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.”

Vaccines Never Prevented the Transmission of COVID

Allowing zealots to censor news in the name of ‘science’ is a danger to public health

Authrs: ALEX GUTENTAG CTOBER 18, 2022 Tablet Science

In late 2021 and early 2022, it was commonplace for journalists and public intellectuals to demonize and shame “the unvaccinated,” a group that in the United States was disproportionately low incomeThe New York Times ran pieces like “I’m Furious at the Unvaccinated,” and “Unvaxxed, Unmasked and Putting Our Kids at Risk.” The Los Angeles Times published a column titled “Mocking anti-vaxxers’ COVID deaths is ghoulish, yes—but may be necessary.” An opinion piece called “The Unvaccinated Are a Risk to All of Us” appeared in Bloomberg, and The Washington Post printed a piece called “Macron is right: It’s time to make life a living hell for anti-vaxxers.”

CNN’s Don Lemon commented that people refusing the vaccines were being “idiotic and nonsensical.” He argued that it was time to “start shaming them” or “leave them behind.” Noam Chomsky, a self-described libertarian socialist, said unvaccinated people should remove themselves from society and be “isolated.” Asked how they would get food that way, he answered, “Well actually, that’s their problem.”

In Canada, columnists for the Toronto Star proclaimed, “Vaccine resisters are lazy and irresponsiblewe need vaccine passports now to protect the rest of us” and “The unvaccinated cherish their freedom to harm others. How can we ever forgive them?” In the U.K., the Daily Mail contended, “It’s time to punish Britain’s 5 million vaccine refuseniks,” and Piers Morgan, a British presenter on TalkTV, suggested that unvaccinated people should not be allowed access to the country’s National Health Service.

Internationally, several politicians threatened to reimplement restrictions and told the public that “the unvaccinated” were at fault. Canadian Prime Minister Justin Trudeau said unvaccinated people “are very often misogynistic and racist,” and asked, “Do we tolerate these people?” President Joe Biden said that his “patience [was] wearing thin” and that we needed to “protect vaccinated workers from unvaccinated coworkers.” Michael Gunner, chief minister of the Northern Territory in Australia, stated that even if you are vaccinated, “if you are anti-mandate, you are absolutely anti-vax.” French President Emmanuel Macron declared that 5 million French people who remained unvaccinated were “not citizens.”

Across parts of the United States, Canada, Australia, and Europe, unvaccinated people were fired from their jobs, excluded from higher education, banned from many sectors of public life, denied organ transplants, and even punished by judges in probation hearings and child custody cases. Meanwhile, COVID cases continued to rise in many highly vaccinated countries with vaccine passports and other restrictions in place.

Vaccine mandates were mainly rationalized through the belief that the higher the rate of vaccination, the less the virus would spread. For example, during oral arguments for Biden’s health care worker mandate, Associate Justice of the Supreme Court Elena Kagan claimed that health care workers had to get vaccinated “so that you’re not transmitting the disease.” But recently, on Oct. 10, 2022, a Pfizer spokesperson told the European Parliament that the vaccines had never actually been tested for preventing transmission. While this was presented on social media as “breaking news,” the fact that the vaccines were not tested for this purpose has been documented extensively ever since Pfizer and Moderna received their original Emergency Use Authorization (EUA).

During the Dec. 10, 2020, Food and Drug Administration (FDA) meeting when the first mRNA vaccines were authorized, FDA adviser Dr. Patrick Moore stated, “Pfizer has presented no evidence in its data today that the vaccine has any effect on virus carriage or shedding, which is the fundamental basis for herd immunity.” Despite the data presented for individual efficacy, he continued, “we really, as of right now, do not have any evidence that it will have an impact, social-wide, on the epidemic.” The FDA EUA press release from December 2020 also confirms that there was no “evidence that the vaccine prevents transmission of SARS-COV-2 from person to person.”

Simply put, the reason many people believed the vaccines stopped transmission was because government officials and media outlets across the Western world were either careless with their words or did not tell the truth. In 2021, for instance, Director of the Centers for Disease Control (CDC) Rochelle Walensky claimed that vaccinated people “do not carry the virus,” and Dr. Anthony Fauci said they would become “dead ends” for the virus. Any speculation that the vaccines significantly reduced transmission was based on limited results from independent studies and the false assumption that the vaccine would prevent infection. Without adequate evidence, vaccination campaigns called on people to get vaccinated not just for their own protection, but to help “protect others” and “save lives.”

Meanwhile, social media companies coordinated with the Biden administration to censor dissent. Many people who asked questions about efficacy or safety risked banishment from Twitter, Facebook, or YouTube. Now, however, as more and more studies come out, it is increasingly clear that some of the information these companies censored was true.

For anyone content with their vaccination status, this might not be a big deal. Yes, the vaccine information that was provided in 2021 wasn’t entirely accurate, but you might still feel that getting vaccinated was the right decision. However, being misinformed about potential benefits and risks is an enormous deal for, say, a male college athlete who got vaccinated because he wanted to protect his elderly family members, but who then developed myocarditis. Telling him that this is fine because “there was so much unknown” is probably not much of a consolation, especially since his decision to get vaccinated was never going to protect his family members in the first place, and the vaccine manufacturers were given blanket immunity from liability.

It is one thing for the pharmaceutical companies, the Biden administration, the CDC, and the media to intentionally or unintentionally mislead the public; but it is another thing entirely for them to do this while government agencies actively coordinated to suppress alternative views or inconvenient data. While executives and bureaucrats may excuse their errors by claiming that “the science changed,” the public has every right to demand better. Science is the process of discovery through observation and experimentation; of course it changes. That’s why “settled science” is obviously a political, not a scientific term, and why anyone should be able to publicly question scientific consensus at any time. Instead of allowing for debate, political and bureaucratic officials conducted a campaign of mass censorship and coercion. This effectively undermined the principle of informed consent and has resulted in a scandal affecting millions of people.

It was not until August 2022 that the CDC issued guidance that called for vaccinated and unvaccinated people to no longer be subjected to different testing or quarantine protocols. To justify this change in guidance, the CDC cited the protection provided by previous infection as well as breakthrough infections. Yet studies had already shown by the fall of 2021 that the vaccines did not prevent infection, that natural immunity was at least as protective, that vaccinated people had similar viral loads to unvaccinated people, and that vaccinated people had a role in transmission.

All this was true before the arrival of the omicron variant, and all of this was true before the majority of U.S. vaccine mandates were issued. Nevertheless, YouTube, Twitter, and Facebook all had policies that made questioning the CDC, the WHO, and government authorities potential grounds for censorship, prohibiting discussion of alternative treatments or suggestions that vaccination has varying levels of benefits for different people. Documents from the Missouri v. Biden case have revealed that the CDC proposed a monthly “debunking” meeting with Facebook and that Facebook and Twitter sought input from the CDC in deciding what to censor. For the Biden administration, it was a foregone conclusion that everyone should get vaccinated, so the goal of censorship was simply to increase vaccine uptake.

This was an anti-science stance that stripped people of their right to make informed choices or to even access verified data. On Facebook, for instance, a thorough investigation by the British Medical Journal into data integrity problems with the Pfizer trial was flagged as “missing context,” and Facebook directed readers to an inaccurate “fact check” of the investigation. On Twitter, as a result of censorship policies, accounts have been suspended temporarily or permanently for displaying Pfizer’s own trial data and sharing information from peer-reviewed papers. Why? Because the official vaccine message was so rigid that basic reality was considered “misleading.”

By now, many studies have shown that some of the once-censored concerns of “vaccine hesitant” people actually had validity. Facebook explicitly prohibited the claim that breast milk from vaccinated women could be harmful, but now a recent study has found that mRNA was present in breast milk, and the study urged caution when breastfeeding shortly after vaccination. The CDC previously told breastfeeding mothers that getting vaccinated was likely to benefit their babies, and many pregnant women were mandated to get vaccinated even though this population had been excluded from the vaccine trials.

A claim on Facebook or Twitter like “children who have had COVID should not get vaccinated” could also be subject to censorship, but new data suggests that young children who were previously infected might not see long-term benefits from vaccination. A study in the New England Journal of Medicine now shows that children ages 5-11 who had a prior infection but were not vaccinated had a lower risk of being reinfected than children who had a prior infection and did get vaccinated. After five months, protection against reinfection for the vaccinated children was negative.

Concealing important data and censoring the debate helped create an illusion of consensus and, as people were removed from social media platforms, erased the record of disagreement and skepticism. Open discussion of conditions like myocarditis and pericarditis or cardiac deaths was also penalized despite 2021 data from Israel that confirmed elevated rates of myocarditis linked to vaccination. A later Israeli study from May 2022 found that cardiac arrest among people under 40 increased by 25% during the vaccine rollout. In the United States, the CDC was supposed to make its “v-safe” safety data public by Sept. 30. The CDC failed to do so but was forced to reveal this data through a Freedom of Information Act lawsuit. Of 10 million people in the “v-safe” program, 25% had a vaccine side effect that caused them to miss school or work and 7.7% had to seek medical care. Should Americans only be hearing about this kind of safety data now, or should it have been available before vaccine mandates were put in place?

Censorship of medical dissent is now being expanded in California, where Gov. Gavin Newsom has signed Assembly Bill 2098 into law, officially granting the California Medical Board the authority to penalize and suspend the licenses of doctors who intentionally spread “misinformation or disinformation” about COVID risks and prevention, as well as the safety and efficacy of COVID vaccines. In the U.K. and Sweden, by contrast, COVID vaccines are no longer offered to healthy children under 12, and in Denmark boosters are not available for anyone under 50. Clearly there is no international consensus on COVID vaccines for young people. Should California doctors really lose their medical licenses if they favor guidance from Sweden and Denmark over guidance from the CDC?

Apart from being a potential first amendment violation and intrusion on the doctor-patient relationship, this new misinformation bill raises the question of whether, after everything we have just witnessed, a single medical authority should really be presumed to be all-knowing or infallible. Time and again, the “medical consensus” has proved to be incorrect. In the 19th century, doctors believed it was safe to deliver babies without washing their hands, resulting in the deaths of countless women from puerperal fever. In the 20th century, compulsory sterilization of disabled people was considered to be a legitimate and ethical medical practice, and in 1949, the developer of the lobotomy won the Nobel Prize for medicine. As recently as this year, scientists discovered that the entire basis for over a decade of Alzheimer’s research was fraudulent.

In the case of COVID, while claiming that it was the dissenters who caused harm, it was in fact the censors and enforcers of speech restrictions who caused immense damage to the social fabric and to the lives of individuals. The excuse that medical segregation was once necessary but is no longer necessary because “the facts changed” or “the science changed” is demonstrably false. The facts didn’t change. They were just banned

Medical experts question Paxlovid study on symptoms in people under 65

Authors: Bart Jones August 27, 2022 Newsday

Some medical experts on Long Island are disputing a new study that said Paxlovid did not help relieve COVID-19 symptoms in people under 65.

Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults, while still reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday.

The results from the 109,000-patient Israeli study are likely to renew questions about the U.S. government’s use of Paxlovid, which has become the go-to treatment for COVID-19 due to its at-home convenience.

But two leading infectious disease specialists on Long Island said they had seen the opposite — Paxlovid did help people in various age groups.

“I don’t think that’s really correct,” Dr. Sharon Nachman, chief of the division of pediatric diseases at Stony Brook Children’s Hospital, said of the study. “I do think that those that were under 65 and have taken Paxlovid have actually done quite well with it.”

“We haven’t seen that much relapse of COVID in that population and we’ve certainly not seen those who took Paxlovid coming to the hospital with COVID and being sick,” she said. “The vast majority infected it did help.”

“Sometimes when you do a study you have to be careful how you ask the question and who you ask it of, because that may skew what you are able to interpret from the results,” she added.

Dr. Bruce Hirsch, an infectious disease specialist at Northwell Health, said he agreed that Paxlovid had helped many patients of different age groups.

“Paxlovid really improves clinical well-being within two or three days of taking the medicine,” he said.

“The younger people are doing OK anyway” for the most part when they get infected with the Omicron variant, he added, “but I have seen people who are younger feel better faster with Paxlovid.”

The Biden administration has spent more than $10 billion purchasing the drug and making it available at thousands of pharmacies through its test-and-treat initiative.

The researchers found that Paxlovid reduced hospitalizations among people 65 and older by roughly 75% when given shortly after infection. That’s consistent with earlier results used to authorize the drug in the United States and other nations.

But people between the ages of 40 and 65 saw no measurable benefit, according to the analysis of medical records.

The findings reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus due to vaccination or prior infection. For younger adults, in particular, that greatly reduces their risks of severe COVID-19 complications. The Centers for Disease Control and Prevention recently estimated that 95% of Americans 16 and older have acquired some level of immunity against the virus.

“Paxlovid will remain important for people at the highest risk of severe COVID-19, such as seniors and those with compromised immune systems,” said Dr. David Boulware, a University of Minnesota researcher and physician, who was not involved in the study. “But for the vast majority of Americans who are now eligible, this really doesn’t have a lot of benefit.”

A spokesman for Pfizer declined to comment on the results, which were published in the New England Journal of Medicine.

The U.S. Food and Drug Administration authorized Paxlovid late last year for adults and children 12 and older who are considered high risk due to conditions like obesity, diabetes and heart disease.

“Game-changer” Paxlovid turns into pandemic enigma

Authors: Arielle Dreher Axios September 2, 2022

Paxlovid, once hailed as a “game-changer” for its ability to treat COVID-19 infections at home, is becoming one of the pandemic’s biggest enigmas.

The intrigue: There’s growing concern about the link between Pfizer’s antiviral pill and COVID rebound, in which patients test positive or have symptoms days after a course of the drug is completed. President Biden, First Lady Jill Biden and NIAID Director Anthony Fauci have each relapsed.

  • The FDA has asked Pfizer to investigate whether a second five-day course of the drug will prevent the virus from returning.
  • Pfizer executives in May suggested patients who can’t clear the virus with the first course should take more, Bloomberg reported.

The big picture: Paxlovid use surged over the summer, with as many as one-third of reported coronavirus cases treated with the drug.

  • But uncertainty over what’s causing the relapses, and whether the drug helps younger patients, is making some people wary of taking the treatment, physicians say.
  • At least part of the problem is that people are not routinely tested after taking Paxlovid, which makes it hard to establish how often rebound happens or why the virus lingers in some people, Leana Wen, an emergency physician and a professor at George Washington University, told CNN.
  • A large study of more than 109,000 people in the New England Journal of Medicine concluded the drug significantly reduced hospitalizations and deaths among patients aged 65 and older but that there was no evidence of benefit in younger adults.
  • The prospect of reinfection shouldn’t discourage older or high-risk patients from taking the pills, said Yale infectious diseases specialist Scott Roberts.
  • “Rebound is almost always more mild than initial course,” Roberts told Axios.
  • Paxlovid could have the added benefit of warding off long COVID, or symptoms that linger beyond the first 30 days after testing positive, and studies to determine this are underway.

But availability of the drug could change before clear answers emerge.

  • The Biden administration has only bought enough pills to supply Paxlovid through the middle of next year, after which it will transition to the commercial market, HHS Assistant Secretary for Preparedness and Response Dawn O’Connell wrote in a blog post on Tuesday.

Between the lines: COVID rebound has also been observed in people who have not taken Paxlovid, and some experts believe it might be a natural course of the infection to see symptoms ebb, then return.

  • COVID’s course “is not a purely linear process; it waxes and wanes a little bit,” said Jonathan Li, a Harvard Medical School researcher and co-author of a pre-print that found high levels of rebound in people who hadn’t been treated with the drug.

State of play: The CDC recommends Paxlovid for those over the age of 50, and for those with medical conditions like lung or heart disease that makes them high-risk, although the drug’s emergency authorization covers anyone 12 years old and up.

  • Research in Clinical Infectious Diseases found the drug remains effective for vaccinated people who contract COVID-19, reducing emergency room visits by lowering the risk of complications like lower respiratory tract infection and cardiac arrhythmia.
  • Beyond the Pfizer study requested by the FDA, a clinical trial of immunocompromised people is evaluating if Paxlovid should be used for five, 10 or 15 days.

What they’re saying: “The consensus by the vast majority of people caring for COVID patients is that the rebound is not really a side effect of Paxlovid, it is more that are we really treating people for long enough or not?” Sarju Ganatra, a cardiologist at Lahey Hospital and co-author of the Clinical Infectious Diseases study, told Axios.

Yes, but: “This is where having a well-designed, well-controlled study helps us understand disease better, and this is the challenge of anecdotal reports. Without a control, it’s really hard to know what’s actually happening,” said Kara Chew, an infectious disease physician at University of California Los Angeles.

The bottom line: Paxlovid remains an important tool to keep some people out of the hospitals, especially with the highly contagious Omicron variant still circulating and many people not staying current on boosters, experts said.

  • Isolation will also be critical as long as enough people are experiencing COVID rebound and stay infectious beyond the five-day isolation period recommended by the CDC.

Vaccination increases Covid risk according to study published in New England Journal of Medicine

Authors: Wire servicesJune 21, 2022

Individuals who received two doses of a COVID-19 vaccine have been linked with negative protection against the disease, scientists say in a study analyzing the Omicron wave in Qatar. The research also finds a previous infection without vaccination offers near 50 percent immunity,

Published in the New England Journal of Medicine on June 15, the research examined the Omicron wave in Qatar that occurred from December 2021 to February 2022, comparing vaccination rates and immunity among more than 100,000 Omicron infected and non-infected individuals.

The authors of the study found that those who had a prior infection but no vaccination had a 46.1 and 50 percent immunity against the two subvariants of the Omicron variant, even at an interval of more than 300 days since the previous infection.

However, individuals who received two doses of the Pfizer and Moderna vaccine but had no previous infection, were found with negative immunity against both BA.1 and BA.2 Omicron subvariants, indicating an increased risk of contracting COVID-19 than an average person.

Over six months after getting two doses of the Pfizer vaccine, immunity against any Omicron infection dropped to -3.4 percent.

But for two doses of the Moderna vaccine, immunity against any Omicron infection dropped to -10.3 percent after more than six months since the last injection.

Though the authors reported that three doses of the Pfizer vaccine increased immunity to over 50 percent, this was measured just over 40 days after the third vaccination, which is a very short interval. In comparison, natural immunity persisted at around 50 percent when measured over 300 days after the previous infection, while immunity levels fell to negative figures 270 days after the second dose of vaccine.

These figures indicate a risk of waning immunity for the third vaccine dose as time progresses.

The findings are supported by another recent study from Israel that also found natural immunity waned significantly more slowly compared to artificial, or vaccinated, immunity.

The vaccination study found that both natural and artificial immunity waned over time.

Individuals that were previously infected but not vaccinated had half the risks of reinfection as compared to those that were vaccinated with two doses but not infected.

“Natural immunity wins again,” Dr. Martin Adel Makary, a public policy researcher at Johns Hopkins University, wrote on Twitter, referring to the Israeli study.

“Among persons who had been previously infected with SARS-CoV-2, protection against reinfection decreased as the time increased,” the authors concluded, “however, this protection was higher” than protection conferred in the same time interval through two doses of the vaccine.

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.

Pfizer Stops Enrollment in COVID-19 Pill Trial After Latest Results

Authors: Mimi Nguyen Ly June 16, 2022 The Epoch Times

Paxlovid, a Pfizer COVID-19 pill, is seen manufactured in Ascoli, Italy, in this undated photo obtained by Reuters on Nov. 16, 2021. (Pfizer/Handout via Reuters)

Pfizer has announced it will stop enrollment in a clinical trial for Paxlovid—its COVID-19 antiviral pill—for standard-risk COVID-19 patients after the latest results suggested the drug did not reduce symptoms or hospitalizations and deaths to a statistically significant degree.

Paxlovid, which consists of two different antiviral drugs—nirmatrelvir and ritonavir—is currently approved or authorized for conditional or emergency use in more than 65 countries, including the United States, to treat COVID-19 patients at high risk of severe illness, including hospitalization or death.

Pfizer said on June 14 that it will “cease enrollment into the EPIC-SR trial due to low rate of hospitalization or death in the standard-risk population.”

However, the company said it will still include the new data in its upcoming application to the U.S. Food and Drug Administration (FDA) to seek full approval for Paxlovid to be prescribed for high-risk COVID-19 patients.

“The company will focus efforts on generating further data on PAXLOVID in vulnerable populations, including longer treatment durations in immunocompromised individuals, as well as exploring other clinical development opportunities, such as its potential use in hospitalized patients with severe disease,” Pfizer added.

Standard-risk patients refers to COVID-19 patients who don’t have risk factors for severe disease. They can be vaccinated or unvaccinated.

Results From Trial

The EPIC-SR trial, which started in August 2021, sought to compare Paxlovid to a placebo in adult patients with symptomatic COVID-19, who are not in hospital and “are at low risk of progressing to severe illness.”

In December 2021, Pfizer announced that results for Paxlovid did not meet the study’s goal of continuous symptom relief, or “self-reported, sustained alleviation of all symptoms for four consecutive days, as compared to placebo.”

At the time, Pfizer noted that there was a 70 percent reduction in hospitalizations in the Paxlovid group (three out of 428 hospitalized, with no deaths) compared to placebo (10 out of 426 hospitalized, with no deaths). The results were not statistically significant, however, which means it could possibly be down to chance.

On June 14, Pfizer announced that an updated analysis from 1,153 patients enrolled through December 2021 showed a 51 percent difference in hospitalization or death between the two groups—with five out of 576 in the Paxlovid group, compared to 10 out of 569 in the placebo group having required hospitalization or dying. The results were again not statistically significant.

There were no deaths in patients who received Paxlovid, but there was one death in the placebo group, the company stated.

The EPIC-SR study originally included fully-vaccinated people with at least one risk factor for progression to severe COVID-19, but after Paxlovid was authorized for the group in December 2021, this cohort was no longer enrolled in the study. Pfizer then adjusted its study eligibility criteria to allow people whose last vaccination was 12 months or more prior to enrollment.

A sub-group analysis of 721 vaccinated people with at least one risk factor for progression to severe COVID-19 showed there was a 57 percent risk reduction for hospitalization or death—with three out of 361 in the Paxlovid group, and seven out of 360 in the placebo group needing to be hospitalized or dying. The results did not reach statistical significance, Pfizer said.

Paxlovid also showed a non-significant 62 percent decrease in medical visits related to COVID-19 per day across all patients, relative to placebo.

Albert Bourla, the CEO and chairman of Pfizer, said in a statement that results from the company’s studies so far “support the efficacy and safety profile for PAXLOVID in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status.”

“With up to 40–50 [percent] of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of PAXLOVID,” he added.

Data from a retrospective cohort study in Israel in early June, in a largely-vaccinated population, reported that Paxlovid reduces COVID-19 hospitalization and deaths by 46 percent. The study said the drug was “more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease.”

Paxlovid, a Pfizer COVID-19 pill, is seen manufactured in Ascoli, Italy, in this undated photo obtained by Reuters on Nov. 16, 2021. (Pfizer/Handout via Reuters)

WORLD

Pfizer Stops Enrollment in COVID-19 Pill Trial After Latest Results

By Mimi Nguyen Ly June 16, 2022 Updated: June 16, 2022

Pfizer has announced it will stop enrollment in a clinical trial for Paxlovid—its COVID-19 antiviral pill—for standard-risk COVID-19 patients after the latest results suggested the drug did not reduce symptoms or hospitalizations and deaths to a statistically significant degree.

Paxlovid, which consists of two different antiviral drugs—nirmatrelvir and ritonavir—is currently approved or authorized for conditional or emergency use in more than 65 countries, including the United States, to treat COVID-19 patients at high risk of severe illness, including hospitalization or death.

Pfizer said on June 14 that it will “cease enrollment into the EPIC-SR trial due to low rate of hospitalization or death in the standard-risk population.”

However, the company said it will still include the new data in its upcoming application to the U.S. Food and Drug Administration (FDA) to seek full approval for Paxlovid to be prescribed for high-risk COVID-19 patients.

“The company will focus efforts on generating further data on PAXLOVID in vulnerable populations, including longer treatment durations in immunocompromised individuals, as well as exploring other clinical development opportunities, such as its potential use in hospitalized patients with severe disease,” Pfizer added.

Standard-risk patients refers to COVID-19 patients who don’t have risk factors for severe disease. They can be vaccinated or unvaccinated.

Results From Trial

The EPIC-SR trial, which started in August 2021, sought to compare Paxlovid to a placebo in adult patients with symptomatic COVID-19, who are not in hospital and “are at low risk of progressing to severe illness.”

In December 2021, Pfizer announced that results for Paxlovid did not meet the study’s goal of continuous symptom relief, or “self-reported, sustained alleviation of all symptoms for four consecutive days, as compared to placebo.”

At the time, Pfizer noted that there was a 70 percent reduction in hospitalizations in the Paxlovid group (three out of 428 hospitalized, with no deaths) compared to placebo (10 out of 426 hospitalized, with no deaths). The results were not statistically significant, however, which means it could possibly be down to chance.

On June 14, Pfizer announced that an updated analysis from 1,153 patients enrolled through December 2021 showed a 51 percent difference in hospitalization or death between the two groups—with five out of 576 in the Paxlovid group, compared to 10 out of 569 in the placebo group having required hospitalization or dying. The results were again not statistically significant.

There were no deaths in patients who received Paxlovid, but there was one death in the placebo group, the company stated.

The EPIC-SR study originally included fully-vaccinated people with at least one risk factor for progression to severe COVID-19, but after Paxlovid was authorized for the group in December 2021, this cohort was no longer enrolled in the study. Pfizer then adjusted its study eligibility criteria to allow people whose last vaccination was 12 months or more prior to enrollment.

A sub-group analysis of 721 vaccinated people with at least one risk factor for progression to severe COVID-19 showed there was a 57 percent risk reduction for hospitalization or death—with three out of 361 in the Paxlovid group, and seven out of 360 in the placebo group needing to be hospitalized or dying. The results did not reach statistical significance, Pfizer said.

Paxlovid also showed a non-significant 62 percent decrease in medical visits related to COVID-19 per day across all patients, relative to placebo.

Albert Bourla, the CEO and chairman of Pfizer, said in a statement that results from the company’s studies so far “support the efficacy and safety profile for PAXLOVID in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status.”

“With up to 40–50 [percent] of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of PAXLOVID,” he added.

Data from a retrospective cohort study in Israel in early June, in a largely-vaccinated population, reported that Paxlovid reduces COVID-19 hospitalization and deaths by 46 percent. The study said the drug was “more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease.”

In a separate instance where Paxlovid failed to produce a statistically significant result, Pfizer announced in April that the antiviral pill was not effective at preventing symptomatic COVID-19 infection in household contacts of the COVID-19 patient who took the pill.

The United States has spent more than $10 billion to order from Pfizer 20 million courses of Paxlovid, and the White House has been seeking for more funds from Congress to support purchasing more of the antiviral pill as well as other treatments and vaccine booster doses.

The Centers for Disease Control and Prevention (CDC), warned in late May that some people may experience a rebound in COVID-19 symptoms after taking Paxlovid—meaning they may experience symptoms again after having had their symptoms resolved, or test positive for COVID-19 after having tested negative. The CDC said at the time that the rebound may be unrelated to the pill and “may be part of the natural history of SARS-CoV-2” in some people, “independent of treatment with Paxlovid and regardless of vaccination status.”

Mask mandate and use efficacy in state-level COVID-19 containment

Authors: Damian D. Guerra, Daniel J. Guerra doi: https://doi.org/10.1101/2021.05.18.21257385

Abstract

Background Containment of the COVID-19 pandemic requires evidence-based strategies to reduce transmission. Because COVID-19 can spread via respired droplets, many states have mandated mask use in public settings. Randomized control trials have not clearly demonstrated mask efficacy against respiratory viruses, and observational studies conflict on whether mask use predicts lower infection rates. We hypothesized that statewide mask mandates and mask use are associated with lower COVID-19 case growth rates in the United States.

Methods We calculated total COVID-19 case growth and mask use for the continental United States with data from the Centers for Disease Control and Prevention and Institute for Health Metrics and Evaluation. We estimated post-mask mandate case growth in non-mandate states using median issuance dates of neighboring states with mandates.

Results Case growth was not significantly different between mandate and non-mandate states at low or high transmission rates, and surges were equivocal. Mask use predicted lower case growth at low, but not high transmission rates. Growth rates were comparable between states in the first and last mask use quintiles adjusted for normalized total cases early in the pandemic and unadjusted after peak Fall-Winter infections. Mask use did not predict Summer 2020 case growth for non-Northeast states or Fall-Winter 2020 growth for all continental states.

Conclusions Mask mandates and use are not associated with slower state-level COVID-19 spread during COVID-19 growth surges. Containment requires future research and implementation of existing efficacious strategies.

Peer-Reviewed Studies Confirm Vaccine/Mask Mandates Did Not Stop COVID Spread In Schools & Universities

Authors: Enrico Trigoso The Epoch Times  June 3, 2022

During the Covid-19 pandemic, school and university administrators have dogmatically, and in many cases forcefully implemented mask and vaccine mandates with the intention to prevent the spread of SARS-CoV2, however, these policies haven’t had much effect, according to recent peer-reviewed studies.

research paper published on May 18 underscores the deficiencies of current mask and vaccination mandates, as these policies did not contain the spread of SARS-CoV2 at Cornell University.

Despite the university having required masks on campus, isolation, and contact tracing within hours of any positive result, the paper recognizes that: “Cornell’s experience shows that traditional public health interventions were not a match for Omicron. While vaccination protected against severe illness, it was not sufficient to prevent rapid spread, even when combined with other public health measures including widespread surveillance testing.”

Another study found that secondary transmissions were “markedly lower in school compared with household settings, suggesting that household transmission is more important than school transmission in this pandemic.”

Toward the end of the semester in 2021, the almost completely vaccinated Cornell University shut down its campus due to a surge in COVID cases.

Mask mandates have failed to control the spread of infection in schools, as this analysis of schools with and without mask mandates demonstrates. Prior studies have demonstrated that COVID vaccines do not prevent the spread of transmission,” Dr. Sanjay Verma told The Epoch Times, referring to the May 18 study.

Dr. Verma, a cardiologist practicing in California who has seen a spike in heart problems since mass vaccine implementation, thinks that the mask and vaccine mandates were not the best way to handle COVID.

“There was little, if any, emphasis on other more effective mitigation efforts: Ventilation-filtration, exercise, weight loss, and personal responsibility would be far more effective.”

“So these school and university mandates beg the question: what are they hoping to achieve?” he asked rhetorically.

Former Pfizer VP Michael Yeadon, a toxicologist and allergy/respiratory research expert, maintains that since the infection fatality ratio (IFR) of COVID-19 has not been high, the vaccines should not have been mandated, and that the masks were known to be useless in stopping respiratory viruses from previous scientific literature.

It was known long before COVID-19 that face masks don’t do anything,” Yeadon said in a statement he sent to The Epoch Times.

“Many don’t know that blue medical masks aren’t filters. Your inspired and expired air moves in and out between the mask & your face. They are splashguards, that’s all.”

“This is a good review of the findings with masks in respiratory viruses by a recognized expert in the field. No effect,” Yeadon added. “Neither masks nor lockdowns prevented the spread of the virus. [Here is] a review and summary of 400 papers.”

“We know from recent research that COVID vaccines increase the risk of myocarditis, especially in males 16–29 years old,” Dr. Verma further noted.

“The putative and unproven benefits of such school and university policies need to be balanced with the very real risks (no matter how rare they may seem). Also, we must not forget that CDC data reveals zero excess deaths in 0–24 [year olds] in 2020 and 2021 compared to prior years. The overall hospitalization rate and IFR for this age group are very low and do not seem to warrant such mandates, which seem to be ineffective in stopping the spread anyway. Public health officials would better serve the public by emphasizing N95 masks for all high-risk individuals, ventilation-filtration improvements, exercise and weight loss, and isolating when symptomatic.”

Another study from May 25 found “no significant relationship between mask mandates and case rates,” after replicating a “highly cited CDC study showing a negative association between school mask mandates and pediatric SARS-CoV-2 cases,” with a larger sample of districts and a longer time interval.

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.