New COVID Booster Approved From Final Study of Mice, Not Humans, But Using Only Animal Data Is a Needless Gamble

VERIFY: New COVID booster approved from final study of mice, not humans

According to documents on the CDC website, human tests of Moderna’s version of the new booster are still “ongoing.” Right now, there is only final evidence from “8-10 mice” per group.”

The FDA’s website shows for Pfizer the agency also relayed on the final study evidence from “8 mice.” But human trials are also ongoing. So far, the new boosters “showed a similar local reaction and systemic event profile.” That means side effects appear to be about the same including “mild to moderate injection site pain, fatigue, and muscle pain.”

“To advance the Omicron BA.4/BA.5 bivalent vaccine as rapidly as possible, regulators, including the FDA, WHO and EMA, have advised that our submissions be based on safety and immunogenicity data generated in adults with an Omicron BA.1 bivalent vaccine and supported by BA.4/BA.5 bivalent pre-clinical data and BA.4/BA.5 bivalent quality and manufacturing data. These packages follow a similar model to that provided to public health officials who evaluate seasonal flu vaccines each year. Moving forward, this approach may help address the pressing need for vaccines that provide a high level of protection against current and emerging variants of concern so that we can remain vigilant against this evolving virus. The FDA has authorized our Omicron BA.4/BA.5 bivalent vaccine based on clinical data generated in adults with an Omicron BA.1 bivalent vaccine, pre-clinical data with a BA.4/BA.5 bivalent vaccine and BA.4/BA.5 bivalent quality and manufacturing data. Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5- bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5 bivalent vaccine in individuals 12 years of age and older is ongoing. Data will be shared with regulators when available. We are facing a virus with an exceptionally high mutation rate, which the nimble mRNA platform is well situated to address. Only the mRNA sequence requires updating to match emerging strains, and utilizing a bivalent vaccine aims to provide broader coverage against known and future COVID-19 variants of concern.”

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Pfizer’s anti-COVID pill Paxlovid shows no benefit for younger adults

Pfizer’s anti-COVID pill Paxlovid shows no benefit for younger adults

The report’s authors found that Pfizer’s antiviral medication Paxlovid offered little to no benefit for younger adults. However, it did reduce the risk of hospitalization for high-risk seniors. Notably, supplementary material from the original study of Paxlovid in high-risk non-hospitalized adults with COVID-19 during the Delta wave had demonstrated benefits in those younger than 65, albeit the difference compared to the placebo was much less than in those 65 and older.

Among those over 65, there was a 73 percent decrease in the hospitalization rate and a 79 percent reduction in the risk of death. However, patients between the ages of 40 and 65 saw no benefit in taking the antiviral medication in either category, regardless of previous immunity status.

Another critical study from Hong Kong published in Lancet Infectious Diseases on the same day as the Israeli study but which went unmentioned in the press offered further evidence of Paxlovid’s limited therapeutic role. The authors reviewed their clinical experience with Paxlovid and Lagevrio, Merck’s antiviral pill, Molnupiravir, in hospitalized patients. They compared them to hospitalized patients who did not receive those medications during the horrific wave of infections that slammed into the semi-autonomous region in February and March.

The mortality risk reduction for Lagevrio was 52 percent, and for Paxlovid it was 66 percent. Those receiving antivirals had a lower risk of their disease progressing, but the drugs did not significantly impact their need for mechanical ventilation or ICU admission. The patients in the study averaged in age from mid-70s to early 80s.

Given the results of these studies, it bears mentioning that the Centers for Disease Control and Prevention (CDC) has recently estimated that approximately 95 percent of Americans aged 16 and older have some level of immunity against COVID-19.

CDC reports fewer COVID-19 pediatric deaths after data correction

CDC reports fewer COVID-19 pediatric deaths after data correction

The health agency, in a statement to Reuters, said it made adjustments to its COVID Data Tracker’s mortality data on March 14 because its algorithm was accidentally counting deaths that were not COVID-19-related.

Children accounted for about 19% of all COVID-19 cases, but less than 0.26% of cases resulted in death, according to the American Academy of Pediatrics, which summarizes state-based data.