BOOST ME UP, SCOTTY — It’s been a nonstop week of news on Covid-19 vaccines, and we’re not even getting into the Nicki Minaj tweet-heard-’round-the-world . Today a panel of independent advisers to the FDA will vote on whether to recommend that regulators approve booster doses of Pfizer’s Covid vaccine for Americans 16 and older. We’re expecting things to get a bit testy after weeks of tension over what some say is a White House not run by former President Donald Trump getting ahead of science. Lay of the land: The meeting kicks off at 8:30 with roll call, followed by opening remarks from Center for Biologics Evaluation and Research Director Peter Marks and Office of Vaccines Research and Review Director Marion Gruber. Yes, the same Gruber who signed onto the Lancet essay panning widespread booster shots. Israeli scientists will present their data showing that boosters cut the risk of severe Covid in elderly citizens, and Pfizer will make its case before an afternoon of discussion and voting. Tea leaves: FDA has yet to post its voting questions, making it unclear what exactly its advisers will be voting on. The discussion topic, per a document posted Wednesday, is “whether the data presented by Pfizer support the safety and effectiveness of a booster dose of COMIRNATY administered 6 months post primary vaccination series.” The agency stayed neutral on the question in its briefing document and expressed skepticism toward some of Pfizer’s claims — namely that waning vaccine effectiveness is most likely a function of time rather than the Delta variant evading antibodies, and that the Israeli data made the case for boosters. “US-based studies of post-authorization effectiveness of [the Pfizer-BioNTech vaccine] may most accurately represent vaccine effectiveness in the US population," regulators said. The Israeli data’s limitations — short follow-up window, sparse information about the booster’s effects on younger populations — has some public health experts worried. “In an ideal world, we’re not talking about Israeli real-world data when we’re deciding if we’re going to give millions of people an extra dose of the vaccine,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. The roster: Several advisory committee members are marked as absent for the meeting. One of them, Paul Spearman of Cincinnati Children’s Hospital Medical Center, told Rx Pulse he has a conflict of interest since he’s involved in ongoing vaccine trials, as are other members. Temporary voting members have been added to the docket. Looking ahead: Should the FDA give regulatory approval to the booster following the meeting, CDC’s own advisory panel will meet Wednesday and Thursday to consider clinical recommendations for the third dose’s administration. White House spokesperson Jen Psaki said the Biden administration is “prepared” to act on boosters — once, of course, the government follows the proper regulatory channels. “Our objective is to be prepared should all of this process move forward,” she said Thursday. “It's always been pending the approval of the ACIP and the FDA.” ICYMI: Pfizer and BioNTech plan to seek approval from FDA to give the vaccine to children between 6 months and 5 years old in November, provided the data holds up, POLITICO Europe’s Jules Darmanin reports. MODERNA PLUGS DATA IT ARGUES SUPPORTS AUTHORIZATION OF BOOSTER — Moderna announced Wednesday it intends to seek emergency use authorization of a third dose of its vaccine, citing data it says demonstrates a booster minimizes the chance of breakthrough infection. Moderna executives insisted Wednesday that it was essential to move fast on boosters and forecast that waning immunity among people with two doses would drive 600,000 additional Covid-19 cases in the U.S. this fall and winter. "We think the time to [administer boosters] is too early rather than too late," Moderna President Stephen Hoge said in a briefing. The company said people who received their second shot roughly eight months ago were 36 percent less likely than people vaccinated 13 months ago to experience a breakthrough infection, suggesting immunity wanes over time. Eighty-eight people in the more recent vaccination batch reported breakthrough cases compared to 162 cases in the group vaccinated last year. Among those cases, 19 were severe but there was not a significant difference between the two groups on serious illness. NOVAVAX RE-EMERGES — The company said Thursday that participants in the ongoing Phase III trial of its Covid-19 vaccine are considered fully vaccinated by the CDC two weeks after their last dose. That means those volunteers won’t have to drop out of the trial to get additional shots to meet Covid vaccination requirements, such as President Joe Biden’s mandate for companies with 100 or more employees. The CDC’s guidance applies to clinical trial participants who have received any vaccine that FDA has not yet authorized or approved but which has been listed for emergency use by the World Health Organization. BIDEN PREPS GLOBAL COVID PLAN AHEAD OF UN SUMMIT — The Biden administration met Wednesday with several groups to discuss a slate of proposals expected to be announced at a virtual global Covid-19 summit on the sidelines of the United Nations General Assembly next Wednesday. A document obtained by POLITICO proposes detailed global targets on vaccination, treatments and testing amid surging global infections fueled by the Delta variant and criticism of the U.S. for pushing ahead on booster plans while low- and middle-income countries struggle to obtain initial vaccine doses. The Washington Post first reported the top-line goals of Biden’s vision, including a goal to vaccinate 70 percent of the world population by this time next year. The U.S. wants to gather at least $12 billion to fund the global vaccination effort and address a global shortage of oxygen. It also wants to make authorized Covid-19 therapeutics available for 12 million severe and critical patients and expand global manufacturing by promoting technology transfers. Another goal is to donate at least 1 billion tests by 2022 and make antigen tests available for no more than $1 per kit in low- and middle-income countries. |