FDA Renews Emergency Use Authorization for Updated COVID-19 Vaccines

The FDA has approved new formulations of the COVID-19 vaccines under Emergency Use Authorization (EUA). The fact sheet released by the FDA states, “An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. A product authorized for emergency use has not undergone the same type of review by the FDA as an FDA-approved product.  FDA may issue an EUA when certain criteria are met, which include the fact that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective in preventing COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks. All of these criteria must be met to allow the product to be used during the COVID-19 pandemic.”

The EUA has renewed authorizations for new COVID-19 vaccine formulas produced by Pfizer BioNtech, Moderna, and Novavax. The HighWire has reported extensively about the adverse events associated with these vaccines, including the statements from the V-safe data uncovered only from a lawsuit by the Informed Consent Action Network (ICAN) led by Attorney Aaron Siri.

Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, stated, “The COVID-19 vaccines have had a tremendous positive impact on public health, and vaccination continues to be the most effective method for COVID-19 prevention.” ICAN wrote a letter to Peter Marks in 2022 accusing him of violating the terms of the EUA by releasing promo videos for the COVID-19 vaccines. Within those promo videos, Marks and the FDA fail to state that the vaccines have “not been approved or licensed by the FDA.” Nearly two years later, both videos are still available on YouTube. Marks has not responded to the allegations as Siri requested. The HighWire also reported on this event in the fall of 2022.

The Novavax, Pfizer, and Moderna fact sheets for recipients and caregivers state, “If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.” The fact sheet for health care providers administering vaccines states, “All pregnancies have a risk of birth defect, loss, or other adverse outcomes.” It goes on to say, “Available data on [Novavax, COMIRNATY (Pfizer), Spikevax (Moderna)]  administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

All of the vaccine inserts also state that it is unknown whether the vaccine ingredients are excreted in human milk, which is a concern for lactating mothers.

Jeffery Jaxen reported on the questions arising from Pfizer’s human trials regarding the safety of the COVID-19 vaccines for pregnant mothers and their offspring. Jaxen showed 348 maternal participants in the study, and 335 infants were born. Jaxen described the study as “underpowered,” meaning the sample sizes are too small to effectively determine some risk factors.

In that study, 13 infants are unaccounted for. As Jaxen reported, the FDA gave the “green light” to Pfizer to conduct their clinical study with a smaller sample size. There was one fetal death reported while the outcome of the other 12 pregnancies remains unknown. 29 babies in the placebo group and 15 babies in the vaccine group did not make it to the 6-month surveillance period. In the long-term follow-up, the placebo group also received the BioNTech vaccine, which means there is no real control group.

The fact sheets state, “Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant individuals.” They also point to animal studies to say that there is no evidence of fetal risk when taking these vaccines.

Naomi Wolf appeared on The HighWire to explain that Pfizer hid potential harm from pregnant individuals. The only study they conducted to evaluate the effect on fetal health was on 42 rats that were followed up for 44 days. They did not allow the rats to give birth but autopsied the pregnant rats and determined it was safe. The study was conducted by employees of Pfizer and BioNTech, who also own company stock.

The CDC is currently recommending updated COVID-19 shots for everyone over the age of 6 months old and continues to state that “hundreds of millions of people in the United States received COVID-19 vaccines under the most intense safety monitoring in U.S. history.” This seems contradictory to the FDA statement, “A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product.”

The CDC currently tracks testing data, hospitalizations, ER visits, and deaths. The CDC shows a 17% positive COVID test rate as of September 4, 2024. This means 17% of the COVID tests that have been tracked were positive. This number may be misconstrued to mean that 17% of the population tested for COVID over the week. 2.5% of ER visits were by patients who tested positive for COVID-19. Hospitalizations, ER visits, and deaths are referred to as “COVID-19-associated.” This means the primary cause of the death or hospitalization could be related to other factors, but the patient tested positive for COVID-19 at the time.

The HighWire reported in July about recent studies that link COVID-19 vaccines to excess deaths and heart failure.