4 min read.Updated: 17 Nov 2020, 01:50 PM ISTJared S. Hopkins, The Wall Street Journal
Distribution could begin in December if the shot proves safe and FDA authorizes it, though it would take well into 2021 for most people to get access, given limited initial
Moderna Inc. reported its Covid-19 vaccine was 94.5% effective against Covid-19, results indicating the shot can protect people from contracting the disease with symptoms. Here’s what we know and don’t know.
As soon as next month. Moderna says it expects to ask U.S. Food and Drug Administration to authorize use by early December. It is unclear how long the agency will take to make a decision, and the agency is expected to first ask an outside panel of experts to weigh in. Yet federal officials have said it could get a green light to go into distribution that month, if everything checks out. One key issue researchers and regulators are waiting on: proof the vaccine is safe. So far, subjects have reported only mild or moderate side effects, such as fatigue and redness at the injection site. Before making a judgment on safety, the FDA wants to see how half of the trial’s 30,000 subjects fare for at least two months on the two-dose regimen.
When would people start getting vaccinated?
Vaccinations could start in December, if the shot is authorized. Yet initial supplies will be very limited. Moderna says it expects to have 20 million doses ready to ship by the end of the year, enough supply of the two-dose shot for 10 million people. That means the first to get the shots will probably be people at the highest risk of Covid-19 with symptoms, like doctors and nurses on the front lines treating coronavirus patients. How the vaccine will be rolled out is still unclear, however, as the U.S. hasn’t completed recommendations. A National Academy of Medicine panel recommended people whose health conditions put them at high risk of severe Covid-19, elderly in nursing homes and prisoners should be next in line. Teachers and transportation workers would follow.
What does this mean for the timing of reopenings?
Return to a normal kind of life will likely take months. Even if Pfizer Inc. and Moderna vaccines begin distribution before year’s end, the shots won’t be widely available until some time next year, probably spring or summer, mostly due to production lag times. As a result, precautions such as mask-wearing and social distancing will continue to be key to stopping the spread of the virus. “It’s not going to be flipping a switch and everything going back to normal," said Dr. Saad Omer, director of the Yale Institute for Global Health. He doesn’t expect large groups of people could safely congregate before early 2022, even with vaccines. “It will be gradual."
What does this mean for other Covid-19 vaccines in development?
Moderna’s results, similarly to those announced last week by Pfizer, advance the new technology of mRNA that was in development for years but yet to be approved for use. Other leading vaccines developed by AstraZeneca PLC, Johnson & Johnson and Novavax Inc. don’t use mRNA-based technologies, but they target the spike protein of the coronavirus that is also targeted by mRNA vaccines. The Moderna and Pfizer effectiveness results might augur well for shots generally targeting the spike protein, but we won’t know how the other vaccines will perform in late-stage testing until their makers report results over the coming months. “They’re all pretty much concentrating on the spike protein and that seems to have been the right thing to have selected," said Paul Duprex, director of the University of Pittsburgh Center for Vaccine Research.
What don’t we know yet about Moderna’s vaccine?
Moderna’s vaccine results are preliminary and they only speak to whether the vaccine is effective at protecting against symptomatic Covid-19 disease. The company plans to release additional results later, including effectiveness in specific groups such as the elderly and against infections that don’t produce symptoms. Additional data on how well the vaccine works to reduce severe cases of Covid-19 is also expected. The company also plans to provide additional safety data, which the company said it intends to submit to regulators in the coming weeks as it seeks authorization. It is also unclear how long any protection from Moderna’s vaccine lasts. Like Pfizer’s, Moderna’s results were issued via company press release and haven’t been published in a peer-reviewed medical journal.
How does Moderna’s vaccine compare with Pfizer’s?
Both are based on mRNA technology, and both appeared to be effective in protecting people against symptomatic Covid-19 in early data from late-stage trial results. It is hard to compare the shots, however, since they weren’t tested against each other and testing is ongoing. Moderna did provide a bit more information than Pfizer and partner BioNTech SE about the performance of its shot so far. For example, Moderna provided some data indicating the shot protected against severe disease. Moderna also announced its vaccine, which has to be stored and shipped at temperatures equal to most home or medical freezer temperatures, could remain stable at a refrigerator’s temperature for up to 30 days, up from an earlier estimate of a week.
“The Moderna vaccine has much less stringent shipping and handling constraints,“ said William Schaffner, professor of preventive medicine at Vanderbilt University School of Medicine. “This vaccine really does look like a conventional influenza vaccine, which means it can be distributed much more widely." Pfizer’s vaccine can be stored refrigerated for up to five days once thawed.
This story has been published from a wire agency feed without modifications to the text
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