderna gained 4.4%.
Progress continues to be made on a universal Covid vaccine. How A New COVID Vaccine Type Could Eliminate The Need For Boosters https://www.medicaldaily.com/how-new-covid-vaccine-type-could-eliminate-need-boosters-467394 Groundbreaking research is working on a new vaccine that could change how the medical community handles the COVID-19 pandemic. Scientists in San Antonio, Texas, are creating an entirely new type of COVID-19 vaccine that could eliminate the need for boosters in the future, KSAT reported Monday. “We know the virus is like a ball with spikes on it,” said Dr. Sherwyn Schwartz, adding that the current vaccines target the spikes on the virus. Schwartz’s team at Endeavor Clinical Trials in San Antonio is one of the 10 locations hosting clinical trials of a new type of vaccine for COVID-19 infections. Instead of the spikes, the new vaccine would be targeting the ball itself to prevent mutation in the body. “This is going to be a mechanism of action going after the ball, and the ball doesn’t mutate as much. If this vaccine is going to work and not be affected by mutations, my gosh, we won’t have to take one every year,” he told the news outlet. According to Schwartz, this could make it possible for everyone to get boosters every two or three years. But he is hopeful that the boosters could ultimately become a “one and done” thing. Clinical trials for the vaccine will commence in two weeks, so Schwartz and his team are eager to get participants onboard. The volunteers they are looking for should be aged between 18 and 55 and must have had three mRNA vaccine shots from Moderna or Pfizer before entering the trial. Participants should also be healthy and free from underlying conditions, with Schwartz saying, “We want to be sure that you don’t have an underlying illness that’s going to act like a side effect of the vaccine.” Trial participants will be compensated for their time and transportation since they stay in the clinic for a few hours after receiving the shot for monitoring. Schwartz said that if phase one becomes a success, they will move forward with phases two and three, and the people of San Antonio would be the first to gain access to the vaccine. Those interested in the clinical trials can sign up online via this site, or simply call (210) 880-9440. Based on the updated statistics presented by The New York Times, the United States has recorded a total of 97.3 million cases and 1.07 million deaths due to COVID-19 thus far.
Moderna data suggest new Covid booster is more effective against Omicron variants https://www.statnews.com/2022/11/14/moderna-bivalent-covid-booster-effective-omicron/ New data indicate Moderna’s Covid bivalent booster may be more effective against currently circulating Omicron variants of the virus than its original vaccine, the company said Monday. Like data released by Pfizer and BioNTech regarding their Covid vaccine, the new data involves lab measurements of antibodies and their ability to neutralize the SARS-CoV-2 virus, not data on how well the vaccines prevent cases of symptomatic illness or severe disease. Moderna said in a press release that giving its current booster led to an increase in the number of antibodies that neutralize the most common Omicron variants, BA.4 and BA.5, by 15-fold. The data have not been published in a peer-reviewed journal or released in a preprint. That meant that the geometric mean titers of BA.4/BA.5 antibodies were 5.11-fold higher for those who received the new booster compared to those who received a booster of the original Moderna Covid vaccine if those people had been previously infected with Covid. For those without previous Covid infection, those numbers were 6.29 times higher than with the original vaccine. One caveat is that with previous studies of experimental Moderna boosters that targeted new strains of the virus, it was possible to compare volunteers who received the original vaccine and the modified one at the same time. But the new booster, which targets both the original strain of the SARS-CoV-2 virus and the Omicron sub-variants BA.4/BA.5, was authorized by the Food and Drug Administration before such a study was conducted. Jacqueline Miller, a Moderna senior vice president, said that the company did not think it was ethical to enroll a new cohort on the original Moderna booster when the recommendations from the FDA and the Centers for Disease Control and Prevention were that people should get a booster that is more targeted at the BA.4/BA.5 strains. So far, results have been mixed as to whether the BA.4/BA.5 boosters are more effective against the new strains than the original shots. Studies conducted in the laboratories of the vaccine researcher Daniel Barouch, of Beth Israel Deaconess Medical Center, and the virologist David Ho, of Columbia University, have indicated that the new shots may not be more effective than the original one. But studies conducted at the University of Texas and at Emory University have shown that the new shots may yield better antibody protection. Miller emphasized that Moderna has used consistent methods for its antibody studies, including for the earlier studies that showed the original vaccine was effective, and that those studies have been greenlit by the FDA. Eric Topol, director and founder of the Scripps Research Translational Institute, said that he viewed the new results as positive and largely confirmatory of the Emory work. He also praised the study for its relatively large size, involving 511 previously vaccinated volunteers. “This study is encouraging and suggests that the bivalent boosters provide an added benefit compared to the prior mRNA-1273 booster,” said Mehul Suthar, lead author of the Emory analysis, in an email. “We will need to stay up to date with this bivalent booster to protect against yet another Omicron wave this fall/winter.” Moderna also said that the new booster appeared to be effective against a new worrisome variant, BQ1.1, in a preliminary study using samples from 40 of the study’s volunteers. “What people have been looking for is an understanding of, ‘if I got this booster what does my protection look like against BQ1.1 or some other variant,’” Miller said. “Ultimately the effectiveness data are the really important data.” She said that Moderna expects data from an ongoing observational study to help answer that question in the first quarter of next year.
As expected the bivalent booster is far more effective against Omicron infection than the original Covid vaccinations in a large scale study. New booster shots cut risk of symptomatic COVID-19 White House begins booster push as holiday season begins https://rollcall.com/2022/11/22/new-booster-shots-cut-risk-of-symptomatic-covid-19/ The new bivalent COVID-19 booster shots are up to 56 percent more effective at preventing symptomatic COVID-19 infection than the two original COVID-19 vaccines in adults ages 18 and up, according to new data from the Centers for Disease Control and Prevention. The data, released Tuesday, is the first batch of effectiveness data from an official, large-scale study on the updated shots, which have been on the market since early October. The updated boosters target the BA.4 and BA.5 strain of the omicron variant, as well as the original strain. The original shots and first booster that Americans received targeted only the ancestral strain of COVID-19. The data comes as the White House launches a six-week public education initiative to get Americans boosted ahead of the holidays. The push includes $350 million for community health centers and $125 million for organizations serving the elderly and disabled, as well as targeted ad campaigns. Just 11 percent of Americans 5 and older have received an updated booster, although officials are not expecting a wave of hospitalizations and deaths similar to those in previous years. Outgoing and longtime director of the National Institute of Allergy and Infectious Diseases Anthony Fauci encouraged all eligible Americans to get booster shots in the coming weeks to provide protection before the holidays. Tuesday likely marked Fauci’s last time at the White House podium before he retires at the end of the year after 38 years working at the National Institutes of Health. “It is clear now, despite an initial bit of confusion, that the BA.4/5 bivalent booster, what we refer to as the updated vaccine, clearly induces a better response against BA.4/5 and the sub lineages of BA.4/5 than does the ancestral strain,” Fauci said. “So from a pure immunological standpoint, it looks quite good.” Among people who received their last COVID-19 shot more than eight months ago, the updated boosters provided more protection against symptomatic disease compared to two monovalent shots. Adults ages 18 to 49 received as much as 56 percent more protection, people ages 50 to 64 received as much as 48 percent more protection, and adults 64 and older received 43 percent more protection, the data found. More than 360,000 people participated in the study. Just 13.1 percent of adults ages 18 and up have received the updated booster shot, according to agency data. Fauci noted that the booster offers less protection against the XBB variant — which is currently circulating abroad — because that variant evades antibodies. But he also noted that antibodies are only one component of the body’s defense system, which includes memory B cells and T cells. “It doesn't fall off the map,” he said of the booster’s protection against XBB. “But it goes down. So you can expect some protection but not the optimal protection.” Tempers flared during the briefing as several reporters attempted to shout questions about whether Fauci has done anything to personally investigate COVID-19’s origins, which has evolved into a serious question and a political flashpoint. Those questions were ignored, but Fauci reiterated his willingness to testify before House Republicans after they recaptured the majority in the midterm elections. “If there are oversight hearings, I absolutely will cooperate fully and testify before the Congress when asked,” he said. “You may not know, but I have testified before the Congress a few hundred times over the last 40 years or so. So I have no trouble testifying. We can defend and explain and stand by everything we’ve said. So I have nothing to hide.”