Cramer: Abbott, Regeneron can go higher thanks to Covid delta surge

 CNBC’s Jim Cramer said Tuesday he sees more near-term upside for shares of Abbott Laboratories as the U.S. grapples with the Covid delta variant.

The “Mad Money” host pointed specifically to the company’s BinaxNOW coronavirus test, a self-administered diagnostic that can be bought over the counter at pharmacy chains like Walgreens and CVS.

“This Binax is now the hottest product on the market. Just as Abbott had to pre-announce how poorly Binax was doing, sometimes I wonder if they have to pre-announce to the upside now that it’s doing so well,” Cramer said.

The Food and Drug Administration authorized Abbott Labs’ rapid Covid test for at-home use in December, right around the time vaccines for the disease were cleared on an emergency use basis. As availability of the BinaxNOW test increased during the spring, so too did access to Covid vaccines, which helped drive down coronavirus infection levels across the country.

Now, in recent weeks, coronavirus cases have jumped in the U.S., leading Cramer to believe more and more Americans are going to seek out Abbott Labs’ rapid test.

“We’ve got so many antivaxxers in this country that they’ve kept the pandemic alive and now we’ve got new variants with a decent chance of breaking through the vaccines from Pfizer and, to a lesser extent, Moderna. You know what that means? Testing, testing, testing,” Cramer said.

The Covid situation also is benefiting shares of Regeneron, which makes an antibody therapy to treat the disease, Cramer said.

“The tables have turned, the fortunes restored for Regeneron and Abbott Labs. Their stocks have been up all along with all the other slowdown winners,” Cramer said, alluding to the fact shares of Regeneron and Abbott Labs are up 11% and 7%, respectively, in the past month. That compares with the S&P 500′s roughly 2.8% gain in the same time period.

“Now they have another kicker, and I think they’ve still got higher to go,” Cramer said.

https://www.cnbc.com/2021/08/17/jim-cramer-says-abbott-laboratories-shares-can-go-higher-thanks-to-covid-delta-surge.html

Third COVID Vaccine Dose Could Be the Last?

 As the Biden administration prepares to recommend booster shots for the majority of Americans, some experts are saying the third dose could be the final one.

But what evidence leads them to believe that COVID-19 can be defeated by a three-dose series?

For starters, a longer duration between the second and third dose may provide stronger and longer-lasting immunity, experts said.

Peter Hotez, MD, PhD, of Baylor College of Medicine in Houston, said on CNN Monday night that a 3-week interval between the first and second doses of Pfizer's mRNA vaccine, for instance, may not have been enough time to spur an extended immune response, with the initial shots acting only as a primary immunization.

An 8-month lag, on the other hand, could boost immunity significantly, Hotez said, with the potential to yield high levels of virus-neutralizing antibody and an immune response that is "really robust."

"That may be it for a while, we may not need annual boosters," Hotez said. "This could be the third and done."

Since it's typical for antibodies to wane over time, it's common for vaccines to be administered in multiple doses over a longer time period. People get three shots over a 6-month period for hepatitis B, for instance, and a four-dose regimen is recommended for polio.

"In fact, it is unusual to give a one-dose, give-and-go vaccine," John Moore, PhD, professor of microbiology and immunology at Weill Cornell Medicine in New York, told MedPage Today. "Most vaccines require at least two shots."

In a multi-dose vaccine regimen, a longer interval between doses gives the immune system time to mature, Moore said. During this time period, a process called affinity maturation takes place, which causes antibodies to improve in quality while dwindling in number, he said.

Moore said studies have shown that people who were previously infected with COVID-19 experience affinity maturation, as they have higher quality antibodies months after initially getting sick.

However, a third dose may also promote this process, he added. When a vaccine delivers another round of antigen to the body, it activates memory B cells, and allows them to produce improved, higher-quality antibodies to fight COVID-19.

Monica Gandhi, MD, MPH, of the University of California San Francisco, said that a longer duration between COVID-19 injections will certainly improve the immune response. Gandhi -- who does not believe a third dose for immunocompetent people should be given ahead of global vaccination distribution -- added that boosters would likely not be recommended if not for the highly transmissible Delta variant.

Once caseloads are down, she added, people probably won't need regular COVID-19 vaccinations in the future.

"I don't think we are going to need boosters every year," Gandhi told MedPage Today. Coronaviruses do not have a high propensity to mutate like influenza, so by the time antibodies wane -- an expected outcome -- higher levels of immunity in the general population will probably prevent people from needing additional jabs, she said.

But Moore said there's still not enough data to know for sure whether an annual booster will be needed. Unknown factors such as new outbreaks or emerging variants will influence recommendations for additional immunizations.

"It's crystal-ball gazing," Moore said. "Who knows where we are going to be in a year's time."

https://www.medpagetoday.com/special-reports/exclusives/94089

Soligenix: Positive Preclinical Data with Multiple Heat Stable Filovirus Vax Candidates

 Soligenix Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive data demonstrating the efficacy of multiple filovirus vaccine candidates in NHPs, including thermostabilized multivalent vaccines in a single vial platform presentation.  Collaborators at the at the University of Hawaiʻi at Mānoa (UHM) describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology. These vaccine candidates contain highly purified protein antigens combined with the novel CoVaccine HT™ adjuvant, in both monovalent (single antigen) and bivalent (two antigen) formulations. Most recently, efforts to formulate all three antigens and adjuvant into a thermostable single-vial vaccine platform has also been shown to protect 75% of vaccinated NHPs against subsequent Sudan ebolavirus challenge, with further development to test efficacy against other filovirus infections ongoing.

https://www.biospace.com/article/releases/soligenix-announces-positive-preclinical-data-with-multiple-heat-stable-filovirus-vaccine-candidates/

Werewolf to Study WTX-124 With Merck's Keytruda in Solid Tumors

 Werewolf Therapeutics Inc. on Wednesday said it formed a collaboration and supply agreement with Merck & Co. to study Werewolf's WTX-124 product candidate in combination with Merck's blockbuster cancer drug Keytruda.

Werewolf, a Cambridge, Mass., biopharmaceutical company, said it plans to conduct a Phase 1 clinical trial to evaluate the safety and preliminary efficacy of WTX-124 as a monotherapy and in combination with Keytruda in patients with solid tumors.

Werewolf said it plans to file for U.S. Food and Drug Administration approval of the trial in the first half of 2022.

https://www.marketscreener.com/quote/stock/WEREWOLF-THERAPEUTICS-IN-122186740/news/Werewolf-to-Study-WTX-124-With-Merck-s-Keytruda-in-Solid-Tumors-36192561/

Zimmer Biomet Gets FDA OK for ROSA Hip System

 Zimmer Biomet Holdings Inc. on Wednesday said the U.S. Food and Drug Administration approved the company's ROSA Hip System for robotically-assisted direct anterior total hip replacement.

The Warsaw, Ind., musculoskeletal healthcare company said the new product adds to a ROSA portfolio that already includes systems for is total and partial knee arthroplasty, and for neurosurgical and spine procedures.

Zimmer said ROSA Hip also enhances its ZBEdge suite of integrated digital and robotic technologies.

https://www.marketscreener.com/quote/stock/ZIMMER-BIOMET-HOLDINGS-I-14996/news/Zimmer-Biomet-Gets-FDA-OK-for-ROSA-Hip-System-36192727/

Third Pfizer dose 86% effective in over 60s, Israeli HMO says

 A third dose of Pfizer /BioNTech's COVID-19 vaccine was found to be 86% effective in people aged over 60, an Israeli healthcare provider said on Wednesday, citing initial results from a study of thousands of members.

Israeli HMO Maccabi, which covers around a quarter of the country's 9.3 million population, compared results from 149,144 people aged over 60 who received their third dose at least a week ago against those from 675,630 more who had received only two doses, between January and February.

Some 37 people tested positive for coronavirus after their third jab, compared with 1,064 positive cases among those who had received only two doses, Maccabi said in a statement. The comparison groups had similar demographic profiles, it added.

Maccabi did not provide any information on the severity of the 37 positive cases, or whether they had any underlying conditions. The Health Maintenance Organisation (HMO) did not immediately respond to a request for comment.

Pfizer has said that its vaccine's efficacy drops over time, and that a third dose showed significantly higher neutralising antibodies against the initial SARS-CoV-2 virus as well as against the Beta and highly infectious Delta variants.

Israel began administering third Pfizer doses last month to confront a surge in local infections driven by the Delta variant. Some 1.1 million eligible Israelis - people over 50, healthcare workers, and others - have received their third dose.

The United States and several European countries are expected to begin offering boosters to the elderly and people with weak immune systems, and some are considering whether to make a third dose available more widely.

Nonetheless, Israeli health officials worry that cases will continue to mount given that another 1.1 million Israelis - around 11% of the population - remain unvaccinated. Severe cases have also continued to climb, mostly among the unvaccinated.

Health ministry data released on Wednesday, based on data per 100,000 people, showed 172 serious cases among unvaccinated people over 60, compared with 21 serious cases among vaccinated individuals in the same age group.

Dr. Anat Ekka Zohar of Maccabi said that the third dose "has again proved its effectiveness," and had "demonstrated protection (against) the Delta variant".

"The triple dose is the solution to curbing the current infection outbreak," she said. 

https://www.marketscreener.com/news/latest/Third-Pfizer-dose-86-effective-in-over-60s-Israeli-HMO-says--36192668/

Fed minutes likely to detail bond-buying taper talks, inflation worries

 

Insight into the Federal Reserve's debate over when to end its pandemic-era emergency programs and the level of concern among officials over a spike in inflation should emerge on Wednesday with the release of a readout of the U.S. central bank's policy meeting last month.

The minutes of the July 27-28 meeting, which are due to be released at 2 p.m. EDT (1800 GMT), will cover a session at which the Fed said it still had faith in the U.S. economic recovery even as the Delta variant of the coronavirus was fueling a troubling rise in cases. Officials also continued laying plans for the eventual end of the central bank's $120 billion in monthly purchases of Treasury bonds and mortgage-backed securities (MBS).

Although the health crisis has intensified in the past three weeks, the economic recovery remains largely on track. U.S. job growth was strong through July and inflation remained well above the Fed's 2% target - so much so that some central bank policymakers have since urged a quick end to emergency programs that they argue have outlived their usefulness.

Analysts expect the Fed to announce its plan for a "taper" of its asset purchases as early as the Sept. 21-22 meeting of the policy-setting Federal Open Market Committee (FOMC), with less certainty about how fast the actually reduction in the bond-buying program will proceed.

Fed Chair Jerome Powell may provide information as well in remarks to the central bank's annual research conference in Jackson Hole, Wyoming, next week.

A "uniquely uneven economic recovery has led to a splintering within the (FOMC)" among those who feel the purchases should be reduced soon and ended fast, and those who feel the Fed should be patient until the job market recovers more fully, wrote Kathy Bostjancic, chief U.S. financial economist for Oxford Economics.

Demand is outstripping the ability of global supply chains and labor markets to keep pace and driving inflation higher, prompting officials like St. Louis Fed President James Bullard to argue the bond purchases should end soon so the central bank can raise its benchmark overnight interest rate from the current near-zero level if needed. Fed officials want the bond-buying program completed before any hike in borrowing costs.

On the other hand, "dovish committee members believe (quantitative easing) should continue until greater clarity is garnered on the prospective pace of inflation and until the recovery in the labor market" is more complete, Bostjancic wrote.

BENCHMARKS

The Fed at its last meeting acknowledged that progress had been made in recovering the jobs lost to the pandemic. The minutes may offer further clues on how much more progress must be made to clear the benchmark the Fed has established for reducing its asset purchases, and whether another month or two of strong employment gains would be enough.

The Fed said in December that it would not reduce those purchases until there had been "substantial further progress" in the jobs recovery. At that point, the economy was around 10 million jobs shy of where it was before the pandemic. Employers have added 4.3 million jobs since then, including a total of nearly 1.9 million jobs in June and July, a pace some analysts expect to continue into the fall.

The minutes may also reflect the early stages of discussion about another consequential Fed decision: When to raise interest rates.

Though that is unlikely to occur anytime soon, several Fed officials have noted since the July meeting that one of the key tests for doing so is already on the verge of being met, with inflation by some measures approaching a multi-year average at the Fed's 2% target, and likely to stay there.

Atlanta Fed President Raphael Bostic said last week that he felt the central bank needed to begin discussing in more detail how it intends to apply a new framework that allows periods of higher inflation to offset periods of weaker price increases. The terms of any "overshoot" have never been specified, and some policymakers are beginning to argue that the pace of price hikes this year is adequate.

The Fed's preferred measure of prices, the personal consumption expenditures (PCE) index excluding food and energy costs, rose at a 3.5% annual rate in June, its quickest pace in nearly 30 years. July's reading is due late next week.

https://www.marketscreener.com/news/latest/Fed-minutes-likely-to-detail-bond-buying-taper-talks-inflation-worries--36189056/