Pfizer's COVID-19 vaccine appears set to be authorized for adolescents between 12 and 15, and the company aims to further expand the vaccine's use this September.
Pfizer during an earnings call on Tuesday said it expects to apply for emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine for children between 2 and 11 in September, CNN reports.
A study to examine the safety and efficacy of the vaccine among those between 6 months and 11 years old is ongoing. Additionally, Pfizer said it's expecting to seek authorization for its vaccine among children between 6 months and 2 years in the fourth quarter of 2021.
This comes after The New York Times reported on Monday that the Food and Drug Administration is set to authorize Pfizer's vaccine for adolescents between 12 and 15 by early next week, allowing this group to start getting vaccinated before the beginning of the new school year.
Pfizer also announced Tuesday it plans to file for a full FDA approval of its COVID-19 vaccine by the end of the month, which CNBC notes would mean "the company will be able to market the shot directly to consumers." Brendan Morrow
Florida on Thursday joined Georgia in enacting a sweeping Republican election law that constricts voting rights in the state, and Texas, which already had some of the most stringent voting laws in the country, is on the cusp of joining them. Democrats were not able to stop the new voting laws in the country's biggest red states, but House Democrats passed their own countervailing national voting rights legislation, the "For the People Act" or HR1, in March, and Senate Democrats are working on their own version, S1.
When Senate Minority Leader Mitch McConnell (R-Ky.) said Wednesday that "100 percent of my focus is on stopping this new administration," these voting reform bills might have been what he had in mind. McConnell has publicly and privately conveyed his fervent opposition to the legislation. But "what's different, conservatives say, is his personal level of commitment behind-the-scenes to educate activists on just how damaging the legislation would be to the future electoral prospects of Republicans," McClatchy D.C. reports.
"So many times the conservative movement only works with McConnell when it's a Supreme Court nomination, or a Supreme Court fight," Jessica Anderson, executive director of Heritage Action, tells McClatchy. "And so we've been trying to change that with HR 1 and S1 and really make this fight similar and more akin to a Supreme Court fight, where it's like an all-hands-on-deck effort."
As the Senate prepares to mark up the legislation in the Rules & Administration Committee next week, "some progressives have warned that McConnell is taking the legislation more seriously than even Democrats are," McClatchy reports. "At the moment, McConnell looks to hold the advantage," with moderate Democrats "fretting about the sheer size of the bill" and Republicans confident Sen. Joe Manchin (D-W.Va.) will side with them in the 50-50 Senate. Peter Weber
The COVID-19 vaccine from Pfizer and BioNTech could become the first in the United States to receive full FDA approval.
The companies announced Friday they have initiated an application seeking full approval of the vaccine for people 16 and over from the Food and Drug Administration, CNN reports. The vaccine is now being administered under an emergency use authorization, a "mechanism to facilitate the availability and use of" vaccines "during public health emergencies," per the FDA.
Receiving full FDA approval requires six months of safety and efficacy data, as opposed the two months required for the emergency use authorization, according to NBC News. CNN chief medical correspondent Sanjay Gupta stressed Friday this isn't to suggest that data didn't already show the vaccine to be safe and effective or that the process to get the emergency authorization wasn't rigorous, but the "bar of data that you now have to show" to get full approval is even higher, he said on New Day.
With that in mind, experts have said full FDA approval could help reduce vaccine hesitancy and further demonstrate that the vaccines are safe. Former U.S. Surgeon General Jerome Adams wrote in The Washington Post that "many people who are lower risk" have expressed uncertainty over whether the "benefits justify taking a medication that has not received the full and traditional FDA stamp of approval." So full approval might provide a "boost of confidence to people who were on the fence about getting vaccinated," Brown University School of Public Health dean Ashish Jha said.
If the vaccine is fully approved, Pfizer can also start marketing and distributing it. Another key difference, CNN writes, is that full approval could "have an impact on vaccine mandates," as "some organizations say they expect to require the vaccine, but have opted not to while it's authorized and not yet fully approved." ABC News reports it's likely to take "several months" for the FDA to make a decision. Brendan Morrow
India set another global COVID-19 record Friday, reporting 414,188 new confirmed cases in the past 24 hours plus 3,915 new deaths. Both numbers are believed to be significant undercounts. With daily deaths remaining above 3,800 for the past 10 days and hospitals running out of beds, oxygen, and other critical supplies, Prime Minister Narendra Modi is facing increasing pressure to put the country back under lockdown for 2-4 weeks or launch some other coordinated central response to the pandemic.
An earlier strict lockdown is credited with India's success, until March, in containing the coronavirus outbreaks, but it took a terrible economic toll on India and especially its poorest citizens. Modi so far has left it up to India's 28 states to set their own mitigation measures, and fewer than a dozen have instituted some lesser restrictions.
India isn't alone in battling new variant-driven waves of COVID-19, and Egypt, Turkey, and other countries are "trying to ensure they aren't hit by an India-style disaster," The Associated Press reports. "They face many of the same risks, including large populations that have shirked restrictions and fragile health systems shaken under the strain." In wealthier nations, aggressive vaccination campaigns have sent cases and deaths on downward trajectories.
Worldwide, however, there have been more COVID-19 cases reported over the past two weeks than in the first six months of the pandemic, World Health Organization director general Tedros Adhanom said. India and Brazil account for a large share of those numbers, "but there are many other countries all over the world that face a very fragile situation," he added. "What is happening in India and Brazil could happen elsewhere unless we all take these public health precautions." Peter Weber
The Federal Election Commission announced Thursday that it will not investigate possible campaign finance violations by former President Donald Trump's 2016 campaign, tied to a $130,000 hush payment made to adult film actress Stormy Daniels. Trump's former personal lawyer and fixer Michael Cohen had paid Daniels right before the election to keep her from disclosing an extramarital affair she says she had with Trump.
The payment was not reported on Trump's campaign filings. Cohen, who said he paid off Daniels and another woman on Trump's behalf and on his orders, was jailed in 2018 for violating campaign finance laws, tax evasion, and lying to Congress.
The FEC deadlocked over investigating Trump in a closed-door meeting in February, with two Republican commissioners voting to drop the issue, two Democratic commissioners voting to push forward, one Republican commissioner recusing himself, and the sixth commissioner, an independent, absent. The FEC's nonpartisan general counsel's office had advised investigating Trump, reporting in December it found "reason to believe" his campaign had "knowingly and willfully" violated campaign finance laws.
The two voting GOP commissioners, Trey Trainor and Sean Cooksey, explained in a letter that they "voted to dismiss these matters as an exercise of our prosecutorial discretion," arguing that "the public record is complete" due to Cohen's punishment and "pursuing these matters further was not the best use of agency resources."
The two Democratic commissioners, Ellen Weintraub and Chairwoman Shana Broussard, disagreed, noting that agency staff had recommended an investigation. "To conclude that a payment, made 13 days before Election Day to hush up a suddenly newsworthy 10-year-old story, was not campaign-related, without so much as conducting an investigation, defies reality," they wrote.
Cohen told The New York Times in a statement that "the hush money payment was done at the direction of and for the benefit of Donald J. Trump," adding: "Like me, Trump should have been found guilty. How the FEC committee could rule any other way is confounding." Peter Weber