AND THEN THERE WERE TWO — Moderna joins Pfizer in the ranks of promising coronavirus vaccines with a shot that's almost 95 percent effective in the first slice of Phase III data. Barring any last-minute safety or efficacy concerns, both companies will seek emergency use authorization within weeks — and millions of doses could be shipped in December. "We should be celebrating," Akiko Iwasaki, an immunobiologist and professor at Yale School of Medicine told Zachary Brennan. "This is a big win for science." While both vaccines are similarly effective with mostly mild side effects, Moderna's should be easier to distribute than Pfizer's because it can be refrigerated for 30 days, whereas Pfizer's can only be refrigerated for up to 24 hours. Pfizer has not provided any data on severe Covid cases from its trial, but Moderna said that of the 11 severe cases in its trial so far, zero of those occurred in people receiving the vaccine. Paul Offit, an infectious disease doctor at Children's Hospital of Philadelphia and a member of the FDA committee tasked with reviewing the vaccines, called Moderna's severe data "dramatically striking." What's next: Once the drugmakers file, FDA will convene an independent panel of experts to review the safety and efficacy data for each vaccine at a public meeting. Ideally FDA would hold one advisory committee for both vaccines, said Eric Topol, director of the Scripps Research Translational Institute. Offit also said he expects both vaccines to be reviewed in one committee meeting, possibly in early December. What changes: More positive vaccine news means more potential shots for the first wave of high-priority people. Pfizer and Moderna each say they can bring 20 million doses to the table by the end of the year, meaning 20 million total people could potentially get vaccinated in that timeframe since each vaccine is a two-dose shot. What doesn't: While those two and others with shots in late-stage trials — namely AstraZeneca and Johnson & Johnson — are ramping up production to supply billions of doses next year, widespread access still won't be likely until late spring or early summer. And details on who exactly will receive these first doses has yet to be set. The government has said its highest priority will be the elderly, health care workers and others who are medically vulnerable, but states will also draw up distribution plans. We also don't know who the vaccines are 90 percent to 95 percent protective for, Offit noted. Or to what extent they're effective for certain subgroups, like the elderly or people with preexisting conditions. What else we know: Pfizer and Moderna's results suggest that other coronavirus vaccines targeting a portion of the coronavirus that invades cells, known as the spike protein, might prove effective too. That's good news for J&J and AstraZeneca. Pfizer and Moderna also offer proof that vaccines made with the mRNA technology may work for other diseases. The data so far "highlight the power that the mRNA vaccine platform offers to very rapidly develop potent vaccine candidates and enter clinical trials," Amesh Adalja, senior scholar at Johns Hopkins Center for Health Security, said. "This will change the entire way we approach infectious disease emergencies in the future." HHS, FDA FEUD OVER LAB DEVELOPED TESTS — HHS directed the FDA to conduct speedy reviews of emergency-use applications for coronavirus tests developed by labs for their own use — three months after stripping the agency of its ability to require review of the so-called lab-developed tests, David Lim writes. "What we're speaking about here is whether universities primarily will be given the same liability protections as major corporate developers," HHS testing czar Brett Giroir said Monday. "Although these new [tests] will not make a significant impact on the nation overall, they are critically important, especially now with rising cases in many universities and university towns." FDA leaders, including Commissioner Stephen Hahn, opposed HHS' move in August to revoke the agency's authority over lab-developed tests. But HHS said that labs could seek emergency-use authorization for their tests on a voluntary basis, which would provide them a liability shield they wouldn't otherwise have. Last month, FDA said it would stop reviewing those voluntary applications to focus its limited regulatory resources on tests that could significantly increase the country's testing capacity or make testing easier. Now HHS has effectively overridden the agency's handling of lab-developed tests for a second time, by instructing it to complete reviews within 14 days. The latest HHS policy "sounds legally incoherent" and is an effort to fix "absolutely foreseeable" consequences of the department's August action, said Jeffrey Gibbs, a medical device attorney at Hyman, Phelps & McNamara. FDA isn't playing ball: The agency Monday updated its website doubling down on its stance of not reviewing LDTs. | 
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