FDA: New Variants Mean COVID-19 Vaccines, Tests May Need Tweaking
TUESDAY, Feb. 23, 2021 -- The emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants could require a quick pivot on the part of pharmaceutical and medical device companies to help stay one step ahead of COVID-19.
The U.S. Food and Drug Administration issued guidelines Monday encouraging drug and test developers to pay attention to new coronavirus variants and be prepared to make that pivot if necessary. The guidance provides recommendations for companies seeking to tweak already-approved vaccines, medicines, and tests so that they will remain effective against any new variants that emerge.
The emergence of highly infectious new SARS-CoV-2 variants out of the United Kingdom, South Africa, and Brazil has raised concerns that mutations might weaken the effectiveness of vaccines and drugs currently used to treat the disease. Studies have shown that the two vaccines now on the market remain effective in thwarting the U.K. and South African variants of the virus that causes COVID-19, but experts are worried that monoclonal antibody treatments might not work as well.
There are similar concerns about the effectiveness of COVID-19 tests to detect the new variants. The FDA has already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test. The agency also issued guidance to help pharmaceutical companies prepare for tweaks to vaccines if a new variant emerges that flouts the antibody protection provided by the Pfizer and Moderna vaccines.
"We recognize we are in a pandemic situation and we need to make sure that health care providers have the best available diagnostics, therapeutics, and vaccines to fight the virus," acting FDA Commissioner Janet Woodcock, M.D., said during a media briefing Monday. "These may need to be modified over time to remain maximally effective."
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Posted: February 2021
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