Asmita Koladiya, 29, a healthcare worker, carrying her eight-month-old daughter Jiyanshi Gaurang, prepares to give a dose of vaccine against the coronavirus disease (COVID-19) to a villager in Lodhida village in Rajkot district in the western state of Gujarat, India, February 1, 2022. Picture taken February 1, 2022. REUTERS/Amit Dave
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March 16 (Reuters) - The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.
Omicron linked with croup in babies
The Omicron variant of the coronavirus is causing a dramatic rise in cases of croup, a dangerous respiratory condition usually seen in babies and toddlers, new data suggest.
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Croup, which causes a distinctive barking-like cough and high-pitched sounds when patients inhale, happens when viruses cause swelling in the respiratory tract that makes it hard to breathe. From the start of the pandemic until mid-January 2022, emergency physicians at Boston Children's Hospital treated 75 children with croup, all but one of whom had COVID infections. Eighty percent of those cases occurred after Omicron began circulating in December 2021, they reported in Pediatrics. Most of the children were treated with steroids and sent home, but some required hospitalization. Overall, the children required more medication doses compared to children with croup caused by other viruses, the doctors found.
"There was a very clear delineation from when Omicron became the dominant variant to when we started seeing a rise in the number of croup patients," study leader Dr. Ryan Brewster said in a statement. While many viruses can cause croup, parents should be aware of the possibility that a child with croup has COVID-19 and consider having them and other family members tested, the researchers advised.
Tuberculosis vaccine improves immune response to coronavirus
New research sheds light on how a tuberculosis vaccine might help protect against COVID-19.
Early in the pandemic, studies began to suggest that people who received the so-called BCG vaccine as children had lower rates of SARS-CoV-2 infection. Research in hamsters now shows that animals vaccinated with BCG had less pneumonia due to COVID-19 and lower levels of the coronavirus in their lungs. Doctors at Johns Hopkins University in Baltimore found important differences in lung cells between animals infected with SARS-CoV-2 who did or did not get the BCG vaccine, they reported on Tuesday on bioRxiv ahead of peer review. Upon infection with the coronavirus, for the BCG-treated animals, antibodies came to lung cells much faster, lung repair mechanisms got underway much more quickly, and tissue-damaging inflammation was blunted, said coauthor Dr. William Bishai. Earlier this month, researchers in India reported on the effects of BCG in recipients of the COVID-19 vaccine from AstraZeneca (AZN.L) in a small study. The 21 subjects who had received the TB vaccine showed significantly "more robust" antibody- and T-cell attacks against the coronavirus than the 13 people who had not, they reported on Research Square ahead of peer review. Combining BCG vaccines with COVID-19 vaccines "may offer synergistic protection," the Johns Hopkins team said. Clinical trials testing BCG vaccines for protection against COVID-19 are underway.
Critically ill COVID patients slow to wake after ventilator
Compared to how quickly an average patient "wakes up" after being taken off a mechanical ventilator, critically ill COVID-19 patients often take much longer to regain consciousness, researchers have found.
They reviewed data on 795 patients hospitalized with severe COVID-19 at three medical centers during the first two surges of the pandemic. All were on mechanical ventilation for at least six days, during which they were comatose. After removal from respiratory support, 72% eventually regained consciousness, but 25% of them needed at least 10 days to wake up, and 10% needed 23 days or more to recover. Patients who had experienced the most episodes of oxygen deprivation took the longest to recover consciousness, the researchers reported in Annals of Neurology.
"Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn't be based solely on prolonged periods of unconsciousness, as these patients may eventually recover," Dr. Jan Claassen of New York-Presbyterian/Columbia University Irving Medical Center said in statement. "These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients," Classen's colleague, Dr. Brian Edlow of the Massachusetts General Hospital, said in a statement.
Click for a Reuters graphic on vaccines in development.
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Reporting by Nancy Lapid; Editing by Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.
In 1985, the first HIV vaccine trial was launched with great fanfare. The previous year, Margaret Heckler, the U.S. Secretary of Health and Human Services, confidently declared that an HIV vaccine would be created within two years. But almost four decades after the initial discovery of the HIV virus, there is still no viable HIV/AIDS vaccine. That doesnt mean, though, that there is no cure. The grueling and largely thankless work of trialing an HIV/AIDS vaccine has continued steadily over the past four decades (the most recent one launched in January 2022, using Modernas mRNA technology), making it the longest-running modern pandemic.
But failure, in the hands of scientists, doesnt mean the end. Instead, it is a sturdy foundation for scientific discovery. Rather than giving up, the failure to create a viable HIV vaccine spurred scientists to develop a whole new strategy to end the AIDS pandemic. Without vaccines available to teach human immune systems to kill the virus, scientists were forced to find other ways to keep infections at bay. And heres where four decades of scientific failure was transformed into a radical approach to pandemic control, with direct implications for the future of the global effort to end COVID-19.
Without vaccines to stop new infections, HIV scientists pivoted to developing antiviral treatments to slow the replication of HIV in human hosts and thereby keep the tens of millions of HIV-infected people from becoming sick and dying. And this is where failure was transformed into unfettered success. The cocktail of HIV treatments known collectively as highly active antiretroviral therapy (HAART) is so effective at disrupting viral replication that it has transformed infection with that most deadly and protean virus, HIV, into a chronic condition. Whats more, HAART is so good at disrupting HIVs ability to replicate that it can reduce the amount of virus in a persons bloodstream to undetectable levels. That keeps people alive but it does something else as well: it makes it essentially impossible for a person living with HIV to transmit the virus to others. Treatment has become an unmatched strategy to prevent the spread the virus.
Thats a remarkable feat for a retrovirus like HIV, which has the highest recorded mutation rate of any biological entity. To overcome that innate advantage, the drugs in the HAART cocktail target multiple parts of the HIV virus. Simply put, the virus cant mutate its way out of the multiple attacks the drugs make on its ability to replicate. This multi-pronged strategy has made HAART a long-term solution that hasnt lost its effectiveness over time even as HIV has continued to evolve at a rapid clip. Its also where HIV prevention intersects neatly with the COVID-19 Test to Treat strategy that President Biden announced at the State of the Union. It could not come at a better time, as recent evidence suggests that a post-Omicron wave is steadily rising across Europe and Asiaand that the U.S. is at risk of a renewed surge.
Read More: Omicron Is Receding But the Pandemic Is Not Over
We now have three antivirals approved for use against COVID-19, all of which target regions of SARS-CoV-2 that are highly conserved, meaning they dont mutate very much at all. That makes them far more resilient to variants compared to the COVID-19 vaccines, all of which target the fast-mutating spike protein. And that gives us a fighting chance to end this pandemic using weapons we can be confident wont be obsolete in a years time. All we have to do is embrace the failure playbook.
Molnupiravir, Paxlovid, and Remdesivir, the three FDA-approved COVID-19 antivirals, target regions of SARS-CoV-2 critical to its ability to copy itself. At their most effective, they nullify the viruss basic programming feature: replication. Instead of an elegant entity made up of macromolecules spring-loaded to enter cells, unfurl, and produce progeny ad nauseam, the antivirals make sure that the viruses that enter human hosts are the last of their kind. And thats where effective treatment can become prevention: as the AIDS pandemic taught us, as long as you can stop a virus from replicating, you can stop it from spreadingboth through a persons body, ending their life, and across a population of transmissible hosts, ending an epidemic.
The Test to Treat plan is part of a larger containment strategy in which the role of COVID-19 antivirals is only going to become more critical. With Test to Treat, the Biden administration is looking to rapidly increase access to antivirals (specifically Pfizers Paxlovid, which reduces the risk of hospitalization for COVID by nearly 90%) for people who test positive for infection at pharmacies. Its a smart approach to reducing illness and death from COVID-19, and it may also set the stage for the end of this pandemic. Thats because, even if new variants find a way to escape the vaccines (the U.K. government estimates that a two-dose vaccine regimen is only 10% effective against Omicron), we can be confident that they wont elude the antivirals, at least not in the short term. Thats why Test to Treat should be the first step in a wholesale adoption of the failure playbook to end COVID-19.
Maintaining a supply of effective antivirals could allow them to be deployed strategically when outbreaks of new variants occur. That way, frontline healthcare workers, along with the families and close contacts of infected people, can be given doses to protect them from severe infections even before theyre infected, stamping out the next wave before it starts. Of course, that will only be possible with long-term funding for the initiative, something that is looking much more perilous after a congressional decision last week halted additional COVID-19 funding, causing the White House to announce that it would soon have to stop covering the costs of testing, vaccines, and antivirals and other treatments for uninsured people.
Read More: What to Know About the 4th COVID-19 Vaccine Dose
Thats shortsighted thinking, because whats perhaps most impressive about the failure playbook is that it might just spell the end of all coronavirus pandemics, now and forever. Thats because the regions that the antivirals target arent just similar across SARS-CoV-2 variants: they are remarkably conserved across every one of the hundreds of coronavirus strains discovered, as quintessentially a part of coronaviruses as prehensile hands are to human beings. To date, the antivirals have been tested against SARS-CoV-2, SARS (the first human pathogenic coronavirus ever discovered), MERS (Middle East Respiratory Symdrome), and many, many other coronaviruses; in every trial, they were effective at significantly reducing the capacity of the viruses to replicate.
And thats where the failure playbook, starting with Test and Treat, becomes truly great news for our speciess long conflict with coronaviruses. Regardless of whatever pathogenic coronavirus next emerges, it will also have those same genomic regions as the ones that came before, making it just as susceptible to the antiviral treatments developed to stop SARS-CoV-2. That should help blunt our understandable anxiety about a repeat of the last two years. Instead, as we look to the future, our species might for the first time in our history have something that has eluded us until now: a weapon to fight the future progeny of our ancient viral nemesis.
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Contact us at letters@time.com.
On the eve of the pandemics two-year anniversary, the U.S. Department of Justice (DOJ) released updated statistics on its efforts to combat COVID-19 related fraud and announced the appointment of a director of COVID-19 Fraud Enforcement. To date, DOJ has charged over 1,000 individuals with criminal offenses involving losses exceeding $1.1 billion; seized over $1 billion in Economic Injury Disaster Loan (EIDL) proceeds; and conducted over 240 civil investigations into more than 1,800 individuals and entities for alleged misconduct in connection with pandemic relief loans totaling more than $6 billion.[1]
This client alert reviews the status of COVID-19 relief, explains recent enforcement trends against COVID-19 related fraud, and predicts future enforcement trends as the pandemic enters its third year. In short, the rush to implement pandemic relief created opportunities for confusion and outright fraud, driving the aggressive pursuit of COVID-19 related fraud. We predict continued scrutiny of COVID-19 relief loans, which may impact financial technology (fintech) firms and the healthcare industry.
Companies can prepare in two ways: (1) by remaining up to date with changes in the COVID-19 enforcement framework and (2) by investing in whistleblower policies and procedures. As to the first point, keeping apprised of how DOJ and its law enforcement partners pursue COVID-19 related fraud will enable companies to remain diligent in their compliance programs and maintain strong internal controls to combat misconduct and mitigate risks related to prior conduct.
As to the second point, companies should also continue investing in their whistleblower programs. Companies should investigate whistleblower claims in a timely and objective manner in order to avoid False Claims Act suits and DOJ action. If an investigation results in a finding of misconduct, a company should consult experienced counsel to weigh the advantage of self-reporting the misconduct and determine how their compliance efforts could potentially mitigate potential fines and other penalties.
The federal government has allocated over $4.5 trillion in COVID-19 relief over the last two yearsa figure that exceeds the entire 2019 federal budget.[2] Two bills provided most of this funding: the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and the American Rescue Plan Act.
Less than two weeks after the World Health Organization declared COVID-19 a pandemic, Congress passed the CARES Act, which authorized the first Paycheck Protection Program (PPP) loans for small businesses, as well as other types of relief. [3] As our recent client alert explained, PPP loans made to eligible borrowers qualify for forgiveness during the 8-to-24 week period following disbursement so long as employers have met and maintained certain program criteria.[4]
Businesses quickly depleted the first wave of PPP loans.[5] In late December 2020, the Consolidated Appropriations Act, 2021, extended the PPP, but restricted the eligibility of qualifying businesses.[6] The PPP eventually stopped accepting new loan applications in May 2021 as vaccinations turned a new page in the pandemic.[7] Borrowers may still receive forgiveness of up to the full amount of the principal of their PPP loan, in addition to any interest for the eligible costs incurred.[8] A similar loan program called the COVID-19 EIDL program has also stopped accepting new loan applications.[9]
In March 2021, Congress passed the American Rescue Plan Act, which provided several types of COVID-19 relief, including direct payments to individuals and more generous unemployment benefits.[10] As of September 2021, the federal government has paid out at least $872 billion in pandemic unemployment benefits.[11] Although numbers vary, a recent U.S. Department of Labor study estimates that at least $87 billion in unemployment benefits was lost to fraud.[12]
In the early days of the pandemic, federal law enforcement cracked down on individuals seeking to capitalize on the fears surrounding COVID-19 by marketing fake cures and treatments. For example, federal agencies enjoined the sale of products marketed to treat or prevent COVID-19, including industrial bleach and nano silver particles.[13] DOJs COVID-19 Hoarding and Price Gouging Task Force pursued price gouging of face masks and other personal protective equipment.[14] More recently, DOJ prosecuted individuals for selling COVID-19 vaccination cards issued by the Centers for Disease Control and Prevention.[15]
The vast majority of DOJs enforcement efforts over the last two years has focused on individuals, organized groups, and companies taking advantage of COVID-19 loan relief programsnamely PPP and EIDL loans. And with good reason. Since the start of the pandemic, the U.S. Secret Service estimates that actors have diverted close to $100 billion in pandemic relief funds.[16] There are two, not mutually exclusive, ways for loan applicants to defraud COVID-19 relief programs: (1) by submitting false loan applications, and (2) by submitting false loan forgiveness applications after misappropriating loan proceeds. Across DOJ, approximately 500 defendants have been charged in over 340 cases with losses of over $700 million.
Federal law enforcement continues to target healthcare fraud. DOJ continues to focus its investigations on fraudulently billed telemedicine fees by healthcare providers in connection with the $180 billion Provider Relief Fund, which was part of the CARES Act.[17] Meanwhile, the U.S. Securities and Exchange Commission (SEC) has charged at least 10 biotech and other companies and individuals with making false and misleading statements to investors, including regarding their abilities to procure protective equipment and testing supplies.[18] Both investors and issuers continue to receive SEC subpoenas concerning COVID-19-related insider trading, although SEC has yet to bring an action in this area.[19]
As highlighted in recent client alerts, we expect to see more fraudand fraud enforcementwith respect to the loan forgiveness process.[20] DOJs recent appointment of a director of COVID-19 Fraud Enforcement is a strong indicator of enhanced enforcement. The new director emphasized continued reliance on data analytics to detect and disrupt fraud, as well as the creation of strike force teams with analysts and data scientists to review data, agents to investigate the cases, and prosecutors and trial attorneys to bring charges and try the cases.
Even companies with forgiven loans are not necessarily off the hook. DOJ and the Small Business Administration (SBA) retain a lingering right to review loan forgiveness applications up to six years from the date of forgiveness.[21] Indeed, a recent SBA report shows that SBAs automated system flagged almost 40% of all PPP loans in 2020 for potential noncompliance with program requirements and required a manual review of each of the flagged loans.[22] The threat of future enforcement action against noncompliance will remain, even after loan forgiveness.
The healthcare industry will likely be subject to additional False Claims Act cases as DOJ focuses on combatting healthcare and COVID-19 related fraud.[23] In general, 2021 was a record year for False Claims Act recoveries, and healthcare fraud was DOJs leading source of False Claims Act settlements and judgments.[24] DOJ also recently announced its first False Claims Act settlements in connection with the PPP this past year.[25] Although additional cases have been slow to unfold, we expect that to change. False Claims Act cases, like many others, take time to investigate and develop. But this steady pursuit suggests that civil enforcement against COVID-19 related fraud has already become a priority for DOJ.[26]
The pandemic has also heightened scrutiny of fintech companies. Fintech grew rapidly during 2020 as digital finance improved access to COVID-19 relief programs.[27] Many fintech lenders facilitated PPP loan applications alongside traditional big banks and community lenders. However, recent studies suggest that fintechs digital platforms may have been less vigorous in vetting loan applications than traditional lenders during the PPP process.[28] While this may not necessarily constitute misconduct, DOJ has begun investigating many fintech firms.[29]
[1] Justice Department Announces Director for COVID-19 Fraud Enforcement, available at https://www.justice.gov/opa/pr/justice-department-announces-director-covid-19-fraud-enforcement.
[2] How the $4 Trillion Flood of Covid Relief Is Funding the Future, available at https://www.nytimes.com/2021/11/24/magazine/pandemic-aid.html.
[3] $2 Trillion Coronavirus Stimulus Bill Is Signed Into Law, available at https://www.nytimes.com/2020/03/27/us/politics/coronavirus-house-voting.html.
[4] DOJ Enforcement Actions Involving COVID-19 Relief Fraud: An Update, available at https://www.mofo.com/resources/insights/210310-doj-enforcement-actions-covid-19-relief-fraud-update.html#_ftn2.
[5] Paycheck Protection Program has run out of money for most borrowers, available at https://www.cnbc.com/2021/05/05/ppp-has-run-out-of-money-for-most-borrowers-what-to-know.html.
[6] Text of the Consolidated Appropriations Act, 2021, available at https://www.washingtonpost.com/wp-stat/graphics/BILLS-116HR133SA-RCP-116-68.pdf.
[7] Paycheck Protection Program, available at https://www.sba.gov/funding-programs/loans/covid-19-relief-options/paycheck-protection-program.
[8] DOJ Enforcement Actions Involving COVID-19 Relief Fraud: An Update (September 2021), available at https://www.mofo.com/resources/insights/210910-doj-enforcement-actions.html.
[9] COVID-19 Economic Injury Disaster Loan, available at https://www.sba.gov/funding-programs/loans/covid-19-relief-options/eidl.
[10] Biden Outlines $1.9 Trillion Spending Package to Combat Virus and Downturn, available at https://www.nytimes.com/2021/01/14/business/economy/biden-economy.html.
[11] More than $87 billion in federal benefits siphoned from unemployment system, says Labor Department, available at https://www.cnbc.com/2021/12/02/over-87-billion-in-federal-benefits-siphoned-from-unemployment-system.html.
[12] Id.
[13] See, e.g., Department Of Justice Acts To Stop Sale Of Nano Silver Product As Treatment For Covid-19, available at https://www.justice.gov/opa/pr/department-justice-acts-stop-sale-nano-silver-product-treatment-covid-19; Justice Department Seeks to End Illegal Online Sale of Industrial Bleach Marketed as Miracle Treatment for COVID-19, available at https://www.justice.gov/opa/pr/justice-department-seeks-end-illegal-online-sale-industrial-bleach-marketed-miracle-treatment.
[14] Combatting Hoarding and Price Gouging, available at https://www.justice.gov/coronavirus/combattingpricegouginghoarding.
[15] Pharmacist Arrested for Selling COVID Vaccination Cards Online, available at https://www.justice.gov/opa/pr/pharmacist-arrested-selling-covid-vaccination-cards-online.
[16] Criminals have stolen nearly $100 billion in Covid relief funds, Secret Service says, available at https://www.cnbc.com/2021/12/21/criminals-have-stolen-nearly-100-billion-in-covid-relief-funds-secret-service.html.
[17] DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19, https://www.justice.gov/opa/pr/doj-announces-coordinated-law-enforcement-action-combat-health-care-fraud-related-covid-19.
[18] See, e.g., SEC Charges Biotech Company and CEO With Fraud Concerning COVID-19 Blood Testing Device, available at https://www.sec.gov/news/press-release/2020-327; SEC Charges Companies and CEO for Misleading COVID-19 Claims, available at https://www.sec.gov/news/press-release/2020-111.
[19] See, e.g., SEC Obtains Court Order to Enforce Investigative Subpoena for Testimony, available at https://www.sec.gov/litigation/litreleases/2021/lr25261.htm.
[20] DOJ Enforcement Actions Involving COVID-19 Relief Fraud: An Update, available at https://www.mofo.com/resources/insights/210310-doj-enforcement-actions-covid-19-relief-fraud-update.html; DOJ Enforcement Actions Involving COVID-19 Relief Fraud: An Update (September 2021), available at https://www.mofo.com/resources/insights/210910-doj-enforcement-actions.html.
[21] Paycheck Protection Program, PPP Loan Forgiveness Application Form 3508S Revised January 19, 2021, available at https://www.sba.gov/sites/default/files/2021-01/PPP%20--%20Loan%20Forgiveness%20Application%20and%20Instructions%20--%20Form%203508S%20%281.19.2021%29.pdf.
[22] SBAs Paycheck Protection Program Loan Review Processes, available at https://www.sba.gov/sites/default/files/2022-02/SBA%20OIG%20Report%2022-09.pdf?utm_medium=email&utm_source=govdelivery.
[23] Attorney General Announces Task Force to Combat COVID-19 Fraud, available at https://www.justice.gov/opa/pr/attorney-general-announces-task-force-combat-covid-19-fraud.
[24] Justice Departments False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021, available at https://www.justice.gov/opa/pr/justice-department-s-false-claims-act-settlements-and-judgments-exceed-56-billion-fiscal-year.
[25] See, e.g., id.; Eastern District of California Obtains Nations First Civil Settlement for Fraud on Cares Act Paycheck Protection Program, available at https://www.justice.gov/usao-edca/pr/eastern-district-california-obtains-nation-s-first-civil-settlement-fraud-cares-act.
[26] Justice Departments False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021, available at https://www.justice.gov/opa/pr/justice-department-s-false-claims-act-settlements-and-judgments-exceed-56-billion-fiscal-year.
[27] Coronavirus Drives 72% Rise In Use Of Fintech Apps, available at https://www.forbes.com/sites/simonchandler/2020/03/30/coronavirus-drives-72-rise-in-use-of-fintech-apps/.
[28] See, e.g., PPP Loan Scammers Used Fintech Companies to Carry Out Fraud, available at https://www.bloomberg.com/news/articles/2020-10-07/ppp-loans-scammers-used-fintech-companies-to-carry-out-fraud.
[29] See, e.g., U.S. Justice Department probing Kabbage, fintechs over PPP loan calculations sources, available at https://www.reuters.com/article/us-health-coronavirus-usa-probe-idCAKBN2CP020.
[View source.]
The Biden administration made a firm push for Congress to provide additional funding to fight COVID-19 on Tuesday after $15.6 billion was dropped from a spending bill, arguing that it needs to make sure there are enough doses on hand to provide fourth jabs for all Americans if such boosters are needed - or to provide variant-specific vaccines if those are needed. Without additional funding, the government does not have the ability to maintain the country's domestic testing capacity beyond June, another official said. Officials also warned that providers soon would no longer be able to submit claims for testing, treating and vaccinating uninsured people, and the government would face a reduced ability to rapidly identify and assess new strains of COVID.The U.S. COVID numbers continue to decline, and the nation is now averaging 32,094 new cases a day, according to a New York Times tracker, down 46% from two weeks ago. The average daily number of hospitalizations stands at 26,436, down 44% from two weeks ago. Deaths are averaging 1,226 a day, down 36% from two weeks ago, but still an undesirably high number. Globally, there have been 461.8 million confirmed cases, according to data aggregated by Johns Hopkins University, and 6.05 million deaths. The U.S. leads the world with 79.6 million cases and 966,470 fatalities.
"It's a great thing": Red Cross resumes testing blood donations for coronavirus antibodies WACH.com
The thing I hate most during the day isn't traffic; it's not when Dunkin' makes my coffee order wrong or when your leg falls asleep from being on Instagram too long on the throne.
It's when I get a phone call. Like, legit, someone dialed my number instead of texting me.
I don't care if I'm lying on my bed using a large feather for a fan while eating grapes. If you call me, I will more than likely ignore your call and text back, "Can't talk, can text. What's up?"
I began to think about other things that fit these anti-social categories and realized that I've regressed in wanting to talk to people or hang out with them.
It wasn't that long ago that we would drive by our friends and family's homes, waving at them and giving air hugs. I remember bringing a bottle of Jack and sitting on the other side of the street while my buddies Dre and Sammy Lopez joined me for a drink but 200 feet away.
And funniest of all, I remember the surprise FaceTime calls. When that FT ring would pour out of my phone, I would get giddy and make sure I didn't have a boogie hanging from my nose, trying my best to look cute (hilariously enough, I looked like wolf-man jack because ain't nobody getting haircuts during the pandemic).
So why is it that when things open back up do I have this significant regression?
Two years ago, I just wanted to sit at a bar to drink and have a normal conversation about sports or something insane Kanye did. Now, as soon as I go out, I can't wait to get back home. I find myself unable to communicate with people in public again. When I look normal and do not have any issues, my anxiety level is through the roof, anticipating the end of whatever interaction I'm having.
I spoke to my friend Dr. Napoleon Wells,local-based clinical psychologist and author, about these feelings. I wondered if he's come across anyone else dealing with these feelings after dealing with COVID restrictions the past two years.
"We are seeing more studies emerging in and around what you have with the emotional and psychiatric correlates of having (lived) so long with Rona, he said. "I've just taken to calling it Coronaralized Anxiety Disorder and Ronaphrenia."
These comments were during a casual conversation with my bro, and it was an unofficial diagnosis with the term, but the ideals began to make sense as he further explained.
"It looks like anxiety in terms of engaging with other people but it also looks like depression in terms of day to day motivation and energy level. Sense of disconnection but wanting to be connected."
He also poses that our sense of reality has shifted when we ask, "What does it mean to be outside?"
The question also hits from a creative perspective. I make hip-hop music. One of the main genres that require crowd participation and energy. What happens when you're making music just in your home with no venue to perform it at or someone's car to bump it in and see that seductive head-nod?
The answer is simple: Own your feelings. My "Ronalized Anxiety Disorder," if you will.
During the past two years, I forced myself to create out of emotional survival and not commerce. I made music and hated 90% of it, but I could hear my emotions in real-time and hear the anguish I didn't know was there. I put some of those pieces, flawed and at times incomplete, in a project appropriately called the 'Rona Tape.'
After I put it out last week, someone called me, and in an out-of-the-norm moment, I answered the call. Funny enough, out of anguish, the project generated an hour-long conversation with my friend. It felt great. Now next time you call, there's a good chance I will answer.
I look forward to hearing from you.
Preach Jacobs is a musician, artist and activist and founder of Cola-Con and indie label Sounds Familiar Records. You can hear his podcasts and read more work at FightThePower.co.
Patient deaths: 965,105
Total vaccine doses distributed: 695,949,235
Patients whove received the second dose: 216,690,804
% of population fully vaccinated: 65.3%
% of infections tied to the Omicron Variant: 100%
SAN DIEGO (KGTV) - For two years, the COVID-19 pandemic has transformed pregnancy from one of the happiest times in many people's lives into a constant state of worry and fear.
"It was eye-opening to see these young, healthy women get sick and get sick quite severely," says Dr. Joanna Adamczak, the Chief Medical Officer at Sharp-Mary Birch Hospital for Women and Newborns.
Dr. Adamczak says the number of women getting pregnant declined throughout the pandemic. Meanwhile, fear kept many of the women who did get pregnant from attending routine medical appointments.
"The mood, in the beginning, was everywhere, fear," Dr. Adamczak says. "Fear of the unknown."
Because COVID-19 was a brand new virus, no one knew how it would impact pregnant women or their unborn children. And even when vaccines got approval, the lack of pregnant women involved in the trials meant there was very little information on how they could affect pregnancies.
"We had very little data," says Dr. Cynthia Gyamfi-Bannerman, the Chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at UC San Diego Health. "Our recommendations were based on hypotheses and theories."
But a lot of that fear went away as more information came out. Research done in San Diego helped provide answers.
A June 2020 report from the National Institutes of Health found that pregnant women were particularly at-risk for COVID-19 infections. Not only were the women more susceptible to severe outcomes like hospitalizations or death, but their unborn babies were also at risk. They had higher incidences of preeclampsia, hypertension, premature birth, low birth weight, and stillbirth/miscarriages.
"We knew it was bad," said Dr. Gyamfi-Bannerman. "But then we had data to confirm it."
A lot of that data came from UC San Diego's MotherToBaby and the Center for Better Beginnings. They launched a handful of studies to follow pregnant women throughout the Pandemic and learn the impacts. Around 3200 women signed up over two years.
"We've had to learn what are the risks to pregnant women who become infected," explains MotherToBaby Co-Director Dr. Christina Chambers. "All of which led to, don't get infected if you can avoid it. And if you do get infected, seek treatment immediately."
MotherToBaby also worked to determine if the COVID-19 vaccine would be safe for pregnant women to take and if it would still provide protection against the virus.
As data showed vaccines were safe and effective for pregnant women, MotherToBaby became an essential CDC resource advocating for vaccinations.
"We have taken tens of thousands of calls and questions from pregnant women or women planning pregnancy," says Dr. Chambers. "All of them ask what we know about the safety of the vaccine."
Meanwhile, MOMI CORE, the Mother Milk Infant Center for Research Excellence, led a study to determine if COVID-19 could be passed from mother to baby through breast milk. It took just 160 days for them to publish a study showing that the infection did not transmit through breastfeeding. They also found that protective antibodies from infection or the vaccine did.
"The speed sounds fast," says MOMI CORE Director Dr. Lars Bode. "But really, that's 160 days of uncertainty. 160 days, half a year can be a very long time if you don't know exactly if your breast milk is safe or not."
Still, having all of that data gave doctors the tools they needed to debunk many of the myths surrounding the virus and its impact on pregnancy and lactation.
As studies continue, they hope to shed more light on the issue.
"We are in a much better place now than we were," says Dr. Gyamfi-Bannerman.
In the future, doctors say COVID-19 will become a manageable risk during pregnancy, similar to the flu or other respiratory diseases. They think booster shots may be recommended, along with masking and extra health and safety precautions during pregnancy.
"It's going to become part of daily life," says Dr. Gyamfi-Bannerman. "But, thankfully, we have treatments for that."
And research will continue. Dr. Chambers says they hope to follow many of their pregnant volunteers for years to learn how their children develop.
"For COVID, especially, and also for the vaccines, we need to capture the long-term neurodevelopmental outcomes," she says. "We really want to know how your kids are doing when they're four or five."
Dr. Bode adds that it will be essential to keep all of the connections, funding, and protocols from this Pandemic in place. That will help researchers work quickly when the next Pandemic arrives.
And doctors on the front lines say women must get vaccinated and stay in contact with their physicians.
"Speak to your health care providers," says Dr. Adamczak. "Talk to them about your fears and your concerns."
For the latest information about COVID and Pregnancy, visit the CDC website here.
1. Three Covid-19 vaccines from Pfizer, Moderna, and Johnson & Johnson provided durable protection against hospitalization and death.
2. However, effectiveness against infection waned due to decreasing immunity and new variant emergence.
Evidence Rating Level: 2 (Good)
Study Rundown: There has been a resurgence of Covid-19 cases in the United States, but its cause, whether due to waning vaccine effectiveness over time or emergence of new variants, remains unclear. The current study examined vaccination and outcome data for Covid-19 during a 9-month period (December 2020-September 2021) for North Carolina residents. The three vaccines of interest were BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson & Johnson-Janssen) and their effectiveness in reducing the risks of infection, hospitalization, and death were estimated from this database. It was found that all three vaccines were effective in reducing these risks, but protection against hospitalization and death was sustained better than against infection, which declined over time. Furthermore, the two mRNA vaccines conferred higher protection than the adenovirus-based Ad26.COV2.S. The observational study showed that for North Carolina residents, all three Covid-19 vaccines provided lasting protection against hospitalization and death, despite waning protection against infection. The rising infection rate was attributed to both declining immunity and the emergence of the B.1.617.2 Delta variant.
Click here to read the study in NEJM
Relevant Reading: Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study
In-Depth [retrospective cohort]: This retrospective cohort study examined Covid-19 vaccination and outcomes over a 9-month period (December 11, 2020, to September 8, 2021) for 10.6 million North Carolina residents. This data was compiled from the North Carolina Covid-19 Surveillance and Vaccine Management systems. The three vaccines of interest were BNT162b2, mRNA-1273, and Ad26.COV2.S. The outcomes of interest were Covid-19 infection (either symptomatic or asymptomatic), and Covid-19-related hospitalization and death. The effectiveness of the vaccines over time was evaluated based on a Cox regression model and compared against the unvaccinated population. The mRNA vaccines, BNT162b2 (30g per dose) and mRNA-1273 (100g per dose) were evaluated following one and two doses, whereas the adenovirus-based Ad26.COV2.2 (5 x 1010 viral particles) was evaluated following one dose, in accordance with the manufacturers regimens. It was found that two doses of BNT162b2 and mRNA-1273 provided effectiveness rates against infection of 94.5% (95% confidence interval [CI], 94.1-94.9) and 95.9% (95% CI, 95.5-96.2), respectively at 2 months after the first dose was administered. At 7 months, however, their effectiveness against infection declined to 66.6% (95% CI, 65.2-67.8) and 80.3% (95% CI, 79.3-94.9). For the Ad26.COV2.S vaccine, its effectiveness against infection was 74.8% (95% CI, 72.5-76.9) at 1 month following administration and fell to 59.4% (95% CI, 57.2-61.5) at 5 months post-vaccination. By considering the varying times of vaccination, the results suggested that this waning effectiveness against infection was primarily due to declining immunity over time, rather than a specific period of delta variant emergence. Nevertheless, the effectiveness was observed to decline sharply by 15% and 10% among early recipients of BNT162b2 and mRNA-1273 (first dose given before March 2021), respectively, from mid-June to mid-July, which coincided with the delta variant surge. This suggested that the emergence of the delta variant exacerbated the declining effectiveness. Protection against hospitalization and death, however, was sustained better for all three vaccines. Specifically, the BNT162b2 conferred the effectiveness against hospitalization and death of 96.4% and 98.0% at 2 months, respectively; and 88.7% and 90.5% at 7 months. The mRNA-1273 effectiveness against hospitalization and death was 97.2% and 98.6% at 2 months and maintained at 94.1% and 95.5% at 7 months. The Ad26.COV2.S effectiveness against hospitalization and death was 85.8% and 85.95% at 2 months and remained higher than 80% and 70%, respectively, at 6 months. Similar to infection prevention, the effectiveness of BNT162b2 and mRNA-1273 against hospitalization and death was declining during the emergence of the Delta variant. The vaccine effectiveness as estimated by the current study was consistent with efficacy results from phase 3 clinical trials as well as cohort studies internationally. Despite its observational nature, its large sample size provided strong evidence that the effectiveness of Covid-19 vaccines waned over time, significantly more so for infection than hospitalization and death, and this decline was further exacerbated by the emergence of the new variant.
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While many people in wealthier countries have been vaccinated against Covid-19, there is still a need for vaccination in much of the world. A new vaccine developed at MIT and Beth Israel Deaconess Medical Center may aid in those efforts, offering an inexpensive, easy-to-store, and effective alternative to RNA vaccines.
In a new paper, the researchers report that the vaccine, which comprises fragments of the SARS-CoV-2 spike protein arrayed on a virus-like particle, elicited a strong immune response and protected animals against viral challenge.
The vaccine was designed so that it can be produced by yeast, using fermentation facilities that already exist around the world. The Serum Institute of India, the worlds largest manufacturer of vaccines, is now producing large quantities of the vaccine and plans to run a clinical trial in Africa.
There's still a very large population that does not have access to Covid vaccines. Protein-based subunit vaccines are a low-cost, well-established technology that can provide a consistent supply and is accepted in many parts of the world, says J. Christopher Love, the Raymond A. and Helen E. St. Laurent Professor of Chemical Engineering at MIT and a member of the Koch Institute for Integrative Cancer Research and the Ragon Institute of MGH, MIT, and Harvard.
Love and Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center (BIDMC) and a professor at Harvard Medical School, are the senior authors of the paper, which appears today in Science Advances. The papers lead authors are MIT graduate students Neil Dalvie and Sergio Rodriguez-Aponte, and Lisa Tostanoski, a postdoc at BIDMC.
Optimizing manufacturability
Loves lab, working closely with Barouchs lab at BIDMC, began working on a Covid-19 vaccine in early 2020. Their goal was to produce a vaccine that would be not only effective but also easy to manufacture. To that end, they focused on protein subunit vaccines, a type of vaccine that consists of small pieces of viral proteins. Several existing vaccines, including one for hepatitis B, have been made using this approach.
In places in the world where cost remains a challenge, subunit vaccines can address that. They could also address some of the hesitancy around vaccines based on newer technologies, Love says.
Another advantage of protein subunit vaccines is that they can often be stored under refrigeration and do not require the ultracold storage temperatures that RNA vaccines do.
For their subunit vaccine, the researchers decided to use a small piece of the SARS-CoV-2 spike protein, the receptor-binding domain (RBD). Early in the pandemic, studies in animals suggested that this protein fragment alone would not produce a strong immune response, so to make it more immunogenic, the team decided to display many copies of the protein on a virus-like particle. They chose the hepatitis B surface antigen as their scaffold, and showed that when coated with SARS-CoV-2 RBD fragments this particle generated a much stronger response than the RBD protein on its own.
The researchers also wanted to ensure that their vaccine could be manufactured easily and efficiently. Many protein subunit vaccines are manufactured using mammalian cells, which can be more difficult to work with. The MIT team designed the RBD protein so that it could be produced by the yeast Pichia pastoris, which is relatively easy to grow in an industrial bioreactor.
Each of the two vaccine components the RBD protein fragment and the hepatitis B particle can be produced separately in yeast. To each component, the researchers added a specialized peptide tag that binds with a tag found on the other component, allowing RBD fragments to be attached to the virus particles after each is produced.
Pichia pastoris is already used to produce vaccines in bioreactors around the world. Once the researchers had their engineered yeast cells ready, they sent them to the Serum Institute, which ramped up production rapidly.
One of the key things that separates our vaccine from other vaccines is that the facilities to manufacture vaccines in these yeast organisms already exist in parts of the world where the vaccines are still most needed today, Dalvie says.
A modular process
Once the researchers had their vaccine candidate ready, they tested it in a small trial in nonhuman primates. For those studies, they combined the vaccine with adjuvants that are already used in other vaccines: either aluminum hydroxide (alum) or a combination of alum and another adjuvant called CpG.
In those studies, the researchers showed that the vaccine generated antibody levels similar to those produced by some of the approved Covid-19 vaccines, including the Johnson and Johnson vaccine. They also found that when the animals were exposed to SARS-CoV-2, viral loads in vaccinated animals were much lower than those seen in unvaccinated animals.
For that vaccine, the researchers used an RBD fragment that was based on the sequence of the original SARS-CoV-2 strain that emerged in late 2019. That vaccine has been tested in a phase 1 clinical trial in Australia. Since then, the researchers have incorporated two mutations (similar to ones identified in the natural Delta and Lambda variants) that the team previously found to improve production and immunogenicity compared to the ancestral sequence, for the planned phase 1/2 clinical trials.
The approach of attaching an immunogen RBD to a virus-like particle offers a plug and display-like system that could be used to create similar vaccines, the researchers say.
We could make mutations that were seen in some of the new variants, add them to the RBD but keep the whole framework the same, and make new vaccine candidates, Rodriguez-Aponte says. That shows the modularity of the process and how efficiently you can edit and make new candidates.
If the clinical trials show that the vaccine provides a safe and effective alternative to existing RNA vaccines, the researchers hope that it could not only prove useful for vaccinating people in countries that currently have limited access to vaccines, but also enable the creation of boosters that would offer protection against a wider variety of SARS-CoV-2 strains or other coronaviruses.
In principle, this modularity does allow for consideration of adapting to new variants or providing a more pan-coronavirus protective booster, Love says.
Researchers from the Serum Institute and SpyBiotech also contributed to the paper. The research was funded by the Bill and Melinda Gates Foundation and the Koch Institute Support (core) Grant from the National Cancer Institute.
