Study Finds Covid Boosters Cause “Net Harm” In Young Adults

Authors:  QUOTH THE RAVEN QTR Finance September 16, 2022

It was just a couple of days ago that I wrote about the explosive chronology of events laid out by Rutgers professor and Harvard PhD Dr. Richard Ebright that made it clear to me that the Covid “lab leak” origin was the most reasonable explanation for the pandemic.

And now, before we’ve even had a chance to digest that information, it looks as though we are getting another desperately needed Covid reality check: a new study conducted by scientists from University of Washington, Harvard and Johns Hopkins, emerged just hours ago and makes arguments against vaccine booster mandates for young adults. The findings of the study were stunning.

The study, which is still in pre-print and has not yet been peer reviewed, is called “COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities”.

The study looks at how, as of May 2022, at least 1,000 colleges and universities have required vaccination, with over 300 of them requiring boosters. Despite “more than fifty petitions” in writing against these mandates, “young people, parents and faculty have been ignored by administrators and mandate proponents”, the study says.

Led by researchers from the University of Washington, University of Oxford, Harvard and Johns Hopkins University, it set out to look at the problems of students facing disenrollment at North American universities due to third dose COVID-19 vaccine mandates.

The says that “two main factors” are driving scientific controversy over boosters: “a lack of evidence that booster doses provide meaningful reduction in hospitalisation risk among young people and mounting evidence that (widespread) prior infection confers significant protection against hospitalisation 50 due to (re-)infection.”

Remember earlier this year when the idea of “natural immunity” all of a sudden went from conspiracy theory topic to widely accepted by Dr. Fauci?

The paper seeks to provide the first “risk benefit assessment of SARS-CoV-2 boosters for young previously uninfected adults under 40 years old”.

The study found that requiring third boosters may provide “net expected harm”, as the study estimated that “22,000 – 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation.”

COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities

Authors: Kevin Bardosh University of Washington; University of Edinburgh – Edinburgh Medical School Allison Krug Artemis Biomedical Communications LLC Euzebiusz Jamrozik University of Oxford Trudo Lemmens University of Toronto – Faculty of Law Salmaan KeshavjeeHarvard University – Harvard Medical School Vinay Prasad University of California, San Francisco (UCSF) Martin A. Makary Johns Hopkins University – Department of Surgery Stefan Baral John Hopkins University Tracy Beth Høeg Florida Department of Health; Sierra Nevada Memorial HospitalDate Written: August 31, 2022

Abstract

Students at North American universities risk disenrollment due to third dose COVID-19 vaccine mandates. We present a risk-benefit assessment of boosters in this age group and provide five ethical arguments against mandates. We estimate that 22,000 – 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation. Using CDC and sponsor-reported adverse event data, we find that booster mandates may cause a net expected harm: per COVID-19 hospitalisation prevented in previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities. Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favourable. University booster mandates are unethical because: 1) no formal risk-benefit assessment exists for this age group; 2) vaccine mandates may result in a net expected harm to individual young people; 3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission; 4) US mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and 5) mandates create wider social harms. We consider counter-arguments such as a desire for socialisation and safety and show that such arguments lack scientific and/or ethical support. Finally, we discuss the relevance of our analysis for current 2-dose CCOVIDovid-19 vaccine mandates in North America.

Download Complete Study Publication

https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID4206070_code5055014.pdf?abstractid=4206070&mirid=1

Omicron’s Mutations Impaired Vaccine Effectiveness, CDC Says

Authors: Madison Muller  August 25, 2022 Bloomberg

Almost 40% of people hospitalized in the US with the Covid subvariant that circulated this spring were vaccinated and boosted, highlighting how new strains have mutated to more readily escape the immunity offered by current shots.

The findings from scientists at the US Centers for Disease Control and Prevention underscore the importance of having Covid shots that are better at targeting omicron subvariants. 

From the end of March through May, when the omicron BA.2 and BA.2.12.1 subvariants were dominant in the US, weekly hospitalization rates increased for all adults — with those over 65 hit the hardest. Even so, the total number of hospitalizations remained much lower than when the delta variant was rampant last fall. 

The overall number of hospitalizations is an important point, said Abraar Karan, an infectious disease doctor at Stanford University.

“When you look at who’s hospitalized, it’s much more likely that they will have been vaccinated because so many people are vaccinated now,” Karan said. “The real comparison is how many hospitalizations do we have now versus in the past when people were not vaccinated or not up-to-date with boosters.”

CDC scientists found that vaccines and boosters did a better job of keeping people with delta infections out of the hospital than those with later variants. Effectiveness decreased slightly with the BA.1 variant, then changed significantly with BA.2 — with a much greater share of hospitalized adults who had been vaccinated with at least one booster. 

Read more: Retiring Fauci expected Covid to be ‘behind us’

Immunity from vaccines starts to wane within six months, so staying up-to-date with shots is key to being fully protected. Fewer than half of Americans have gotten a booster shot.

Adults with at least two booster shots fared better than other people when BA.2 was dominant. The majority of those admitted to the hospital also had at least one underlying condition. Unvaccinated adults were more than three times as likely to be hospitalized, but breakthrough infections still represented a significant number of the severe Covid cases, the data show.

US regulators have pushed Moderna Inc., Pfizer Inc. and BioNTech SE to expedite development of omicron-specific boosters for a September rollout. The drugmakers this week submitted early data to the US Food and Drug Administration seeking emergency clearance for updated shots that target the BA.4 and BA.5 virus strains. Scientists and vaccinemakers are already beginning to look toward next-generation shots that may provide longer-lasting protection against more variants. 

The new report’s findings also indicate that along with vaccination, other pharmaceutical and non-pharmaceutical measures should be used by those at highest risk of getting Covid. That includes easy access to therapeutics such as Pfizer’s antiviral drug Paxlovid and Gilead Sciences’ remdesivir, as well as AstraZeneca’s Evusheld for immunocompromised people. Scientists also note that wearing a mask can help guard the wearer from getting sick.  

Though the number of Covid deaths is the lowest it has been since last July, the US continues to see hundreds of deaths each day from Covid, CDC data show.

New England Journal of Medicine: “Conspiracy Theory” confirmed

The America First Report breaks the story: July 12, 2022

Several recent studies have indicated the Covid-19 vaccines actually increase the risk of contracting the disease over time, but these studies have been ignored or even debunked by corporate media and Big Pharma for months. Now, they’ll have to contend with a new study published in the highly respected New England Journal of Medicine.

This study was huge in scale, sifting through data collected from over 100,000 people infected by the Omicron variant. It lends credibility to the statistical significance of the findings, which are absolutely startling. Here are the key points:

  • Those who have been “fully vaccinated” with two shots from Moderna or Pfizer are more likely to contract Covid-19 than those who have not been vaccinated at all
  • Booster shots offer protection approximately equal to natural immunity, but the benefits wane after 2-5 months
  • Natural immunity lasts for at least 300-days, which is the length of the study; it likely lasts much longer

This jibes with the current narrative coming from Big Pharma and their minions in government and corporate media that the jabs are supposed to mitigate the effects. But even that claim has been called into question as recent studies indicate the vaccinated may be dying even more than the unvaccinated. According to The Exposé:

The Government of Canada has confirmed that the vaccinated population account for 4 in every 5 Covid-19 deaths to have occurred across the country since the middle of February 2022, and 70% of those deaths have been among the triple vaccinated population.

Despite the scope of the study and the credibility of the source, it will not receive any attention from corporate media. It is imperative that our readers get the word out because this is an absolute narrative-buster for Big Pharma. Now more than ever, we must alert the people of the truth because we are on the verge of seeing millions of children under the age of five-years-old injected.

Children do not readily acquire this pathogen, spread to other children, spread to adults, take it home, get severely ill, or die from it. It is that simple. We know children tend not to transmit Covid-19 virus and that the concept of asymptomatic spread has been questioned severely, particularly for children.

Children, if infected, just do not spread Covid-19 to others readily, either to other children, other adults in their families or otherwise, nor to their teachers. This was demonstrated elegantly in a study performed in the French Alps. The pediatric literature is clear science on this. Overwhelming data shows that the SARS-CoV-2-associated burden of severe disease or death in children and adolescents is very low (statistically zero).

Swedish data by Ludvigsson reported on the 1,951,905 children in Sweden (as of December 31, 2020) who were 1 to 16 years of age who attended school with largely no lockdowns or masks. They found zero (0) deaths. “Despite Sweden’s having kept schools and preschools open, we found a low incidence of severe Covid-19 among schoolchildren and children of preschool age during the SARS-CoV-2 pandemic.”

recent German study (collating evidence from three sources 1) a national seroprevalence study (the SARSCoV-2 KIDS study), 2) the German statutory notification system and 3) a nationwide registry on children and adolescents hospitalized with either SARS-CoV-2 or Pediatric Inflammatory Multisystem Syndrome (PIMS-TS)) reported that there were zero (0) deaths in children 5 to 18 years old across the period of study.

Governments and public health officials have driven this pandemic of fear and propaganda. But parents willing to assess this purely from a benefit versus risk position might ask themselves: ‘If my child has little if any risk, near zero risk of severe sequelae or death, and thus no benefit from the vaccine, yet there could be potential harms and as yet unknown harms from the vaccine (as already reported in adults who have received the vaccines), then why would I subject my child to such a vaccine?

Because the life of your child (or yourself) is a price the purveyors of this genocide are entirely willing to pay in exchange for a nice, fat paycheck.

Comport yourselves accordingly.

COVID Boosters Might Be Less Than 20% Effective After a Few Months: Study

An Italian review of COVID studies found that boosters restore vaccine effectiveness against omicron initially, but that protection falls off quickly

Authors: NBC News July 8, 2022

COVID booster shots appear to be less than 20% effective against infection with the omicron variant of the virus just a few months after the booster is given, a new study found this week.

The Italian study, which is a pre-print review and re-analysis of prior studies and has not been peer-reviewed, suggests boosters are effective in the short term to restore protection against the virus. But over just a few months, that wanes quickly.

“Booster doses were found to restore the VE [vaccine effectiveness] to levels comparable to those acquired soon after administration of the second dose; however, a fast decline of booster VE against Omicron was observed, with less than 20% VE against infection and less than 25% VE against symptomatic disease at 9 months from the booster administration,” the authors wrote in the paper released Wednesday.

It’s a crucial question to understand, given that boosters widely became available about 9 months ago in the United States, and that a new surge is now happening with the BA.5 variant of omicron — which appears to be better at reinfecting people than any past strain of the virus.

Overall, the researchers found that nine months after administration, two doses of a vaccine were less than 5% effective at stopping a symptomatic omicron infection, and three doses were no more than about 22% effective.

According to the CDC, less than a third of Americans have had a first booster dose at any point since they became available, and only about 5% of Americans have had a second booster dose.

Why are boosted Americans testing positive for COVID more than those without extra shot?

Authors: Julia Marnin, McClatchy Washington Bureau June 7, 2022

Since late February, Americans who have gotten a booster shot appear to be testing positive for COVID-19 more often than those vaccinated without the extra shot, according to Centers for Disease Control and Prevention data.

This is based on numbers up until the week of April 23, which is the most recently released CDC data comparing case rates of those boosted, vaccinated and unvaccinated against the coronavirus. Ultimately, the numbers, which are updated monthly, showed those unvaccinated had the highest case rates overall.

Meanwhile, about 119 out of 100,000 boosted individuals tested positive for COVID-19 during the week of April 23, according to CDC data. In comparison, 56 out of 100,000 individuals vaccinated with only a primary series tested positive.

But why are the case rates higher for boosted individuals than for those vaccinated without a booster?

Dr. Sheela Shenoi, an infectious disease doctor and assistant professor at Yale School of Medicine, told McClatchy News over the phone that “there’s no biological reason that people who have had (the vaccine) and boosters are going to be at increased risk for COVID.”

“These numbers are not telling us the whole truth,” Shenoi said.

The CDC wrote in a summary accompanying its data that “several factors likely affect crude case rates” and this makes “interpretation of recent trends difficult.”

Here are some potential factors to keep in mind, according to health experts, when looking at the data.

At-home testing

“The wide availability of at-home tests has substantially muddied the waters, because these do not necessarily show up in official figures,” Bill Hanage, an associate professor of epidemiology at Harvard University’s T.H. Chan School of Public Health and a co-director for the Center for Communicable Disease Dynamics, told McClatchy News in a statement.

“Individuals receiving boosters may be more likely to have their cases counted,” Hanage said.

Hanage said this is because “just in being boosted, they are displaying ‘health seeking’ behavior” and “they are more likely to have contact with healthcare and get a test that ends up in official stats.”

In the U.S., more than 221 million people are fully vaccinated and more than 103 million of those people have received their first booster dose as of June 7, according to the CDC.

Those vaccinated without a booster “are more likely young, and so less likely to be severely ill in general,” Hanage said. “If they do a rapid test, they may not report it. They may not even do a test.”

Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University’s Mailman School of Public Health and director of ICAP, told McClatchy News over the phone that the wide availability of self testing “has completely changed the picture overall.”

“We don’t know the number of tests that are done and we don’t know how many are positive, how many are negative,” El-Sadr said. “So it’s a whole kind of black box that makes looking at case rates really very unreliable.”

Behaviors

Shenoi said it’s possible that individual behaviors might influence why CDC data shows those with booster shots are testing positive more than those vaccinated with a primary vaccine series.

Those boosted may feel more comfortable and safe, according to Shenoi, and as a result, they might be taking less COVID-19 precautions such as masking and social distancing “because they feel like they’re protected by the booster.”

Over the past few months, Shenoi said the country has seen “people getting infections, although overwhelmingly mild, thankfully, and that may correlate with people feeling that they’re protected and engaging in kind of their normal activities where they may be more exposed to other people with COVID and facilitating spread.”

El-Sadr said the issue with the CDC case rate data is that it depends “very much on behaviors, whether it be testing behavior” or “the characteristics of people who are boosted versus people who are not boosted.”

Prior infections and those at higher risk

It’s possible that people who have gotten their primary vaccine series but not a booster “are more likely to have been recently infected during the first omicron wave,” Hanage said.

With that “additional immunity from that infection,” they are less likely to be infected now, he added.

Dr. Peter Gulick, an associate professor of medicine at Michigan State University and the director of its Internal Medicine Osteopathic Residency Program, told McClatchy News in a statement that “one thing to consider is the group that gets the boosters.”

He described this group as older, immunocompromised individuals who are at a higher risk when it comes to COVID-19 breakthrough infections because of their “only partial response (to the) vaccines.”

El-Sadr also said those who are boosted may be at a higher risk of testing positive for COVID-19.

Because of this, “you can’t really attribute their higher risk of getting infected with COVID to the booster.”

The CDC’s late April case rate data was recorded when COVID-19 cases were trending upward in the U.S. due to the omicron variant and its subvariants.

The omicron variant, which is highly infectious and generally causes less severe symptoms compared with other variants, continues to dominate cases in the U.S. as of June 4, according to the CDC.

Shenoi said she predicts cases are going to continue to rise in the summer based on how infectious the variant and its subvariants are and how Americans appear ready to “move on and get back to their normal lives.”

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Association Between COVID-19 Booster Vaccination and Omicron Infection in a Highly Vaccinated Cohort of Players and Staff in the National Basketball Association

Authors:

Caroline G. Tai, PhD, MPH1Lisa L. Maragakis, MD, MPH2Sarah Connolly, PhD, MPH1et alJohn DiFiori, MD3Deverick J. Anderson, MD, MPH4Yonatan H. Grad, MD, PhD5Christina DeFilippo Mack, PhD, MSPH1 JAMA. Published online June 2, 2022. doi:10.1001/jama.2022.9479

Evaluation of COVID-19 vaccine booster effectiveness is essential as new variants of SARS-CoV-2 emerge. Data support the effectiveness of booster doses in preventing severe disease and hospitalization; however, the association with reducing incident SARS-CoV-2 infections is not clear.13 We compared the incidence of SARS-CoV-2 infection in players and staff of the National Basketball Association (NBA) who did vs those who did not receive a booster dose.

Methods

Players and staff who were tested more than once between December 1, 2021, and January 15, 2022, were included. Individuals were tested via the nucleic acid amplification test when symptomatic, after a known exposure, or during daily enhanced surveillance testing triggered by multiple cases on 1 team. Player vaccinations were not mandated. Staff were required to be fully vaccinated by October 1, 2021, and to have received a booster dose by January 5, 2022, if eligible. Masking requirements were similar between players and staff, with the exceptions of players unmasking on court and head coaches unmasking during games.

Genome sequencing was performed for all infections to determine the SARS-CoV-2 variant, but some sequencing failed due to inadequate sample volume, viral load, or genome coverage. Vaccination status was considered as a time-varying exposure; individuals could dynamically move through multiple categories during the study and contribute person-days accordingly. Fully vaccinated was defined as 2 doses of a 2-dose vaccination course (Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273) or 1 dose of the 1-dose vaccination course (Johnson & Johnson JNJ-78436735)4 and fully boosted was defined as 14 days after receiving any booster dose.

Hazard ratios (HRs) from an Andersen-Gill Cox proportional hazards model5 compared time to infection for individuals who were fully vaccinated vs those who were fully boosted. Infections occurring after vaccination but prior to 14 days after vaccination were censored. The outcomes included confirmed SARS-CoV-2 infections, symptomatic infections, COVID-19 hospitalizations, and COVID-19 deaths.

The models were adjusted for age and prior SARS-CoV-2 infection and the analyses were performed using SAS version 8.2 (SAS Institute Inc) and R version 4.1.1 (R Foundation for Statistical Computing). Statistical significance was defined as a 2-sided P < .05. The Advarra institutional review board determined the study met criteria for exemption status. Individuals signed health information authorizations allowing collection, storage, and use of health information by the NBA for monitoring purposes, including disclosure to medical experts.

Results

Of 2613 players and staff, 67% were followed up the entire 45-day study period, with 74 165 person-days contributed by fully boosted individuals and 10 890 person-days by those who were fully vaccinated but not boosted though eligible to receive a booster dose. From the start to the end of the study period, the percentage of individuals who were fully vaccinated and eligible for a booster dose decreased from 26% (n = 682) to 8% (n = 205) and the percentage of individuals who were fully boosted increased from 49% (n = 1282) to 85% (n = 2215); the remainder were in other categories, such as fully vaccinated but not yet eligible for a booster or within 14 days of their booster dose. In the overall cohort, 88% were male with a median age of 33.7 years (IQR, 27.3-45.2 years; Table 1).

Individuals who were fully boosted experienced 608 confirmed SARS-CoV-2 infections and were significantly less likely to be infected than fully vaccinated individuals who were booster eligible and had not received a booster, who had experienced 127 confirmed infections (adjusted HR, 0.43 [95% CI, 0.35-0.53], P < .001; Table 2). The secondary analyses evaluating symptomatic infection showed a similar association (adjusted HR, 0.39 [95% CI, 0.30-0.50]; P < .001). No hospitalizations or deaths occurred. Omicron was the dominant variant, representing 93% of 339 sequenced cases.

Discussion

This study found that in a young, healthy, highly vaccinated cohort frequently monitored for SARS-CoV-2, booster vaccination was associated with a significant reduction in incident infections during the Omicron wave. Study limitations include generalizability to older populations and the possibility that some infections may have been undetected in the absence of daily surveillance testing. This is a population that was recently boosted (median of 20 days as of December 1, 2021) and may not reflect waning efficacy over time. Surveillance testing in this population captured both symptomatic and asymptomatic infections, which differs from studies of the effectiveness of boosters that did not assess risk of asymptomatic infections.2,3 Continued research is required to assess the need for additional booster doses beyond a single booster dose.

References

1.Johnson  AG, Amin  AB, Ali  AR,  et al.  COVID-19 incidence and death rates among unvaccinated and fully vaccinated adults with and without booster doses during periods of Delta and Omicron Variant Emergence—25 US jurisdictions, April 4-December 25, 2021.   MMWR Morb Mortal Wkly Rep. 2022;71(4):132-138. doi:10.15585/mmwr.mm7104e2PubMedGoogle ScholarCrossref

2.Thompson  MG, Natarajan  K, Irving  SA,  et al.  Effectiveness of a third dose of mRNA vaccines against COVID-19–associated emergency department and urgent care encounters and hospitalizations among adults during periods of Delta and Omicron variant predominance—VISION Network, 10 states, August 2021-January 2022.   MMWR Morb Mortal Wkly Rep. 2022;71(4):139-145. doi:10.15585/mmwr.mm7104e3PubMedGoogle ScholarCrossref

3.Accorsi  EK, Britton  A, Fleming-Dutra  KE,  et al.  Association between 3 doses of mRNA COVID-19 vaccine and symptomatic infection caused by the SARS-CoV-2 Omicron and Delta variants.   JAMA. 2022;327(7):639-651. doi:10.1001/jama.2022.0470
ArticlePubMedGoogle ScholarCrossref

4.US Centers for Disease Control and Prevention. Stay up to date with your vaccines. Accessed April 10, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html

5.Andersen  PK, Gill  RD.  Cox’s regression model for counting processes: a large sample study.   Ann Stat. 1982;10(4):1100-1120. doi:10.1214/aos/1176345976Google ScholarCrossref

Why boosted Americans seem to be getting more COVID-19 infections

BAuthors: ALEXANDER TIN JUNE 2, 2022

As COVID-19 cases began to accelerate again this spring, federal data suggests the rate of breakthrough COVID infections in April was worse in boosted Americans compared to unboosted Americans — though rates of deaths and hospitalizations remained the lowest among the boosted.

The new data do not mean booster shots are somehow increasing the risk. Ongoing studies continue to provide strong evidence of additional protection offered by booster shots against infection, severe disease, and death.

Instead, the shift underscores the growing complexity of measuring vaccine effectiveness at this stage of the pandemic. It comes as officials are weighing key decisions on booster shots and pandemic surveillance, including whether to continue using the “crude case rates” at all.

It also serves to illustrate a tricky reality facing health authorities amid the latest COVID-19 wave: even many boosted Americans are vulnerable to catching and spreading the virus, at a time when officials are wary of reimposing pandemic measures like mask requirements.

“During this Omicron wave, we’re seeing an increased number of mild infections — at-home type of infections, the inconvenient, having a cold, being off work, not great but not the end of the world. And that’s because these Omicron variants are able to break through antibody protection and cause these mild infections,” John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, told CBS News.

“So, one of the dynamics here is that people feel, after vaccination and boosting, that they’re more protected than they actually are, so they increase their risks,” he said. “That, I think, is the major driver of these statistics.”

On the CDC’s dashboard, which is updated monthly, the agency acknowledges several “factors likely affect crude case rates by vaccination and booster dose status, making interpretation of recent trends difficult.”

The CDC had rolled out the page several months ago, amid demands for better federal tracking of breakthrough cases. It has now grown to encompass data from immunization records and positive COVID-19 tests from 30 health departments across the country

For the week of April 23, it said the rate of COVID-19 infections among boosted Americans was 119 cases per 100,000 people. That was more than double the rate of infections in those who were vaccinated but unboosted, but a fraction of the levels among unvaccinated Americans.

That could be because there is a “higher prevalence of previous infection” right now among those who are unvaccinated and unboosted, the CDC said. More boosted Americans may now have abandoned “prevention behaviors” like wearing masks, leading to an uptick.

Some boosted Americans might be more likely to seek out a lab test for COVID-19, as opposed to relying on over-the-counter rapid tests that go largely unreported to health authorities.

“Home testing has become, I think, the single biggest concern in developed countries that can interfere with our measurements,” CDC’s Ruth Link-Gelles told a conference hosted by the National Foundation for Infectious Diseases last month. 

Some federal officials have floated the possibility of adopting a survey — similar to those relied on by authorities in the United Kingdom — as an alternative way to track a “ground truth” in COVID-19 cases, though plans to stand up such a system do not appear imminent.

“Moving beyond this crisis, I do think the future is in random sampling. And that’s an area that we’re looking at closely,” Caitlin Rivers, a top official on the agency’s disease forecasting team, told an event hosted by the National Academies last week. 

Meanwhile, federal officials are also preparing for key decisions on future COVID-19 vaccine shots, which might up the odds that additional shots might be able to fend off infections from the latest variants. 

In the short term, CDC Director Dr. Rochelle Walensky recently told reporters that her agency was in talks with the Food and Drug Administration about extending the option for second boosters to more adults. 

Right now, only adults 50 and over and some immunocompromised Americans are eligible to receive a fourth dose

Next generation of vaccines and boosters

Further down the road, a panel of the Food and Drug Administration’s outside vaccine advisers is scheduled to meet later this month to weigh data from new booster candidates produced by Pfizer and BioNTech as well as Moderna. 

BioNTech executives told investors last month that regulators had asked to see data for both shots specifically adapted for the Omicron variant in addition to “bivalent vaccines,” which target a blend of mutations. 

Those new vaccines would take about three months to manufacture, the White House’s top COVID-19 official Dr. Ashish Jha told reporters.

“It’s a little bit of a challenge here because we don’t know how much further the virus will evolve over the next few months, but we have no choice because if we want to produce the hundreds of millions of doses that need to be available for a booster campaign, we have to start at risk in the early July timeframe or even somewhat sooner,” Dr. Peter Marks, the FDA’s top vaccines official, said at a recent webinar hosted by the American Medical Association. 

Marks said that bivalent shots seemed likely to be favored, given the “wiggle room” it could offer for unforeseen variants beyond Omicron. 

Vaccines that might offer even better “mucosal immunity” – actually fighting off the virus where it first infects the respiratory system – are still a ways off, Marks cautioned. 

“I think that we are in a transition time and I, again, will speak openly to the fact that 2022 to 2023 is a year where we have to plan for trying to minimize the effect of COVID-19 with the tools that we have in hand,” Marks said at a recent event with the National Foundation for Infectious Diseases. 

“I do believe that, potentially by the 2023-2024 season, we’ll start to see second generation SARS-CoV-2 vaccines,” he added later.

More of the vaccinated and boosted landing in hospital with COVID-19

Authors: By Ariel Hart Zachary Hansen May 19. 2022 – The Atlanta Journal-Constitution

Doctors say it’s caused by a combination of a variant that can escape the vaccine’s effects and the most vulnerable also being the most vaccinated

As summer once again brings signs of a coming COVID-19 wave, an unusual trend has emerged: The Georgians who are fully vaccinated and boosted are increasingly winding up in the hospital with serious COVID-19 symptoms.

The phenomenon points to two changes in the unpredictable pandemic battleground more than two years in. The circulating omicron variant has become better at evading the vaccine, which was designed on the first version of coronavirus to appear in China. And the people most likely to get boosted are those who were most vulnerable to begin with: the elderly, or patients with pre-existing conditions. Despite the extra vaccine protection, those people remain the most vulnerable.

Even in light of the unexpected hospitalizations of those vaccinated and boosted, doctors say it’s still true that boosted groups are the least likely to die.

“I’ve had several older patients who have been boosted and had the vaccine,” said Dr. William Cleveland, a nephrologist in southwest Atlanta. “They get hospitalized, and they had to have some significant medical attention, but they get discharged. And I know that just because of their frailty, without having had the vaccine they would not have survived.”

The rate of hospitalizations for boosted Georgians fell again this week, but still remains higher than the rate of hospitalizations for those with only the primary vaccine series (2 shots). The fact that boosted patients’ hospitalizations nearly outstripped all others even for one week was an unprecedent moment in the pandemic. In the past, hospitalization rates for unvaccinated groups have drastically outnumbered those who have taken the vaccine — sometimes tenfold.

The trend emerged at the tail-end of the omicron variant outbreak and has accelerated over the past two months, setting off alarm bells for state public health experts already expecting a surge in cases this summer.

Dr. Eva Lee, director of the Center for Operations Research in Medicine and Healthcare at Georgia Tech, agreed that the rate of hospitalizations among boosted people was on track to outpace other populations. However, she said it’s not a sign of vaccines losing all effectiveness — it has to do with who is choosing to get boosted.

“A big part of the people that are boosted are also the ones that are really at high risk already to begin with, right?” Lee said. “But what has remained and hasn’t changed is the following: The people that are at risk remain at risk. That means the people that are immune-compromised and the people that are like the elderly people, and people who have coexisting conditions, their risk is still higher.”

Growing number of breakthroughs

Overall, the number of people hospitalized with COVID remains at or near the lowest rate since the beginning of the pandemic. But state data shows that the most protected and least protected groups are starting to find themselves fighting for their lives in Georgia hospitals at nearly the same levels.

According to Georgia Department of Public Health data, unvaccinated groups were being hospitalized due to COVID at twice the rate of other populations at the beginning of March. By the end of April, there were 1.3 hospitalizations per 100,000 vaccinated and boosted Georgians compared to 1.6 hospitalizations for every 100,000 unvaccinated Georgians.https://datawrapper.dwcdn.net/qtaSR/1/

In addition to at-risk groups being more likely to get every shot available to them, omicron and its subvariants have presented a challenge for the U.S.’s current vaccines. Breakthrough cases of less serious illness are now common, and health experts warn they are a sign of the vaccines’ waning immunity.

“Prior to Omicron we could, with a booster, assume there was well over 90-95% vaccine effectiveness vs severe disease,” Eric Topol, founder and director of the Scripps Research Translational Institute in New York, wrote in a recent column sounding the alarm for a summer surge in COVID-19 infections. “It is clear, however, from multiple reports … that this level of protection has declined to approximately 80%, particularly taking account the more rapid waning than previously seen. That represents a substantial drop-off.”

The growing number of breakthrough cases has prompted national health officials to discuss reformulating the current vaccines to specifically target omicron and its subvariants. The U.S. Food and Drug Administration has a meeting scheduled for June 28 to evaluate vaccine efficiency and composition.

Georgia hasn’t seen any noticeable uptick in COVID-19 deaths, but death reports often lag behind increasing hospitalization rates by several weeks.

While health experts are troubled by the rising hospitalization rates, they emphasize that COVID’s death toll would already be on the rise if the most at-risk Georgians weren’t vaccinated and boosted.

Surprised to still be alive

Raymond Fain knew he couldn’t risk getting COVID-19. Given he has kidney disease, the 58-year-old made sure to not only get fully vaccinated but he took a Pfizer booster shot to boot.

Just two months later, during the onslaught of the omicron variant this winter, he was shocked to be told that in spite of his vaccinations he caught COVID. What followed was a bad sickness and two rounds of hospitalization that totaled nearly a month. But at the end of it, came another surprise: He lived.

“I was sort of shocked that that disease that I caught didn’t overcome me with, the failed kidneys. You know what I’m saying?” Fain said.

Cleveland works with Fain’s doctor, both of whom have pleaded with their kidney patients to get vaccinated. Cleveland is all too familiar with kidney patients who get COVID and don’t make it. He’s heard all the excuses, and he’s ready to counter them.

“I’ve seen so much of that (kidney patients succumbing to COVID) that I do not hesitate to try to explain to my patients that I’ve just seen this too many times to to be comfortable with them saying that they are afraid,” Cleveland said.

The percentage of Georgia residents who’ve been vaccinated is among the lowest in the country — the peach state currently ranks 45th. The state’s booster adoption rate is even worse, with less than half of all fully vaccinated people choosing to get one booster dose.

There’s also a large age disparity among those getting boosted. Nearly 60% of all Georgia seniors, people 65 and older, have gotten a booster dose, but there’s a stark drop-off for younger populations. Only about 15% of 25- to 34-year-old Georgians are boosted.

The low booster adoption rate for younger people, who are less likely to be at a high risk of life-threatening infections, is an explanation for why boosted groups seem to be hospitalized at higher rates, health experts said.https://datawrapper.dwcdn.net/KYHdI/1/

“All such people need to have vaccination and booster coverage but our (Centers for Disease Control and Prevention) has failed to convey their life-saving impact from the get go…” Topol wrote in his column. “That’s why we have 31% of Americans who had had 1 booster shot whereas most peer countries are double that proportion.”

For Fain, he’s surprised he was able to pull through his severe bout with COVID and get back on his feet, but his friends and loved ones haven’t let him forget how close he was to death.

“Everybody’s going to talk to me now, they say, ‘Boy when you started, we thought you was going to get gone. You sounded so bad,’” Fain said. “Yeah, but everything is okay now. I’m strong.”

Growing share of Covid-19 deaths are among vaccinated people, but booster shots substantially lower the risk

Authors: Deidre McPhillips, CNN Updated 7:58 AM ET, Wed May 11, 2022 CNN Health

Since Covid-19 vaccines became widely available, there has been a wide gap in deaths between the vaccinated and unvaccinated. But recent Covid deaths are much more evenly split as highly transmissible variants take hold, vaccine protection wanes and booster uptake stagnates. Breakthrough infections have become more common in recent months, putting vulnerable populations at increased risk of severe disease or death as more and more transmissible variants continue to spread. This seems to be especially true for seniors in the United States, who were among the first to get their initial vaccine series. In the second half of September — the height of the Delta wave — less than a quarter of all Covid-19 deaths were among vaccinated people, federal data shows. But in January and February, amid the Omicron surge, more than 40% of Covid-19 deaths were among vaccinated people.

Covid-19 vaccines have saved millions of lives in the United States since the first shot was administered in December 2020, and the unvaccinated are still far more likely to be hospitalized or die than people who are vaccinated with at least two doses of the Moderna or Pfizer/BioNTech mRNA vaccines or a single dose of the Johnson & Johnson vaccine.

But evidence continues to build around the critical importance of booster shots.

Why Covid-19 vaccine boosters may be more important than ever Of those vaccinated people who died from a breakthrough case of Covid-19 in January and February, less than a third had gotten a booster shot, according to a CNN analysis of data from the US Centers for Disease Control and Prevention. The remaining two-thirds had only received their primary series. Overall, the risk of dying from Covid-19 is still about five times higher for unvaccinated people than it is for those vaccinated with at least their primary series, CDC data shows.

But there’s a significant disparity by level of vaccination, too: When adjusted for age, people vaccinated with only their initial series faced about three times greater risk of dying than those who also have their booster shot.The CDC encourages people to be “up-to-date” on Covid-19 vaccinations — which includes getting boosters at the appropriate time — but still defines a person to be “fully vaccinated” if they’ve received at least their initial vaccination series.But this week, a senior Biden administration official was more direct: All adults need a third shot.Vaccination is the best way for individuals to protect themselves against Covid-19, and protection is most effective with at least three shots, the official said.Others have emphasized the importance of boosters to save lives, too.”Almost no one in this country should be dying from Covid” with up-to-date vaccinations and appropriate antiviral treatments, Dr. Robert Califf, commissioner of the US Food and Drug Administration, said Saturday on CNN Newsroom.”What we really should be worried about is getting the boosters that we need to stay up to date so with the new variants that we have, we don’t have unnecessary deaths and hospitalizations.”

Boosters benefit high-risk seniors most

In the first year of the pandemic, before vaccines were available, the vast majority of Covid-19 deaths — more than 80% — were among seniors age 65 and older.

In 2021, especially during the Delta surge, the average age of people dying of Covid-19 shifted younger. Less than 60% of those who died in September were 65 or older, according to provisional data from the CDC.

Covid-19’s full death toll is nearly three times higher than reported, WHO data suggests But 2022 has looked a lot more like 2020 and the first winter surge; so far this year, about three-quarters of all Covid-19 deaths have been among seniors. Studies have suggested that Covid-19 vaccine effectiveness wanes over time. Data from the CDC published in January found that getting boosted was 90% effective at preventing hospitalizations during a period when Omicron was the dominant variant. In comparison, getting two shots was 57% effective when it had been at least six months past the second shot.The vast majority of seniors completed their initial series more than a year ago now. And while booster uptake among seniors is better than other age groups, less than two-thirds of seniors have gotten a booster shot.The CDC now recommends a second booster shot for this age group, too, and uptake is even lower.CNN’s analysis of CDC data from recent months suggests that disparities in risk among vaccinated people who are boosted compared with those who only have their initial series are most prominent among this vulnerable age group.

Covid-19 deaths are preventable

Daily Covid-19 deaths in the US have fallen to a fraction of what they were in January and February amid the Omicron surge, but hundreds are still dying each day.Cases are rising in nearly all states right now, and the White House has warned that another wave in the coming fall and winter could cause 100 million new cases — both raising the potential for more severe disease and tragic loss. But experts say we have the tools to ensure infections don’t turn tragic.

Getting more Americans boosted against Covid-19 could make a big difference as the country heads into the fall and winter, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Monday.”It’s really important that we try to get the half — or a little bit more than a half — of Americans who have only received two doses to get that third dose,” he said. “That may make a difference moving forward here, and it may particularly make a difference now that we’re coming into yet another wave of Covid-19.”