#MAHA-FDA has approved Moderna's "next generation" mRNA shot for covid.

New mRNA and saRNA vaccines are getting funded by HHS and BARDA despite cancellations of some contracts.

Jun 01, 2025

Clarification (June 1): There is some confusion as to whether this version of Moderna shot is “self-amplifying”. We are going to FOIA the FDA to get the exact information. At this time, the vax is described as:

Moderna’s candidate, mRNA-1283, is one-fifth the dose of the first-generation Spikevax, accomplished by replicating specific regions of the virus’ protein as opposed to the entire thing. The company has said that the specific regions, the receptor-binding domain and the N-terminal domain, have shown to be critical to eliciting neutralizing antibodies.

Given the statement about 1/5 of the dose and replication of specific regions, I am inclined to think it is self-replicating, but will confirm once we get better information.

May 31, 2025: The FDA has approved Moderna’s next-generation self-amplifying Covid-19 vaccine. The labeling indication is consistent with the new #MAHA [zero]-evidence-based policy by Makary and Prasad, which I previously discussed here.

Makary & Prasad new covid vax FDA policy pushes injections on pregnant women!

Sasha Latypova

May 21

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This “new” policy targets approximately 75% of the US population, but this number can be easily pushed up by the goons in white coats paid to label every child or adult “immunocompromised” at every health encounter, and bully them into more shots.

According to Endpoints News:

The approval is the first for a vaccine since the Trump administration issued a new review framework which says that trials using an inert placebo — not an older shot — will be recommended if vaccine makers want to give shots to healthy people.

Let’s pause here for a sec. I had numerous MAHA-mates tell me that this new FDA policy will ensure placebo-controlled trials for vaccines, and therefore I should sit down, shut up, and start cheerleading for brave MAHA-HHS. What is spelled out in the MAHA-FDA policy is very clear:

For “healthy” (aka “fit”) people - placebo controlled trials testing for safety and efficacy; Note - these will not be done because there is neither time for them between “updated strains” nor enforcement from the FDA.
For “unhealthy” (aka “unfit”) - no such trials needed! Untested poison is ok for these folks. Why don’t they start loading them into the boxcars already, I wonder?

No placebo-controlled study was done or was required by the FDA, because this “approval” is for the “unfit”:

The vaccine will be sold as mNexspike, Moderna said in a statement Saturday announcing the approval. It was approved for use in people aged 12 and up who have at least one risk factor for Covid-19, as well as for all people 65 and older.

mNexspike??? Who comes up with shitty names like that? However, it’s quite fitting.

Quoting from Moderna’s press release:

The approval was based on an 11,400-person trial that tested the new shot against its older product, to determine whether it was at least as effective, according to the company. The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498) is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older. Half of the participants received a 10 μg dose of mRNA-1283, while the other half received a 50 μg dose of mRNA-1273 (Spikevax).

This gets very interesting for several reasons.

I would like to repeat that this clinical trial had NO PLACEBO CONTROL! Please, all MAHA-mates - note that this trial is fully compliant with the current, brand new MAHA-FDA policy by Makary & Prasad: there is no requirement for a placebo-controlled trial before the approval of new versions of mRNA, even radically new versions like this self-amplifying RNA shot.

Obviously, Moderna was told by the FDA, many months ago, what the “new” policy for approval of the new mRNA versions will be, because planning and conducting even a short study with 11,400 participants across 230 clinical sites takes at least a year. In fact, the earliest record for this study is from April 13, 2023 with the same study design! That means that this “new policy” was already designed by the FDA (or perhaps by DOD and Moderna, who knows?) before Trump won the elections and MAHA was installed at HHS. All we can blame Makary & Prasad for is fronting this FDA policy from Biden admin as an “evidence-based” (my elbow it is!) “gold standard science” from completely transparent Trump-MAHA admin.

Furthermore:

Today's vaccine efficacy data are consistent with the previously announced immunogenicity results from the study, which showed that mRNA-1283 had higher neutralizing antibody responses against both Omicron BA.4/5 and ancestral SARS-CoV-2 than mRNA-1273, with the highest geometric mean titer ratios observed in adults and in the subset of participants aged 65 years and older.

The trial tested ONLY “immunogenicity”, i.e. antibody titers (endpoint that has nothing to do with prevention of transmission or “immunity”, and is involved in vaccine-enhanced disease, too). They simply compared the antibody titers in the blood after injecting people with Spikevax and mNexspike and found the latter statistically non-inferior to the former. Voila. Nothing else was necessary for this approval.

Oh, safety… let’s look at safety:

In the trial, mRNA-1283 was found to have a similar safety profile to Spikevax. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.

There is no published data on this yet, so I can’t check this statement (but I will, if and when they publish). Safe to assume, this was done in the same way as when they collected safety/adverse event data in the original Spikevax trials - solicit only mild AEs, make it very difficult to report severe AEs, and find ways to disqualify/kick out, etc. participants that got severe injuries or may have died in these trials.

Reviewing inclusion/exclusion criteria for study participants (emphasis mine):

Key Inclusion Criteria:
Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration.
Part 1: Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable.

Pregnant women were EXCLUDED from this “trial”, just like they were excluded from the original Spikevax one. Remember that MAHA geniuses Makary & Prasad recommend ALL pregnant women in the US as soon as it becomes available, which is now:

Lastly, Moderna’s combo flu shot has not been abandoned, it is being formulated with this newly approved self-amplifying RNA:

Moderna's combination vaccine candidate against influenza and COVID-19, mRNA-1083, includes mRNA-1283. That vaccine candidate recently announced positive results in its separate Phase 3 trial.
Moderna plans to present the Phase 3 clinical data for mRNA-1283 at an upcoming conference as well as submit it for publication. The Company will also engage with regulators on the next steps for the program.

The trial looked at people aged 12 and older, but wasn’t designed to only include people with risk factors, according to a listing on a government database.
“Covid-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA’s timely review,” Moderna CEO Stéphane Bancel said in the announcement.
Moderna’s new vaccine is intended to elicit a stronger immune response at a fraction of the dose of the first-generation shot, which is sold as Spikevax. It was successful in a Phase 3 study that showed it was at least as effective as the existing vaccine.
FDA’s new standards
When data were presented to the CDC advisors in April, FDA liaison Tracy Beth Høeg appeared to throw cold water on the study’s primary endpoints measuring how the new vaccine compared to the older version at preventing infections. At the time, Høeg implied that the measure couldn’t adequately account for natural immunity to the virus.
Despite that, Moderna projected confidence to investors, even as fellow Covid vaccine maker Novavax wrestled with an FDA delay through April and the first half of May. Moderna told investors in its May 1 earnings call that its applications before the agency were progressing normally.
The approval follows a newly-issued FDA framework for the Covid vaccines, suggesting they could be confidently approved for adults 65 and older and people 6 months to 65 years old who were at higher risk of severe illness — a designation used for the Novavax approval. Expansion to healthy, younger populations could come through post-marketing studies.
Moderna and its mRNA-based technology have been challenged by the Trump administration, which on May 28 pulled a $766 million award given to the company to help finance development of a bird flu vaccine, with an HHS spokesperson saying part of the rationale had to do with mRNA being “under-tested.”
Moderna is still waiting for the FDA to decide whether it will expand the label of its RSV vaccine to include high-risk adults 18 to 59. The company used priority review vouchers for both that application and for the next-generation Covid shot.

More about happenings at MAHA-HHS in this excellent post by

Conspiracy Sarah

HHS redirects $500 million to Trump appointee's vaccine project, bypassing reviews

Taubenberger, who holds a patent for the BPL vaccine platform, was picked to be the acting head of the National Institute of Allergy and Infectious Diseases, or NIAID, after the institute's previous director was ousted.
Well shut the front door. Taubenberger happens to hold a patent for a universal flu vaccine! Amazing.

Hey, don’t be a black-piller, Sarah! It says right here, it’s going to be “gold-~~plated bullshit~~ standard” with full transparency:

NIH is developing the next-generation, universal vaccine platform, Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated, whole-virus platform.
This initiative represents a shift toward transparency, effectiveness and comprehensive preparedness, funding the NIH’s in-house development of universal influenza and coronavirus vaccines, including candidates BPL-1357 and BPL-24910. These vaccines aim to provide broad-spectrum protection against multiple strains of pandemic-prone viruses such as H5N1 avian influenza and coronaviruses.
The program realigns the operations of Biomedical Advanced Research and Development Authority (BARDA)—an agency within HHS—with its statutory mission to prepare for all influenza viral threats, not just those currently circulating.

Arcturus is the new pony.

BARDA gave Arcturus $63M to develop self-amplifying mRNA vaccines, designed to replicate inside the body for stronger, longer-lasting responses, and consequently produce spike forever and shed forever. Isn’t science great? The self-amplifying vax was fast-tracked by the FDA. This miracle of science will be tested in a NON-placebo-controlled study, following Makary & Prasad MAHA policy, where “long-term” safety will be assessed for a whole of 7 days! (credit Dr. Ealy on X):