Record Hospitalisations in Highly Vaccinated U.S. States as Omicron Surge Peaks

The Omicron surge in America, which has accelerated at an incredible rate, appears to be peaking, according to analysis by J.P. Morgan.

In a report published on Tuesday, the investment banking company notes that the U.S. peak has not come any later than in the U.K., despite the lower vaccination rate.

The Omicron wave in the U.S. also looks to be peaking, despite a significantly worse vaccination profile. The overall level of fully vaccinated individuals in the US, at 62% of the total population, is lower than in the U.K., where 70% of the total population have been fully vaccinated, but the difference is not huge. More striking is the difference in the share of the population who have received a booster shot, 24% of the total population in the U.S. compared with 54% in the U.K. Given the importance of boosters in lifting protection, after the protection from the primary doses fades over time, it might have been expected that the Omicron infection upswing would last longer in the U.S. than in the U.K.. But this does not seem to be the case. It looks like the effective reproduction number in the U.S. returned to 1.0 on January 16th, only 31 days after the Omicron variant first pushed it above 1.0 in mid-December

Reported infections vary considerably by state, with some on their way down while others have yet to peak (note in the below that while all the charts show reported infections per 100,000, the scale for each state is different).

Natural Immunity Superior to Vaccine Immunity, CDC Study Finds

A study by the U.S. CDC (a Federal Government health agency) has found that natural immunity is superior to vaccine immunity alone, and that being vaccinated on top makes little difference, confirming the findings of several studies in other countries.

The study looked at Covid infection and hospitalisation rates in California and New York during the Delta period, June to November 2021. The chart below shows the hazard rates over time for the four cohorts (no vaccine and no prior infection; no vaccine and prior infection; vaccine and no prior infection; vaccine and prior infection) for hospital admissions, adjusted for age – focus especially on the relative heights of the three dashed lines near the bottom.

The authors write: “These results demonstrate that vaccination protects against COVID-19 and related hospitalisation, and that surviving a previous infection protects against a reinfection and related hospitalisation.” Note that the unvaccinated group here is split between those who are and are not previously infected, so is not directly comparable to the UKHSA data which does not make this distinction.

The authors note that, while prior to July the vaccinated were better off than the previously infected, come the summer and the arrival of Delta, prior infection was stronger.

Similar to the early period of this study, two previous U.S. studies found more protection from vaccination than from previous infection during periods before Delta predominance. As was observed in the present study after July, recent international studies have also demonstrated increased protection in persons with previous infection, with or without vaccination, relative to vaccination alone.

In a nod to the superior effect on the immune system of exposure to the virus, they comment : “This might be due to differential stimulation of the immune response by either exposure type.”

The vaccines waned in efficacy over time and against Delta, the authors note: “Importantly, infection-derived protection was greater after the highly transmissible Delta variant became predominant, coinciding with early declining of vaccine-induced immunity in many persons.”

In contrast, protection from natural immunity didn’t appear to wane: “Whereas French and Israeli population-based studies noted waning protection from previous infection, this was not apparent in the results from this or other large U.K. and U.S. studies.”

U.S. Government Drops Requirement to Test at End of Self-Isolation Because PCR Tests Produce So Many False Positives

The U.S. CDC has finally acknowledged that PCR tests produce false or cold positives following infection and dropped the requirement to be tested at the end of self-isolation, bringing American practice in line with the U.K.’s. ABC News has the story.

The newly updated CDC guidelines don’t require testing at the end of isolation because PCR tests can stay positive for up to 12 weeks, CDC Director Dr. Rochelle Walensky told “Good Morning America” Wednesday.

“So we would have people in isolation for a very long time if we were relying on PCRs,” Walensky said.

What’s baffling is that this is only now being acknowledged, when it has been a known issue since the beginning of the pandemic. How many people have had to remain isolated as PCRs have kept coming back positive? How much has this unnecessary isolation cost them and the wider economy?

This is tantamount to an admission by the CDC of gross incompetence, as the agency doesn’t even claim anything has changed or been newly discovered. Its experts either knew this information previously and didn’t act on it or didn’t know and have only just come across it even though it’s been highlighted as an issue for over 18 months. Either way, it is incompetence.

Vaccinated “No Less Infectious” Than Unvaccinated, CDC Study Finds

A pre-print study out this week from the U.S. Government’s Covid Response Team at the Centers for Disease Control and Prevention (CDC) has found vaccinated people to be “no less infectious” than unvaccinated people.

The study tested inmates in a federal prison with high vaccination rates daily during a SARS-CoV-2 Delta variant outbreak.

The study was very thorough. Inmates who tested positive for SARS-CoV-2 were, where willing, PCR-tested for 10 consecutive days and reported symptoms via a questionnaire. The researchers performed whole genome sequencing and viral culture analysis on a high proportion of the 978 specimens collected, allowing them to assess the duration of PCR positivity and viral culture positivity.

There were 95 participants in total, of whom 78 (82%) were double vaccinated and 17 (18%) were not double vaccinated (two having received one dose and 15 having received none). No significant differences were found between double vaccinated and not double vaccinated either in duration of PCR positivity (13 days each) or in duration of culture positivity (five days each).

The authors conclude that “clinicians and public health practitioners should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons”.

This is in line with the findings of Public Health England and others.

While this sounds like more good news for countering vaccine passports, vaccine mandates and all other vaccine-based coercion and discrimination, it may be less good news for ending general restrictions and interventions. The authors state: “These findings are critically important, especially in congregate settings where viral transmission can lead to large outbreaks.” Which suggests they think the lack of efficacy against transmission is a reason to intervene more generally to prevent “large outbreaks” in “congregate settings”. It could be a long winter.

CDC Approves the Pfizer Vaccine for Five Year-Olds

28 million U.S. children between five and 11 years-old have just become eligible for the Pfizer vaccine today after the Centres for Disease Control and Prevention (CDC) gave the green-light to the jab. The decision was rubber-stamped by the CDC Director Dr. Rochelle Walensky, who spoke of the vital importance of vaccinating young children. Sky News has the story.

The Food and Drug Administration (FDA) had already approved the shots for the age group, but the Centers for Disease Control and Prevention (CDC) formally recommends who should receive FDA-cleared vaccines – which it has now done.

CDC director Dr. Rochelle Walensky made the announcement just hours after an advisory panel unanimously decided Pfizer’s vaccine should be opened to the 28 million youngsters in that age category.

“As a mum, I encourage parents with questions to talk to their paediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” she said in a statement.

U.S. President Joe Biden marked the decision, describing it as a “turning point”.

He said: “It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others.

“It is a major step forward for our nation in our fight to defeat the virus.”

Worth reading in full.

Stop Press: Yesterday, we highlighted a concerning article published by the BMJ where a whistleblower calls into question the integrity, legitimacy, and safety of Pfizer’s vaccine trials in Texas, which can be found here.

U.S. Vaccine Panels Approve The Pfizer Vaccine For Five-to-Eleven Year-Olds.

Advisory boards working in the Food and Drug Administration (FDA) as well as for the Centers for Disease Control and Prevention (CDC) have approved the use of the Pfizer jab for five to 11-year olds, outlining that the benefits outweigh the potential risks posed to this age demographic. Although the decision now awaits formal approval from the FDA and CDC as a whole, it is expected that both organisations will confirm the original verdict, meaning that 28 million U.S. schoolchildren will soon be eligible for the vaccine. BBC NEWS has the story.

Following the FDA independent advisory committee’s green light on Tuesday, the CDC is expected to follow suit on November 2nd, meaning jabs for five-year olds could begin as soon as a day later.

The Pfizer vaccine is already approved for American adults and adolescents, but it has not yet been fully approved for most school-aged children.

Among those between five and 11 years-old, there have been about 1.8 million Covid cases confirmed in the US, according to the CDC. Fewer than 200 have died, and most of those had underlying medical conditions.

Some medical experts say that, given the persistence of the Delta variant and the return to in-person schooling, vaccinating children is a crucial next step in fighting the pandemic.

“Parents need to understand the urgency of vaccination because the pandemic is not over”, said Dr. James Versalovic, pathologist in chief at Texas Children’s Hospital (TCH)…

Vaccine hesitancy remains a challenge for US medical authorities. Uptake in the adult population has stalled below 60% over the past several months.

Only a third of parents in a poll last month by the Kaiser Family Foundation said they would get their children vaccinated ‘right away’. Another third said they would like to ‘wait and see’.

Some parents have expressed concern about hundreds of cases of myocarditis, an inflammation of the heart muscle, that have been reported predominantly in young adults who took the vaccine, mostly after the second jab.

Worth reading in full.

CDC Ignores Advisory Panel and Backs Booster Jabs for Under-65s in ‘High-Risk’ Work Settings, Including Teachers

The U.S. Centers for Disease Control and Prevention (CDC) says that Covid booster vaccines should be given not only to the over-65s and to those with underlying medical conditions but also to adults who work in ‘high-risk’ settings, such as teachers. The recommendation comes in spite of the red light given on additional doses for people in more ‘risky’ settings by the centre’s own Advisory Committee on Immunisation Practices. Reuters has the story.

CDC Director Rochelle Walensky said her agency had to make recommendations based on complex, often imperfect data.

“In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,” she said in a statement. …

The CDC recommendation follows U.S. Food and Drug Administration authorisation and clears the way for a booster roll-out to begin as soon as this week for millions of people who had their second dose of the Pfizer shot at least six months ago.

The CDC said that people 65 years and older should get a booster. Beyond older Americans, the CDC also recommended the shots for all adults over 50 with underlying conditions.

It said that, based on individual benefits and risks, 18 to 49 year-olds with underlying medical conditions may get a booster, and people 18-64 at increased risk of exposure and transmission due to occupational or institutional setting may get a shot. …

The CDC’s Advisory Committee on Immunisation Practices on Thursday gave the thumbs down to additional doses for groups including healthcare workers, teachers and residents of homeless shelters and prisons.

Panel member Lynn Bahta, who works with the Minnesota Department of Health, voted against that measure. She said the data does not support boosters in that group yet. “The science shows that we have a really effective vaccine,” she said.

The committee had said it could revisit the guidance later. …

Vaccine expert Dr. Paul Offit said he believed the CDC advisers were worried that recommending boosters based on employment would allow overly broad use, especially in younger people for whom the health benefits of a booster shot are still unclear.

“That was a hole that you could drive a truck through, that essentially what we were doing was basically what the (Biden) administration initially asked – to just have a vaccine for the general population, because obviously the pharmacists aren’t going to figure out whether you’re working in a grocery store or hospital,” he said.

Worth reading in full.

CDC Study Claiming Unvaccinated Have More Than Double the Risk of Re-infection is Full of Holes

The Centers for Disease Control and Prevention (CDC) in America has published a new study claiming to show that, among the previously infected, the unvaccinated are at more than double the risk of re-infection than the vaccinated.

It forms part of their evidence for why people who have had COVID-19 before should get vaccinated and not rely on natural immunity.

It has a number of problems, however.

The study looks retrospectively at data from the U.S. state of Kentucky. The researchers identify all those in the state who were re-infected during May and June 2021 (defined in terms of positive tests a certain number of days apart) and compare their vaccination rates to a control group. They find 246 re-infections in that period, and calculate that those who were not vaccinated were 2.34 times more likely to be re-infected than those who were vaccinated.

The study has a number of limitations, however, some of which the authors acknowledge.

Firstly, the study period of May and June 2021 is notable for being a period of very low prevalence in the state, meaning it is not a good time to study acquired immunity, which is best studied during a new surge when it is most put to the test. The authors themselves acknowledge that because the study covers just one period in one state, the “findings cannot be used to infer causation”.

The authors also acknowledge that test-seeking behaviour may skew the findings to exaggerate vaccine effectiveness, as vaccinated people are probably less likely to get tested.

Another weakness is that the study doesn’t include symptom data so we don’t know whether the “reinfections” were actual disease or just asymptomatic and mild infections of the kind that are characteristic of the immune system working.

A related problem is that there is no discussion of how big the problem of re-infection is from an absolute standpoint. With only 246 re-infections (of unknown severity) in a population of 4.5 million over a two month period, it’s not clear that even if vaccination did halve your probability of re-infection it would be a difference worth getting vaccinated (which carries its own risks) to achieve.

CDC U-Turns on Face Masks – Tells Vaccinated Americans to Put Coverings Back On

“Look, we’ve gotten this far. Please protect yourself until you get to the finish line.” With these words, spoken in May, President Joe Biden instructed unvaccinated Americans to continue wearing face masks indoors but echoed advice from the Centers for Disease Control and Prevention (CDC) that fully vaccinated Americans could ditch their coverings. On Twitter, he said: “The rule is now simple: get vaccinated or wear a mask until you do.”

It turns out the rule wasn’t as simple as he made out.

The CDC has told vaccinated Americans that they must put their face masks back on when indoors, less than three months after announcing that it was safe to remove them, citing fears over the Delta Covid variant. CDC Director Rochelle Walensky told reporters: “The Delta variant is showing every day its willingness to outsmart us and to be an opportunist in areas where we have not shown a fortified response against it.” The Washington Post has more.

On Tuesday… the CDC announced it had again changed its guidance on masks, recommending once more that all Americans wear masks indoors in public spaces. The game-changer for the agency was data showing that vaccinated people infected with the highly infectious delta variant carry the same viral load as unvaccinated people who are infected, the Washington Post reported.

Whiplash recommendations carry downsides. “Once you’ve let the genie out of the bottle, it’s really hard to put it back in,” said Lawrence Gostin, a Professor of Global Health Law at Georgetown University. Americans who have set aside their masks might not be persuaded to don them again.

Last year, the CDC was not alone in its scepticism. The World Health Organisation (WHO) did not publish global guidance supporting masks until June 5th, more than two months after the United States did. The lack of mask availability early in the pandemic made recommending them difficult.

The WHO currently advises all people, vaccinated or not, to continue wearing masks when around others.

WHO spokesman Tarik Jasarevic said Tuesday that the global health body advises governments to continue emphasising proven public health and social measures, including masks, “as long as there is community spread”.

There was community spread when the CDC issued its May 13th guidance. The United States that day recorded almost 50,000 new Covid cases. But vaccination rates were dipping. The message about masks appeared to be an attempt to incentivise the shots.

That gambit may have failed: the number of Covid vaccine doses given out this week across the United States is less than half of what it was the week of May 13th. Many unvaccinated Americans appear to have ditched their masks anyway. …

Reinstating mask rules that have been lifted can be difficult. Israel has struggled with mask compliance since June 25th [when the mask mandate was reimposed just 10 days after it was lifted].

Worth reading in full.

Stop Press: Reporters had to be handed face masks at a White House event on Tuesday evening, minutes after the CDC updated its advice, according to MailOnline.

U.S. Medicines Regulator to Add Warning to Pfizer and Moderna Vaccines Over Link to Heart Inflammation

The U.S. Food and Drug Administration (FDA) is set to add a warning to the Covid vaccines made by Pfizer and Moderna after the Centers for Disease Control and Prevention (CDC) said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults. The MailOnline has the story.

The CDC made the announcement Wednesday during a presentation. 

The Covid Vaccine Safety Technical (VaST) Work Group discussed nearly 500 reports of heart inflammation, known as myocarditis, in vaccinated adults under the age of 30.

The group of doctors said the risk of myocarditis or pericarditis following vaccination with the mRNA-based shots in adolescents and young adults is notably higher after the second dose and in males  

It comes as the Advisory Committee on Immunisation Practices (ACIP) is set to meet this week to assess the possibility of a link between the heart condition and the mRNA vaccines. 

The Moderna and Pfizer vaccines use mRNA technology, while the Johnson & Johnson vaccine uses the more traditional virus-based technology. 

According to the presentation, there have been 484 preliminary reports of myocarditis or pericarditis in young people under age 30 as of June 11th.

So far, 323 have been confirmed by CDC and 148 are still under review.

In total, 309 patients were hospitalized, of which 295 were discharged and 79% have since recovered.

Nine patients are still hospitalized with two in intensive care units. There was no data available for five patients. 

Males were much more likely to report heart inflammation after receiving a second dose than women.

As of June 11th, there were 9.1 per million reported cases of myocarditis/pericarditis in females ages 12-to-17 compared to 66.7 per million in males of that age group.

What’s more, rates among females ages 18-to-24 and ages 25-to-29 were 5.5 per million and 2.6 per million respectively.

Ang [among] males, rates were 56.3 per million for the 18-to-24 age group and 20.4 per million in the 25-to-29 group.

In Australia, the AstraZeneca Covid vaccine is facing further criticism over its links to a variety of side effects. The vaccine will have been almost completely phased out of the country’s roll-out by October.

Worth reading in full.