New recommendations on social distancing after vaccination coming: Fauci

 New guidance on what social distancing measures are best for people who are fully vaccinated is on the way, Dr. Anthony Fauci said Monday.

Right now, the advice from health officials is to keep wearing your mask, keep social distancing and keep away from gatherings after you receive both shots of coronavirus vaccine.

But during a meeting of the American Association for the Advancement of Science, 91-year-old Esther Cohen asked Fauci when she and her friends—who all have received both vaccine shots—can safely resume their mah-jongg games, CNN reported.

In response, Fauci, the director of the National Institute of Allergy and Infectious Diseases, said there is no CDC guidance on what to do when groups of people who have received both vaccine doses want to get together.

"But I believe that's going to change," Fauci said. "We're talking about this at the level of the CDC."

Vaccinations began in the United States on Dec, 14. More than 9.5 million people have been fully vaccinated with two doses of a COVID-19 vaccine, according to CDC data updated Monday.

The two authorized vaccines from Moderna and Pfizer prevent symptomatic infections in most, but not all, cases. And it is still unclear whether they stop asymptomatic infection, CNN reported.

If you are asymptomatic, you would still test positive for COVID-19, and even if you are vaccinated, you could still spread the virus. That's why the guidance now is that even the vaccinated still need to wear masks. A person could be an asymptomatic carrier and have the virus in their nasal passageways, so when they are breathing or speaking or sneezing they could still pass the novel coronavirus on to others, health experts have explained.

Fauci said that he and his daughter, who have both been fully vaccinated, still follow the standard social distancing and quarantine guidelines before seeing each other.

"I'm doubly vaccinated. My daughter is doubly vaccinated. The last time she tried to come home, she had to go quarantine for 14 days and get tested," he said. "It was a big, big deal to finally see my daughter in the same room. I think that's going to have to change."

"What's the reason to get vaccinated in the first place, if you don't want to get to normal?" he added.

British COVID variant spreading rapidly across U.S.

The highly contagious coronavirus variant that drove Britain into lockdown in December is now spreading quickly across the United States, a new study shows.

What has been dubbed the B.1.1.7 variant is doubling its prevalence every nine days in this country, according to a report posted on the preprint server MedRxiv on Sunday and not yet peer-reviewed or published in a journal. The findings, from a large collaboration of scientists, buttresses a forecast issued last month by the U.S. Centers for Disease Control and Prevention that showed the variant becoming dominant in this country by late March.

The researchers scrutinized genomic analyses of the virus samples from 10 states, including from 212 infections involving the variant, and concluded that the variant has been 35% to 45% more transmissible than other variants in the United States.

"It is here, it's got its hooks deep into this country, and it's on its way to very quickly becoming the dominant lineage," study co-author Michael Worobey, an evolutionary biologist at the University of Arizona, told the Washington Post.

"Those models are very sensitive to assumptions about how many people the average infected person passes the virus to. If those assumptions are off by just a bit, or if we let our guard down and relax mitigation measures, I believe we could well see a dangerous upward surge of cases as B.1.1.7 comes to dominate the U.S. epidemic in March," Worobey added.

"Our study shows that the U.S. is on a similar trajectory as other countries, where B.1.1.7 rapidly became the dominant SARS-CoV-2 variant, requiring immediate and decisive action to minimize COVID-19 morbidity and mortality," the authors of the new report said.

In the study, Florida stands out as the state with the highest estimated prevalence of the variant. The new report estimated the doubling time of B.1.1.7 prevalence in positive test results at just over nine days.

Florida leads the nation in reported B.1.1.7 cases, with 201 as of Tuesday, followed by much more populous California with 150, according to the CDC. A total of 690 cases have been reported in 33 states, according to the CDC.

The new study only looked at data through the end of January, but the percentage of B.1.1.7 infections in Florida may have risen from a little less than 5 percent to approximately 10 percent in just the past week in Florida, study co-author Kristian Andersen, an immunologist at Scripps Research Institute, told the Post.

Mary Jo Trepka, an epidemiologist at Florida International University, told the newspaper she is not surprised by the spread of the variant in Florida, because the state has not been strict about mask mandates or other restrictions, while at the same time it is a hub for international travel.

"The message is that we have to work harder to prevent transmission of all these cases of COVID," she said. "If we don't, we'll potentially see more variants. We need to get everybody vaccinated and we need to do a much better job at preventing transmission."

The variant first appeared in genomic surveys in the United Kingdom in September, but did not get tagged as a "variant of concern" until early December when its rapid spread stunned scientists and prompted lockdowns in southern England.

"What concerns me is the exponential growth in the early stages doesn't look very fast," Andrew Noymer, an epidemiologist at the University of California, Irvine, who was not part of the new study, told the Post. "It kind of putzes along—and then goes boom."

U.S. health officials say they are in a race against time to increase the number of Americans vaccinated as more contagious variants of the virus spread across America. By Tuesday, more than 42.4 million Americans had been vaccinated, while 59.3 million doses have been distributed. Just over 9.5 million people have had their second shot, according to the CDC.

https://medicalxpress.com/news/2021-02-social-distancing-vaccination-fauci.html

If you've had COVID, maybe one dose of vaccine is enough

 Could one shot of a coronavirus vaccine be sufficient if you suffered a case of COVID-19 earlier in the pandemic?

Yes, new research claims.

A pair of new, small studies found that patients previously infected with COVID who were given their first vaccine dose showed the sort of robust immune response that people generally tend to have following their second "booster" dose.

"People that have had COVID before, they make antibodies very quickly to much higher levels than those that had no experience with the virus," said Dr. Viviana Simon, senior researcher on one of the studies and a professor of microbiology and infectious diseases at the Icahn School of Medicine at Mount Sinai in New York City.

"That led us to the conclusion that a second shot of the vaccine should not be necessary in individuals that have been previously infected," Simon said. "That would save vaccine doses and also would limit the discomfort experienced by people upon vaccination."

However, these findings are likely a moot point given the practical considerations of the pandemic, other experts said.

The new papers, published recently on the preprint server medRxiv, need to be peer-reviewed and verified by follow-up research before a single-shot strategy could be implemented in previously infected people, and that will take precious time.

Future studies examining whether a single vaccine dose would be sufficient in any group of people "would take several months to get a meaningful answer," said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases.

"At that time, the amount of vaccine that would be available would almost be making that question somewhat of a moot point," Fauci said during a Monday briefing of the White House COVID-19 response team. The current vaccine supply shortages are expected to clear up as Pfizer and Moderna ramp up production and other vaccine candidates receive approval from the U.S. Food and Drug Administration.

Measuring the antibody response

Mount Sinai researchers have been following health care workers who've fallen ill with COVID, to see how long a natural antibody response to the novel coronavirus will last and to track whether any patients suffer a reinfection, Simon said.

When the COVID-19 vaccines were rolled out in December, the researchers extended their study to see how previously infected people would respond to the vaccine.

They found that the antibody response in 41 people with preexisting immunity was equal to or exceeded 68 others who've never had COVID, results show.

This strong response occurred even in people who'd had no symptoms from their COVID infection or had lower antibody levels before receiving the first dose, Simon said.

"This makes sense if we think of the natural infection as being the prime, like the first dose, and then the vaccine is like the boost, or the second shot, for someone who hasn't seen the natural infection," Simon said.

Another study out of the University of Maryland recently came to a similar conclusion—33 previously infected people responded more strongly to their first shot than 26 others who were never infected.

"I do think that there is emerging evidence that someone with prior COVID infection may be able to achieve sufficient immunity with just a single dose of a two-dose vaccine regimen," said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore. "Prior immunity through natural infection can be boosted by a vaccination to give more durable and robust immunity."

But Adalja noted that these small studies need to be verified by larger trials, as did Dr. Andrew Badley, head of the Mayo Clinic's COVID task force.

"The concept of preserving vaccine supply by giving those who have recovered from SARS-CoV2 infection just a single dose of vaccine rather than the usual two-dose regime is a very reasonable idea that may in fact be effective," said Badley, an infectious disease expert. "Today, however, we do not have sufficient data to recommend that approach, but I would personally be in favor of testing the approach under the rubric of a controlled clinical trial."

B memory cells vital to immunity

Dr. Thad Stappenbeck, chair of inflammation and immunity at the Cleveland Clinic's Lerner Research Institute, is hesitant to embrace the one-shot strategy because higher antibody levels don't always protect people against severe disease.

"To me, that's really the critical data here, right? It's hospitalizations and deaths. That's what we're trying to prevent," Stappenbeck said.

Clinical trials have shown that two doses are incredibly effective in creating antibodies that can fight off not only the novel coronavirus but also the variants that have cropped up in recent weeks, Stappenbeck noted.

Most important in that response are the immune system's B memory cells, which show that the body has learned the lessons taught by the vaccine, Stappenbeck said. More study would need to be done to show that a single shot in previously infected people would provide a sufficient boost to their immune memory.

"While the level of antibody is important, these B memory cells are really critical," Stappenbeck said. "Having a finely tuned immune response is the key to longer-term immunity."

https://medicalxpress.com/news/2021-02-youve-covid-dose-vaccine.html

White House: Secured deals for 200M more Covid vaccine dose

 President Joe Biden announced Thursday that his administration has secured deals for another 200 million doses of Covid-19 vaccine, bringing the U.S. total to 600 million.

“Just this afternoon, we signed the final contracts for 100 million more Moderna and 100 million more Pfizer vaccines,” Biden said Thursday while on a tour at the National Institutes of Health, adding the U.S. will have enough supply for 300 million Americans by the end of July.

The Washington Post first reported the news. Earlier, White House chief of staff Ron Klain appeared to confirm the news, retweeting the Post story from his official White House Twitter account.

Because both Pfizer’s and Moderna’s authorized vaccines require two doses given about three to four weeks apart, the total of 600 million doses would be enough to inoculate 300 million people.

Roughly 34.7 million out of some 331 million Americans have received at least their first dose of Covid vaccine, according to data compiled by the Centers for Disease Control and Prevention. And 11.2 million of those people have already gotten their second shot.

The schedule for delivery of the additional doses was not immediately clear.

Each company will leverage U.S.-based manufacturing capacity “to fill, finish and ship vials as the bulk material is produced,” the Department of Health and Human Services said in a separate statement.

Pfizer already has a deal with the U.S. to deliver 200 million doses. The company said earlier this month that it planned to finish those shipments by May, earlier than its initial forecast of July. Moderna also has a deal with the U.S. for 200 million doses.

States have complained that demand for the vaccines is outpacing supply. The administration has previously said it using the Defense Production Act to help Pfizer meet its manufacturing targets for its vaccine.

In addition to securing more doses for states, the Biden administration is using the military to help administer doses and is setting up mass vaccination centers across the United States.

On Wednesday, the administration announced it would partner with Texas officials to build three new community vaccination centers, in Dallas, Arlington and Houston. A few days earlier, the administration said it was sending active-duty troops to California to help staff Covid-19 vaccine sites there.

U.S. officials are also hoping vaccine supply will increase after Johnson & Johnson’s Covid-19 vaccine is authorized for emergency use by the Food and Drug Administration, which could happen as early as this month. The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26 to discuss the vaccine, and the U.S. could authorize the vaccine the next day.

The Department of Health and Human Services announced in August that it reached a deal with Janssen, J&J’s pharmaceutical subsidiary, worth approximately $1 billion for 100 million doses of its vaccine. The deal gives the federal government the option to order an additional 200 million doses, according to the announcement.

https://www.cnbc.com/2021/02/11/white-house-200-million-more-covid-vaccine-doses-.html

Enlivex Rallies On Encouraging Allocetra Data In Mid-Stage COVID-19 Study

 

• Enlivex Therapeutics Ltd (NASDAQ: ENLV) stock rises sharply on the heels of positive data from the Phase 2 trial evaluating Allocetra in severe and critical COVID-19 patients. 

• Data showed that out of 16 patients treated, 14 patients (87.5%) recovered and were discharged from the hospital by day-28. Zero mortality rate was observed on day-28.

• The average duration of hospitalization post administration of Allocetra for discharged patients was 5.3 days.

• 2/16 (12.5%) patients, both of whom had a critical illness at the time of Allocetra treatment, were hospitalized in the ICU on a respirator on day-28.

• Based on the results and in consultation with the trial's principal investigator, the Company has completed the trial early. It plans to submit a summary of the data for review by the relevant regulatory bodies later this month.

• Allocetra is a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state.

https://finance.yahoo.com/news/enlivex-rallies-encouraging-allocetra-data-173433658.html

SARS-CoV-2 transmission, vaccination rate and the fate of resistant strains

 Simon Rella, Yuliya Kulikova, Emmanouil Dermitzakis, Fyodor Kondrashov

doi: https://doi.org/10.1101/2021.02.08.21251383

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2021.02.08.21251383v1.full.pdf

Abstract

Vaccines are thought to be the best available solution for controlling the ongoing SARS-CoV-2 pandemic [1,2]. However, the emergence of vaccine-resistant strains [3-6] may come too rapidly for current vaccine developments to alleviate the health, economic and social consequences of the pandemic [7,8]. To quantify and characterize the risk of such a scenario, we created a SIR-derived model [9,10] with initial stochastic dynamics of the vaccine-resistant strain to study the probability of its emergence and establishment. Using parameters realistically resembling SARS-CoV-2 transmission, we model a wave-like pattern of the pandemic and consider the impact of the rate of vaccination and the strength of non-pharmaceutical intervention measures on the probability of emergence of a resistant strain. We found a counterintuitive result that the highest probability for the establishment of the resistant strain comes at a time of reduced non-pharmaceutical intervention measures when most individuals of the population have been vaccinated. Consequently, we show that a period of transmission reduction close to the end of the vaccination campaign can substantially reduce the probability of resistant strain establishment. Our results suggest that policymakers and individuals should consider maintaining non-pharmaceutical interventions [7,11,12] throughout the entire vaccination period.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

ETD is supported by the Swiss National Science and Louis Jeantet Foundation. The work of FAK was in part supported by the ERC Consolidator grant (771209-CharFL).

https://www.medrxiv.org/content/10.1101/2021.02.08.21251383v1

Does Prior Exposure to Coronaviruses Protect You?

 By Derek Lowe

There’s a new paper out that clears up some of our thinking about the current pandemic and what protection people might have had before the latest coronavirus showed up. As so many people know by now, there are a lot of coronaviruses running around out there, and they are responsible for a small-but-real fraction of “common cold” type illnesses every year. Here’s the CDC page on that topic, and here (from Wikipedia) is the phylogenetic tree of coronaviruses in general.

A lot of people have had one or more of the coronaviruses that are listed on the CDC page (229E, NL63, OC43, HKU1). But none of these are in the exact same family as the current beast – the first two are alpha-coronaviruses and are fairly closely related to each other. The second two are in another genus, beta-coronaviruses, and are also pretty closely related to each other, but they’re off in a different lineage inside the beta-coronaviridae compared to the SARS-type coronaviruses like the current one. All of these things have “spike” proteins decorating them, but the spikes themselves vary in sequence, enough so that some of them have found completely different surface proteins to use for viral entry, as opposed to the SARS ones going for the ACE2 protein.

Still, immunology being what it is, the question has been open whether the B-cell and T-cell memory of past infections with these other coronviruses might give a person some protection against the current one. I’ve wondered about that here on the blog myself. It’s not at all a crazy idea, because what we have seen is that there are people out there who with cross-reactive antibodies that can bind to the pandemic coronavirus, some of these in blood samples from well before the current one started going through the human population. but (until now) we’ve lacked enough hard data to say.

Here’s the MedrXiv version of the paper under discussion, and here’s the version coming out now in Cell. The authors looked at 431 pre-pandemic blood samples, and compared them to 251 samples from people who have been infected in the current outbreak and recovered, as well as analyzing antibody profiles in people who are currently hospitalized. What they’ve found is first, that most people have indeed been infected with one or more of the “garden-variety” coronaviruses. The pre-pandemic samples show plenty of antibody responses to these. Second, about 20% of these patients raised antibodies that do cross-reaction with the Spike or nucleocapsid proteins of the current pandemic coronavirus. And what’s more, levels of such antibodies are elevated when a person in this group gets infected with SARS-Cov2: the immune system memory (as present in these patients’ B cells) responds by increasing production of the antibodies to the previous coronaviruses.

But here’s the key part: “cross-react” does not mean “neutralize” and it does not mean “provide protection from”. These antibodies may or may not have been neutralizing against the other coronaviruses, but they don’t seem to have any such effect on the current one. And in keeping with that, having such cross-reactive antibodies seems to provide no protection against catching SARS-Cov2 or against being hospitalized with it if you do. There’s no difference in the infection/hospitalization rates of the people who had cross-reactive coronavirus serum antibodies ready to go versus those who didn’t. They’re basically useless.

Now, you can still make an argument that the T cell component of immunity might provide some protection after a previous coronavirus infection. The current study didn’t address this directly, but after these results, it’s at least less likely that that’s happening. The authors make a note of this, and also note that pre-existing mucosal antibodies might exert a protective effect (which this study didn’t examine, either). But prior circulating human coronavirus antibodies, even ones that can bind to the current one – those it looks like we can rule out. Which is too bad.

https://blogs.sciencemag.org/pipeline/archives/2021/02/10/does-prior-exposure-to-coronaviruses-protect-you

State, local governments don't need most American Rescue Plan funds

 “California is not only poised for recovery, but we’re seeing real signs of recovery in our state,” Governor Gavin Newsom announced in early January, as he unveiled a state budget with record spending fueled by a $15 billion budget surplus. Yet two weeks later, Newsom sent a letter to President Biden expressing support for his plan to give an additional $350 billion in aid to state and local governments.

Similar stories have played out in other states. “We’re going to need a robust federal support system to help our states and economies recover beyond the federal CARES funds that expire at the end of the year,” said Wisconsin governor Tony Evers in November. Yet within weeks, the state was projecting a budget surplus, and by January it had revised that estimate up to $1.8 billion. Rather than drawing on these reserves, Wisconsin added to its “rainy day” fund, the balance of which is expected to hit nearly $1 billion this year.

Undoubtedly some states and cities have faced challenges, but nationwide, state and local governments have seen tax revenue rebound to pre-pandemic levels, even as they have continued to receive a large influx of federal funds. When the pandemic began, states and local governments naturally feared that they would suffer a huge budget hit. Indeed, state and local tax revenue did decline by more than 17 percent from the first to the second quarter of 2020. In response, Congress allocated $280 billion to state and local governments under the CARES act, plus $120 billion in the December stimulus package. This aid, along with the recovery of state and local revenue, has more than filled the gaps in state and local budgets.

During 2020, a year in which real GDP fell by 3.5 percent, state and local government revenue grew by 8.4 percent in real terms, a rapid increase from its 2 percent growth rate in 2019 (based on data from the Bureau of Economic Analysis and my own projections). After plummeting in the second quarter, state and local current tax receipts recovered sharply in the second half of the year, ending 2020 essentially unchanged from 2019 in real terms, after growing by 1.9 percent in 2019. Income-tax revenue made the strongest recovery in the second half, as the revenue decline in the first half of the year was partly due to delayed tax filings. Real income-tax revenue ended the year up nearly 1.8 percent, showing a strong rebound (albeit a slowdown from 2019’s 3.1 percent real growth).

By far the biggest contributor to the growth in state and local budgets was federal aid, which totaled $265 billion in the BEA data, an increase of 42 percent in real terms. How is it that state and local tax revenue rebounded, even though employment and output remain below pre-pandemic levels? The states largely rely on income and sales taxes, while local governments largely rely on property taxes. Real personal consumption expenditures fell by 3.9 percent in 2020, and accordingly, sales tax revenue was down 3.4 percent in real terms. However, real incomes grew by 5.1 percent in 2020, thanks to transfers like the federal relief checks and enhanced unemployment benefits. In addition, the real-estate market stayed strong in the work-from-home environment. The Case-Shiller home price index was up 9.5 percent year-over-year in November 2020. Accordingly, property-tax revenue grew 2.6 percent in real terms in 2020, after increasing by only 1 percent the previous year.

States also entered the 2020 budget year, which started in June in most states, with a record $119 billion in balances, including $75 billion in rainy-day funds. At least ten states drew on these funds to close deficits in fiscal 2020, and at least eight have enacted legislation to do so in 2021. In most cases, these withdrawals did not deplete the funds. At least five states have added to their rainy-day fund balances during the pandemic.

The lack of interest in the Federal Reserve’s Municipal Lending Facility also suggests no emergency in state and local finances. The facility was authorized to lend up to $500 billion to states, counties, and cities. Before this facility closed for new loans at the end of 2020, only $6.6 billion in loans had been issued to only two borrowers: the State of Illinois and the New York Metropolitan Transit Authority. Both had planned to borrow from the private market but used the Fed Facility to lower their borrowing costs.

State and local revenues undoubtedly collapsed early in the pandemic, but they have now recovered even better than the overall economy. The $400 billion in federal transfers already allocated should drive growth in state and local revenues well into 2021. While state and local governments may need targeted federal funds for vaccinations and other expenses tied to the pandemic, the broad $350 billion in aid to state and local governments in Biden’s American Rescue Plan is unnecessary.

Noah Williams is the Juli Plant Grainger Professor of Economics and director of the Center for Research on the Wisconsin Economy at the University of Wisconsin–Madison.

https://www.city-journal.org/state-and-local-revenue-has-rebounded-to-pre-pandemic-levels