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MORE INFORMATION ABOUT ORAL ANTI-COVID DRUGS

(MONOCLONAL ANTIBODIES (Given IV)

Monoclonal antibodies blocking surface proteins of the coronavirus can slow the infection of new cells with SARS-CoV-2, but their application has been hamstrung by cost, availability, and the need to infuse or inject them.)

PFIZER’S NEW DRUG: (PR-07321332)

In contrast, Pfizer’s ingestible candidate operates inside an infected cell; it blocks enzymes, called proteases, that normally act early in a virus’ life cycle to help it replicate (see graphic, below). Many protease inhibitors are approved for HIV treatment, and Pfizer’s compound has a nearly 20-year history. Pfizer scientists designed a version of the compound back in 2003 to block a protease in the coronavirus that causes severe acute respiratory syndrome (SARS), a cousin of SARS-CoV-2….Then SARS abated, and Pfizer shelved the product. Last year, the company dusted it off, discovered it could stop SARS-CoV-2 from replicating in human cells, and began to develop it for COVID-19….Monoclonal antibodies blocking surface proteins of the coronavirus can slow the infection of new cells with SARS-CoV-2, but their application has been hamstrung by cost, availability, and the need to infuse or inject them. In contrast, Pfizer’s ingestible candidate operates inside an infected cell; it blocks enzymes, called proteases, that normally act early in a virus’ life cycle to help it replicate (see graphic, below). Many protease inhibitors are approved for HIV treatment, and Pfizer’s compound has a nearly 20-year history. Pfizer scientists designed a version of the compound back in 2003 to block a protease in the coronavirus that causes severe acute respiratory syndrome (SARS), a cousin of SARS-CoV-2….Monoclonal antibodies blocking surface proteins of the coronavirus can slow the infection of new cells with SARS-CoV-2, but their application has been hamstrung by cost, availability, and the need to infuse or inject them. In contrast, Pfizer’s ingestible candidate operates inside an infected cell; it blocks enzymes, called proteases, that normally act early in a virus’ life cycle to help it replicate (see graphic, below). Many protease inhibitors are approved for HIV treatment, and Pfizer’s compound has a nearly 20-year history. Pfizer scientists designed a version of the compound back in 2003 to block a protease in the coronavirus that causes severe acute respiratory syndrome (SARS), a cousin of SARS-CoV-2….There’s broad agreement among doctors and scientists that drugs that cripple SARS-CoV-2 directly and early in an infection are crucial to helping end the COVID-19 pandemic.(They are quick to emphasize that such treatments shouldn’t replace vaccines as the first line of defense.)…The regimen is also being tested in two additional trials. One is enrolling people who have a standard risk of developing severe COVID-19, including those who are vaccinated; the other offers the pills as a preventive therapy to people who’ve had a member of their household test positive for the virus. Those trials continue and Pfizer hasn’t yet reported their results….

MERCK’S NEW DRUG: (MOLNUPIRAVIR)

On 1 October, Merck and Ridgeback Biotherapeutics announced their antiviral, called molnupiravir, cut hospitalization by half in trial volunteers. (That trial was also halted early because of the drug’s effectiveness.) Yesterday, U.K. regulators approved molnupiravir for people with mild or moderate COVID-19 and at least one risk factor, such as obesity. An advisory committee to the U.S. Food and Drug Administration will consider the therapy later this month….Molnupiravir works very differently from a protease inhibitor: It tricks SARS-CoV-2 into incorporating the compound into its genetic information, encoded by RNA, and in doing so mutates the virus to a point where it can longer replicate. But some experts worry that in the long term, widespread use of the drug could spur the evolution of additional harmful viral variants. There also remain theoretical concerns about whether the drug could cause mutations in people. So having another COVID-19 drug option like Pfizer’s protease inhibitor is welcome. …“Protease inhibitors are really powerful antivirals, and that’s been demonstrated with HIV and hepatitis ….Other protease inhibitors for SARS-CoV-2 are racing through their own clinical trials. In its press release, Pfizer said there were no notable side effects associated with its drug candidate.

 Ultimately, scientists say, drug combinations may be key to treating early COVID-19; that molnupiravir and protease inhibitors act on the virus in different ways could make stacking them together a potent strategy if resistance to one becomes widespread. HIV and hepatitis C treatments both employ such combinations now,…[and] combining the oral antivirals now hitting the scene might change the pandemic’s trajectory.

Next-gen supercharged COVID-19 vaccines may also target the common cold

Coverage and Estimated Effectiveness of mRNA COVID-19 Vaccines Among US Veterans

”…Question  What was the COVID-19 vaccination coverage and estimated mRNA COVID-19 vaccine effectiveness (VE) among US veterans in the first 3 months following vaccine rollout?

Findings  In this case-control study including 6 647 733 veterans, 23% of veterans received at least 1 COVID-19 vaccination during the first 3 months of vaccine rollout. VE against infection was estimated to be 95% for full vaccination; estimated VE against COVID-19-related hospitalization was 91%, and there were no COVID-19–related deaths among fully vaccinated veterans… These findings suggest that early vaccination rollout for veterans was efficient, and estimated VE was high for this diverse US population…Conclusions and Relevance  For veterans of all racial and ethnic subgroups living in urban or rural areas, mRNA vaccination was associated with a substantially decreased risk of COVID-19 infection and hospitalization, with no deaths among fully vaccinated veterans.

Evaluating the reliability of mobility metrics from aggregated mobile phone data as proxies for SARS-CoV-2 transmission in the USA: a population-based study

”…In this study we describe changes in the relationship between mobile phone data and SARS-CoV-2 transmission in the USA….The effective reproduction number (Rt) represents the expected number of infections caused by a single infectious case, accounting for existing immunity in the population. Rt provides an important measure of epidemic trajectory and indicates whether incidence is growing, shrinking, or holding steady.

(J. Harris: Unless I missed something, this study shows that mobility metrics is not helpful in rural areas.)

AND LAST BUT NOT LEASED;

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A judge says Texas’ ban on mask mandates violates the rights of students with disabilities.

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

CONCLUSIONS

A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age.

How Easily Can Vaccinated People Spread COVID?

‘‘’…even if vaccinated and unvaccinated people have the same viral load, it may not necessarily mean they are just as likely to spread the virus…. One reason for this may be that vaccinated people carry less infectious virus particles, as (not-yet-peer-reviewed) research from the Netherlands has recently illustrated. Although it’s widely assumed that virus particles carried by the vaccinated and unvaccinated are the same, basic principles of immunology actually predict otherwise… Virus particles expelled by a vaccinated person are thought to be coated in antibodies—some of which are produced in the nose and mouth and are considered part of “mucosal” immunity—so “we can expect less of a downstream transmission,”…. A recent paper …showed that vaccinated people shed less virus, stop shedding virus sooner than the unvaccinated, and shed particles that are less infectious—supporting the notion that they’re less likely to transmit disease. One study from the Netherlands found a 63 percent reduction in household transmission among the vaccinated… (However, another recent study didn’t find a statistically significant difference in household transmission between vaccinated and unvaccinated people.)

”Ultimately… you can certainly say the transmission risk for vaccinated people is lower, “but I don’t really know how you define ‘low.’”…. The new research so far hasn’t swayed the CDC, which remains cautious….[The CDC Says] that the data that have come out since the Provincetown study make it clear that fully vaccinated people with a breakthrough infection can spread the virus to other people, including the vaccinated. Although the science is still emerging, “it seems that at least early after infection, fully vaccinated people with breakthrough infection can be equally as infectious, and [probably] somewhat less infectious to others than unvaccinated people who are infected…

‘’… All the researchers [contacted said] Vaccination is still the best way to protect against infection and transmission. The vaccines may not be perfect, but they are by far the best tool we have in the fight against COVID-19—for protecting both yourself and others. Moreover, vaccinated people can tamp down on spreading the virus by steering clear of situations in which that’s more likely to happen…. The “million-dollar question” now…is how often we’ll need boosters in the months and years ahead…

(J. Harris: Should I find myself in a ” bad crowd” I would also continue to wear my top-of-the-line mask. Maybe people will think I’m sick and stay away from me?)

 Germany debates imposing tighter rules as infections surge.

Nearly 40,000 new cases were registered in the country on Tuesday — the third time a daily record has been set within a week. And 236 people died of the disease in that 24-hour period….Experts say that the recent surge in infections has resulted from the relatively low vaccination rate in some regions of Germany and the slow rollout of booster shots. About 67 percent of the country’s population is fully vaccinated….Another factor is the waning immunity from the vaccines, and Germany’s booster campaign is running behind some wealthy countries. Only about 3.4 percent of the population has received a booster shot, compared with about 7.6 percent in the U.S. (and the weather is colder).

FROM HOPKINS:

1. Novel Suction-based In Vivo Cutaneous DNA Transfection Platform (Science Advances) This work reports a suction-based cutaneous delivery method for in vivo DNA transfection. Following intradermal Mantoux injection of plasmid DNA in a rat model, a moderate negative pressure is applied to the injection site, a technique similar to Chinese báguàn and Middle Eastern hijama cupping therapies.Specific utility was demonstrated with a synthetic SARS-CoV-2 DNA vaccine, which generated host humoral immune response in rats with notable antibody production. This method enables an easy-to-use, cost-effective, and highly scalable platform for both laboratorial transfection needs and clinical applications for nucleic acid–based therapeutics and vaccines.

(We looked at this last week. I hope it works in humans, and it probably will.)

2. How An Outbreak Became a Pandemic: a Chronological Analysis of Crucial Junctures and International Obligations in the Early Months of the COVID-19 Pandemic (The Lancet) Understanding the spread of SARS-CoV-2, how and when evidence emerged, and the timing of local, national, regional, and global responses is essential to establish how an outbreak became a pandemic and to prepare for future health threats. The retrospective analysis of the chronology shows a dedicated initial response by WHO and some national governments, but also aspects of the response that could have been quicker, including outbreak notifications under the International Health Regulations (IHR), presumption and confirmation of human-to-human transmission of SARS-CoV-2, declaration of a Public Health Emergency of International Concern, and, most importantly, the public health response of many national governments. The chronology also shows that some countries, largely those with previous experience with similar outbreaks, reacted quickly, even ahead of WHO alerts, and were more successful in initially containing the virus. Mapping actions against IHR obligations, the chronology shows where efficiency and accountability could be improved at local, national, and international levels to more quickly alert and contain health threats in the future.

 Association of Self-reported High-Risk Allergy History With Allergy Symptoms After COVID-19 Vaccination

”…Conclusions and Relevance  This cohort study found that self-reported history of high-risk allergy was associated with an increased risk of self-reported allergic reactions within 3 days of mRNA COVID-19 vaccination. However, reported allergy symptoms did not impede the completion of the 2-dose vaccine protocol among a cohort of eligible health care employees, supporting the overall safety of mRNA COVID-19 vaccine.

(J. Harris: So allergic people had a little bit more trouble with vaccine, but not enough to prevent completion of the vaccine series.)

Evaluation of a COVID-19 Vaccine Campaign and SARS-CoV-2 Infection and Mortality Among Adults Aged 60 Years And Older in a Middle-Income Country

Conclusions

The present analysis shows that the pragmatic implementation of a vaccination plan including 3 different vaccine options in older adults in the City of Buenos Aires was associated with a significant reduction in documented COVID-19 infection and death from any cause as well as death presumably associated with COVID-19. These results suggest the need to implement mass vaccination strategies with the vaccines that each country has available in the shortest possible time.

(These were “Brand X” vaccines and they still helped.)

Estimating the early impact of the US COVID-19 vaccination programme on COVID-19 cases, emergency department visits, hospital admissions, and deaths among adults aged 65 years and older: an ecological analysis of national surveillance data

(J. Harris: Yeah! The vaccines work. This complicated and complete article proves it, once again. Why don’t our elderly neighbors get vaccinations, locally? What can I do to help? What can you do? 

”…In conclusion, we found that the initial phases of the US COVID-19 vaccination programme were associated with reductions in COVID-19 cases, emergency department visits, and hospital admissions among older adults, a group prioritised for vaccination and at higher risk of severe outcomes from COVID-19. Our findings, which are consistent with the established high effectiveness of available vaccines,… reinforce the importance of increasing vaccination coverage among all eligible people and support continued investment in COVID-19 vaccination. Nationally, as of June 8, 2021, more than 86% of people aged 65 years and older had received at least one dose of a COVID-19 vaccine, but this figure varied widely by state. Among all US people aged 12 years and older, 61% had received at least one dose of COVID-19 vaccine, and 50% were fully vaccinated. Continued monitoring will be important to further evaluate the impact of the COVID-19 vaccination programme on outcomes in younger adults and children, in addition to the impact of booster doses. The present methodology, with some modifications, might provide important insight into these new situations as they unfold.

AND LASTLY:

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FROM THE MNM:

HIGH TEXAS DEATH RATES DUE TO UNVACCINATED PEOPLE

(J. Harris: Several sources for this story. See the chart below as well from the TEXAS DEPARTMENT OF STATE HEALTH SERVICES: SEE ATTACHMENT FOR COMPLETE REPORT)

HOPKINS SELECTIONS: 

CHILDHOOD VACCINATION Now that a SARS-CoV-2 vaccine is authorized for children ages 5 to 11 years in the US, state regulators—along with parents, pediatricians, and public health officials—are contemplating when and if the shots should become mandatory for children. All 50 US states have requirements for school-age children to be immunized against other diseases such as polio, chickenpox, and measles. The nation’s second-largest school district, Los Angeles Unified School District in California, already has said children aged 12 and older must be vaccinated by mid-December to continue in-person learning, and several other jurisdictions and states have plans to make SARS-CoV-2 vaccination mandatory for children and adolescents to attend school as soon as the US FDA grants a vaccine full approval for those age groups.

Breaking News: Pfizer is expected to ask the F.D.A. to expand authorization of its Covid booster to all adults, a request the agency is likely to grant.

Pfizer and BioNTech are expected on Tuesday to ask federal regulators to expand authorization of their coronavirus booster shot to include all adults, according to two people familiar with the situation….An advisory board of outside experts to the Food and Drug Administration voted against a similar request from Pfizer in mid-September. Instead, the committee recommended booster shots on an emergency basis for those 65 and older or at high risk of Covid-19 because of their medical conditions or jobs.

Those categories were still broad enough to cover at least 60 percent of the population….All Johnson & Johnson recipients are eligible for a second shot as a booster. And adult recipients of all three brands for their initial shots are allowed to pick which brand they would prefer as a booster shot. Nearly 25 million people have received additional shots so far, according to the Centers for Disease Control and Prevention, including those who are eligible because of immune deficiencies. 

In Romania, Hard-Hit by Covid, Doctors Fight Vaccine Refusal

COPACENI, Romania — As a new wave of the coronavirus pandemic crashed over Eastern Europe last month, devastating unvaccinated populations, an Orthodox Church bishop in southern Romania offered solace to his flock: “Don’t be fooled by what you see on TV — don’t be scared of Covid.”

Most important, Bishop Ambrose of Giurgiu told worshipers in this small Romanian town on Oct. 14, “don’t rush to get vaccinated.”

The bishop is now under criminal investigation by the police for spreading dangerous disinformation, but his anti-vaccine clarion call, echoed by prominent politicians, influential voices on the internet and many others, helps explain why Romania has in recent weeks reported the world’s highest per capita death rate from Covid-19…

”….Vaccine hesitancy, stoked by powerful forces online and in the real world, has left Romania with Europe’s second-lowest vaccination rate; around 44 percent of adults have had at least one dose, ahead of only Bulgaria, at 29 percent. Overall, the European Union stands at 81 percent, with several countries above 90 percent….

”…Bulgaria, too, has a very high Covid mortality rate, with already overwhelmed hospitals flooded by new patients. This past week, one of the big hospitals in the capital city, Sofia, issued a plea for medical students and volunteers to help…“Fake news has a huge influence on our population, and in Eastern Europe in general,” said Valeriu Ghorghita, an army colonel leading Romania’s vaccination effort. ‘Something we all have in common in this part of Europe is our political history of communism.’…..”

WHY DOES HARRISON COUNTY HAVE A LOWER OVERALL VACCINATION RATE THAN ROMANIA? 

WOW, WE AT LEAST BEAT BULGARIA WHO HAS ONLY 29% ALL AGE VACCINATIONS COMPARED TO OUR 36%. …WE ACTUALLY HAVE READERS FROM BULGARIA, AND I WISH THEM LUCK. HOWEVER, THEY SHOULD BE CAREFUL LEST SOME OF OUR VACCINE-HESITANT POPULATION WANT TO VACATION IN BULGARIA. 

AND LASTLY:

I WENT TO SEE THE DOCTOR ABOUT MY SHORT-TERM MEMORY PROBLEMS. THE FIRST THING HE DID WAS MAKE ME PAY IN ADVANCE.

TONIGHTS’S FORECAST FROM GEORGE CARLIN: 

DARK TONIGHT, TURNING TO PARTLY LIGHT IN THE MORNING. 

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NYT’S KEN BELSON ON ARROGANT AARON RODGERS, PACKER QB,  AND COVID

(J. Harris: Ken Belson has written several stories about Marshall and maintains ties to our community. He knows a lot about football — and Covid. Why or why couldn’t Bart Starr been as stupid and careless as is Rodgers?!!!)

We’re close to the end of the pandemic phase’

”…”I think that we’re close to the end of the pandemic phase of this virus, and we’re going to enter a more endemic phase,” said Dr. Gottlieb, former FDA commissioner and current Pfizer board member…..This delta virus is going to play out through the country,” Dr. Gottlieb said. “There’s not much we’re going to be able to do at this point to interrupt it. We’ve seen the South be engulfed with the infection and it’s recovered. The reality is this delta infection is going to capture most people who remain unvaccinated at this point.”…He highlighted the recent approval of Pfizer’s COVID-19 vaccine for young children and the development of two potential COVID-19 antivirals as the beginning of the end of the virus’s pandemic status….

“We’ve always said that two [ONE]of the events that would demarcate the end of this pandemic was being able to vaccinate our children,” Dr. Gottlieb said. “We’re now able to do that down to age 5, and [?2} also having a widely available or orally accessible drug that could treat coronavirus at home to prevent people from being hospitalized or dying,” he said, referring to Merck and Pfizer’s experimental antiviral pills.

COVID-19 vaccination in pregnancy—number needed to vaccinate to avoid harm

(J. Harris: Study discusses pregnance and Covid vaccination.)

”…The balance of risk favours COVID-19 vaccination in pregnancy, particularly to avoid severe maternal infection or preterm or caesarean birth. These data should be used to address and avoid vaccine hesitancy driven by knowledge gaps…’

Transmission of SARS-CoV-2 After COVID-19 Screening and Mitigation Measures for Primary School Children Attending School in Liège, BelgiumDespite the implementation of several mitigation measures, the incidence of COVID-19 among children attending primary school in this study was comparable to that observed among teachers and parents. Transmission tree reconstruction suggests that most transmission events originated from within the school. Additional measures should be considered to reduce the transmission of SARS-CoV-2 at school, including intensified testing.

The partisan [political] gap in Covid deaths has grown larger.

An Unsolved Mystery: Why Do More Men Die of Covid-19?

(J. Harris: Interesting article that is worth the time to read.)

”…Yale University researchers noted that there are well-established differences in immune responses to infections between men and women. Diseases like tuberculosis are more common among men, for example, and men tend to have higher viral loads of hepatitis C virus and H.I.V. The same researchers found differences in men’s and women’s immune responses to Covid-19. Men with Covid-19 had higher blood levels of inflammatory proteins that regulate immune responses, for example. This could lead to an overexuberant immune response to the coronavirus….Other researchers argue that hormonal factors might be at play. Testosterone may tamp down men’s immune response, while estrogen may play a role in women’s tendency to have more immune B cells, which produce antibodies. Estrogen may inhibit the kind of immune cells that are thought to play a role in myocarditis…”

Assessment of Cognitive Function in Patients After COVID-19 Infection

”…In this study, we found a relatively high frequency of cognitive impairment several months after patients contracted COVID-19. Impairments in executive functioning, processing speed, category fluency, memory encoding, and recall were predominant among hospitalized patients. The relative sparing of memory recognition in the context of impaired encoding and recall suggests an executive pattern. This pattern is consistent with early reports describing a dysexecutive syndrome after COVID-194 and has considerable implications for occupational, psychological, and functional outcomes. It is well known that certain populations (eg, older adults) may be particularly susceptible to cognitive impairment after critical illness5; however, in the relatively young cohort in the present study, a substantial proportion exhibited cognitive dysfunction several months after recovering from COVID-19. The findings of this study are generally consistent with those of research on other viruses (eg, influenza)…”

Regeneron COVID-19 antibody drug reduces infection risk 82% in clinical trial

REGEN-COV is a combination of the monoclonal antibodies casirivimab and imdevimab. In November 2020, it received FDA emergency use authorization. The FDA revised its emergency use authorization July 30, allowing the treatment to be used as a postexposure prophylaxis for COVID-19 in individuals who are at high risk for progression to severe COVID-19.

(J. Harris: This is an IV antibody cocktail that works. We also now have two new oral theuraputic drugs (Merck and Pfizer) that just came out. 

AND LASTLY:

THE DOCTOR GAVE ME SOME CREAM FOR MY SKIN RASH. HE SAID I WAS A SIGHT FOR PSORIASIS.

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