Written by Steven Hansen

The U.S. new cases 7-day rolling average are 10.5 % LOWER than the 7-day rolling average one week ago and U.S. deaths due to coronavirus are now 25.1 % LOWER than the rolling average one week ago. Today’s posts include:

• U.S. Coronavirus New Cases are 61,204
• U.S. Coronavirus deaths are at 1,769
• U.S. Coronavirus immunizations have been administered to 30.2 % of the population
• The 7-day rolling average rate of growth of the pandemic shows new cases worsened and deaths improved
• First Pill for COVID-19 Could Be Ready by Year’s End
• The U.S. Is Sitting on Tens of Millions of Vaccine Doses the World Needs
• Here’s Why Viral Vector Vaccines Don’t Alter DNA
• Early concerns raised over levels of intact mRNA in Pfizer vaccine
• How concerned should the U.S. be over homegrown variants?
• Digital contact tracing could help suppress COVID-19 outbreaks, suggests modeling study

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Hospitalizations Are The Only Accurate Gauge But Unfortunately No Longer Updated Daily

Hospitalizations historically appear to be little affected by weekends or holidays – the daily counts do not vary significantly from day-to-day.

The hospitalization growth rate trend is improving.

Historically, hospitalization growth follows new case growth by one to two weeks.

As an analyst, I use the rate of growth to determine the trend. But, the size of the pandemic is growing in terms of real numbers – and if the rate of growth does not become negative – the pandemic will overwhelm all resources.

The graph below shows the rate of growth relative to the growth a week earlier updated through today [note that negative numbers mean the rolling averages are LOWER than the rolling averages one week ago]. As one can see, the rate of growth for new cases peaked in early December 2020 for Thanksgiving, and early January 2021 for end of year holidays – and it now shows that the coronavirus effect is now shrinking.

In the scheme of things, new cases decline first, followed by hospitalizations, and then deaths.

Will The New Variants Cause The Next Spike?

Maybe and maybe not. It all depends on vaccinations:

• the more people that are vaccinated reduces the pool of people that can be infected. Today we have removed over 30 % of the population from being infected which theoretically should reduce the infection rate by 30 % [it is unproven whether the vaccines prevent a vaccinated person from being a carrier of the virus even though showing no signs]. If the vaccines are shown to stop transmission, then in theory it would reduce the infection rate by double the percent vaccinated [in this case you prevent your own infection and do not pass it along to another].
• it is also unknown what the effective rate of the current vaccines is against mutations that seem to appear almost daily. As an example, if the effective rate drops to 60%, it means the 30 % reduction in the infection rate discussed above is almost cut in half. The South African and Brazilian variant is reported somewhat immune to the current vaccines.
• The pandemic should be over immediately if everyone could be vaccinated today. The problem is that every day brings a new mutation (which would not appear if the pandemic was stopped). The longer the immunization process takes – the more ineffective the vaccine will become.
• It is not clear whether the vaccine prevents those vaccinated from spreading the virus. It seems to be well documented that it normally stops the virus from taking hold and when it does not – the infection is mild.

Coronavirus News You May Have Missed

One year ago this week, the world began to shut down as the global pandemic hit.

The U.S. Is Sitting on Tens of Millions of Vaccine Doses the World Needs – New York Times

Those tens of millions of doses from AstraZeneca are waiting for trial results, while countries that authorized the vaccine beg to have them.

Tens of millions of doses of the coronavirus vaccine made by the British-Swedish company AstraZeneca are sitting idly in American manufacturing facilities, awaiting results from its U.S. clinical trial while countries that have authorized its use beg for access.

The fate of those doses of AstraZeneca’s vaccine is the subject of an intense debate among White House and federal health officials, with some arguing the administration should let them go abroad where they are desperately needed while others are not ready to relinquish them, according to senior administration officials.

AstraZeneca is involved in those conversations.

“We understand other governments may have reached out to the U.S. government about donation of AstraZeneca doses, and we’ve asked the U.S. government to give thoughtful consideration to these requests,” said Gonzalo Viña, a spokesman for AstraZeneca.

About 30 million doses are currently bottled at AstraZeneca’s facility in West Chester, Ohio, which handles “fill-finish,” the final phase of the manufacturing process during which the vaccine is placed in vials, one official with knowledge of the stockpile said.

Here’s Why Viral Vector Vaccines Don’t Alter DNA – MedPage

Adenoviral vector vaccines have been in development for decades, but very few have been approved for use in humans. What does the history of adenoviral vector vaccine development tell us about their safety and their potential to alter DNA?

How Do Adenoviral Vector Vaccines Work?

Essentially, these types of vaccines act like delivery shuttles. They use an adenovirus — which has been engineered to be incapable of replicating and causing disease — to deliver the genes for making the antigen; in this case, that’s the SARS-CoV-2 spike protein. That in turn elicits an immune response and provides protection against the coronavirus.

Adenoviruses are basically common cold viruses that can cause illnesses ranging from cold-like symptoms to bronchitis, gastroenteritis, and conjunctivitis.

“I think people are unfortunately familiar with adenoviruses … [A]t far too many points, you know, you’ve had the sniffle. You’ve had the cough. You felt crummy. If it’s a cold it’s often adenovirus,” Daniel Griffin, MD, PhD, said on a recent episode of MedPage Today‘s “Track the Vax” podcast. Griffin is chief of infectious disease at ProHEALTH Care, an Optum unit.

Humans are infected with multiple different types of adenoviruses throughout their lifetimes. Most serotypes cause mild illness, although adenovirus serotype 7 has been associated with more severe illness. Older adults and people who are immunocompromised or have pre-existing respiratory or cardiac disease may have worse illness.

Precisely because adenoviruses are so common, one problem with using them in vaccines is that people may already have antibodies to them, overwhelming them before they can do their assigned work. Researchers get around that issue by using adenoviruses that humans are unlikely to have encountered before.

Currently, five adenovirus vector vaccines for COVID-19 are in use worldwide.

Each works on the same basic principle, although delivery platforms differ. The AstraZeneca/Oxford vaccine uses the ChAdOx1 platform, which is based on a modified version of a chimpanzee adenovirus.

The Johnson & Johnson vaccine uses a proprietary AdVac platform, made up of a recombinant human adenovirus (adv26). It’s the same platform used in the company’s Ebola virus vaccine (which is approved in Europe) and its investigational Zika, RSV, and HIV vaccines.

Russia’s Sputnik V uses recombinant human adenoviruses Ad26 and Ad5 for the first and second doses, respectively. Finally, China’s CanSino vaccine uses the recombinant human adenovirus Ad5.

Potential to Change DNA?

Adenoviruses deliver DNA that can enter the cell nucleus, which brings up the question of whether they can alter DNA. That’s an easy one — no.

Adenoviruses — even as they occur in nature — just do not have the capacity to alter DNA. Unlike retroviruses such as HIV or lentiviruses, wild-type adenoviruses do not carry the enzymatic machinery necessary for integration into the host cell’s DNA. That’s exactly what makes them good vaccine platforms for infectious diseases, according to Coughlan.

… And, engineered adenoviruses used in vaccines have been further crippled by deleting chunks of their genome so that they cannot replicate, further increasing their safety.

How concerned should the U.S. be over homegrown variants? – National Geographic

The fear is that some of these so-called “variants of concern”—including newly reported ones in the United States—could diminish the power of our vaccine arsenal. That’s because people who have been vaccinated, or who gained immunity through natural infection, may still be vulnerable to these variants—a vulnerability that’s at odds with recommendations the U.S. Centers for Disease Control and Prevention released this week saying that the vaccinated people could safely gather indoors with other vaccinated people.

… In response, vaccine makers are scrambling to study and manufacture variant-specific boosters. At the same time, the Biden administration has promised to make vaccinations available for every adult in the U.S. by the end of May.

The faster the coronavirus is brought under control, experts say, the fewer chances it has to mutate into more lethal and transmissible versions that could fuel another deadly wave.

… What is clear is that the viral variants are accumulating mutations faster than they did at the beginning of the pandemic and becoming more infectious, says Johns Hopkins Medicine’s Ray, who studies RNA virus evolution.

And what fascinates many scientists is that the lineages of the British, Brazilian, and South African variants all contain mutations that alter the biology of the spike protein, the part of the virus that invades a human cell and makes people sick. “They all changed three separate times on three separate continents within months of each other,” says Ray. Similar mutations were also found in the New York and California variants.

Although such changes might seem random, Paul Bieniasz, a virologist at Rockefeller University in New York City, suggests there are bigger forces at work. “It’s clear there’s convergent evolution going on,” says Bieniasz, referring to an evolutionary principle in which organisms independently evolve similar traits due to similar environments or pressures.

… Yet generating more sequencing data provides only one clue into how the coronavirus is behaving. “We need more sequencing, but it has to be smartly targeted to identify the virus and what’s driving the virus to mutate and change,” adds Rick Bright, senior vice president of pandemic prevention and response at the Rockefeller Foundation. “We need geographic representation—not just in New York City, but also rural areas.”

This would provide a snapshot of a virus emerging among vaccinated people or within certain vulnerable communities; for instance, one study found that the CAL.20C variant made up more than half of January cases in the predominantly Latino community in San Francisco’s Mission District—up from just 16 percent in November. That’s valuable information for public health officials to target and contain the spread.

“We’d be able to stay two steps ahead of the virus instead of five steps behind it,” adds Bright, former director of the Biomedical Advanced Research and Development Authority.

Digital contact tracing could help suppress COVID-19 outbreaks, suggests modeling study – EurekAlert

Informing how COVID-19 response plans may incorporate digital contact tracing, a model of COVID-19 spread within a simulated French population found that if about 20% of the population adopted a contact tracing app on their smartphones, an outbreak could be reduced by about 35%. If more than 30% of the population adopted the app, the epidemic could be suppressed to manageable levels. Jesús Moreno López and colleagues note that the effectiveness of digital contact tracing would depend on a given population’s level of immunity to the virus; the intervention alone would be unable to suppress a COVID-19 epidemic where transmission – and especially asymptomatic transmission – remains high. While many countries have implemented lockdowns and rigorous social distancing measures when COVID-19 activity has crescendoed, these interventions are typically short-lived, with new waves emerging after restrictions are lifted. More sustainable strategies, such as digital contact tracing, are important for keeping outbreaks under control. However, scientists have debated the efficacy of digital contact tracing, since in many countries, a large portion of the population does not have smartphones – particularly the elderly. To investigate digital contact tracing’s ability to mediate the spread of COVID-19, Moreno López et al. developed a model that simulates a synthetic French population based on census data from the National Institute of Statistics and Economic Studies (INSEE). The researchers used this synthetic population to explore the impact of digital contact tracing – as well as detection of COVID-19 cases, quarantines, and isolation of household contacts – under scenarios in which the virus was more or less transmissible based on the prevalence of face mask use and hand washing. They found that when the virus was highly transmissible, household isolation alone reduced COVID-19 cases by 27%, while pairing this strategy with digital contact tracing reduced COVID-19 cases by 35% when only 20% of the population adopted the app. Simulating increased rates of app adoption also led to further reductions in cases. Moreno López et al. note that additional information would be required to adapt this approach to a specific outbreak within a particular country.

First Pill for COVID-19 Could Be Ready by Year’s End – Medscape

New pills to treat patients with COVID-19 are currently in midstage clinical trials and, if successful, could be ready by the end of the year.

Only one treatment — remdesivir (Veklury) — has been fully approved by the US Food and Drug Administration (FDA) for patients in the hospital and it must be administered intravenously.

Hopes for a day when patients with COVID-19 can take a pill to rid their bodies of the virus got a boost over the weekend when early trial results were presented at a medical conference.

Interim phase 2 results for the oral experimental COVID-19 drug molnupiravir, designed to do for patients with COVID-19 what oseltamivir (Tamiflu) can do for patients with the flu, were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2021 Annual Meeting, as reported by Medscape Medical News.

In the small study, the pill significantly reduced infectious virus in patients who were symptomatic and had tested positive for COVID-19 during the previous 4 days but were not hospitalized.

After 5 days of treatment, no participants who received molnupiravir had detectable virus, whereas 24% who received placebo did.

Two other oral agents are being developed by RedHill Biopharma: one for severe COVID-19 infection for hospitalized patients, and one for patients at home with mild infection.

COVID-19 Vaccines and Fetal Tissue: The Science and Controversy Explained – Newsweek

In 1972, Alex van der Eb, a molecular biologist, took cells from an aborted human embryo and cultured them in his lab in Leiden University in the Netherlands. The cells have since become “immortal,” meaning the descendants of the original cells have played a role in the research of numerous vaccines, including rubella, adenovirus, polio, rabies, chickenpox, Ebola and, most recently, several of the most widely used coronavirus vaccines.

That puts the Roman Catholic Church, which opposes abortion and any use of cells obtained from human embryos, in a tough spot. Since 2005, the Vatican has made an exception for vaccines for diseases that pose a “grave danger” and for which there are no “morally acceptable” alternatives, and it confirmed this stance for the coronaviruses in December: “The morality of vaccination depends not only on the duty to protect one’s own health, but also on the duty to pursue the common good. In the absence of other means to stop or even prevent the epidemic, the common good may recommend vaccination, especially to protect the weakest and most exposed.” Pope Francis took this advice to heart by taking Pfizer‘s COVID-19 vaccine.

However, in early March, Catholic Bishops in the U.S. muddied the waters by calling out the Johnson & Johnson vaccine as having “additional moral concerns.” At issue is the precise role fetal-cell lines played in the development of the vaccine. While Moderna and Pfizer used them in testing only, J&J also used them in the production of its vaccine. “If one has the ability to choose a vaccine,” the bishops said, “Pfizer or Moderna’s vaccines should be chosen over Johnson & Johnson’s.”

The Bishops’ moral concern arises from the relative proximity of the J&J vaccine to the “evil” of abortion.

Fetal-cell lines played a vital role in the development of all three vaccines. Moderna and Pfizer used Van der Eb’s original cell line, called HEK 293, in the testing of their coronavirus vaccines—that is, scientists first developed the vaccines using their mRNA technologies and subsequently tested them on lab-cultured HEK 293 cells, ancestors of the original cells that Van der Eb took from an embryo almost 50 years ago. Johnson & Johnson used a different fetal-cell line, called PER.C6, that was cultured in Van der Eb’s lab in 1995.

While Moderna and Pfizer used fetal cells for testing their vaccine after it was already produced, J&J used fetal cells as tiny “factories” that produced the active ingredient in its vaccine. It was inside PER.C6 cells where a gene for the coronavirus’ spike protein was attached to a modified adenovirus. (The vaccine works when the adenovirus infects human cells and the added gene instructs the cells to manufacture the spike protein, which elicits an immune response.)

The Moderna and Pfizer vaccines are morally acceptable, according to the Archdiocese of New Orleans, because their scientists did not use the cells in the “manufacturing process,” which means that “the connection to abortion is extremely remote.” The J&J vaccine, by contrast, “is morally compromised as it uses the abortion-derived cell line in development and production of the vaccine as well as the testing.”

Public health officials worry that this judgment will give anti-vaccination groups ammunition to sow doubt about vaccines in general, and coronavirus vaccines in particular. “Diehard anti-vaxxers use it,” Arthur Caplan, a bioethicist at New York University, told Newsweek. “They’ll say, ‘Catholics won’t take it because there’s something wrong with it.’ They don’t care about the details; they’re just going to stir the pot. And it’s a pot they need to stir because they’ve been losing the safety argument in the past few years.”

IRS started processing stimulus checks Friday, money begins arriving in accounts – CNBC

• The IRS on Friday began processing stimulus checks, which could arrive in Americans’ bank accounts as soon as this weekend.
• Unlike the prior rounds of checks, families will get a payment for all their dependents claimed on a tax return, not just their qualifying children under 17.
• Americans can check the status of their third payment by using the Get My Payment tool starting on Monday.

[editor’s note: also read Some Americans have already received the third stimulus payment]

Early concerns raised over levels of intact mRNA in Pfizer vaccine – Medical News Today

• Recent studies confirm that mRNA vaccines are safe and provide a high degree of protection against COVID-19.
• However, leaked emails show that there were doubts last year about early commercial batches of the Pfizer-BioNTech mRNA vaccine.
• The emails reveal that the European Medicines Agency (EMA) raised concerns with Pfizer that the vaccine contained lower levels of intact mRNA molecules than expected.
• The company resolved the issue to the satisfaction of the EMA and regulatory agencies in the United States and Canada.

… Internal emails reveal that in November 2020, the EMA had concerns that batches of the Pfizer vaccine that were proposed for commercial use contained less intact mRNA than previous batches made for clinical trials.

Only around 55% of the mRNA molecules in those early commercial batches remained intact.

The doubts the emergency EMA had have come to light only as a result of a cyberattack on the agency’s computer system in December 2020.

Unknown persons sent the leaked emails to several journalists, including at The BMJ, and the journal have now published an investigation into the agency’s concerns.

Pfizer do appear to have addressed all the questions raised by the EMA, which authorized the vaccine on December 21, 2020.

According to one of the leaked emails, dated November 25, 2020, an undisclosed source in the U.S. had given the agency positive news: “The latest lots indicate that % intact RNA are back at around 70-75%, which leaves us cautiously optimistic that additional data could address the issue.”

The following are foreign headlines with hyperlinks to the posts

China asks visa applicants to get inoculated with Chinese-made vaccines.

The following additional national and state headlines with hyperlinks to the posts

While President Biden boasted about expanding access to vaccines by bringing together two rivals in the business, Johnson & Johnson and Merck, former Trump administration officials say it was their idea.

The Biden administration also announced plans to incorporate 950 community health centers that target underserved and vulnerable Americans into its vaccine program.

One in three Republican voters in another poll said they “definitely won’t” get a COVID-19 vaccine, which could put herd immunity farther out of reach.

At the Capitol, one wavering Democrat stuck by his party and a Republican crossed party lines, allowing the Senate to vote on HHS nominee Xavier Becerra.

DA warned against using ivermectin to treat COVID-19, urging people to “never use medications intended for animals on yourself,” while also noting that overdose could lead to “seizures, coma, and even death.”

updated NIH guidelines now recommend tocilizumab (Actemra) with dexamethasone for hospitalized COVID-19 patients.

US passes 100 million COVID-19 vaccinations

Judge sides with Austin in Texas mask lawsuit

EMA Launches Review of Clot Risk With AstraZeneca COVID Vaccine

California Leaders Look to Reopening, Push 1-Shot Vaccine

Florida Gov. Ron DeSantis Says He Will Not ‘Let’ Biden ‘Lock Down’ Florida

Spring Break Hotel Occupancy Nears Pre-COVID Levels in 4 Cities

Today’s Posts On Econintersect Showing Impact Of The Pandemic With Hyperlinks

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