In order to roll out new Omicron-specific vaccines this fall, the government and vaccine makers have had to move fast. Pharmaceutical companies were told in June to quickly readjust their new shots to better target the BA.4 and BA.5 subvariants—now the dominant strains of COVID-19 in the U.S.—rather than focus on BA.1 as they originally had planned. Now, the government is streamlining its review and regulatory process to ensure the next round of boosters are available sooner than later. As my colleague Alice Park reports, that includes considering safety and efficacy data that’s so far only based on testing the vaccine in animals, not people.
This has caused some experts to worry, arguing it doesn’t provide enough data to show the new vaccine provides sufficient protection. Dr. Paul Offit, a member of the U.S. Food and Drug Administration’s (FDA) advisory committee, told Alice he’d like to see even just a small 100-person trial to get an initial sense of the shot’s efficacy. This, he says, would also go a long way in better setting the public’s expectations by not over-selling the booster’s potential to ward off any infection: “I get a little nervous, frankly, when I hear this [booster] is going to be miraculous,” Offit says.
But there are a few reasons why things are moving ahead this way. As we head into the fall and winter—the season in which respiratory viruses spread more easily as people head indoors and back to school—there simply isn’t enough time to do wide-scale human trials like during the development of the original COVID-19 vaccines. And experts point out that the bulk of the work has already been done to show that mRNA vaccines work; millions of people have safely been vaccinated. Plus, the new boosters under consideration contain a combination of mRNA that targets both the original virus and BA.4/BA.5. As Alice explains, some argue “this means that changing the strain of virus in the vaccine doesn’t require the same extensive testing that the original shot did.”
The FDA is expected to authorize the new bivalent vaccines within the next week or so. In the meantime, human studies of the latest vaccine booster are planned, and will proceed even if distribution begins first. At the same time, health officials will keep a close eye on vaccine data and hospitalization rates.
More than 600 million people around the world had been diagnosed with COVID-19 as of 1:00 am. E.T. today, and nearly 6.5 million people have died. On Aug. 28, there were 396,748 new cases and 899 new deaths confirmed globally.
Here's how the world as a whole is currently trending, in terms of cases:
And in terms of deaths:
Here's where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:
And here's every country that has reported over 10 million cases:
The U.S. had recorded over 94 million coronavirus cases as of 1:00 am. E.T. today. More than 1.04 million people have died. On Aug. 28, there were 6,833 new cases reported in the U.S., and 2 deaths were confirmed.
Here's how the country as a whole is currently trending in terms of cases:
And in terms of deaths:
Here's where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:
All numbers unless otherwise specified are from the Johns Hopkins University Center for Systems Science and Engineering, and are accurate as of Aug. 29. To see larger, interactive versions of these maps and charts, click here.
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WHAT ELSE YOU SHOULD KNOW
The U.S. government is ending its free at-home COVID-19 test program this week, CNN reported today. Since the beginning of the year, people have been able to order rapid antigen tests online for their household. But according to a White House official, this will no longer be the case due to “a lack of funding and efforts to preserve supply ahead of an anticipated fall surge in cases,” CNN wrote.
The U.S. Centers for Disease Control and Prevention recently loosened quarantine and testing recommendations for COVID-19. Amid this ever-shifting uncertainty and risk evaluation, back-to-school rituals are more valuable than ever, writes Katie Gutierrez, author of the novel More Than You'll Ever Know, in a personal essay for TIME. With her daughter about to start preschool, Gutierrez recalls how choosing her new school outfits used to hold special promise: “I’d decide who I wanted to be that year, how I wanted to be perceived.”
In January, the FDA deauthorized the use of two types of monoclonal antibody treatment when they were shown not to be effective against Omicron. A new study, however, reveals that within the six months after the deauthorization, many doctors continued administering monoclonal antibodies despite “providing little to no benefit to patients” while “potentially contributing millions of dollars in costs.”
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Today's newsletter was written by Kyla Mandel and edited by Angela Haupt.
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