FDA Authorizes New COVID-19 Vaccine Without Clinical Data

A dose of Novavax's COVID-19 vaccine is prepared, in this file image. Joroen Jumelet/ANP/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer.

Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product.

FDA officials said that animal testing data supported the decision.

“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,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 30 statement.

The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid (mRNA) technology earlier in the month.

Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data.

“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,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times previously via email.

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.

JN.1 was displaced in the spring by KP.3 and other variants, according to sequencing performed by the U.S. Centers for Disease Control and Prevention.

The CDC estimates that KP.3 and the closely related KP.3.1.1 caused about four in 10 cases in the two weeks that ended on Aug. 3. The agency estimated that KP.3.1.1 became the dominant strain by the end of August.

The Pfizer and Moderna vaccines 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 mRNA shots. Company officials told FDA advisers over the summer that they were planning to continue manufacturing a JN.1-based vaccine and believed it would perform well against KP.3 and other strains from the JN.1 lineage.

The authorization is for people aged 12 and older. People who have never received a vaccine can get two doses of Novavax’s vaccine about three weeks apart. People who have received a vaccine before can get a single dose.

The Moderna and Pfizer vaccines are available for individuals who are at least 6 months old.

The CDC is recommending vaccination for all people aged 6 months and older.

The United States ended the COVID-19 public health emergency in 2023 but 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. Hospitalizations and deaths attributed to COVID-19 have also been climbing, although the numbers are far lower than the highs recorded in 2021 and 2022.