FDA says two studies showing omicron boosters weren’t much better than old Covid shots were too small to come to any conclusions

Authors: Spencer Kimball PUBLISHED FRI, OCT 28 2022 MSNBC

KEY POINTS

  • Scientists at Columbia and Harvard, in two independent studies, found the new boosters and the old shots basically performed the same against omicron BA.5.
  • Dr. Peter Marks, head of the FDA’s vaccine division, said the new studies are small and subject to limitations. Data from larger well-controlled studies are coming soon, he added.
  • The FDA encouraged people to get boosted ahead of “the wave of Covid-19 that appears to be coming,” Marks said.

The Food and Drug Administration said two studies this week showing that the new omicron boosters weren’t that much better than the old shots were too small to come to any real conclusions.

Scientists at Columbia and Harvard, in two independent studies, found the new boosters and the old shots basically performed the same against omicron BA.5, raising doubts about whether the vaccines will live up to high expectations set by the Biden administration. The antibody responses were slightly higher with the omicron boosters, though the studies concluded the difference wasn’t significant.

Dr. Peter Marks, head of the FDA’s vaccine division, said the studies are small and subject to limitations. Data from larger well-controlled studies are expected in the near future, he said. Pfizer and Moderna are conducting clinical trials on the new boosters and are expected to provide data later this year.

“It is important to note that even the data from these initial small studies indicate that the bivalent vaccines are generally at least as good or better as the original vaccines in generating an immune response, particularly to BA.4/BA.5 and other newer variants,” Marks said in a statement.

Even modest increases in immune response could have positive consequences for public health, he added.

“FDA continues to encourage eligible individuals to consider receiving an updated vaccine to help protect against the currently circulating Covid-19 variants and the wave of Covid-19 that appears to be coming,” Marks said.

Top U.S. health officials have said the new boosters should perform better because they are now matched to the dominant circulating strain, omicron BA.5, for the first time since the pandemic began as well as the original strain of Covid that emerged in China. These are called bivalent shots.

The old shots, called monovalent, were designed against the first strain of Covid. Their effectiveness has declined over time as the virus has mutated away from the original strain.

“It is reasonable to expect based on what we know about immunology and the science of this virus that these new vaccines will provide better protection against infection, better protection against transmission and ongoing and better protection against serious illness,” Dr. Ashish Jha, head of the White House Covid task force, told reporters in September.

The Columbia and Harvard studies clearly demonstrate that the boosters work, but it’s still an open question whether they’re going to do a much better job preventing disease, particularly infection and mild illness, than the old shots.

“The take-home lesson is the people who were in high risk groups and benefit from booster doses as we enter this late fall and early winter — those who are immunocompromised, who have high risk medical conditions, who are elderly — they should get this booster dose,” said Dr. Paul Offit, a member of the FDA’s independent vaccine advisory committee.

But Offit said public health officials should be cautious about overselling the shots as a major upgrade.

“We have to be careful when we get in front of the American public and try and sell this vaccine as something that’s significantly better when all the evidence we have so far doesn’t support that,” said Offit.

The Columbia study looked at 21 people who received the new booster while the Harvard study looked at 18 who got the new shot. Both studies are preprints, which means they haven’t undergone peer review by others in the field.

The Columbia study found that antibody levels were about 1.2 times higher with a bivalent booster compared with a fourth dose of the monovalent shots, while the Harvard study found they were 1.3 times higher. Though the antibody levels were slightly higher with the bivalent booster, the studies both concluded the difference was not significant.

Dr. Dan Barouch, the lead author of the Harvard study, acknowledged that the preprints are small but emphasized that they were conducted independently and basically came to the same conclusion, which is noteworthy.

“It’s important to note that the two studies were done independently. They’re small studies but there are two of them — it’s not just a fluke,” said Barouch, whose lab played a pivotal role in the development of the Johnson & Johnson Covid vaccine.

Dr. Peter Hotez, co-director of vaccine development at Texas Children’s Hospital, said the studies were conducted by two of the best virology labs in the country and the methodology was sound. Still, the findings should be viewed as preliminary until more data comes in, Hotez cautioned.

“We have to be careful not to draw too many conclusions from it,” said Hotez, who also co-led a team that developed a patent-free vaccine called Corbevax that India authorized for use last December.

The studies are of public interest because there’s very limited human data on how the omicron BA.5 boosters perform right now. The FDA authorized the shots in September based on clinical trial from a similar shot developed against the first version of omicron, BA.1.

Pfizer and Moderna were originally developing their new boosters against BA.1, but the FDA asked the companies to switch gears over the summer and target BA.5 instead because that subvariant had become dominant. As a consequence, there wasn’t enough time for Pfizer and Moderna to run clinical trials and present direct human data on the shots before authorization.

The FDA also looked at data directly on the BA.5 shots that came from animal studies. The agency was acting urgently to get the shots out by the fall in the hope they’d do a better job heading off a Covid wave.

But new subvariants are also now gaining ground in the U.S., particularly BQ.1 and BQ.1.1, which now represent about 27% of new infections. It’s unclear how the boosters will perform against these subvariants. Health officials expect the shots to continue to provide protection because the subvariants are descended from BA.5.

Omicron-specific boosters fail to show benefit over original shots, study finds

by Abigail Adcox, Healthcare Reporter October 25, 2022 Washington Examiner

who had received three shots with the original formula and a fourth shot of Moderna’s or Pfizer-BioNTech’s omicron booster compared to 19 people who had received four shots targeting the original strain.

The study suggests that the omicron booster may not protect people from getting infected with the highly transmissible subvariant BA.5, which accounts for most COVID-19 cases in the U.S. currently, any more than the previous shots, despite the updated boosters being formulated to provide better protection against infection and severe disease against the current strains.

“When given as a fourth dose, a bivalent mRNA vaccine targeting Omicron BA.4/BA.5 and an ancestral SARS-CoV-2 strain did not induce superior neutralizing antibody responses in humans, at the time period tested, compared to the original monovalent vaccine formulation,” the researchers wrote.

The updated boosters have a new vaccine formula that targets both the original strain of the virus from 2020 and the omicron subvariants BA.4 and BA.5.

While researchers noted that further follow-up studies were needed, the results are some of the first tracking how the omicron booster stands against previous ones. It also starkly differs from early data released by vaccine manufacturers Pfizer-BioNTech and Moderna earlier this month from clinical trials. Pfizer-BioNTech said that their omicron booster showed a “substantial increase” in antibody levels compared to pre-booster levels.

Moderna also said early data from clinical trials indicated that the omicron booster had a “superior immune response.”

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.