FDA issues updated guidance on adapting Covid-19 vaccines, tests and therapeutics for coronavirus variants
3 years, 10 months ago

FDA issues updated guidance on adapting Covid-19 vaccines, tests and therapeutics for coronavirus variants

CNN  

CNN — The US Food and Drug Administration has issued updated guidance for companies that plan to adapt their Covid-19 medical products – including vaccines, tests and therapeutics – to address the emergence of coronavirus variants. The agency said in an announcement on Monday that it expects that “manufacturing information will remain generally the same” for authorized Covid-19 vaccines that may be updated to target variants. “For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine,” the agency noted in its announcement. According to the FDA guidance, studies to assess the effectiveness of a Covid-19 vaccine’s primary shot and booster dose should compare the immune response induced by the modified version of the vaccine to the original vaccine, and researchers should conduct a “booster study” in which the modified vaccine is administered to those who previously received the original vaccine. FDA officials said during Monday’s call that some of the updated guidance for Covid-19 vaccines is modeled after what is already done for the development of seasonal influenza vaccines.

History of this topic

Coronavirus FAQ: I didn't get the latest COVID vaccine. Should I? And if so ... when?
2 weeks, 5 days ago
Wondering If It's Too Late To Get A COVID Vaccine Before Thanksgiving? Read This.
4 weeks, 1 day ago
New COVID-19 vaccines targeting JN.1 variant under review by Therapeutic Goods Administration
3 months, 3 weeks ago
As COVID wave wallops California, new vaccines arrive this week. Will it be a turning point?
3 months, 4 weeks ago
An update on fall respiratory viruses
4 months ago
FDA approves updated COVID-19 vaccines; shots should be available in days
4 months ago
The new COVID shot is now available. Here's what you need to know
4 months ago
COVID-19 variant KP.3.1.1 predominant in US as infections continue ticking up
4 months ago
‘Playing COVID roulette’: Some infected by FLiRT variants report their most unpleasant symptoms yet
5 months, 2 weeks ago
As COVID-19 ticks up in some places, US health officials recommend a fall vaccination campaign
5 months, 3 weeks ago
As COVID-19 ticks up in some places, US advisers recommend a fall vaccination campaign
5 months, 3 weeks ago
FDA advisers urge targeting JN.1 strain in recipe for fall’s COVID vaccines
6 months, 2 weeks ago
There’s a new highly transmissible COVID-19 variant. Could FLiRT lead to a summer uptick?
7 months, 2 weeks ago
Does frequently updating COVID-19 vaccines have any benefits? | Explained
10 months, 1 week ago
What you need to know as fall vaccinations against COVID, flu and RSV get underway
1 year, 2 months ago
Where Southern Californians can find the new COVID-19 vaccine
1 year, 3 months ago
When should I get vaccinated for COVID-19? Flu? RSV?
1 year, 3 months ago
COVID-19: US CDC recommends updated boosters for Americans, President Joe Biden calls it important milestone
1 year, 3 months ago
What To Know About New COVID Boosters And Who Is Eligible
1 year, 3 months ago
Americans can now get an updated COVID-19 vaccine
1 year, 3 months ago
New COVID-19 vaccinations are coming, CDC says. The shots will likely be available this week
1 year, 3 months ago
Updated COVID vaccines will be available later this week, recommended for everyone six months and up
1 year, 3 months ago
US FDA authorizes Pfizer-BioNTech, Moderna's updated Covid shots
1 year, 3 months ago
U.S. approves updated COVID vaccines to rev up protection this fall
1 year, 3 months ago
US approves updated COVID vaccines to rev up protection this fall
1 year, 3 months ago
FDA approves updated COVID vaccines to rev up protection this fall
1 year, 3 months ago
Updated COVID shots are coming. They’re part of a trio of vaccines to block fall viruses
1 year, 3 months ago
FDA vaccine adviser Dr Paul Offit says healthy young people don't need another Covid booster - despite new BA.2.86 variant pushing virus rates up
1 year, 3 months ago
Gov. DeSantis and Florida surgeon general warn against new COVID-19 restrictions and vaccine
1 year, 3 months ago
Moderna says updated COVID vaccine is effective against ‘highly-mutated’ BA.2.86 variant
1 year, 3 months ago
New COVID vaccine, due as early as next week, appears to work well against Pirola subvariant
1 year, 3 months ago
Biden says new Covid vaccines are 'likely' to be recommended to EVERY American this fall - including children - amid upswing in infections
1 year, 3 months ago
With coronavirus uptick, should I get a COVID shot? When are new vaccines available?
1 year, 4 months ago
Next round of COVID-19 shots in fall will target latest omicron strain
1 year, 6 months ago
FDA advisers endorse updating COVID vaccines to target latest omicron strain
1 year, 6 months ago
An FDA panel meets about which COVID strains the U.S. will target with vaccines
1 year, 6 months ago
FDA advisers back updated COVID shots for fall vaccinations
1 year, 6 months ago
COVID vaccine should be updated to target XBB strain, FDA committee says
1 year, 6 months ago
CDC signs off on additional Covid-19 booster doses for certain people
1 year, 8 months ago
No need for booster vaccine against coronavirus this spring, experts decide
1 year, 9 months ago
No need for booster vaccine against coronavirus this spring, experts decide
1 year, 9 months ago
FDA advisers set to consider one-and-done annual covid booster plan
1 year, 10 months ago
FDA’s advisors back plan to simplify COVID-19 vaccinations
1 year, 10 months ago
FDA proposes once-a-year COVID-19 shots for most Americans
1 year, 11 months ago
FDA wants to simplify the use and updating of Covid-19 vaccines
1 year, 11 months ago
FDA vaccine advisers ‘disappointed’ and ‘angry’ that early data about new Covid-19 booster shot wasn’t presented for review last year
1 year, 11 months ago
NOT REAL NEWS: A look at what didn't happen this week
2 years ago
As COVID-19 spikes in California, booster shots could make all the difference
2 years ago
US renews push for COVID boosters as data show they protect
2 years, 1 month ago
Panel votes to add COVID shots to recommended vaccinations
2 years, 2 months ago

Discover Related