https://www.thecollegefix.com/after-implementing-a-vaccine-mandate-amherst-requires-double-masking-and-limits-student-travel/
https://amherststudent.com/article/as-delta-variant-surges-college-tightens-covid-rules/
https://www.medpagetoday.com/opinion/vinay-prasad/94188
Over the last week, the topic of COVID-19 booster shots -- a third dose of mRNA vaccine for healthy Americans -- has been thrust into the spotlight. The surgeon general, CDC director, Anthony Fauci, MD, and President Biden have announced that they wish for boosters to be available by late September for healthy adults who are 8 months out from their original two-dose series. While this will be contingent on an FDA evaluation to determine the "safety and effectiveness of the third dose," a clear path forward has already been set. And just like everything else throughout the course of the pandemic, the choice has been made with a dearth of data and an abundance of political pressure.
Diminishing vaccine effectiveness supposedly makes the case for boosters. But there are two big questions here: First, what is current vaccine effectiveness? And second, what justifies boosters? Let's consider these in turn.
What Is Vaccine Effectiveness Now?
We have to be honest, many vaccine effectiveness studies are poorly done. All studies compare the rate of getting a breakthrough infection among vaccinated people against the rate of infection in unvaccinated people. But there are some issues with this approach. First, as time goes on, more unvaccinated people have had and recovered from COVID-19 (and these individuals may be less likely to go on to get a shot). This means that their risk of getting COVID-19 a second time is far less than the typical unvaccinated person who has never been sick. Even if vaccines "work" as well as before, this factor alone will result in the appearance of diminishing vaccine effectiveness.
Second, the order of vaccination in all nations is non-random. The folks who got vaccinated first are often the oldest and most vulnerable people with frailty and senescent immune systems. Vaccine effectiveness after 6 months, 8 months, and 12 months increasingly compares older, frailer people who got vaccinated first against unvaccinated people. These older people may always have a slightly higher risk of breakthrough infections. This bias will also give the false appearance of diminishing vaccine effectiveness.
A third consideration: We're looking at vaccine effectiveness, but for what? People don't want to get severely ill from SARS-CoV-2 and don't want to die, but it might be too much to ask that vaccines prevent the nucleotide sequence of SARS-CoV-2 from ever being in your nose. In other words, vaccine effectiveness against severe disease may be much higher than vaccine effectiveness against asymptomatic or mild infection. This matters a great deal -- if the vaccines continue to be highly effective against risk of severe illness and death, is it really worth boosting people in the U.S. right now?
And putting this all together, the best estimates of vaccine effectiveness do, in fact, still show high protection against severe disease and death.
What Justifies Boosters?
No matter what vaccine effectiveness is against preventing COVID-19 illness generally, the important question for boosters is whether they further lower the risk of severe disease or death. The only way to show this is through randomized controlled trials of the size and duration to measure that outcome. It is entirely possible that vaccine effectiveness is not perfect over time, or slightly lower than initial trials, but it's also possible that boosters do not further reduce the risk of SARS-CoV-2. Only trials can answer this.
While emerging data from Israel suggest boosters may diminish the risk for COVID-19 infection and severe illness in people 60 and older, the data are not based on the types of studies we need. Pfizer has only submitted early trial results to the FDA to support their boosters, with phase III trial data forthcoming. But again, the data may be insufficient if severe outcomes are not captured.
Moreover, we have to consider the risk of new, compounding, and worse toxicity. Randomized trials and close observation will be needed to exclude worse safety signals, particularly increases in myocarditis and pericarditis. These rare adverse events are more common after the second mRNA dose -- will they be even more common after dose three?
In short, diminished vaccine effectiveness does not make the case for boosters. A reduction in severe outcomes makes the case for boosters, but we have no such data to date.
Decisions about boosters have to be based in science and made by vaccine regulators. They should not be subject to the pressure of manufacturers, politicians, or political appointees. They should not be rushed. On Sunday television, Surgeon General Vivek Murthy, MD, was specifically asked if the third shot was safe. His response: "the plan is contingent on that..."
Excuse me? We don't know that to be true, and yet, our top medical and public health experts are pushing for boosters? Drug safety expert Walid Gellad, MD, MPH, tweeted: "It was irresponsible to push for boosters in healthy people before safety review."
Two days after the White House's announcement, two people with knowledge of the FDA's deliberation told The Washington Post that the agency was investigating myocarditis signal with the Moderna vaccination. Canadian data suggest the risk may be 2.5 times that of Pfizer's vaccine. The timing of this internal information leaking to reporters naturally leads me to wonder if reviewers in the agency are attempting to counteract political pressure, and create space to conduct a thorough review of booster data.
Boosters are an important medical question. Their approval must have a favorable safety and efficacy profile. Only randomized trials measuring severe disease can show that.
Vinay Prasad, MD, MPH, is a hematologist-oncologist and associate professor of medicine at the University of California San Francisco, and author of Malignant: How Bad Policy and Bad Evidence Harm People With Cancer.
https://www.medpagetoday.com/opinion/vinay-prasad/94302
School Zone: Approach COVID Outbreak Narrative With Caution
— Media coverage of school outbreaks must include scientific evidence and proper context
Anthony Fauci told NBC's Meet the Press (https://www.nbcnews.com/meet-the-press/meet-press-august-29-2021-n1277894) the absurd claim that pushback on child-mask mandates is "going to really endanger the health of the children."
Biden agrees, opening civil rights investigations
(https://www.ed.gov/news/press-releases/department-educations-office-civil-rights-opens-investigations-five-states-regarding-prohibitions-universal-indoor-masking) into five Republican states for making masks optional in schools.
In the vast majority of Europe, none of this is happening. Many countries will have mask-free learning environments this fall – what the Biden administration calls, without evidence, reckless endangerment.
In England, face masks won’t be required for any students this fall. (Children under 12 were never masked and older kids were unmasked in May — and the Delta wave (https://fortune.com/2021/08/12/as-delta-infections-spiked-covid-cases-in-schools-actually-fell-a-lesson-from-england/) during the summer term had lower school cases than any prior wave.)
Iceland and the Netherlands won’t require any masks for students 15 and younger, and older ones only have to wear them in hallways.
Norway explicitly advises against masking primary school-aged children.
In Denmark, masks are no longer required in any public settings apart from airports.
Switzerland will no longer require masks for secondary students this fall.
While teachers and students must be masked at both the primary and secondary levels in large European countries like Spain, France, and Italy, children under 6 won’t have to mask in nursery schools and child care settings. (Masking pre-schoolers appears to be a uniquely American perversion.(https://osf.io/65tdh/))
The European Center for Disease Control does not recommend masking primary students at all. Countries such as Spain and Italy are free not to follow its guidance and are requiring masks for children over the age of 6.
https://www.medpagetoday.com/opinion/vinay-prasad/94188
Are We Jumping the Gun on COVID Boosters?
— Efficacy, safety, and ethical questions linger
Two days after the White House's announcement, two people with knowledge of the FDA's deliberation told The Washington Post that the agency was investigating myocarditis signal with the Moderna vaccination. Canadian data suggest the risk may be 2.5 times that of Pfizer's vaccine (https://www.washingtonpost.com/health/2021/08/19/moderna-vaccine-myocarditis/). The timing of this internal information leaking to reporters naturally leads me to wonder if reviewers in the agency are attempting to counteract political pressure, and create space to conduct a thorough review of booster data.
https://www.medscape.com/viewarticle/957492
Thousands Protest in Berlin Against COVID Curbs, Vaccines
https://thebluestateconservative.com/2021/09/02/the-whole-truth-on-the-barnstable-county-massachusetts-covid-19-outbreak/
https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm
The study details a COVID-19 outbreak that started July 3 in Provincetown, Mass., involving 469 cases. It found that three-quarters of cases occurred in fully vaccinated people…
The CDC said the finding that fully vaccinated people could spread the virus was behind its move to change its mask guidance.
At least NPR mentioned that it was “Provincetown” that was responsible for this “disturbing” outbreak.
As Mr. Bomberger (The Christian Post) rightly concludes, from an “epidemiological standpoint,” what happened in Provincetown is not at all representative of the general U.S. population.
The CDC has proven wrong numerous times since COVID-19 entered the U.S. This is certainly true when it comes to the widespread masking of school children. https://www.trevorgrantthomas.com/2021/08/stop-foolish-covid-based-restrictions.html
https://apnews.com/article/health-arkansas-coronavirus-pandemic-d7a557384d994fac44ebcab64d177f09
https://www.theatlantic.com/ideas/archive/2021/09/school-mask-mandates-downside/619952/
https://www.thecollegefix.com/judge-denies-msu-employees-natural-immunity-vaccine-exemption-but-grants-students-religious-exemption/
In its first case against George Mason University, the case was resolved after GMU granted the professor who brought the suit forward a medical exemption, but it was for a reason other than naturally acquired COVID immunity.
Although the FDA’s approval of the Pfizer COVID vaccine prompted many observers to suggest the objection to taking a non-FDA approved drug is now moot, Norris’ attorneys say not so fast.
As Just the News reports, the alliance told the Michigan court that “Pfizer’s Comirnaty vaccine is ‘legally distinguishable’ from the drugmaker’s BioNTech vaccine, which remains under emergency use authorization.”
“The former ‘is not widely available in the United States,’ meaning MSU is still ‘essentially’ forcing recovered employees including lead plaintiff Jeanna Morris to take either EUA vaccines or ‘worse yet’ domestically unapproved vaccines,” JTN reported.
“This explicitly violates the federal statutory framework for EUA vaccines, which requires the ‘free and informed consent of individuals’ taking them, as well as the Ninth and Fourteenth Amendment rights of employees, according to the suit.”
https://www.beckershospitalreview.com/public-health/surgical-masks-prevent-covid-19-s-spread-gold-standard-study-finds.html
The eight-week study involved 342,126 people living in 600 villages in rural Bangladesh. Researchers randomly assigned participants to either a control or intervention group. The latter group received free masks that they were encouraged to wear, along with educational materials on why they were important, among other interventions.
Study participants who were encouraged to wear masks were about 11 percent less likely to contract COVID-19 compared to the control group. This percentage was even higher among older adults. People over age 60 were 35 percent less likely to get COVID-19 if they wore a mask.
"We now have evidence from a randomized, controlled trial that mask promotion increases the use of face coverings and prevents the spread of COVID-19," study author Stephen Luby, MD, a professor of medicine at Stanford, said in a news release. "This is the gold standard for evaluating public health interventions. Importantly, this approach was designed [to] be scalable in lower- and middle-income countries struggling to get or distribute vaccines against the virus."
https://med.stanford.edu/news/all-news/2021/09/surgical-masks-covid-19.html
The observers found that just over 13% of people in the villages that received no interventions wore a mask properly, compared with more than 42% of people in the villages where each household received free masks and in-person reminders to wear them. Physical distancing was observed 24.1% of the time in control villages and 29.2% of the time in intervention villages.
About 7.6% of people in the intervention villages reported COVID-19 symptoms compared with about 8.6% of those in the control villages during the eight-week study period — a statistically significant difference that indicates a roughly 12% reduction in the risk of experiencing respiratory symptoms.
The researchers found that among the more than 350,000 people studied, the rate of people who reported symptoms of COVID-19, consented to blood collection and tested positive for the virus was 0.76% in the control villages and 0.68% in the intervention villages, showing an overall reduction in risk for symptomatic, confirmed infection of 9.3% in the intervention villages regardless of mask type.
https://www.washingtonpost.com/world/2021/09/01/masks-study-covid-bangladesh/
NOTE Study completed before Delta variant.
The social, economic, and cultural setting in Bangladesh is so much different from the United States as to render any conclusions irrelevant.
How can it throw in at the very end that the mask group had increased social distancing without qualifying the difference from the control group? Increased social distancing plays a huge role in reducing transmission of covid. If you cannot isolate the impact of this difference, you cannot identify the quantifiable value of mask wearing.
When you click on the actual pre-print paper, you will find that the difference in COVID like symptoms between the control group and the intervention group was 1% (8.62% and 7.62%)—i.e masks made no difference that anyone under the sun actually cares about. However, because of statistics, one can make it sound like there was a meaningful reduction—when in fact, there was none (using ratios, etc, especially if you have a large number of people in your study).
If masks truly “worked” for the general public, then it’s unlikely that Blue States would have had a significant outbreak last winter. But ultimately pre-vaccine Florida and Texas basically had the same outcomes as California. That is at least more profound real world data.
https://www.theblaze.com/news/cdc-80-percent-americans-covid-immunity
A recent survey of blood donations has found that more than 80% of Americans over the age of 16 have some level of immunity to COVID-19 — a figure that could have massive implications on the country's public health policy moving forward.
The survey, conducted by researchers at the U.S. Centers for Disease Control and Prevention, also found that twice as many people have been infected by the pathogen than have been officially counted, CNN reported. As of Thursday, more than 39 million Americans have tested positive for the virus.
According to CNN, the CDC team, led by Dr. Jefferson Jones, embarked on the study to "determine how close the US might be to some kind of herd immunity." Though the news outlet was sure to mention the researchers "do not claim to have any kind of handle on that yet."
They accomplished the task by testing about 1.4 million blood samples provided by 17 different blood collection organizations from all 50 states.
https://jamanetwork.com/journals/jama/fullarticle/2784013
https://twitter.com/JAMA_current/status/1433459717033058311
https://t.co/m5ds4i38fa
https://childrenshealthdefense.org/defender/ny-health-commissioner-mask-mandate-federal-lawsuit-william-ouweleen/
https://www.cnn.com/2021/08/05/health/us-coronavirus-thursday/index.html
“Public health officials around the world acknowledge that these vaccines are for personal protection only. This mandate wasn’t evidence-based. It was meant to coerce people into taking experimental vaccines and to shame and bully those that exercise their federally guaranteed right to opt-out.”
New York’s mask mandate laid the groundwork for other coercive measures imposed on unvaccinated people across the state. Though the repeal of NYCRR 66-3 temporarily resolves some of the issues in the case, attorneys stressed the lawsuit is not over.
“Unfortunately, at the same time they repealed the discriminatory mask mandate, the NYSDOH granted sole authority to New York State Department of Health Commissioner Howard Zucker to issue future mandates, at his discretion, including mandates that discriminate based on vaccine status if he so chooses,” Gibson said.
Zucker has not yet issued any more mask mandates related to vaccine status. However, last Friday, he issued blanket mask mandates for school children and for employees in certain sectors, such as healthcare and correctional facilities.
In the complaint, Ouweleen argued:
“The science does not establish that prolonged use of masks is safe or effective. In fact, the U.S. Food and Drug Administration defines masks as experimental medical devices, and has not licensed them for use by the general public other than through Emergency Use Authorizations (EUA).”
Under the terms of the EUA, manufacturers are expressly forbidden from “misleading” the public by alleging that masks can be reused or used to stop or reduce infection.
“It is black letter law that EUA devices, including masks, cannot be mandated,” said CHD President and General Counsel Mary Holland. “This prohibition arises out of the Nuremberg Code of 1947, and reflects our obligations under the subsequent binding treaties and domestic statutes which incorporate.”
https://www.cnn.com/2021/08/05/health/us-coronavirus-thursday/index.html
https://www.cnn.com/2021/07/30/health/breakthrough-infection-masks-cdc-provincetown-study/index.html
A new study shows the Delta Covid-19 variant produced similar amounts of virus in vaccinated and unvaccinated people if they get infected -- illustrating a key motivation behind the federal guidance that now recommends most fully vaccinated Americans wear masks indoors.
Experts say that vaccination makes it less likely that you'll catch Covid-19 in the first place -- but for those who do, this data suggests they could have a similar tendency to spread it as unvaccinated folks.
"High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus," Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said in a statement Friday.
CDC document warns Delta variant appears to spread as easily as chickenpox and cause more severe infection
CDC document warns Delta variant appears to spread as easily as chickenpox and cause more severe infection
The study, published by CDC Friday, describes 469 Massachusetts residents who were infected in a July outbreak in Barnstable County, which includes the summer vacation destination Provincetown. No deaths were reported among them.
https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm?s_cid=mm7031e2_w
About 74% -- or 346 cases -- had been fully vaccinated. Of those cases, 79% reported symptoms. Genetically sequenced cases revealed the Delta variant as the main culprit.
The researchers found evidence that viral loads were similar among 127 fully vaccinated people and 84 others who were unvaccinated, partially vaccinated or whose vaccination status was unknown. Viral load is a proxy for how likely someone might be to transmit the virus to others.
On Tuesday, Walensky previewed these findings while unveiling guidance that people in areas with "high" or "substantial" Covid-19 transmission should resume wearing masks indoors. Over 75% of the US population live in these areas.
The finding that the Delta variant resulted in similar viral loads "was a pivotal discovery leading to CDC's updated mask recommendation," Walensky said Friday.
"The masking recommendation was updated to ensure the vaccinated public would not unknowingly transmit virus to others, including their unvaccinated or immunocompromised loved ones."