The U.S. Food and Drug Administration (FDA) has authorized yet another COVID-19 “vaccine” for public use.
The FDA approved a new Covid injection from Maryland-based pharmaceutical giant Novavax.
However, the Novavax injection was authorized for public use without any clinical trial data being provided.
Instead, FDA officials insist that animal testing data was enough to support the decision.
Despite COVID-19 not being a threat to public health, the FDA argues that Novavax’s protein-based vaccine must be pushed out quickly to provide the public with an alternative to the nRNA injections from Moderna and Pfizer.
In a statement, Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said:
“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”
Just last month, the FDA cleared new Covid mRNA shots from Moderna and Pfizer.
However, the FDA’s insistence on rushing the approval of experimental shots is causing growing concerns.
Experts warn that the federal agency should not be asserting safety and effectiveness in the absence of clinical trial data.
In a statement, Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, said:
“The assertion rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated.”
Novavax President and CEO John C. Jacobs said in a statement that the company’s vaccine showed “robust cross-reactivity against JN.1 lineage viruses” in animals.
However, the vaccines are not targeting outdated variants as JN.1 is no longer relevant.
According to sequencing performed by the U.S. Centers for Disease Control and Prevention (CDC). JN.1 was displaced in the spring by KP.3 and other variants.
In the two weeks ending August 3, the CDC estimates that KP.3 and the closely related KP.3.1.1 caused about four in 10 cases.
The agency estimated that KP.3.1.1 became the dominant strain by the end of August.
The Pfizer and Moderna injections target KP.3.
FDA officials initially advised manufacturers to target JN.1 but later recommended they target KP.3.
Because Novavax’s vaccine is built on different technology, it takes longer to manufacture than the Pfizer and Moderna shots.
Company officials told FDA advisers over the summer that they were planning to continue manufacturing a JN.1-based vaccine.
They claimed it would perform well against KP.3 and other strains from the JN.1 lineage.
However, they have not provided any data to support these claims.
The authorization is for all Americans aged 12 and older.
People who have never received a vaccine can get two doses of Novavax’s vaccine about three weeks apart.
Those who have received a Covid shot before can get a single dose.
Meanwhile, the Moderna and Pfizer mRNA injections are being pushed onto all individuals who are at least 6 months old.
The CDC recommends Covid “vaccination” for everyone aged 6 months and older.
The United States ended the COVID-19 public health emergency in 2023.
However, the government extended the emergency declaration under the Public Readiness and Emergency Preparedness Act until the end of 2024.
The FDA issued the emergency authorization under that authority.
COVID-19 levels have plummeted since early 2022, although data from wastewater and other sources have indicated a recent uptick.
Twenty-eight states are reporting high levels of COVID-19 and two states are reporting very high levels, based on wastewater, according to the CDC.
Nevertheless, very few people are actually getting sick from the virus, despite testing positive for it.
Hospitalizations and deaths attributed to COVID-19 are virtually non-existent.
