According to a statement by the company, Pfizer has stopped COVID pill trial after the latest results showed that it did not reduce symptoms, hospitalizations and deaths.
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Pfizer has stated it will halt participation in a clinical trial for Paxlovid, its COVID-19 antiviral medication, for standard-risk COVID-19 patients after the most recent findings revealed the medication did not numerically greatly lower symptoms, hospitalizations, or fatalities.
In more than 65 nations, including the United States, Paxlovid, a combination of the antivirals nirmatrelvir and ritonavir, is presently approved or authorized for conditional or emergency use in the treatment of COVID-19 patients at high risk of developing severe illness, including hospitalization or death.
According to a statement made by Pfizer on June 14, it will “cease enrollment into the EPIC-SR trial due to low rate of hospitalization or death in the standard-risk population.”
The business asserted that it will nonetheless incorporate the new information in its impending application to the U.S. Food and Drug Administration (FDA) to request complete authorization for the administration of Paxlovid to high-risk COVID-19 individuals.
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“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.
Patients with COVID-19 who do not have risk factors for serious illness are referred to be standard-risk patients. They may or may not have received vaccinations.
Results From Trial
Paxlovid and a placebo were compared in the August 2021 beginning of the EPIC-SR study in adult patients with symptomatic COVID-19 who are not hospitalized and “are at low risk of progressing to severe illness.”
Pfizer revealed that Paxlovid results fell short of the study’s objective of “self-reported, sustained alleviation of all symptoms for four consecutive days, as compared to placebo” in December 2021.
When contrasted to the placebo group (10 out of 426 hospitalized, with no deaths), the Paxlovid group’s hospitalizations were reduced by 70% (3 out of 428 hospitalizations, with no deaths). But because the findings were not statistically significant, it is possible that chance played a role.
On June 14, Pfizer revealed that an updated assessment of 1,153 patients who had been enrolled through December 2021 had revealed a 51 percent difference between the two groups in terms of hospitalization or death, with five out of 576 patients in the Paxlovid group and 10 out of 569 in the placebo group necessitating hospitalization or passing away. Once more, the outcomes lacked statistical significance.
According to the manufacturer, there was just one death in the placebo group whereas there were none among the patients who took Paxlovid.
People who had received all of their vaccinations and had at least one risk factor for developing severe COVID-19 were initially included in the EPIC-SR investigation; however, after Paxlovid was approved for the cohort in December 2021, this cohort was no longer included in the study. Pfizer then changed its research eligibility requirements to permit participants whose most recent vaccination was 12 months or more ago.
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 requiring to be hospitalized or passing away, according to a sub-group analysis of 721 vaccinated individuals with at least one risk factor for progression to severe COVID-19. Pfizer reported that the results were not statistically significant.
Additionally, Paxlovid exhibited a non-significant 62 percent daily reduction in COVID-19-related medical visits across all patients as compared to placebo.
According to a statement from Pfizer’s CEO and chairman, Albert Bourla, the company’s preliminary research findings “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.
Paxlovid decreases COVID-19 hospitalization and mortality by 46%, according to data from a retrospective cohort study conducted in Israel in early June among a highly immunized community. The study said the drug was “more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease.”
The antiviral medication Paxlovid was not successful in avoiding symptomatic COVID-19 infection in household contacts of the COVID-19 patient who took the tablet, according to a second study in which it failed to yield a statistically significant outcome. Pfizer made this announcement in April.
The United States ended up spending more than $10 billion to purchase 20 million courses of Paxlovid from Pfizer, and the White House has been requesting additional funding from Congress to sustain the purchase of additional courses of the antiviral medication, as well as other treatments and booster doses of vaccines.
The Centers for Disease Control and Prevention (CDC) issued a warning in late May that a few individuals taking Paxlovid may encounter a rebound in COVID-19 symptoms, which means they may experience symptoms again after their symptoms have subsided or test positive for COVID-19 after testing negative.
When the rebound occurred, the CDC stated that it might not have been caused by the medication and that it “may be part of the natural history of SARS-CoV-2” in certain individuals, “independent of treatment with Paxlovid and regardless of vaccination status.”