COVID Vaccine Package Labels ‘Severely Outdated’: Coalition of Health Experts Petition FDA to Update

Pfizer BioNTech and Moderna COVID-19 vaccines. (Shutterstock)

A health expert coalition published a citizen petition on Jan. 31 requesting the U.S. Food and Drug Administration (FDA) to update COVID-19 vaccine package labels with the most recent data on safety and efficacy.

In the filed petition, coalition members argued that the labels are outdated; recent safety and efficacy clinical data have not been included, and adverse events such as sudden cardiac deaths and pulmonary embolisms should also be added.

Represented by professor Linda Wastila from the University of Maryland, the nine members of the Coalition Advocating for Adequately Labeled Medicines (CAALM) petitioned on Jan. 31, 2023, for 10 amendments to messenger RNA (mRNA) vaccine labels.

The Current COVID Vaccine Label is ‘Severely Outdated’

One-half of the requested amendments were related to safety and the other half to vaccine efficacy.

The main message of the petition is that the public and the health care community need to have “the latest and most up-to-date information,” coalition member and renowned drug safety advocate Kim Witczak wrote in an email to The Epoch Times. The current label is “severely outdated.”

People have the right to have informed consent, she added.

The coalition’s first request is to update package labels with a statement saying that the vaccines do not and were not sufficiently tested on their ability to prevent transmissions, since many health officials and leaders of pharmaceutical companies have made comments that suggest there is established evidence that the vaccines are efficacious against infection and transmission.

The coalition also requested fact sheets and package labeling on bivalent boosters to include the most recent safety and efficacy data, and to also include a statement that many of the primary shot and booster authorizations were based on surrogate data that do not predict vaccine efficacy.

Missing Information: Pregnancy Trial Results and 4 Major Adverse Events

A major amendment request that is of personal importance to Wastila is the fifth one, which requests the FDA to add a clear statement disclosing that there was a Pfizer phase 3 randomized trial in pregnant women that was completed as of July 2022, but no results have been reported.

“We think that part of the reason is because the results are so bad,” Wastila, whose expertise is in pharmacotherapy and drug policy, told The Epoch Times. “Or they can’t report it because the samples [are] too small.”

Pfizer originally intended to recruit 4,000 pregnant women, but just short of 350 participated.

Many of the amendments were related to information on vaccine safety or the lack of in-package labels.

The coalition also requested the FDA add four adverse events to mRNA package labels, including multisystem inflammatory syndrome in children, pulmonary embolism, sudden cardiac death, and neuropathic and autonomic disorders.

These four adverse events are either critical or fatal, and evidence of such adverse events is all based on studies funded by U.S. federal or state health agencies.

Evidence From Health Agencies, Manufacturers, and Peer-Reviewed Studies

The coalition previously petitioned in July 2021 requesting the FDA to not give Pfizer and Moderna shots full approval without sufficient data on safety and efficacy. The FDA issued a letter rejecting the petition on Aug. 23, 2021, the same day Pfizer primary shots were given full FDA licensing.

A major reason for the FDA’s refusal was that the amendment requests lacked a scientific basis.

“So the references for this [petition], they almost all come from Pfizer, Moderna, FDA, CDC (U.S. Centers for Disease Control and Prevention), or some top-notched peer-reviewed manuscripts,” Wastila explained. “So I don’t think they can use that claim.”

According to Title 21 of the Code of Federal Regulations, adverse events are defined as “any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.”

Pfizer’s (pdf) and Moderna’s definitions of adverse events are similar to the FDA’s, and this would mean that the studies cited in the petition that tracked untoward medical occurrences after vaccination are arguably vaccine-adverse events.

Causal relationships do not need to be established before the adverse event is added to the label.

However, Wastila acknowledged that everyone may interpret what it means to be an adverse event differently.

She believes that if people exposed to the treatment feel that their health has been negatively impacted, their experiences should be recorded as an adverse event.

“[If] they feel that it was caused by exposure, it should be treated and respected as such,“ Wastila said. ”The integrity of the patient-physician relationship ... [is that] a patient knows best, but we’re not honoring that process at all.”

Other Missing Information

Additional updates to package labeling requested by petitioners include adding adverse events related to reproductive health. This includes statements on decreased sperm concentration, heavy menstrual bleeding, menstrual cycle changes, and detection of vaccine mRNA in breast milk.

Myocarditis, which is listed as an adverse event on the package labels, would need to be updated for frequency, as per the petition’s requests.

A prospective study in Thailand that measured cardiovascular injuries in 301 students given two doses of the Pfizer vaccine found one case of myopericarditis, giving a possible frequency of one out of 301 per two-dosed individuals.

A study in Hong Kong male teens reported the suspected risk of myocarditis or pericarditis to be around one out of 2,700 following two Pfizer doses. The FDA’s own analysis estimated myocarditis or pericarditis risk to be about one out of 5,000 among double-dosed 16-to-17-year-old males.

Other amendment requests are to add that Pfizer’s vaccine efficacy starts to wane after two months, supported by data from the company’s own clinical trial, and that the authorized vaccines have a buffering ingredient that was not tested for safety, efficacy, and bioavailability in the clinical trials.

The FDA’s Response

Under the Code of Federal Regulations Title 21, the FDA has until April 30, 2023, to respond to the petition.

The FDA issued a letter on Jan. 31, 2023, acknowledging that the letter has been received, but has not issued any statement since responding to the contents of the petition.

“I would like to think that our petition would get a serious consideration by the FDA,” Witczak wrote to The Epoch Times. “However, I am not holding my breath, given that our first citizen petition that raised many of these concerns in early 2021 was denied the day that FDA approved Comirnaty.”

Wastila said that if the FDA denies part of the petition on scientific merit, “they would be contradicting their own positions and analyses.”

This will open up an opportunity for debate and discussion, which will increase transparency.

The FDA did not immediately respond to requests for comment.

Pfizer and Moderna also did not immediately respond to requests for comment.