Booster strategy could backfire

https://www.axios.com/covid-vaccine-boosters-thanksgiving-5851be4a-79a7-423a-93bb-390d1eb7d4d3.html

Federal officials waited months before making all American adults eligible for a COVID-19 booster shot — meaning millions of Americans may not have the strongest possible protection as they head into holiday travel.

Why it matters: Critics say the confusing process undermined what has now become a critical effort to stave off another wave of the pandemic.

  • Most vaccinated people, even without a booster, still have very strong protection against serious illness or death. But a third shot drastically increases people’s defenses against even mild infections, which could in turn help reduce the virus’ spread.
  • And some vulnerable vaccinated adults are at risk of serious breakthrough cases.

What they’re saying: “We have a consensus. Boosters are very important in maintaining people’s defenses against COVID. We need to get as many people vaccinated and boosted [as possible] as the winter sets in,” David Kessler, the chief science officer of Biden’s COVID response, said in an interview.

Context: Preliminary data released months ago suggested a significant decline in the vaccines’ effectiveness at preventing infection, although they held up well against severe disease.

  • Based on that data, the Biden administration had hoped to begin allowing booster shots in September for any American adult who was at least eight months removed from their second dose.
  • The CDC and the FDA opted instead to only authorize boosters for seniors, people with high-risk medical conditions and people at high risk of infection, before opening them last week to everyone at least six months out from their initial shots.

In the meantime, red and blue states alike decided to ignore the CDC and open up booster eligibility on their own, and breakthrough infections have become increasingly common.

  • Millions of people who weren’t technically eligible for boosters got them anyway, and a large portion of the most vulnerable patients still haven’t gotten one.
  • Where it stands: Only 41% of vaccinated Americans 65 and older have received a booster shot, as have 20% of all vaccinated adults, per the CDC.

“Some of us were there several months ago. Some wanted more data. In the end, there’s a convergence of opinions. It’s the way an open scientific public health process should work,” Kessler said.

Between the lines: The U.S. drug approval process — with its insistence on high-quality data and careful expert reviews — is the world’s gold standard precisely because it moves deliberately. Regulators have been trying this whole time to figure out how to adapt that system to a fast-moving pandemic.

Some federal officials, as well as many outside experts, said there wasn’t enough data to make a broad booster recommendation earlier this fall.

  • Early on, many public health experts also argued that it was unethical to give Americans a third shot while much of the rest of the world awaited their first shots.
  • Israel embraced boosters before the U.S. beginning over the summer, and its emerging data has been key to making the case that boosters are needed and can help bring surges under control. However, experts still don’t know how long the enhanced protection they give will last.

What they’re saying: “Some argued early on that the primary series was good enough and we should conserve doses for the world. What’s emerging is that all people in the world are going to need to be boosted,” a senior administration official said.

  • “Everyone has a different threshold for how much data they need in making a decision,” the official added. “What made this different is that there’s a pandemic underway, and many saw we were heading into a winter surge.”

An unsettling start to the school year

https://mailchi.mp/a2cd96a48c9b/the-weekly-gist-october-1-2021?e=d1e747d2d8

As a long hoped-for sign of the “return to normal”, most children went back to in-person learning this fall. And with the patchwork of COVID safety protocols and masking policies across school districts, classrooms became a learning lab for scientists studying the efficacy of masking and other precautions.

Unsurprisingly, getting a bunch of unvaccinated kids back together caused a surge in pediatric COVID cases. But recent Centers for Disease Control and Prevention (CDC) data from 500 counties demonstrate just how effective mask mandates have been at mitigating outbreaks.

The graphic above shows that cases in counties without school mask mandates increased at nearly three times the rate of those with mask mandates. In the five-week period spanning the start of the school year, cases in counties without a mask mandate rose by 62.6 cases per 100K children, while cases in counties with a mask mandate rose by only 23.8 per 100K. COVID outbreaks are incredibly disruptive to learning; according to a recent KFF survey, nearly a quarter of parents report their child has already had to quarantine at home this school year following a possible COVID exposure.

Even once vaccines are approved for children under 12, recent data suggest that a majority of parents will be hesitant to vaccinate their child. Just over half of 12- to 17-year-olds have received at least one dose of the vaccine so far, and only a third of parents of 5- to 11-year-olds plan to vaccinate their child right away, once the shot is approved.

Many want more information, or are worried about side effects—concerns that will best be assuaged by their pediatricians and other trusted sources of unbiased information.

A new antiviral pill shows promise, as do vaccine mandates

https://mailchi.mp/a2cd96a48c9b/the-weekly-gist-october-1-2021?e=d1e747d2d8

Everything we know about the covid-19 coronavirus

Two pieces of hopeful news on the COVID front this week.

First, pharmaceutical manufacturer Merck announced this morning that molnupiravir, the oral antiviral drug it developed along with Ridgeback Biotherapeutics, reduced hospitalizations among newly diagnosed COVID patients by 50 percent. A five-day course of the drug was so successful in Merck’s clinical study that an independent monitoring group recommended halting the study and submitting the pill to the Food and Drug Administration (FDA) for emergency use authorization. Molnupiravir is activated by metabolism, and upon entering human cells, is converted into RNA-like building blocks, causing mutations in the COVID virus’s RNA genome and interfering with its replication. For that reason, the drug is unlikely to be prescribed during pregnancy, but otherwise the therapy seems to hold great promise in adding to the limited armamentarium available to fight the pandemic. One possible concern: the drug’s price tag. The federal government has agreed to purchase 1.7M courses of the drug at $700 per course, and with most insurance companies having returned to normal cost-sharing for COVID treatments, the drug may be out of reach for some patients. Still, a major clinical development to be celebrated, and more to come as Merck’s drug is vetted by the FDA.
 
At $20 to $40 per dose, with costs fully absorbed by the federal government, and remarkable effectiveness at preventing severe disease, hospitalizations, and deaths, vaccines remain far and away our best frontline weapon for fighting the COVID pandemic. Promising, then, that the much-debated vaccine mandates have begun to demonstrate success in increasing vaccination rates, even among those who have thus far resisted getting the shot.

Despite concerns about massive staffing shortages among hospitals resulting from the implementation of its mandate, the state of New York found that 92 percent of healthcare workers had been vaccinated by Monday, when the mandate went into effect. That was a 10-percentage-point increase from a week earlier, holding promise that the Biden administration’s planned federal mandate for healthcare workers could have the desired effect.

California’s mandate for healthcare workers went into effect yesterday, and was credited with boosting vaccination rates to 90 percent at many of the state’s health systems. Among private employers considering mandates, the experience of United Airlines may also be instructive: its employee mandate led to the vaccination of more than 99 percent of its workers, resulting in the termination of only 700 of its 67,000 employees. Of course, everyone prefers carrots to sticks, but sweepstakes and bonuses have only gotten so far in encouraging people to get vaccinated—now it appears mandates have a useful role to play as well.

With 56 percent of the population fully vaccinated, the US now ranks 43rd among nations, just ahead of Saudi Arabia and far behind most of Europe. In the next few days we’ll reach the grim milestone of 700,000 COVID deaths in this country—anything that helps stop that number from growing further should be welcome news.

Cartoon – State of the Union (Unvaccinated)

Dave Granlund cartoon on anti-vaccination people

The Research on Ivermectin and Covid-19

Interest in the antiparasitic drug Ivermectin has increased drastically as of late thanks to the belief that it can help to prevent and/or treat Covid-19. In today’s episode we examine recent data on the efficacy of Ivermectin as an antiviral and discuss the history behind how it gained this reputation.