Manufacturers may need to modify vaccines to protect against new coronavirus variants - U.S. FDA


By Reuters Staff

(Reuters) - Vaccine developers may need to modify their vaccines to provide protection against any potential new variants of the coronavirus in the United States should they fail to elicit immune response in their current form, the U.S. health regulator said on Monday.

"At this time, available information suggests that the FDA-authorized vaccines remain effective in protecting the American public against currently circulating strains of SARS-CoV-2," the U.S. Food and Drug Administration said in a statement.

The agency made the comments as part of a newly updated guidance for companies making vaccines, tests and therapeutics for COVID-19 (

The emergence of new variants that are considered more infectious has prompted the U.S. government to step up efforts to track coronavirus mutations and keep vaccines and treatments effective against any new variants.

As part of its updated guidance, the FDA recommended that vaccine makers test any modified vaccines in both previously unvaccinated people and vaccinated people. The manufacturers should compare the immune response of a modified vaccine against both the new variant as well as the original virus.

The FDA also recommended monitoring test subjects' safety for at least seven days, to support emergency use authorization for modified vaccines.

Related Articles

Option B+ antiviral regimen helps mothers achieve HIV suppression

By Lisa Rapaport (Reuters Health) - Antiretroviral therapy (ART) initiated during pregnancy and continued postpartum to help prevent maternal-child transmission of HIV may also help mothers sustain Read More »

Brazil prosecutors seek to stop purchase of Indian vaccine

By Reuters Staff BRASILIA (Reuters) - Brazilian prosecutors are seeking the immediate suspension of purchases of India's COVID-19 vaccine COVAXIN, according to a document seen by Reuters on Friday, Read More »

U.S. urges vaccine-sceptical Tanzania to review evidence on the COVID-19 shots

By Reuters Staff NAIROBI (Reuters) - The Unites States urged vaccine-sceptical Tanzania on Friday to review evidence on the drugs, saying they work and are one of the tools to fight off the COVID-19 Read More »

© 2021 /alert® unless otherwise noted. All rights reserved.
Reproduction in whole or in part without permission is prohibited.
Privacy Policy | Terms of Use
Do Not Sell My Personal Information