STATEN ISLAND, N.Y. — The Food and Drug Administration (FDA) announced Monday that manufacturers of vaccines adapted for emerging coronavirus (COVID-19) variants would not be required to complete lengthy clinical trials.
The guidance, issued by the agency in a 24-page document, comes as concerning mutated forms of the virus that sparked the pandemic are becoming more widespread in the United States.
“By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts,” said Acting FDA Commissioner Dr. Janet Woodcock.
While the FDA said available information suggests that the vaccines currently granted emergency use authorization — from Pfizer and Moderna — remain effective in protecting against currently circulating coronavirus strains, the agency said the possibility of a mutated form of COVID-19 becoming moderately or fully resistant to the antibody response caused by the current immunizations could warrant alterations to the inoculations.
So, the FDA is enabling the eligible vaccine manufacturers to forego time-consuming clinical trials and instead utilize a process used for annual flu vaccines.
Under the new guidance, companies would have to submit new data indicating the modified vaccine was safe and produced an immune response similar to the company’s originally-authorized vaccination.
The FDA also expects the vaccine creators to continue to study the modified vaccines’ efficacy against emerging strains.
“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” Woodcock added.
Variations of the coronavirus, first discovered in the United Kingdom and South Africa, are believed to be more transmissible, officials have said. Currently available vaccines have been shown to have reduced effectiveness against both forms of the virus — particularly the South African variant, known as B.1.351 — but still appear to lessen the severity of the disease.
The Centers for Disease Control and Prevention (CDC) previously said the U.K. variant of the coronavirus — known as B.1.1.7 — could become predominant in the U.S. by March. The British government previously said B.1.1.7 is “likely” to carry an increased risk of hospitalization and death.
Both Pfizer and Moderna said they intend to test COVID-19 “booster” shots to help offer additional protection against the South African variant.
The FDA also issued guidance Monday aimed at diagnostic test makers and those who utilize monoclonal antibody treatments — advising both groups to monitor how emerging variants might alter their effectiveness.