Search This Blog

Monday, February 8, 2021

Moderna, Pfizer vaccines likely less effective on some virus variants: Gottlieb

 Former FDA Commissioner Scott Gottlieb, MD, said Feb. 7 that Moderna and Pfizer's COVID-19 vaccines are likely to be about 20 percent less effective against variants of the coronavirus that were first discovered in South Africa and Brazil, The Hill reported. 

But the vaccines will still offer significant protection against the virus variants, he said. 

"The mRNA vaccines … are very efficacious. And so even if we see a reduction in the efficacy of those vaccines, and it may not be as profound with those vaccines, you're still getting very good protection with those vaccines," Dr. Gottlieb told CBS

“We also may be able to develop in a timely fashion, maybe in four or six months, a consensus strain that bakes in a lot of the different variation that we're seeing to have boosters available for the fall. So I think that there is a reasonable chance that we're going to be able to stay ahead of this virus as it mutates," he added, according to The Hill

https://www.beckershospitalreview.com/pharmacy/moderna-pfizer-vaccines-likely-less-effective-on-some-virus-variants-former-fda-chief-says.html

Atea Preclinical Data Highlights Potent Activity of AT-527 Against SARS-CoV-2

 Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced the publication of new data highlighting the highly potent in vitro antiviral activity of AT-527 against SARS-CoV-2. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform. The new findings are available in a manuscript published online in Antimicrobial Agents and Chemotherapy.

“To be effective, a direct-acting antiviral needs to be administered orally, and early, in the course of viral infection in order to inhibit viral replication and thereby reduce disease progression. These new data underscore AT-527’s potential to treat COVID-19 and to have an impact on global health,” said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. “The results demonstrated in several in vitro assays that AT-527 has highly potent antiviral activity against several human coronaviruses, including SARS-CoV-2, the causative agent of COVID-19. AT-527 was activated in cultured normal human nasal and bronchial epithelial cells, which are the primary targets of SARS-CoV-2 infection. Since the respiratory tract is the initial site of the SARS-CoV-2 infection, activation of AT-527 with its substantial half-life suggests sustained inhibition of viral replication of SARS-CoV-2 in these tissues.”

Antiviral therapeutics are expected to have the greatest effect if given in early stages of the COVID-19 infection when SARS-CoV-2 is rapidly replicating in the respiratory epithelium and viral load levels are high. The goal of a direct-acting antiviral is to prevent disease progression by minimizing, or eliminating, viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it ideal for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

Why the US Is Underestimating COVID Reinfection

 Kaitlyn Romoser first caught covid-19 in March, likely on a trip to Denmark and Sweden, just as the scope of the pandemic was becoming clear. Romoser, who is 23 and a laboratory researcher in College Station, Texas, tested positive and had a few days of mild, coldlike symptoms.

In the weeks that followed, she bounced back to what felt like a full recovery. She even got another test, which was negative, in order to join a study as one of the earliest donors of convalescent blood plasma in a bid to help others.

Six months later, in September, Romoser got sick again, after a trip to Florida with her dad. This second bout was much worse. She lost her sense of taste and smell and suffered lingering headaches and fatigue. She tested positive for covid once more — along with her cat.

Romoser believes it was a clear case of reinfection, rather than some mysterious reemergence of the original infection gone dormant. Because the coronavirus, like other viruses, regularly mutates as it multiplies and spreads through a community, a new infection would bear a different genetic fingerprint. But because neither lab had saved her testing samples for genetic sequencing, there was no way to confirm her suspicion.

"It would be nice to have proof," said Romoser. "I've literally been straight up called a liar, because people don't want to believe that it's possible to be reinfected. Why would I lie about being sick?"

As millions of Americans struggle to recover from covid and millions more scramble for the protection offered by vaccines, U.S. health officials may be overlooking an unsettling subgroup of survivors: those who get infected more than once. Identifying how common reinfection is among people who contracted covid — as well as how quickly they become vulnerable and why — carries important implications for our understanding of immunity and the nation's efforts to devise an effective vaccination program.

Scientists have confirmed that reinfections after initial illness caused by the SARS-CoV-2 virus are possible, but so far have characterized them as rare. Fewer than 50 cases have been substantiated worldwide, according to a global reinfection tracker. Just five have been substantiated in the U.S., including two detected in California in late January.

That sounds like a rather insignificant number. But scientists' understanding of reinfection has been constrained by the limited number of U.S. labs that retain covid testing samples or perform genetic sequencing. A KHN review of surveillance efforts finds that many U.S. states aren't rigorously tracking or investigating suspected cases of reinfection.

KHN sent queries about reinfection surveillance to all 50 states and the District of Columbia. Of 24 responses, fewer than half provided details about suspected or confirmed reinfection cases. Where officials said they're actively monitoring for reinfection, they have found far more potential cases than previously anticipated.

In Washington state, for instance, health officials are investigating nearly 700 cases that meet the criteria for possible reinfection, with three dozen awaiting genetic sequencing and just one case confirmed.

In Colorado, officials estimate that possible reinfections make up just 0.1% of positive coronavirus cases. But with more than 396,000 cases reported, that means nearly 400 people may have been infected more than once.

In Minnesota, officials have investigated more than 150 cases of suspected reinfection, but they lack the genetic material to confirm a diagnosis, a spokesperson said.

In Nevada, where the first U.S. case of covid reinfection was identified last summer, Mark Pandori, director of the state public health lab, said there's no doubt cases are going undetected.

"I predict that we are missing cases of reinfection," he said. "They are very difficult to ascertain, so you need specialized teams to do that work, or a core lab."

Such cases are different from instances of so-called long-haul covid, in which the original infection triggers debilitating symptoms that linger for months and viral particles can continue to be detected. Reinfection occurs when a person is infected with covid, clears that strain and is infected again with a different strain, raising concerns about sustained immunity from the disease. Such reinfections occur regularly with four other coronaviruses that circulate among humans, causing common colds.

Centers for Disease Control and Prevention guidelines call for investigating for possible reinfection when someone tests positive for covid at least 90 days after an original infection (or at least 45 days for "highly suspicious" cases). Confirmation of reinfection requires genetic sequencing of paired samples from each episode to tell whether the genomes involved are different.

But the U.S. lacks the capacity for robust genetic sequencing, the process that identifies the fingerprint of a specific virus so it can be compared with other strains. Jeff Zients, head of the federal covid task force, noted late last month that the U.S. ranks 43rd in the world in genomic sequencing.

To date, only a fraction of positive coronavirus samples has been sequenced, though the Biden administration is working to rapidly expand the effort. On Feb. 1, CDC Director Dr. Rochelle Walensky told reporters that sequencing has "increased tenfold" in recent weeks, from 251 sequences the week of Jan. 10 to 2,238 the week of Jan. 24. The agency is working with private companies, states and academic labs to ramp up to 6,000 sequences per week by mid-February.

Washington's state epidemiologist for communicable diseases, Dr. Scott Lindquist, said officials have prioritized genetic sequencing at the state laboratory, with plans to begin genotyping 5% of all samples collected. That will allow officials to sort through those nearly 700 potential reinfections, Lindquist said. More important, the effort will also help signal the presence of significantly mutated forms of the coronavirus, known as variants, that could affect how easily the virus spreads and, perhaps, how sick covid makes people.

"Those two areas, reinfection and variants, may cross paths," he said. "We wanted to be in front of it, not behind it."

The specter of reinfections complicates one of the central questions of the covid threat: How long after natural infection or vaccination will people remain immune?

Early studies suggested immunity would be short-lived, only a few months, while more recent research finds that certain antibodies and memory cells may persist in covid-infected patients longer than eight months.

"We actually don't know" the marker that would signal immunity, said Dr. Jason Goldman, an infectious diseases expert at Swedish Medical Center in Seattle. "We don't have the test you could perform to say yes or no, you could be infected."

Goldman and colleagues confirmed a case of reinfection in a Seattle man last fall, and since then have identified six or seven probable cases. "This is a much more common scenario than is being recognized," he said.

The possibility of reinfection means that even patients who've had covid need to remain vigilant about curbing re-exposure, said Dr. Edgar Sanchez, an infectious diseases physician at Orlando Health in Florida.

"A lot of patients ask, 'How long do I have to worry about getting covid again?' " he said. "I literally tell them this: 'You are probably safe for a few weeks, maybe even up to a couple of months, but beyond that, it's really unclear.' "

The message is similar for the wider society, said Dr. Bill Messer, an expert in viral genetics at Oregon Health & Science University in Portland, who has been pondering the cultural psychology of the covid response. Evidence suggests there may not be a clear-cut return to normal.

"The idea that we will end this pandemic by beating this coronavirus, I don't think that's actually the way it's going to happen," he said. "I think that it's more likely that we're going to learn how to be comfortable living with this new virus circulating among us."

https://www.medscape.com/viewarticle/945448

AstraZeneca Expects US Trial Results in Next 4-6 Weeks

 AstraZeneca expects to have results from a U.S. clinical trial of its COVID-19 vaccine in the next four to six weeks, the company's research chief Mene Pangalos said on Friday.

Asked when the late-stage U.S. trial would read out, particularly given high rates of transmission of the SARS-CoV-2 virus during the months since it began in August, Pangalos agreed the rates had been high in "the latter period" of it, suggesting that was why the read out would come later.

Some experts had expected the data sooner than that, given the high infection rates in the United States during the period of testing.

"I think we're getting very close to getting data. I would say in the next four to six weeks we should have the results for that study reading out," he told reporters.

The former chief adviser for the U.S. government's Operation Warp Speed COVID vaccine development program had said in December that he was expecting U.S. trial data in January.

One of the U.S. trial investigators, who was not authorised to speak on behalf of the company, said on Friday the trial now had enough data to do an interim analysis, and investigators were cleaning the data so that data safety monitors could start analysing it.

"We're all hoping that there will be some data for them to be able to put together a report for the FDA to apply for emergency use authorization by the end of the month (February)," the investigator said.

AstraZeneca and its partner, Oxford University, say their COVID-19 vaccine, which is already approved for emergency use in about 50 countries, has 76% efficacy against symptomatic infection for three months after a single dose, and that this is increased if the second shot is delayed.

https://www.medscape.com/viewarticle/945385

Goldman Sachs ups U.S. GDP estimate, sees COVID relief at $1.5T

 Economists at Goldman Sachs Group Inc on Monday bumped their U.S. GDP forecast for the second quarter up to 11% from 10% and said additional fiscal measures are likely to be valued at $1.5 trillion, up from their previous $1.1 trillion estimate.

On an annual basis, they raised their forecasts for 2021 and 2022 growth by 0.2 percentage points each, to 6.8% and 4.5%, respectively.

The bank’s economists also said that they had brought forward their forecast for the first rate hike by the Federal Reserve from the second half of 2024 to the first half in light of the upgrade to the growth forecast, the larger-than-expected decline in the unemployment rate in January, and signs of a “firmer” inflation outlook.

“We expect the FOMC to start tapering its asset purchases in early 2022,” the note said.

https://www.reuters.com/article/us-usa-economy-goldman-sachs/goldman-sachs-boosts-u-s-gdp-estimate-sees-covid-relief-at-1-5-trillion-idUSKBN2A825H

U.S. COVID-19 cases, hospitalizations in biggest weekly drops since pandemic started

 The United States reported a 25% drop in new cases of COVID-19 to about 825,000 last week, the biggest fall since the pandemic started, although health officials said they were worried new variants of the virus could slow or reverse this progress.

New cases of the virus have now fallen for four weeks in a row to the lowest level since early November, according to a Reuters analysis of state and county reports. The steepest drop was in California, where cases in the week ended Feb. 7 fell 48%. Only Oregon, Puerto Rico, Arkansas and Vermont saw cases rise. (Open tmsnrt.rs/2WTOZDR in an external browser to see a state-by-state graphic.)

At least three new variants of the novel coronavirus are circulating in the United States, including the UK variant B.1.1.7 that is 30% to 40% more contagious, according to researchers.

“I’m asking everyone to please keep your guard up,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on Monday. “The continued proliferation of variants remains a great concern and is a threat that could reverse the recent positive trends we are seeing.”

The average number of COVID-19 patients in hospitals fell by 15% to 88,000 last week, also a record percentage drop, according to a Reuters analysis of data from the volunteer-run COVID Tracking Project. It was the lowest average number in hospitals since late November.

Death fell 2.5% last week to 22,193. Excluding a backlog of deaths reported by Indiana, fatalities were down 9.5% last week. Deaths are a lagging indicator and usually fall several weeks after cases and hospitalizations drop.

Cumulatively, nearly 464,000 people have died from the virus in the United States, or one in every 704 residents.

Nationally, 7.3% of tests of tests came back positive for the virus, down from 8.5% the prior week, according to data from the COVID Tracking Project.

https://www.reuters.com/article/us-health-coronavirus-usa-trends/u-s-covid-19-cases-and-hospitalizations-log-biggest-weekly-drops-since-pandemic-started-idUSKBN2A8286

Corcept Therapeutics Has Q4 Prelims, 2021 Revenue Guidance

 Financial Highlights, 2021 Revenue Guidance and Legal Update

  • Preliminary 2020 revenue $353.9 million, compared to $306.5 million in 2019
  • Preliminary fourth quarter revenue $85.7 million, compared to $87.9 million in fourth quarter 2019
  • 2021 revenue guidance $375 - 405 million
  • Preliminary 2020 fully diluted GAAP net income $0.85 per share, compared to $0.77 per share in 2019
  • Preliminary fourth quarter fully diluted GAAP net income $0.20 per share, compared to $0.24 per share in fourth quarter 2019
  • Preliminary cash and investments at December 31, 2020 of $476.9 million, an increase
    of $161.6 million from December 31, 2019
  • Patent Trial and Appeals Board affirms validity of all claims in Corcept’s U.S. Patent No.10,195,214 (patent term: 2037)