Breaking: the CDC Weighs In On Pfizer-BioNTech Boosters
As Pfizer-BioNTech’s proposed booster shot has moved through its various stages of safety and efficacy review, it’s become clear that there are no simple answers to a pandemic that keeps shifting under our feet. Not long ago, we thought two doses would be enough; today, a U.S. Centers for Disease Control and Prevention Advisory Committee voted in favor of recommending a third shot in people 65 and over and other high-risk populations, including people over 18 years with underlying conditions.
As my colleague Alice Park reports, yesterday, the Food and Drug Administration (FDA)—following a Sept. 17 recommendation of its preliminary advisory committee—green-lit boosters among seniors, as well as others, including health care workers, teachers and day care staff, grocery workers, those in homeless shelters and those in prisons, among others. The shots would be administered at least six months after the administration of the second dose.
The FDA based its ruling on studies of several hundred subjects in whom immunity began to fall several months after the second shot, and in whom boosters elevated antibody levels even higher than they were after the initial two-dose inoculation. The officials also considered Israeli data showing a remarkable 10-fold increase in immunity after a booster dose compared to people who had received only two shots. The FDA ruling was limited to older people and high-risk groups not just because those are the ones most in need. There is also a dearth in data concerning younger vaccine recipients, since they were originally authorized for vaccines later than seniors and thus provide less longitudinal evidence of the vaccine’s effectiveness.
The CDC’s Advisory Committee so far has largely followed the FDA's lead, in recommending a booster for those over 65, those living in long-term care facilities, and anyone over 18 with an underlying condition. The recommendations clear the way for a booster-shot rollout to begin soon.
As of writing, the committee has yet to vote on whether or not to recommend a booster for adults 18-64 who are in occupational or institutional settings that place them at greater risk for exposure to the virus. It also has not made any decisions regarding mixing and matching vaccines—whether the Pfizer-BioNTech shot will be available to people who received two doses of the Moderna or the Janssen/Johnson&Johnson vaccines. The FDA and the CDC will rule later on authorizing boosters of those two vaccines themselves pending more data from the companies.
About 468.2 million doses of the COVID-19 vaccine have been shipped to various U.S. states as of this afternoon, of some 387.5 million doses have been administered thus far, according to TIME's vaccine tracker. About 54.9% of Americans have been completely vaccinated.
More than 230 million people around the world had been diagnosed with COVID-19 as of 3 a.m. E.T. today, and more than 4.7 million people have died. On September 22, there were 537,770 new cases and 10,077 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 4.5 million cases:
The U.S. had recorded more than 42.5 million coronavirus cases as of 3 a.m. E.T. today. More than 681,000 people have died. On September 22, there were 131,903 new cases and 2,785 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 Sept. 23, 9 a.m. E.T. To see larger, interactive versions of these maps and charts, click here.
WHAT ELSE YOU SHOULD KNOW
Early next month, the European Medicines Agency is expected to issue its own ruling on the use of booster shots of the Pfizer-BioNTech vaccine, reports Reuters. The EMA has been evaluating booster data since Sept. 6 with an eye towards possibly green-lighting a third shot for people 16 and over six months after their second dose. The European Union has signed a recent deal with Pfizer and BioNTech for 900 million doses, a large share of which are considered necessary only if the EMA does approve the boosters.
Leaders of multiple African nations today lambasted rich nations for the disparity in vaccine access between the developing and the developed world, in an address to the United Nations General Assembly, reports Al Jazeera . South Africa’s President Cyril Ramaphosa pointed to the fact that more than 82% of global vaccine doses have gone to wealthy countries while just 1% has gone to low-income ones, calling such conditions “an indictment on humanity.” Angola’s President Joao Lourenco labeled the situation “shocking.” Yesterday, President Joe Biden announced that the U.S. would double to 1 billion doses the number of Pfizer-BioNTech shots it donates globally, with an eye toward vaccinating 70% of the world’s population within the next year.
Despite recent stock market volatility, jobless claims in the U.S. remain near a pandemic-era low, according to data published today by the Department of Labor. First-time claims for unemployment rose to 351,000 last week, up slightly from 335,000 the week before. The Wall Street Journal reports that claims have fallen steadily since July, even with the rise of the Delta variant. Still, not all the employment news is positive. Weekly jobless claims remain about 100,000 higher than they were before the pandemic.
Pregnant women who receive the Moderna or Pfizer-BioNTech mRNA vaccines appear to pass some level of immunity to COVID-19 onto their children, according to a new study in the American Journal of Obstetrics and Gynecology. The relatively small study, of 36 newborns, found that 100% of them had antibodies to the virus at birth. The investigators studied umbilical cord blood and found that the highest level of antibodies in newborns came from mothers who were fully vaccinated in the second half of their pregnancies. The antibodies in the infants are thought to confer immunity to the virus at least for the first several months of life.
Mormons worldwide are being asked to wear masks while inside temples, according to a letter distributed by the Church’s Office of the First Presidency. The request affects 16.5 million church members worshiping in 167 temples. The letter cited precedent: In 1900 and 1957, to battle smallpox and polio respectively.
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.
If you were forwarded this and want to sign up to receive it daily, click here.
Today's newsletter was written by Jeffrey Kluger and edited by Elijah Wolfson.
沒有留言:
張貼留言