The U.S. Food and Drug Administration (FDA) has authorized new boosters today for the Moderna and Pfizer-BioNTech COVID-19 shots, even though the companies have not completed trials on human subjects and without the injections going before an advisory panel of doctors.
The FDA announced today that it has “amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as ‘updated boosters,’ contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”
“The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.”
The FDA authorized the boosters that target the BA.4 and BA.5 Omicron subvariants without complete data on how the shots performed in humans, claiming that it has enough alternate data to ensure safety. Instead, the agency is using data from other sources such as research in mice and data from the BA.1 human trials.
In the study for the current boosters, eight mice were given the BA.5 booster dose about 100 days after receiving two doses of Pfizer’s original shot. John Moore, a vaccine and virology expert at Weill Cornell Medicine stated that, “To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows. It doesn’t mimic the human situation.”
In addition to authorizing the boosters without clinical-trial data, the FDA is also bypassing the typical protocol of earlier COVID shot reviews and not having a meeting of advisers who make recommendations whether the agency should authorize a shot.
However, the FDA still insists that the COVID shots are safe and effective.
FDA Commissioner Robert Califf tweeted, “Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe.”
Yet “real world evidence” reveals otherwise.
For example, there were 22 cases of myocarditis after the Pfizer shots by February 2021 even though the drug company stated there were no “new safety issues” and the FDA waited until June 25, 2021, to include the risk of myocarditis in the fact sheets.
The risk of heart inflammation is also higher for men as old as 39 after the Moderna COVID-19 injection than after COVID-19 infection, according to a new study. Both the Moderna and Pfizer shots are associated with heart inflammation, but Moderna’s has been linked with much higher rates.
A recent Israel study found that COVID vaccination decreases sperm counts in males two months following vaccination and persists for at least five months.
Since the rollout of the experimental COVID-19 shots, U.S. health officials have claimed the shots are safe for pregnant women and their unborn babies. However, the court-ordered released Pfizer data reveals significant increased miscarriage rate among pregnant women.
In Canada, the provincial government of Manitoba reported in July 2022 that the booster shot administration rate in the province was 43.8 percent in May 2022. However, people who had received booster injections accounted for more than 70 percent of COVID-related deaths.
In the United Kingdom, the UK Health Security Agency’s COVID-19 vaccine surveillance report published on March 31, 2022, showed that 73 percent of deaths within 28 days of infection were among people who had received their injection doses, before their COVID-19 infection diagnosis was confirmed.