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Covid-19 vaccines work so well that most people don’t yet need a booster, an all-star panel of scientists from around the world said in a review that’s likely to fuel debate over whether to use them. Governments would be better served to focus on immunizing the unvaccinated and to wait for more data on which boosters would be most effective and at what doses, the authors, who included two prominent U.S. Food and Drug Administration experts, argued in the medical journal The Lancet. They based their assessment on a wide range of real-world observational studies as well as data from clinical trials. (Kresge, 9/13)

An expert review of scientific evidence to date has concluded that Covid-19 vaccine booster shots are not needed at this time for the general public, a group of leading U.S. and international scientists said Monday in the peer-reviewed journal The Lancet. The conclusion by scientists, including two senior Food and Drug Administration officials and the World Health Organization, came as studies continue to show the authorized Covid vaccines in the U.S. remain highly effective against severe disease and hospitalization caused by the fast-spreading delta variant. (Lovelace Jr., 9/13)

Two departing Food and Drug Administration regulators argued in a review published Monday that none of the data on coronavirus vaccines so far provided credible evidence in support of booster shots for the general population. Their assertion revealed significant disagreement between career scientists at the agency and top Biden health officials, who have already started planning a broad booster campaign for this fall. The review, published in The Lancet, was written by an international group of vaccine experts including Dr. Philip Krause and Marion Gruber, longtime F.D.A. scientists who recently announced that they would leave the agency. It comes days before an advisory committee is to publicly discuss and vote on whether the F.D.A. should approve additional doses of Pfizer-BioNTech’s vaccine for people 16 and up. (Weiland and Mandavilli, 9/13)

Gov. Jared Polis announced the COVID-19 vaccine booster shot program for Colorado on Monday afternoon. He said that the boosters would be here by Sept. 20 for Pfizer recipients and Moderna a few weeks later. There is no timeline for a Johnson & Johnson booster. Polis said that boosters are especially important for Pfizer recipients and those who have weaker immune systems. “The benefits outweigh the costs overwhelmingly and the FDA needs to get out of their ivory tower and realize there’s a real-life pandemic with over 900 hospitalizations in Colorado, tens of thousands across the country… We have the ability to end it,” said Polis. (McRae, 9/13)

Amy Piccioni is not a doctor or a scientist, but as word of breakthrough coronavirus infections in vaccinated people started spreading this summer, she waded through an array of technical and often contradictory information about the need for coronavirus booster shots. Then she decided for herself: She would not wait for federal regulators to clear them before finding one. “It takes a long time for scientists to admit that some people need a booster,” said Ms. Piccioni, 55, who received the one-dose Johnson & Johnson vaccine last November through a clinical trial and timed her booster around a visit to her father in July, thinking it would protect her on the plane. She walked into her local Walgreens, asked for a Pfizer shot and got it, no questions asked. (Steinhauer, 9/14)

In just a week, COVID-19 vaccine boosters could begin to be available to all fully vaccinated Americans. But exactly who will be eligible and when won't be decided until two key scientific advisory committees meet days before the Biden administration's Sept. 20 start date. That leaves little reaction time for health care system administrators like Dr. Tammy Lundstrom, chief medical officer for Michigan-based Trinity Health, which operates 91 hospitals and 120 continuing care facilities in 22 states. "We have our data team poised, ready to hit the button to help us identify all our patients who are ready for a booster," Lundstrom said. "We're anxiously waiting for guidance, as is everybody." (Weise, 9/13)

With flu season swiftly approaching in a country already battling a resurgence of the coronavirus, experts are urging Americans to avail themselves of any and all vaccines they are eligible for — whether it’s their first coronavirus vaccination, a booster vaccine dose to combat waning immunity or a flu shot. “It’s terribly important” to get both the flu and coronavirus vaccines, said William Schaffner, medical director of the National Foundation for Infectious Diseases. “They are both very nasty respiratory viruses that can make many people very, very sick.” (Chiu, 9/13)