Morning Briefing
Summaries of health policy coverage from major news organizations
Vaccine Search Progresses, But Is It Too Fast?
Healthcare workers, first responders, and adults with pre-existing conditions that put them at risk for severe symptoms of COVID-19 should be the initial recipients of the first approved vaccine in the United States, according to a framework from the National Academy of Medicine (NAM) published yesterday. Today, NAM will hold a virtual public meeting on the recommendations. The NAM report offers a detailed approach about how to best prioritize and allocate a COVID-19 vaccine. Even though the virus was discovered only in December of 2019, several countries have produced vaccines that are currently in late-stage clinical trials, and US President Donald Trump has said America could see a vaccine by the end of the year. (9/2)
Esther Aviles wants to help her special-needs students and her nine nieces and nephews.Joseph Shilisky believes the world needs ordinary people like him to step up.聽Robert Huebner likes to be among the first, whether it's the first to try a new computer game, a new restaurant, or聽鈥 now聽鈥 a new vaccine. All three are among the early volunteers in clinical trials to test potential COVID-19 vaccines. Vaccine developers have already shown basic safety, with no severe reactions in early trials. And they've shown their candidate vaccines trigger the kind of immune response they want to see. (Weintraub, 9/2 )
As many hope for a vaccine to bring Covid-19 under control, a leading vaccine expert warned against using an emergency use authorization (EUA) to put one on the US market as soon as possible. "How can you justify a substandard or lesser review for something that would be injected in tens of millions, maybe hundreds of millions of Americans?" Dr. Peter Hotez, a professor and the dean of Tropical Medicine at Baylor College of Medicine, said in series of social media posts Wednesday. (Holcombe and Erdman, 9/3)
In April, more than three months before any coronavirus vaccine would enter large clinical trials, the mayor of a picturesque island town in the Pacific Northwest invited a microbiologist friend to vaccinate him. The exchange occurred on the mayor鈥檚 Facebook page, to the horror of several Friday Harbor residents following it.鈥淪hould I pop up and get your vaccine started?????,鈥 wrote Johnny Stine, who runs North Coast Biologics, a Seattle biotech company with a focus on antibodies. 鈥淒on鈥檛 worry 鈥 I鈥檓 immune 鈥 I have boosted myself five times with my vaccine.鈥 (Murphy, 9/1)
Another vaccine heads into human trials 鈥
Vaccine giants Sanofi and GSK are joining the ranks of Covid-19 vaccine makers testing their candidates in people, launching a large Phase 1/2 clinical trial Thursday that will take place at 11 sites across the United States. The trial, which is expected to be completed by early December, would pave the way for a pivotal Phase 3 efficacy trial to start the same month, if the experimental vaccine proves to be safe, tolerable, and appears to be generating enough of an immune response to proceed. (Branswell, 9/3)
As the first generation of Covid-19 vaccines moves into large-scale Phase 3 trials, a slower but much-watched effort from two of the world鈥檚 biggest vaccine makers is now being tested in humans for the first timeGlaxoSmithKline (ticker: GSK) and Sanofi (SNY) announced early Thursday morning that their Covid-19 vaccine was entering a 440-patient Phase 1/2 clinical trial in the U.S. The companies say they could have results in early December, and would aim to start a Phase 3 trial before the end of the year. They say they hope to seek regulatory approval for the drug in the first half of next year. (Nathan-Kazis, 9/3)
French drugmaker Sanofi (SASY.PA) and its British peer GSK (GSK.L) have started a clinical trial for a protein-based COVID-19 vaccine candidate, as pharmaceutical companies race to develop treatments against the COVID-19 pandemic.Sanofi and GSK said on Thursday that they had started the 鈥淧hase 1/2鈥 trial for their adjuvanted COVID-19 vaccine, which they hope to make available across the world. (Kar-Gupta, 9/3)
In other vaccine news 鈥
A systematic review and meta-analysis of 62 studies has found that immunity conferred by the measles, mumps, and rubella (MMR) vaccine fades each subsequent year, suggesting that vaccination strategies should be revisited. The study, published yesterday in The Lancet Infectious Diseases, showed that 96.0% of patients inoculated with the two-dose trivalent MMR vaccine initially developed antibodies against measles, while 93.3% had antibodies against mumps when excluding the Rubini strain (91.1% when including it), and 98.3% produced protective antibodies against rubella. But that immunity lessened each year. (9/2)