The U.S. Food and Drug Administration (FDA) today made official what's been a long time coming: the Pfizer-BioNTech COVID-19 vaccine is now fully approved for people 16 and older, my colleague Alice Park reports. The vaccine was previously being administered under Emergency Use Authorization (EUA), a mechanism by which the FDA can quickly greenlight vaccines or treatments to meet an urgent public health threat.
In approving Pfizer's shot—which the company will now market under the brand name "Comirnaty"—the FDA analyzed data collected from approximately 40,000 study participants, half of whom got the shot and half who got placebo. It found that the vaccine was 91% effective in preventing COVID-19 disease, a slight decrease from the EUA figures, but still representing an extremely high success rate. The FDA also found a slight risk of myocarditis and pericarditis, as previously reported, though it noted that "most individuals have had resolution of symptoms."
Full approval won't change anything about the vaccine itself or how it's administered. It may, however, make a dent in the vaccine hesitancy crisis—only about half of Americans are inoculated, far from enough to end the pandemic. In a June survey, KFF found that three in ten unvaccinated adults said they'd be more likely to get inoculated if the shots received FDA approval. Moreover, many of those opposed to employer-based vaccine mandates have argued that such requirements are unacceptable without full FDA approval, an argument invalidated by today's move.
"While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA commissioner Dr. Janet Woodcock said in a statement . “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated." (Full approval also means the FDA will have to inspect each lot of doses before they're released on the market, as Alice points out.)
Still, it's possible that some in the anti-vaccination or vaccine-hesitant camps were simply using the lack of full approval as a convenient justification for their decisions, and may jump to another line of reasoning after today's developments. We'll keep a close eye on the vaccination data over the next few weeks to see how this all plays out.
It's also important to note that Pfizer's approval does not mean the shot will now be administered to those of all ages. Those between 12-15 can still receive it under EUA, but data for younger groups are still in the process of being collected and reviewed, and it will likely be months until those younger than 12 can be inoculated—meaning this school year could be disastrous , given Delta's breakneck spread around the country. The other two vaccines in use in the U.S, those made by Moderna and Janssen/Johnson & Johnson, will also still be doled out under EUA. The FDA is currently reviewing Moderna's request for full approval; J&J has yet to file such a request with the agency.
About 428.5 million doses of the COVID-19 vaccine have been shipped to various U.S. states as of this afternoon, of which nearly 362.7 million doses have been administered thus far, according to TIME's vaccine tracker. About 51.5% of Americans have been completely vaccinated.
More than 211.8 million people around the world had been diagnosed with COVID-19 as of 3 a.m. E.T. today, and more than 4.4 million people have died. On August 22, there were 446,351 new cases and 7,547 new deaths confirmed globally.
Here's how the world as a whole is currently trending:
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 4 million cases:
The U.S. had recorded more than 37.7 million coronavirus cases as of 3 a.m. E.T. today. More than 628,500 people have died. On August 22, there were 36,692 new cases and 200 new deaths confirmed in the U.S.
Here's how the country as a whole is currently trending:
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. 23, 1 a.m. E.T. To see larger, interactive versions of these maps and charts, click here.
WHAT ELSE YOU SHOULD KNOW
The U.S. is now reporting a seven-day rolling average of about 1,011 daily coronavirus deaths, the first time the country has been over the 1,000 mark since early April. The spike in deaths is being driven largely by relatively under-vaccinated southern states, like Louisiana (where 39.1% of residents are vaccinated), Mississippi (36.2%) and Florida (50.9%)...
...but in better news, the recent spikes in cases and deaths continue to drive vaccine uptake, especially in the hardest-hit states. Daily initial vaccination rates are climbing in all three aforementioned states, further evidence that for at least some of those on the fence about getting their shot, a sense of immediate personal risk can be a strong motivator.
"You are not a horse. You are not a cow. Seriously, y'all. Stop it." So reads an unusual Saturday tweet from the U.S. Food and Drug Administration, which came amid reports that some people are using ivermectin—a drug used to prevent heartworm and parasites in animals—to treat or prevent COVID-19. There's no evidence that ivermectin works against the coronavirus, and human overdoses can lead to symptoms ranging from nausea and dizziness to coma and death.
New York City, home to the largest U.S. public school system, will require every Department of Education worker from teachers to custodians to be at least partially vaccinated by Sept. 27, the New York Times reports. Nearly 150,000 employees will be covered by the mandate, which does not include an option to be tested regularly rather than get the shot. The requirement, which is supported by the local teachers' union, comes as viral outbreaks and quarantines have wreaked havoc on other school districts around the country.
India has approved a first-of-its-kind DNA-based COVID-19 vaccine, Axios reports. The vaccine, which works by producing the virus' spike protein and thus triggering an immune response, is reportedly 67% effective, including against the Delta variant. While India has so far approved six vaccines—double the number of the U.S.—less than 10% of its 1.3 billion residents have been inoculated so far.
While those under 12 still can't get the coronavirus vaccine in the U.S., children are also behind on the shots they can get, per the Associated Press, including those for polio, measles, tetanus and more. In part, that's because many kids haven't seen their pediatrician regularly during the pandemic, nor have many taken part in activities for which vaccines are required, like summer camp. "We’re going to have kids getting seriously sick this fall, and the sad part is, for the most part, it’s preventable," one expert told the AP.
Thanks for reading. We hope you find the Coronavirus Brief newsletter to be a helpful tool to navigate this very complex situation, and welcome feedback at coronavirus.brief@time.com. If you have specific questions you'd like us to answer, please send them to covidquestions@time.com.
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Today's newsletter was written by Alex Fitzpatrick and edited by Elijah Wolfson.
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