Large Real World-Evidence Study Finds COVID-19 Vax + Paxlovid Benefit Against Hospitalization
Nirmatrelvir-ritonavir (Paxlovid) developed by Pfizer, is an antiviral medication that is indicated for individuals with mild-to-moderate COVID-19 who are at risk of progression to severe COVID-19. While initially studied on unvaccinated persons, a growing number of observational investigations provide evidence of the potential for significant protection by Paxlovid against hospitalization among vaccinated individuals at elevated risk for severe COVID-19.
Not a lot of data avails scientists seeking to assess the risk reduction from antivirals together with vaccination. Here, the study team led by researchers from the U.S. Center for Disease Control and Prevention (CDC) as well as the U.S. market’s leading electronic health record (EHR) vendor Epic to estimate the stepwise benefit of monovalent vaccination and Paxlovid against COVID-19 hospitalization in the United States. Overall, the findings complement previous research indicating Paxlovid affords additional protection in high-risk individuals, even if vaccinated.
The findings here, according to the joint CDC and Epic team, complement previous research pointing to the protective overlay afforded by Paxlovid in high-risk individuals, even if vaccinated.
This line of research had not yet examined the protection of treatment and vaccination combined. Treatment with Paxlovid without vaccination does not reduce risk of hospitalization to levels seen in treated individuals with three or more vaccinations.
While the burden and impact of COVID-19 in future respiratory seasons are uncertain, the authors of this study suggest the combination of vaccination and oral antiviral treatment for eligible patients remains an important tool against COVID-19 hospitalization and death. The CDC Advisory Committee on Immunization Practices recently recommended the 2023-2024 (monovalent, XBB-containing) COVID-19 vaccines in persons ≥ 6 months of age. The CDC-led study paper suggests clinicians should consider treatment with Paxlovid among all adults who are at high-risk of severe COVID-19 disease, including vaccinated persons.
Important Caveat
Importantly, this study was limited to adults infected with COVID-19 during the period April and August 2022, and may not be applicable in the current landscape of population hybrid immunity and SARS-CoV-2 strain evolution. The authors acknowledge that more updated estimates over time are necessary to better understand the impact of vaccination and antiviral treatment. The risk-benefit analyses for COVID-19 vaccination have likely changed. Plus, the medical establishment to date has yet to accept the dozens of peer reviewed manuscripts showing risk with the mRNA induced spike protein, capable of distribution in tissue and organs throughout the body, albeit in rare to relatively rare cases.
There are risks associated with COVID-19 vaccination that are not openly talked about in mainstream media, or even to this day in the trade press; but they are discussed in TrialSite, an independent, objective unbiased (as humanly possible) media platform tracking the world of biomedical research. Additionally, the SARS-CoV-2 pathogen has become milder during the Omicron stage, with a case fatality rate similar to influenza. Of course, the risk increases with age as well as co-morbidities and immunocompromised status.
The Study
The CDC and Epic research team conducted the retrospective analysis of patient records in Cosmos, a real world-evidence dataset that, at the time of this study, included EHR information from >160 million individual users of U.S health systems covered by Epic. Inclusion criteria and definitions were described previously in a prior study of real-world effectiveness of nirmatrelvir-ritonavir in this population. Non-pregnant adults were eligible for inclusion if aged ≥50 years or if aged ≥18 years with an underlying health condition associated with progression to severe COVID-19 disease documented in their medical record. All included patients had a COVID-19 diagnosis (defined as a diagnostic code or positive SARS-CoV-2 test result) associated with an outpatient encounter during April 1–August 31, 2022, indicating mild-to-moderate COVID-19.
The investigational team considered patients to have received nirmatrelvir-ritonavir (Paxlovid) if verified it was prescribed during the five days after their COVID-19 diagnosis. Vaccination status was categorized on the date of COVID19 diagnosis using data available in the Cosmos system. As reported in the journal Clinical Infectious Diseases, vaccination categories included 1) unvaccinated if no COVID-19 vaccine had been received; 2) 2 mRNA vaccine-dose recipients if ≥14 days had elapsed since receipt of the second dose and no subsequent doses had been received or <7 days receipt of third dose; 3) ≥3 mRNA vaccine-dose recipients if ≥7 days had elapsed since receipt of the third dose; and 4) other vaccine recipient if any Janssen (Johnson & Johnson) vaccine, other vaccine, or only 1 mRNA vaccine dose had been received any time before COVID19 diagnosis.
The primary outcome was COVID-19 hospitalization within 30 days after diagnosis. A COVID-19 hospitalization was defined as having a COVID-19 specific diagnosis associated with the admission.
The group estimated protection against hospitalization by the Paxlovid combination combined with COVID19 mRNA vaccination based on statistics generated from Cox regression. Presenting adjusted hazard ratios (aHR) for hospitalization adjusting for age group, sex, race and ethnicity, social vulnerability index of the address of residence, number of underlying health conditions, region of residence, and previous infection defined as having a COVID-19 diagnosis code or positive SARS-CoV-2 test result (nucleic acid amplification or antigen) >90 days prior to the included COVID-19 diagnosis.
The reference group comprised unvaccinated individuals who had not received Paxlovid.
Results
Among the unvaccinated, 35,826/141,931 (20.2%) received Paxlovid compared to 42,355/157011 (27.0%) of patients who received 2 mRNA doses, and 130,778/330,448 (33.0%) of those who had received 3 or more mRNA vaccine doses.
During April–September 2022, 5,296 of 731,349 patients (0.72%) with COVID-19 were hospitalized within 30 days after their initial diagnosis.
Hospitalization Rates
After receipt of nirmatrelvir-ritonavir and 3 or more mRNA vaccine doses, there were an estimated 16.9 fewer hospitalizations per 100,000 person-days compared to those who were unvaccinated and untreated.
According to the group of authors:
“Compared with patients who were unvaccinated and had not received a COVID-19 treatment, the rate of COVID-19 hospitalization was lower among both those who were vaccinated but did not receive nirmatrelvir-ritonavir (two mRNA doses, aHR 0.74, 95%CI: 0.67–0.80; three or more mRNA doses, aHR 0.51, 95%CI: 0.47–0.55) and those who were unvaccinated but after receipt of nirmatrelvir-ritonavir (0.47, 95%CI: 0.40–0.55).
After receipt of both treatment and vaccination, the hospitalization rate was reduced further (two mRNA doses and nirmatrelvir-ritonavir aHR 0.33, 95%CI: 0.29–0.39) with the lowest rate of COVID-19 hospitalization among those after receiving three or more mRNA vaccine doses and nirmatrelvir-ritonavir (aHR 0.22, 95%CI: 0.19– 0.24).”
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How low can Covid catastrophists go?
Who’d have guessed that there would be two startling revelations about the great Covid over-reach in the space of about a week, upholding claims previously dismissed as conspiracy theories and misinformation?
First came a peer-reviewed scientific study which linked Covid vaccines to a range of serious health disorders. It was soon followed by the Queensland Supreme Court ruling that vaccine mandates imposed on police and ambulance workers in the state were unlawful.
Both provided a welcome dose of reality after the worst days of lockdowns and vaccine roll-outs when we were bombarded with the message that the jabs were ‘safe and effective’. Years later, we know for certain that they do not prevent contraction or transmission of the virus and there’s an acknowledged chance they could cause serious harm and even death.
Some of us have been aware of this for a long time, but vaccine promoters, including Big Pharma and government bureaucrats, insist that the risk is ‘very low’, the acknowledged disorders are ‘rare’, and that vaccines provide the best means of protection against Covid.
But how low is ‘very low’ and how ‘rare’ is rare? Let’s look at the latest findings from the largest vaccine safety study to date conducted by the Global Vaccine Data Network. A research division of the World Health Organisation, it reportedly looked at 99 million vaccinated individuals across six continents.
The study confirmed connections between Covid vaccines produced by Pfizer, Moderna, and AstraZeneca to several serious but ‘rare conditions’.
According to a report in Forbes:
While the side effects are serious, the chance of experiencing them is low. Some highlighted increases include a 6.1-fold increase in myocarditis from the second dose of the Moderna mRNA vaccine. Cases of pericarditis had a 6.9-fold increase as a result of the third dose of the AstraZeneca vaccine. There is a 2.5-times greater risk of developing Guillain-Barré syndrome from the AstraZeneca vaccine along with a 3.2-times greater risk of developing blood clots from the same vaccine. There is a 3.8-times greater risk of getting acute disseminated encephalomyelitis from the Moderna vaccine, and a 2.2-fold increase in the AstraZeneca vaccine.
When choosing to get vaccinated, it is important to weigh the benefits and risks of the vaccine. Information like this makes it easier to make the right choice…
Well thanks, but my wife and I made that choice a few years ago and we remain very glad we did, given there are some still trying to pedal the message that a six to seven times chance of contracting a serious heart condition is ‘low’.
I’m reminded of the old Chubby Checker hit Limbo Rock, ‘How low can you go’? Much lower than that, if you want to convince people the vaccines are safe – let alone effective.
My own long-term scepticism possibly has links back to my first job after leaving high school many moons ago, when I undertook a pharmacy apprenticeship in a very busy regional pharmacy.
Maybe it didn’t help when I was questioned by a detective when a patient died after taking a sleeping mixture I had dispensed, even though I was later cleared after forensic tests showed the medicine contained the correct level of ingredients and the poor bloke had swallowed an overdose. But possibly the last straw had something to do with a drug I had dispensed many times to pregnant young women suffering morning sickness. Finally, the authorities woke up to the fact that the ‘cure’ – thalidomide – was causing horrific birth defects. Sound familiar?
Fast forward to February 2021, when the novel Covid vaccines were rolled out in Australia after being developed and approved in record time without long-term human trials. Manufacturers were granted immunity from liability for subsequent mishaps despite some of these companies having records of huge fines for past problems.
There were also experts, including highly qualified epidemiologists, sounding warning bells, particularly in Europe and America. Some adverse events might only become apparent months or even years after the jabs were administered, but that was dismissed as ratbag conspiracy theory, disinformation, and misinformation.
Well not any more, and hopefully the Queensland Supreme court ruling that some of these vaccine mandates were unlawful will lead to justifiable and wide-ranging compensations.
As Rowan Dean wrote in The Spectator Australia, ‘The news, of course, is to be welcomed. It is the first crack in the dam wall and will hopefully be followed by significant class actions and further court cases…’
Here, here! And let’s hope that the issue does not become bogged down in appeals courts by a government with a guilty conscience and deep pockets.
Finally, my short-lived dispensing career was never a waste of time and it actually saved one of our young son’s lives when a pharmacist dispensed the wrong medication which I recognised as a potent heart drug that could have stopped his from beating!
Again, that’s another story.
https://www.spectator.com.au/2024/03/how-low-can-covid-catastrophists-go/
*************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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