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Morning Briefing

Summaries of health policy coverage from major news organizations

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Tuesday, May 19 2020

Full Issue

Promising Results In Moderna Trial Just A Baby Step On Long Path Toward Successful Vaccine

The encouraging data comes from just eight people who took part in a 45-subject safety trial that kicked off in March. But the study did find that the vaccine appears to generate an immune response similar to that seen in people who have been infected by the virus and recovered. The FDA gave Moderna the green light to begin a Phase II study expected to enroll an additional 600 volunteers.

The first coronavirus vaccine to be tested in people appears to be safe and able to stimulate an immune response against the infection, the manufacturer, Moderna, announced on Monday, offering a glint of hope to a world desperate for ways to stop the pandemic. The preliminary findings, in the first eight people who each received two doses of the experimental vaccine, must now be repeated in far larger tests in hundreds and then thousands of people, to find out if the vaccine can work in the real world. Moderna鈥檚 technology, involving genetic material from the virus called mRNA, is relatively new and has yet to produce any approved vaccine. (Grady, 5/18)

In a Phase 1 trial, eight patients who received two doses of the vaccine at the lowest and middle doses tested 鈥 25 and 100 micrograms 鈥 developed neutralizing antibodies to the virus at levels similar to people who had recovered from infection, the company said in a statement. The data were limited and from only a small number of participants in the trial, led by the National Institute of Allergy and Infectious Diseases. But they are still likely to be seen as encouraging. (Branswell, 5/18)

Overall, the study showed the vaccine was safe and all study participants produced antibodies against the virus. An analysis of the response in the eight individuals showed that those who received a 100 microgram dose and people who received a 25 microgram dose had levels of protective antibodies to fend of the virus that exceeded those found in the blood of people who recovered from COVID-19, the illness caused by the coronavirus. (Steenhuysen and Joseph, 5/18)

In the next phase of the study, led by the U.S. National Institutes of Health, researchers will try to determine which dose is best for a definitive experiment that they aim to start in July. In all, 45 people have received one or two shots of the vaccine, which was being tested at three different doses. The kind of detailed antibody results needed to assess responses are only available on eight volunteers so far. (Marchione, 5/18)

The Food and Drug Administration has given Moderna the green light to begin a Phase II study expected to enroll an additional 600 volunteers 鈥 half older than 55 鈥 to provide additional immunogenicity data. The company hopes by July to begin a Phase III study, aimed at showing that the vaccine can actually prevent disease. The Moderna vaccine is made using messenger RNA, or mRNA, a molecule containing the genetic instructions to make a protein on the coronavirus surface that is recognized by our immune systems. Although mRNA vaccines have been studied for several years, so far none has been licensed by the FDA. (Palca, 5/18)

Moderna鈥檚 announcement comes days after one of its directors, Moncef Slaoui, stepped down from the board to become chief scientist for Operation Warp Speed, a White House initiative to speed up vaccine development. Watchdogs called out Slaoui鈥檚 apparent conflict of interest. Filings with the Securities and Exchange Commission show Slaoui鈥檚 stock options in Moderna are worth more than $10 million with the company鈥檚 share price at $66.69. In regular trading Monday, Moderna鈥檚 stock soared almost 20 percent to $80. (Johnson, 5/18)

Moderna鈥檚 vaccine is among several front-runners that have emerged from the more than 100 coronavirus vaccines in development world-wide. At least seven other vaccines have started human testing, and several companies including Johnson & Johnson, Pfizer Inc. and AstraZeneca PLC are bulking up manufacturing capacity to make doses to meet global demand if vaccines they or their partners are developing prove successful. The early data suggest Moderna鈥檚 vaccine, code-named mRNA-1273, 鈥渉as a very good chance to provide protection鈥 from Covid-19, the disease caused by the coronavirus, Moderna Chief Executive Stephane Bancel said in an interview. (Lotfus, 5/18)

Stock closed with major gains Monday as Wall Street rallied on potential progress toward a COVID-19 vaccine and hopes of a quick economic rebound.聽The Dow Jones Industrial Average closed with a gain of roughly 912 points Monday, rising more than 3.8 percent, after biotechnology company Moderna announced it had seen 鈥減ositive鈥 results in early trials of a coronavirus vaccine. The company鈥檚 stock rose more than 20 percent on the news. The Nasdaq composite closed with a gain of 2.4 percent, and the S&P 500 rose 3.1 percent. (Lane, 5/18)

In other vaccine news 鈥

The promise of a coronavirus vaccine by the end of the year creates a difficult political and public health question: Who gets the vaccine first? Health care workers would be among the first to receive any vaccine so they can continue to work the pandemic鈥檚 front lines. But deciding which groups come next 鈥 the elderly, medically vulnerable people, grocery store and meat plant workers, children 鈥 is fraught with ethical dilemmas and ripe for political power plays. (Owermohle, 5/18)

From Bill Gates to Angela Merkel, experts and political leaders think the only way to return to normal after the pandemic is to develop a vaccine and immunize billions of people against coronavirus. But as聽the world races to develop a coronavirus vaccine, policymakers may struggle to convince people to get immunized. (Paun, Deutsch and Tamma, 5/18)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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