Outdated package labeling for Moderna Spikevax 24-25 updated product. New FDA approved labeling will indicate “for 6 months through 11 years who are at increased risk for severe COVID-19 disease” .

What happened on July 10?

I have had many requests to clarify what happened with the recent July 10, 2025 FDA general (non-EUA) marketing authorization of Moderna’s SpikeVax for children. The truth of the matter is that I do not really know what happened at FDA to lead to this outcome. Like many, I was shocked and disappointed. Moderna was overjoyed. Their stock value and market capitalization surged, with the climb beginning four days before the announcement, suggesting that someone had insider knowledge. If true, that would likely constitute insider trading. This would precisely be the type of rule-breaking that many have come to expect from this company and sector. You can consider that a hypothesis, for purposes of this discussion.

Moderna’s Spikevax COVID-19 vaccine received full U.S. FDA approval for children aged 6 months through 11 years who are at increased risk for severe COVID-19 disease, as announced on July 10, 2025. This approval transitions the vaccine from its prior availability under Emergency Use Authorization (EUA) for this age group. Spikevax was previously approved for adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for severe disease.

Moderna’s Spikevax was first granted FDA approval in January 2022 for adult use. The vaccine has since undergone updates, including targeting the KP.2 variant of SARS-CoV-2, and has been expanded to cover broader age groups. Moderna plans to make the updated Spikevax vaccine available for eligible populations in the U.S. ahead of the 2025-2026 respiratory virus season.

The approval was based on the FDA’s scientific review, with Moderna’s CEO, Stéphane Bancel, emphasizing the continued threat of COVID-19 to children, particularly those with underlying medical conditions. Despite the approval, critics have raised concerns about the lack of pediatric safety data and the potential for serious adverse events, including myocarditis and pericarditis. The Spikevax package insert lists several adverse events, such as trouble breathing, swelling of the face and throat, rapid heartbeat, dizziness, and weakness.

The FDA and Moderna have acknowledged these risks, and updated package inserts now include stronger warnings about myocarditis and pericarditis. The vaccine is intended for individuals who are at increased risk for severe disease, and vaccination may not protect all people who receive the vaccine.

Moderna also has other vaccines in its portfolio, including mNEXSPIKE (mRNA-1283), which was approved in June 2025 for adults aged 65 years and older and individuals aged 12 to 64 years with at least one risk factor for severe disease. This approval was based on data from the Phase III NextCOVE trial, which showed that mNEXSPIKE was non-inferior to Spikevax.

There are several unresolved questions related to this action.

1. Why approve Moderna’s Spikevax for this indication and not provide similar approval for the Pfizer product?

2. Did FDA Commissioner Dr. Marty Makary know and endorse this decision, or was it decided and acted upon at the level of FDA Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad?

3. Was the timing of this decision occurring while both Secretary Kennedy and his Deputy Chief of Staff Stephanie Spear were on vacation coincidental?

4. Was this decision made in the context of a broader strategic plan within HHS?

5. What are the pre-existing conditions that FDA considers as placing “children aged 6 months through 11 years at increased risk for severe COVID-19 disease.” In other words, using plain language, what are the specific diseases of childhood that your child may have that would make them eligible for this FDA licensed product?

6. What and where are the data that demonstrate that the benefits of receiving this product outweigh the risks for children with these specific diseases? Are medical practitioners and parents going to be allowed to see the risk/benefit analysis data, which (presumably) the FDA used to justify this decision?

7. What are the number of “children aged 6 months through 11 years at increased risk for severe COVID-19 disease” that need to be treated with this product to prevent one death or one avoidable hospitalization unambiguously due to severe COVID-19 disease? Will we be allowed to see this calculation for each of the pre-existing conditions FDA determines as associated with “increased risk for severe COVID-19 disease?”

   These are the data that pediatricians and parents need to make informed choices about accepting this product for their children. Vague statements about increased risk will not suffice. Parents need to know what specific pre-existing conditions they need to worry about, and how significant the risk of severe COVID-19 disease is for their child who has such a condition.

The days of public tolerance of a paternalistic FDA attitude of “we are the professionals and know best, so you do not need to see the data and our analyses” are over.

Show us the data. Plain and simple.

But who will speak for the injured? Who will protect the parents and their children? To be blunt, the FDA/CBER has provided limited general marketing authorization for this product, but who will decide how it should be used? Of course in a rational world, individual pediatricians, general practitioners, and the parents granting informed consent are on the front lines for this decision.

But the truth is that the practice of medicine in the United States is ultimately determined by legal liability. Legal liability concerns drive everything, from the doctor’s office up through the “health care” hospitals and systems, through to the insurance companies. And legal liability hinges on whether or not “standard of care” was met in an individual case. In the case of the vaccine manufacturers, they have successfully lobbied the government for complete liability shields, so in a sense they do not really have a dog in that fight, except that standard of care determines how many doses of product they can sell.

Who will establish the standard of care as it relates to this product?

Historically, the answer has been the CDC Advisory Committee on Immunization Practices (ACIP). That simple fact illuminates why Pharma’s corporate media lapdogs have all been baying at the moon over Secretary Kennedy’s decision to retire the old ACIP that had devolved into a rubber stamp for FDA and Pharma, and to replace it with members who would insist on independently evaluating the actual data supporting (or not) the use of an infectious disease vaccine or related products for the licensed indication(s).

Can you grok that? Referring to the use of the word as coined by Robert Heinlein in his immortal “Stranger in a Strange Land,” meaning to deeply understand something at emotional, intellectual, and social levels.

Technically, constitutionally, FDA / CBER provides authorization for interstate transport and marketing of medical products and devices. CDC/ACIP provides recommendations to the CDC Director (and HHS Secretary) on standard-of-care for infectious disease vaccines and related products. ACIP recommendations only become official CDC policy recommendations after the Director of the CDC accepts them. The CDC Director can and has overruled ACIP advisory recommendations on very rare occasions.

By charter, the ACIP is required to take up the issue of what advice to provide the CDC Director at the next ACIP meeting, following FDA authorization of a new vaccine product. The ACIP failed to meet this requirement in the case of the recently FDA-authorized Moderna product mNEXSPIKE. I have no idea if or when the ACIP may address this FDA action.

Regarding the recent FDA marketing authorization for Spikevax, what will the ACIP do now? Unfortunately, as an ACIP member (we are all “volunteers”, by the way), I am embargoed from commenting on future ACIP plans beyond what is in the public record. Which is as it should be. I do not, and cannot, speak for either the ACIP, the CDC, or the US Government, and internal ACIP deliberations and plans are considered confidential information.

All of which is to say that FDA/CBER director Vinay Prasad has just thrown a hot potato right into the lap of the ACIP, who now stands between this FDA decision and millions of US parents and their children. Well, technically, all the ACIP does is advise the CDC Director, who is currently pending Senate approval. And you know what that means. Dr. Prasad has also functionally tossed that same hot potato into the gears of that Senate Confirmation process.

Just for clarification and context, Moderna justifies introducing and marketing the mNEXSPIKE product in parallel to its Spikevax product as offering design advantages that will provide protection at one-fifth of the Spikevax dose and allow storage between 2°C and 8°C for up to 90 days. Spikevax can be stored at those temperatures for up to 60 days.

The new vaccine can be kept at 8°C to 25°C for twice as long as Spikevax. The enhancements stem from a difference in the design of the vaccines. Spikevax encodes a modified version of the full-length viral spike protein, which has been demonstrated to be associated with a wide range of toxicities. The new vaccine encodes the receptor binding and N-terminal domains of the virus. A shorter length of mRNA is associated with increased stability. Presumably, this recombinantly redacted version of the full-length spike protein will also lack the known toxicities associated with both the virally encoded Spike protein as well as the modified Spike proteins used in virtually all other FDA-authorized COVID-19 “vaccine” products.

Who knew, What and When, and were there larger strategic and tactical considerations

I have limited visibility into these questions. The unfortunate facts are that this decision about FDA/CBER Spikevax authorization “for children aged 6 months through 11 years who are at increased risk for severe COVID-19 disease” was made public by Moderna when both the Secretary of HHS (JFKjr) and his trusted deputy Chief of Staff Stefanie Spears were on vacation. And Moderna certainly made hay while the sun was shining on them.

Neither Sec HHS nor his deputy Chief of Staff (dCOS) were briefed or read in on this decision. Did the FDA Commissioner know? Did (ex) HHS Chief of Staff Heather Flick know? Did POTUS or his COS know? I do not know the answers to these questions. What I do know is that shortly after the HHS Secretary and his dCOS returned from vacation, a major reorganization of HHS leadership occurred. And that POTUS and his COS were briefed on this decision. There is now a new HHS Chief of Staff. The dCOS for policy was walked off the premises and was so upset that she crashed her car into the Secretary’s government-provided vehicle. And I hear drumbeats in the distance signaling that the natives believe additional organizational changes will be forthcoming.

For those, including myself, who insisted that there be consequences for failing to brief the chain of command regarding this disappointing critical decision by the FDA/CBER director, there is solace in knowing that there were prompt consequences. Whether you agree or disagree with the decision, I hope that all can understand that the federal bureaucracy must recognize that there will be consequences for failing to brief their command chain on politically sensitive decisions. A short, sharp shock was precisely what the doctor recommended.

Regarding Strategy and Tactics

The narrative on MAHA Twitter after the FDA approved Moderna’s SPIKEVAX vaccine for high-risk children is that this was a betrayal by Secretary Kennedy. But this is the OPPOSITE of what transpired. The Secretary was on vacation and not even briefed on the decision. It was a working vacation, and I have personal confirmation that he took many calls, briefings, and was constantly managing strategic and tactical decisions during his much-needed and well-earned vacation. He (and his beloved wife) have not had a vacation since launching his Presidential campaign.

The reality is that CBER Director Vinay Prasad overruled the FDA regulators who had recommended that all three COVID vaccines currently under the standing EUA be approved for all age groups, including healthy children. Which begs the question, why do we still have an Emergency Use Authorization for these products when there is clearly no medical emergency?

Prasad’s justification for this denial should be reassuring to the entire medical freedom movement. He said in his justification letter:

• Is there substantial certainty of a net clinical benefit to vaccinating healthy children with this mRNA vaccine? The Office of Communication, Outreach and Development (OCD) within the Center for Biologics Evaluation and Research (CBER) answer is, at the present time, with best available information, no.

• Moderna has never shown a reduction in severe COVID-19, hospitalization, ICU stays or death in a randomized study in children.

• Moderna has not shown that COVID-19 vaccination reduces long COVID or transmission in any setting at any age with high-quality data. Neither has the applicant nor a third party shown fewer missed days of school with high-quality data.

• Vaccinating these individuals (healthy kids with natural immunity) carries massive uncertainty as to whether benefits outweigh risks.

• Although COVID-19 vaccines have been given to billions of individuals and the harms have been studied in depth, no one knows if these products have harms that only materialize 10 or 20 years later, as such is a necessary limit of time. It is ignorant to claim that unknown long-term risks are not possible.

• Antibodies are not gold standard science, and one cannot be certain of net clinical benefit merely because antibodies are increased. Vaccine doses can increase antibodies, but fail to further improve clinical outcomes.

• Randomized trials measuring clinical outcomes will be required to approve these products for healthy individuals.

• FDA is ultimately accountable to the American people, and Americans have overwhelmingly stated that they feel the evidence to vaccinate a healthy child with a COVID-19 mRNA product is not enough to compel them to act. CBER OCD, after careful examination of the scientific evidence, agrees with the vast majority of Americans.

Speaking personally as a medical scientist with particular expertise in this area, I agree with all of these points.

And this comes on the heels of FDA Commissioner Makary telling the Epoch Times that he, “personally knows of people who have been injured by the vaccine. I personally know of friends who have lost a loved one from the mRNA COVID vaccine.”

He addressed critics who say he and Kennedy are not doing enough on the COVID-19 vaccines, “So people have a right to be angry. They have been deceived on different aspects of the COVID pandemic. They have been ordered to march into a vaccine line even if they were healthy and low-risk and already had circulating antibodies. People have a right to be upset, but I would ask people to be patient with us as we do this the proper scientific way.”

Things are moving in the right direction. Secretary Kennedy has always said that we must return gold star science to HHS. When the data are out, and the recommendations are in, I have complete confidence that he will move accordingly.

Do you think any previous FDA would have rejected the approval of any vaccines, let alone COVID-19 vaccines? The evidence suggests otherwise. This is a massive step forward.

I have no impact or control over what decisions are made at FDA. They have made a decision, for better or worse. The decision was made without concurrence or even awareness by the HHS Secretary.

The ACIP charter defines that it is now up to the ACIP to recommend standard of care guidance for use of this product to the Director of the CDC. And it will be up to the Director of the CDC to accept or reject those recommendations. Those are public facts, and so I am at liberty to mention them. Time will tell how the ACIP discharges this responsibility.

And no, despite what some divisive chaos agents have claimed, to date, the new ACIP has not voted to support or not support ANY COVID-19 vaccine product recommendations.

For those interested in further reading, I recommend the following pre-print. The first author of this work is a fellow ACIP member and MIT Full Professor for whom I have deep respect. The senior author is the Surgeon General of Florida, for whom I also have deep respect. mRNA-1273 = Spikevax, and this data supports that, if CBER Director Prasad believed it necessary to approve at least one mRNA COVID-19 product to protect high-risk children of parents who demand access to an mRNA COVID-19 booster product for their child, Spikevax was a reasonable choice. That was his call to make, and he made it, for better or worse.

In a normal and just society, this manuscript would already have completed peer review and been published in a high-profile medical research journal. The fact that it has not, demonstrates that the propaganda, censorship, and PsyWar regarding COVID-19 mRNA products continues.

Twelve-Month All-Cause Mortality after Initial COVID-19 Vaccination with Pfizer-BioNTech or mRNA-1273 among Adults Living in Florida

Retsef Levi, Fahad Mansuri, Melissa M. Jordan, Joseph A. Ladapo

ABSTRACT

Objective To examine the relative impact of the initial series of the messenger RNA (mRNA) BNT162b2 (Pfizer) and mRNA-1273 (Moderna) on all-cause and non-COVID-19 mortality among Florida residents.

Design Matched cohort with cumulative and adjusted assessments of risk over 12 month follow up.

Setting Florida’s state-level public health databases with records about COVID-19 vaccination, sociodemographic characteristics of vaccine recipients, location of vaccination, and vital statistics.

Participants Matched cohort of 1,470,100 noninstitutionalized adult Florida residents receiving at least two doses, less than six weeks apart, of either the BNT162b2 or mRNA-1273 mRNA vaccine between December 18, 2020, and August 31, 2021.

Intervention Initial vaccination with two doses of either BNT162b2 or mRNA-1273

Main outcome measures All-cause, cardiovascular, COVID-19, and non-COVID-19 mortality within 12 months after the second COVID-19 vaccine dose

Results There were 9,162,484 noninstitutionalized adult Florida residents who met inclusion criteria, including 5,328,226 BNT162b2 vaccine recipients and 3,834,258 mRNA-1273 vaccine recipients. A total of 1,470,100 vaccinees were matched 1-to-1 based on seven criteria, including census tract. Compared with mRNA-1273 recipients, BNT162b2 recipients had significantly higher risk for all-cause mortality (847.2 vs. 617.9 deaths per 100,000; odds ratio, OR [95% CI]: 1.384 [1.331, 1.439]), cardiovascular mortality (248.7 vs. 162.4 deaths per 100,000 persons; OR [95% CI]: 1.540 [1.431, 1.657]), COVID-19 mortality (55.5 vs. 29.5 deaths per 100,000 persons; OR [95% CI]: 1.882 [1.596, 2.220]) and non-COVID-19 mortality (791.6 vs. 588.4 deaths per 100,000 persons; OR [95% CI]: 1.356 [1.303, 1.412]). Negative control outcomes did not show any indication of meaningful unobserved residual confounding.

Conclusion Florida adults who received BNT162b2 had significantly higher risk of 12-month all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality compared to matched mRNA-1273 recipients. These findings are suggestive of differential non-specific effects of the BNT162b2 and mRNA-1273 COVID-19 vaccines, and potential concerning adverse effects on all-cause and cardiovascular mortality. They underscore the need to evaluate vaccines using clinical endpoints that extend beyond their targeted diseases.

What is already known on this topic

• Vaccines may have health effects beyond the diseases they target, including potential effects on all-cause mortality.

• The relative impact of the initial series of the messenger RNA (mRNA) BNT162b2 (Pfizer) and mRNA-1273 (Moderna) on all-cause and non-COVID-19 mortality is not well-studied.

What this topic adds

• Florida adults who received BNT162b2 had significantly higher risk of 12-month all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality compared to carefully matched mRNA-1273 recipients.

• These findings are suggestive of differential non-specific effects of the BNT162b2 and mRNA-1273 COVID-19 vaccines, and potential concerning adverse effects on all-cause and cardiovascular mortality.

Competing Interest Statement

MJ, FM, and JL were supported by the Florida Department of Health and JL serves as State Surgeon General; RL has a financial relationship with Bluebell Foundation/Chicago Community Trust; there are no other relationships or activities that could appear to have influenced the submitted work.

Funding Statement

The study did not receive any external funding.