Is It Time To Boost? FDA Scientists Say Vaccine Effectiveness Is Holding Up
Plans from the Biden administration to allow third doses of the Pfizer covid vaccine, targeted to start next week, hinge on FDA approval. But after analyzing data submitted by Pfizer, the agency's scientists are voicing skepticism about that timing. News outlets report on the booster debate.
Stat:
FDA Scientists Strike Skeptical Tone On Covid Vaccine Boosters At This Time
Food and Drug Administration scientists have expressed skepticism about the need for additional doses of Pfizer’s Covid-19 vaccine for all people who have received it. The assessment by the agency’s staff, included in documents released Wednesday, sets up a high-stakes debate over who will need an additional booster dose — and when they will need it — at the meeting of experts being convened by the Food and Drug Administration on Friday. (Herper and Branswell, 9/15)
Roll Call:
COVID-19 Booster Debate Rages Days Before Target Rollout Date
The debate over COVID-19 booster shots for all Americans remains intense with less than a week to go before the target rollout date desired by the White House and days before government advisers plan to vote on the issue. Experts are eagerly parsing the data on booster shots after internal feuding at the Food and Drug Administration spilled into the public this week, with two top vaccine regulators arguing in a review of global data in The Lancet that there is not enough evidence to recommend them. (Kopp, 9/15)
The Wall Street Journal:
FDA Says Covid-19 Vaccines Remain Effective Without Boosters
An outside panel of scientific advisers will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion over who needs booster shots and when. ... The booster campaign hinges on FDA clearance of the additional shots and input by the panel meeting on Friday, plus a separate committee of outside experts that advises the Centers for Disease Control and Prevention. The CDC recommends who gets priority for the vaccines and when. (Hopkins and Schwartz, 9/15)
CNN:
What The Potential Covid-19 Booster Rollout Could Look Like
It's not clear if or when boosters doses of Covid-19 vaccines will be OK'd for fully vaccinated people in the United States, but state and local health departments across the United States are moving ahead with plans for a potential rollout next week. (Howard, 9/16)
More data released on the efficacy of covid vaccines —
Bloomberg:
Pfizer Says Booster Shots of Vaccine Restore Waning Immunity
Pfizer Inc. said that data from the U.S. and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants. The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots. (Langreth, 9/15)
CNBC:
Moderna Releases Data On Breakthrough Cases Backing Need For Third Doses
Moderna on Wednesday released more data on so-called breakthrough cases it says supports the push for wide use of Covid-19 vaccine booster shots. The U.S. drugmaker shared a new analysis from its phase three study that showed the incidence of breakthrough Covid cases, which occur in fully vaccinated people, was less frequent in a group of trial participants who were more recently inoculated, suggesting immunity for earlier groups had started to wane. (Lovelace Jr., 9/15)
Philadelphia Inquirer:
Moderna Vaccine Had Lowest Rate Of COVID-19 Breakthrough Cases In Delaware
Delawareans fully vaccinated with the Moderna vaccine have been the least likely to become infected with COVID-19, according to data analysis by the state, and less than 1% of people immunized with any vaccine later contracted a confirmed case of the virus. The new data from Delaware add to a growing body of early research showing that the shots offer strong protection, even as the highly transmissible delta variant circulates. (McCarthy and McDaniel, 9/15)
Bloomberg:
Booster Dose Slashes Rates Of Covid Infection In Israeli Study
A third dose of the Pfizer Inc.-BioNTech SE Covid vaccine can dramatically reduce rates of Covid-related illness in people 60 and older, according to data from a short-term study in Israel. Starting 12 days after the extra dose, confirmed infection rates were 11 times lower in the booster group compared with a group that got the standard two doses, the analysis released Wednesday by the New England Journal of Medicine found. Rates of severe illness were almost 20 times lower in the booster group. (Langreth, 9/15)
Also —
KHN:
How Fauci And The NIH Got Ahead Of The FDA And CDC In Backing Boosters
In January — long before the first jabs of covid-19 vaccine were even available to most Americans — scientists working under Dr. Anthony Fauci at the National Institute of Allergy and Infectious Diseases were already thinking about potential booster shots. A month later, they organized an international group of epidemiologists, virologists and biostatisticians to track and sequence covid variants. They called the elite group SAVE, or SARS-Cov-2 Variant Testing Pipeline. And by the end of March, the scientists at NIAID were experimenting with monkeys and reviewing early data from humans showing that booster shots provided a rapid increase in protective antibodies — even against dangerous variants. (Tribble and Allen, 9/16)
