Moderna’s Spikevax At A Glance:

  • FDA extends Moderna’s EUA; to include BLA for Spikevax.
  • No safety tests for pregnant women.
  • Moderna use approved by Pfizer’s data.
  • No VRBPAC meeting prior to approval.

On Monday, the FDA granted approval for Moderna’s Spikevax COVID vaccine for people over the age of 18:

On January 31, 2022, the FDA announced the second approval of a COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine, and will now be marketed as Spikevax, for the prevention of COVID-19 in individuals 18 years of age and older. Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.

The procedure here is the same in the conflicted and confusing “approval” of the Pfizer vaccine late last summer. According to the FDA issued letter of authorization issued to Moderna on January 31, 2022:

SPIKEVAX (COVID-19 Vaccine, mRNA) is licensed for individuals 18 years of age and older. There remains, however, a significant amount of Moderna COVID-19 Vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization remains in place for Moderna COVID-19 Vaccine for this population.

So, in short, the Spikevax brand has an approved biologics license (BLA), but the Moderna vaccine is still an EUA approved product. Due to there being no Spikevax product manufactured or available, the EUA product, Moderna, is to be used in the interim. Due to the legal protections of an EUA product, they are to remain two different entities legally, however used interchangeably. One concerning factor regarding this interchangeable use, aside from legal protection for adverse reactions, is that under EUA, current good manufacturing practices (CGMP) can be waived for EUA products that wouldn’t be waived for BLA products.

Moderna Approved by Association?

According to page six of the authorization letter,

For the January 7, 2022 authorization revising the authorized dosing interval of the homologous booster dose to at least 5 months after completion of the primary series, the FDA reviewed: prepublications; accepted publications; published publications; and real world evidence on the safety of booster doses provided by the Israeli Ministry of Health, which includes data from approximately 4.1 million third (booster) doses of the Pfizer-BioNTech COVID-19 Vaccine given to individuals 16 years of age and older at least 5 months after the primary series, and which did not raise new safety concerns associated with the booster dose. Although the overall composition of the Moderna COVID-19 Vaccine is different than the Pfizer-BioNTech COVID19 vaccine, both are mRNA vaccines with safety and efficacy profiles that, though not identical, are relatively similar. Acknowledging the differences, it is reasonable to make the inference that the safety data on the 5 month interval for booster doses obtained in the population in Israel can apply to the Moderna COVID-19 Vaccine.

Israel exclusively uses the Pfizer vaccine. The Pfizer vaccine contains a 30-microgram dose for the teens-adult doses. The Moderna product contains 100 micrograms. That is an increase in dose of 230%, yet considered to be relatively similar.

Many countries in Europe have halted the use of the Moderna vaccines due to an increased risk of myocarditis, yet haven’t restricted the Pfizer vaccines.

Is COVID Reaching ENDemic Phase?

In fact, some major cities are reconsidering their policies regarding masking and proof of vaccination as omicron seems to “run out of fuel.” Countries around the world are ending their restrictions as well.

To further this point, a recent Johns Hopkins study demonstrated that the lockdowns were detrimental to society and individuals.

Hold the Phone — Doc’s Thoughts:

Read that press release by the FDA again. It says for the prevention of COVID 19. That’s really an odd thing to approve it for, since it doesn’t do that. In fact, we’ve heard of these “breakthrough” cases since the vaccines have rolled out. They don’t prevent COVID. If you keep reading below, especially in regard to efficacy, you’ll see that. Also, it is interesting to note that the verbiage on the Patient Package Insert, the word prevent isn’t used, but protect is. If we’re discussing legal, thorough wording, what does protect mean? Oddly, in the FDA approved product insert it states:

SPIKEVAX is a vaccine to help protect you against COVID-19. SPIKEVAX is for people 18 years of age and older. Vaccination with SPIKEVAX may not protect all people who receive the vaccine. (emphasis added)

The general product insert states it this way:

SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. (emphasis added)

The study is considered ongoing–meaning, not yet complete. Yet, here we are with a full approval of data. I am also unsure how that is possible, scientifically speaking.

Study 1 is an ongoing Phase 3 randomized, placebo-controlled, observer-blind clinical trial to evaluate the efficacy, safety, and immunogenicity of SPIKEVAX in participants 18 years of age and older in the United States.

In fact, even during the study for efficacy, the length of follow-up was quite brief:

The median length of follow-up for participants in the blinded placebo-controlled phase of the study was 4 months following Dose 2.

Speaking of efficacy, when testing blood serum for COVID-19 infection, they found:

Among these participants, there were 180 cases of asymptomatic SARS-CoV-2 infection in the SPIKEVAX group compared with 399 cases in the placebo group.

By my math, that would show to be an “efficacy” rate of 55%, not the 93% they reported far and wide. Also, keep in mind, if someone is asymptomatic, they don’t know they are ill, and they are more likely to go out in public and be around others, including vulnerable people, with the belief that because they got the shot that they are safe. If 45% of the group that had the shot are considered asymptomatic and letting their guard down, wouldn’t that likely lead to more cases being spread?

Is Moderna’s Spikevax Safe?

The product insert section titled Risk Summary under the Pregnancy section states:

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on SPIKEVAX administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

However, they did set up a registry for women to reach out to report their birth outcomes to. The study is ongoing, and the general public are the participants.

As far as toxicology:

SPIKEVAX has not been evaluated for carcinogenic, mutagenic potential, or impairment of male fertility in animals.

They’ve not evaluated this product to determine whether it is cancer causing or could mutate cells. However, some how they inherently know it’s safe? That’s odd…

Is Prevention Elusive?

Remember that question of protection versus prevention? Consider all of the breakthrough infections, the booster merry-go-round, and all of the urging for masks as you continue reading here.

In a recent article, the idea of prevention was addressed by Dr. Chris Beyrer whose Johns Hopkins departmental affiliations include Global Disease Epidemiology and Control:

Dr. Chris Beyrer, professor of public health and human rights at the Johns Hopkins Bloomberg School of Public Health, said both the mRNA and J&J vaccines were never designed to prevent infection entirely.

It’s “very hard”, he said, to prevent infection via an injected vaccine when you’re dealing with a virus that enters the body through the nose and mouth.

The Room Where it Happened

Consider the fact that there have not been any Vaccine and Related Biologics Products Advisory Committee meetings scheduled for the FDA recently. The question then is: Who approved this and with what input and considerations?