FDA resists rush to judgment
The Food and Drug Administration is expected to spell out a tough, new standard for an emergency-use authorization of a coronavirus vaccine as soon as this week, The Washington Post reported.
The intent is to boost transparency and public trust as the FDA approaches the momentous decision of whether a prospective vaccine is safe and effective. The practical effect is that it will make it exceedingly difficult for any vaccine to be cleared before Election Day — depriving President Donald Trump of a political opportunity that led him to browbeat health officials in hopes they'll give it to him.
Recent polls have borne out the worries of public health experts that Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to suspect that a vaccine's approval will be based on politics, not sound medicine.
The coming FDA guidance is an effort to shore up public confidence, according to the Post. While it is being reviewed by the White House Office of Management and Budget, elements of it are already being shared with vaccine makers. Its timelines include a minimum two-month period to follow participants in clinical trials after they receive a second shot before granting the vaccine an EUA.
"It’s hard to imagine how an [emergency-use authorization] could possibly occur before December," said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines.
The FDA guidance is unlikely to satisfy critics who say the agency should not use an emergency authorization for a vaccine at all, the Post reported. "Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on," Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told the newspaper. "U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions."
Dr. Anthony Fauci, in an interview with the Daily Beast on Monday evening, sought to temper expectations on Trump's boast that Americans will be able to get a vaccine "very soon." Fauci, the government's top infectious disease expert, said no one in the Trump administration, including the president, has yet to see actual data from the trials that are underway. Fauci has said he would "bet" on a November or December timeline for learning the efficacy of a coronavirus vaccine — not necessarily for guaranteeing its distribution.
Nobody but the 200,000 bodies
Trump is still playing it down. The president falsely told a campaign rally in Ohio on Monday night that aside from "elderly people, elderly people with heart problems and other problems," the coronavirus "affects virtually nobody."
As of Sept. 16, the under-65 population accounts for the majority of infections and about 20% of U.S. coronavirus deaths, according to the Centers for Disease Control and Prevention. Public health agencies have made clear that individuals younger than 18 are at greater risk of falling ill and spreading COVID-19 than originally thought.
Democratic presidential candidate Joe Biden turned Trump's comment into an attack line. "Let me be very clear, @realDonaldTrump: Not a single one of the 200,000 Americans we've lost to this virus was a ‘nobody,’ " Biden tweeted Tuesday.
Trump did not acknowledge that toll in his more than two dozen tweets on Tuesday. Asked about the grim milestone as he left the White House in the late afternoon for a rally in Pennsylvania, Trump at first ignored a question but said after a second reporter's inquiry: "I think it’s a shame. I think if we didn’t do it properly and do it right, you’d have 2.5 million deaths."
Janison: Viral issues for debate
The Commission on Presidential Debates has announced six topic areas for the first one-on-one faceoff between Trump and Biden next Tuesday. One of them — the coronavirus pandemic — likely will spread into the arguments about the others, writes Newsday's Dan Janison.
The reeling economy and its uncertain future can't be isolated from the health crisis. The Supreme Court will be a subject for moderator Chris Wallace's questions, and Biden might connect Trump's nominee with his effort to crush Obamacare in a lawsuit.
There's a connection too with a fourth topic, election integrity. Trump has charged that efforts to make voting by mail easier because of the pandemic will lead to massive voter fraud. Trump's and Biden's records are a fifth topic, and Biden has already made the president's handling of the pandemic a central issue.
A sixth topic is race and violence in cities. Trump's criticism of Democratic-run cities and states echoes his taunts urging faster "reopening" from public-health lockdowns.
Courtship for a justice
Sen. Mitt Romney of Utah, a frequent foe of Trump but a fan of conservative judges, said Tuesday he will support Trump's bid to put a new justice on the Supreme Court before the election. That assures Senate Majority Leader Mitch McConnell will have a Republican majority behind him as he pushes forward against angry Democratic resistance on the nomination, which Trump said he will reveal on Saturday.
Under the plan, The Associated Press reported, the Senate could vote on Oct. 29 — 33 days after Trump makes his choice, and just five days ahead of the election. Trump openly suggested he might need a tiebreaking vote by the court if it has to rule on election disputes. "You're going to need nine justices up there," he said.
Two U.S. Court of Appeals judges are the front-runners, each with a faction of Trump's inner circle behind her. Trump's favorite reportedly is Amy Coney Barrett, with a deeper record of rulings favored by religious conservatives. But boosters of Barbara Lagoa, a Cuban American from Miami, see her as helping Trump in Florida.
Trump met with Barrett at the White House on Monday and may see Lagoa later in the week. Lagoa's supporters hope she can charm the president and cause him to reconsider.
Red-state ties around Trump's neck?
Two red states that were in Trump's column in 2016 are showing a neck-and-neck contests between the president and Biden, according to new polling.
In Georgia, a poll for The Atlanta Journal-Constitution shows Trump and Biden each at 47%. Libertarian nominee Jo Jorgensen had 1%. Only 4% were undecided. Trump won Georgia’s 16 electoral votes by 5.7 points in 2016.
There's another 47%-47% dead heat in Iowa, a new Des Moines Register poll found. Another 4% would vote for someone else and 3% are unsure. Trump carried Iowa by 9 points four years ago. There are 6 electoral votes at stake.
Trump to UN: Make China pay
Trump urged world leaders to "hold China accountable" for the spread of the coronavirus in a video address prerecorded from Washington to a scaled-down UN General Assembly meeting on Tuesday.
Trump accused China of allowing flights of infected people to leave the country in the early days of the COVID-19 outbreak, as well as of spreading false information with the help of the World Health Organization. He spoke for just eight minutes and didn't elaborate on what punishment he thought was warranted.
Later, a prerecorded speech from President Xi Jinping of China called the coronavirus a crisis shared by everyone. Offering no apologies, Xi portrayed his nation as having acted responsibly and said "any attempt of politicizing the issue or stigmatization must be rejected."
More coronavirus news
See a roundup of the latest pandemic developments from Long Island and beyond by Newsday's reporting staff, written by Bart Jones. For a full list of Newsday's coronavirus stories, click here.
What else is happening:
- Biden received an endorsement Tuesday night from Cindy McCain, the wife of the late Republican senator and 2008 presidential nominee John McCain. "My husband John lived by a code: country first," she tweeted. "We are Republicans, yes, but Americans foremost. There's only one candidate in this race who stands up for our values as a nation, and that is @JoeBiden."
- A recent CIA analysis found Russian President Vladimir Putin most likely is approving and directing his country's interference efforts aimed at boosting Trump's reelection chances, according to The New York Times and The Washington Post.
- Air Force Two with Vice President Mike Pence onboard was forced to return to a New Hampshire airport after a suspected bird strike. Pence ended up flying home on a cargo aircraft that the Secret Service uses to transport his vehicles during his travel.
- Florida voters in 2018 passed a referendum to end a lifetime ban on voting by ex-felons, but the Republican legislature passed a law to block them if they hadn't paid court debts. Now $20 million has been raised by Michael Bloomberg, singer John Legend, basketball's LeBron James and Michael Jordan and others to settle the obligations for thousands of them before the state's Oct. 5 voter registration deadline.
- House Speaker Nancy Pelosi and Treasury Secretary Steven Mnuchin reached agreement on a bipartisan short-term spending plan to avert a government shutdown at the end of the month. The House passed it, 359-57, and Senate action is expected in the coming days.
- It's cancel culture, Trump-style. The president on Tuesday extended his administration's ban on training involving race- and sex-based discrimination to include federal contractors, doubling down on an issue to appeal to his base, and white voters in particular, The Hill reported.