It’s Time for the FDA to Issue Full Approval of Vaccines
Say you’re among the vaccine hesitant. You’ve heard all of the rubbish rumors—that COVID-19 vaccines will magnetize you, or mess with your DNA, or that they contain microchips—and let’s say you’re sensible enough to have rejected them. But there’s still the matter of the U.S. Food and Drug Administration: If the vaccines are so good, you might ask yourself, why have they been granted only Emergency Use Authorization? Where’s the full FDA stamp of approval, already?
That, as Dr. Ashish K. Jha, Dean of the Brown University School of Public Health, argues in TIME, is a stubborn question contributing to the stubborn refusal among the approximately 40% of the eligible population that is still not fully vaccinated. And that, in turn, calls upon the FDA to act—and fast. There are some indications that the agency may be responding: as STAT reported, on July 30, one unnamed FDA official promised that the agency would initiate a new “sprint” to full approval—and if so, it’s high time.
Pfizer applied for full approval nearly three months ago, for example. The FDA accepted the application under “priority review” two months later and suggested it might be January 2022 before full approval is issued. That’s less a sprint than a stroll.
As Dr. Jha argues, the key is for the FDA to be exceedingly thorough in pursuing the science and to be less consumed with the official paperwork. The vaccines, after all, have already been tested in a real-world field trial since the beginning of the year and have proven themselves to be extraordinarily effective at preventing serious disease, hospitalization and death.
The clinical trials conducted before the vaccines’ Emergency Use Authorizations were granted were extraordinary in their own way. They rank among the largest clinical trials in history—100 times larger than a study that formed the basis of the FDA’s approval of an H1N1 vaccine in 2009, for example, and 10 times larger than any of the trials underlying the approval of many other vaccines. And serious side effects, while real, are extremely rare.
No vaccine is perfect—neither 100% effective nor 100% without side effects. But no vaccine in recent memory has been needed more acutely than this one. Resistance by the vaccine-hesitant continues, and the FDA has it in its power to help change their minds. It’s time it used that power. It’s time it began that sprint.
About 400.7 million doses of the COVID-19 vaccine have been shipped to various U.S. states as of this afternoon, of which nearly 347 million doses have been administered thus far, according to TIME's vaccine tracker. About 49.7% of Americans have been completely vaccinated.
More than 200.1 million people around the world had been diagnosed with COVID-19 as of 1 a.m. E.T. today, and more than 4.25 million people have died. On August 4, there were 628,145 new cases and 10,050 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 3 million cases:
The U.S. had recorded more than 35.3 million coronavirus cases as of 1 a.m. E.T. today. More than 614,700 people have died. On August 4, there were 92,714 new cases and 490 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. 5, 1 a.m. E.T. To see larger, interactive versions of these maps and charts, click here.
WHAT ELSE YOU SHOULD KNOW
In a statement released yesterday,Moderna reported that its vaccine remains more than 90% effective at least six months after inoculation. The company did concede that a booster could be necessary in the next few months to help deal with the surging Delta variant. Moderna also reported that it is working on developing a new single-dose shot against COVID-19, influenza and respiratory syncytial virus, a generally mild infection that can be serious for infants and seniors.
The situation in Tokyo has only gotten worse as the Olympics have unfolded, with a new daily record of 5,042 cases on Thursday, reports the Associated Press. In mid-July, Tokyo was placed under a state of emergency, but the provisions were mild—principally shorter hours and a ban on alcohol in both restaurants and bars—and they have gone largely ignored by both patrons and owners of the establishments. Four other areas of the country have since been added to the state of emergency, which is scheduled to run through August 31.
Southeast Asia is reeling under a growing onslaught of the Delta variant, with Thailand and Malaysia hit especially hard. According to TIME’s COVID-19 dashboard, Thailand’s 20,200 cases reported yesterday were a record high for a second day in a row; Malaysia’s 19,819 cases yesterday were also a record. Currently Malaysia has vaccinated only 16.9% of its population; in Thailand, it’s just 5.6%. The region’s most populous nation, Indonesia, is also struggling, with over 1,700 daily COVID-19-related deaths reported on average over the past week.
Broadway is back, sort of. Yesterday, the first Broadway play since the pandemic began—”Pass Over,” a modern interpretation of “Waiting for Godot”—opened to a sold-out crowd, reports Reuters. Actors, audiences, theater staff and stage crew were required to be fully vaccinated, and audiences had to wear masks throughout the performance. The rest of Broadway remains shuttered for now, with most shows not scheduled to reopen until September.
When it comes to vaccines, Louisiana appears to have been scared straight. With the state leading the nation in new cases, the rate of vaccinations has also exploded in recent weeks,reports the New York Times. Only 37% of the state is fully vaccinated, but the demand for vaccines has quadrupled in recent weeks. Health officials warn, however, that even with the new push for shots, Louisiana could be weeks from seeing case counts decline, as it will take time for the vaccines to catch up with the surging spread of the virus.
In defiance of Governor Ron DeSantis, some Florida school districts report they will maintain or issue new mask mandates for students and teachers, according to the Washington Post. Last Friday, DeSantis issued an executive order challenging the CDC’s guidance on school masking and warning that the state government could withhold funds from districts that require masking. Nonetheless, four school districts, including Broward County, the sixth largest in the country, insist they will maintain their mask mandates and await further guidance from medical authorities and the government. The other three school districts taking a similar approach are Alachua, Leon and Duval counties.
The Biden Administration is considering requiring all international visitors to be vaccinated before entering the country, according to Reuters. Citing a White House official, the wire service reports that the administration is anxious to boost business for airlines and the rest of the tourist industry but is wary of doing so in the teeth of the Delta surge. The White House has reportedly been in discussions with airlines and other stakeholders about how they would enforce the vaccine requirements and is also considering what forms of documentation it would accept as proof that travelers have gotten their shots.
With mask mandates contributing to a rise in so-called “air rage” on passenger planes, the U.S. Federal Aviation Administration is asking airports to arrest unruly passengers and crack down on those trying to sneak alcohol aboard planes,reports Bloomberg. So far this year there have been 3,715 reports of unruly passengers—628 of which led to FAA investigations, compared to only 183 such investigations in all of 2020.
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Today's newsletter was written by Jeffrey Kluger and edited by Elijah Wolfson.
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