Data published Wednesday from the agency adds to the debate over whether an extra dose of the vaccine is warranted.
To bolster its case, Pfizer pointed the FDA to data from Israel, which began offering boosters over the summer.
The FDA’s reviewers, however, suggested they would mainly look to research on how the vaccines are working among Americans, saying that “may most accurately represent vaccine effectiveness in the U.S. population.” Dr. Anna Durbin of Johns Hopkins School of Public Health said it’s important to understand the FDA’s decision simply is whether an extra dose is safe and does what it promises — to raise immunity levels.does those two things, then the Centers for Disease Control and Prevention will have to decide who should get another dose.
For the average person, what’s the evidence that immunity is waning? The CDC says real-world data show protection against severe illness, hospitalizations and deaths is holding strong. But in one recent study, protection against infection slipped as the delta variant hit: It was 91 percent in the spring but 78 percent in June and July. The CDC also has seen a hint that for people 75 and older, protection against hospitalizations slightly declined in the summer.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Pfizer says data suggests vaccine boosters needed for waning vaccine efficacyPfizer told the FDA Wednesday that data from its clinical trials suggests a third shot of its coronavirus vaccine may be necessary six months after the second dose because of waning efficacy.Why it matters: The FDA's advisory committee on Friday is expected to review Pfizer's clinical trials and other supporting and conflicting data on coronavirus booster shots and make recommendations on whether more Americans 16 years and older should receive an extra dose.Stay on top of the latest market tren
Read more »
New Pfizer data makes case for booster shots 6 months after primary dosesThe Food and Drug Administration on Wednesday released new data from Pfizer's submitted application to approve booster doses of its Covid-19 vaccine. In it, Pfizer demonstrates what it sees as proof that third shot will be both safe and necessary for most Americans to take, arguing that immunity wanes over time -- regardless of any new variant of concern. It comes two days ahead of a critical juncture in the COVID-19 vaccine booster approval process: Friday, the Food and Drug Administration's independent advisory committee (VRBPAC) is set to convene to review and discuss the latest data on potential booster doses of the Pfizer vaccine.
Read more »
New Pfizer data makes case for booster shots 6 months after primary dosesBREAKING: Pfizer demonstrates what it sees as proof that third shot will be both safe and necessary for most Americans to take, arguing that immunity wanes over time—regardless of any new variant of concern—according to new data released by the FDA.
Read more »
Pfizer submits data to FDA showing side effects from Covid booster shots are similar to the second dose
Read more »
Pfizer says third COVID shot gives antibodies in threefold, likely can handle Delta variantThe FDA on Wednesday posted much of the evidence from Pfizer on booster shots to be considered by its advisory panel on Friday.
Read more »
FDA Says Covid-19 Vaccines Remain Effective Without BoostersThe Food and Drug Administration said vaccines cleared in the U.S. currently provide protection against severe disease and death from Covid-19, potentially complicating the Biden administration’s deliberations over the need for booster shots
Read more »