Fauci cautions Arkansas, 6 other states on holiday

Dr. Anthony Fauci, the U.S.’ top infectious-disease expert, said seven states that have seen upticks in covid-19 cas- es, including Arkansas, should be particularly vigilant over the Labor Day holiday and warned that if Americans are “careless” there could be another jump in cases this fall.

“There are several states that are at risk for surging, namely North Dakota, South Dakota, Iowa, Arkansas, Missouri, Indiana, Illinois,” Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in an interview this week. “Those states are starting to see an increase in the percent positive of their testing; that is generally predictive that there’s going to be a problem.”

Also on Thursday, Fauci, a member of President Donald Trump’s coronavirus task force, told CNN that it is unlikely but “not impossible”

that a vaccine could win approval in October, instead of November or December, as many experts believe.

“And I would assume, and I’m pretty sure, it’s going to be the case that a vaccine would not be approved for the American public unless it was indeed both safe and effective,” he said.

Memorial Day marked a turning point for many newly reopened states, which saw previously moderate covid-19 outbreaks start to spread. July Fourth came just a few weeks before the worst of the U.S. spike, with new cases regularly topping 60,000 later that month. While new infections are down significantly, the daily death toll is still hovering near 1,000, based on a seven-day average.

That has many worried about how the country will fare over the long Labor Day weekend, as the U.S. outbreak tops 6 million confirmed cases and 186,000 deaths.

Fauci joined Vice President Mike Pence on a call with governors this week to urge them to tell their residents to follow guidance on masks, social distancing and other measures to lower the risks of contagion to ensure there aren’t repeats of the surges after the Memorial Day and July Fourth weekends.

“If we’re careless about it, then we could wind up with a surge following Labor Day,” Fauci said. “It really depends on how we behave as a country.”

There’s particular concern since the holiday comes as more Americans are going back to schools, colleges and work, and commercial travel expands.

“There is a lot of potential to see a huge explosion of infections in September and October,” said Eleanor Murray, an assistant professor of epidemiology at Boston University School of Public Health who has called for more nuanced social-distancing guidelines. “We seem to go back and forth between people actually realizing that this is a thing that exists and taking precautions and then deciding it’s all over.”

While infections are tapering in recent hot spots including Arizona, Texas and Florida, a major challenge has been persuading people in areas that haven’t experienced major outbreaks that precautions like masks and social distancing are vital. In South Dakota, where hundreds of thousands gathered in August for a 10-day annual motorcycle rally in the town of Sturgis, at least 105 cases have been traced to the event, the state health department said.

The contrast in behaviors is clear for Ashish Jha, dean of Brown University’s School of Public Health. Large parts of the country will behave how one should during a pandemic, he said.

“What I worry about is there are other parts of the country where there is a lot of misinformation, a lot of ‘This is nothing but the flu,’ and a lot of people who haven’t learned the lesson,” he said.

CALIFORNIANS WARNED

If Americans stick with wearing masks, avoiding indoor crowds in favor of small outdoor gatherings over the Labor Day holiday, “we’re going to be in really good shape going into the fall,” Brett Giroir, the Trump administration’s testing coordinator, said Tuesday.

California’s cities were hit hard early in the pandemic. After relaxing a bit this summer after the spread slowed, the state saw surges in less densely populated regions. On Wednesday, Gov. Gavin Newsom issued a stern warning about the long weekend, urging residents to avoid mixing with people from outside their households and wear masks.

“We saw this a few months back,” Newsom said. “We started to see progress over an extended period of time, and invariably people said, ‘Well, looks like we’re out of the woods.”

He warned: “That’s why it’s more important than ever to be vigilant.”

That’s in part because of another concern: The looming influenza season brings the possibility of a “twindemic” if people don’t take precautions, according to Aaron Glatt, chairman of the department of medicine at Mount Sinai South Nassau in Oceanside, N.Y.

“If people do not do anything and flu just comes, that would make it disastrous,” said Glatt, whose hospital took care of 1,500 covid patients. “We had some patients who had both” the coronavirus and the flu.

The last flu season was particularly bad. The CDC’s preliminary estimates put deaths at 24,000-62,000, compared with about 34,000 and 61,000 in the two previous seasons. Final estimates are due this winter.

Fortunately, covid prevention measures also stop the flu.

“We have data now that shows in the Southern Hemisphere masking and social distancing has dramatically reduced in the incidence of flu there,” Glatt said. “It’s imperative that everybody do all three: Take the flu vaccine, mask and distance.”

More studies are needed to gauge the effect of a combined covid-19 and flu infection, said Rajesh Gandhi, infectious-diseases physician at Massachusetts General Hospital, which has treated more than 1,600 covid patients.

“To be really honest, we don’t want to find out,” said Gandhi, who’s also part of the National Institutes of Health Covid-19 Treatment Guidelines Panel.

VACCINE CONCERNS

A letter from federal health officials instructing states to be ready to begin distributing a vaccine by Nov. 1 has been met with suspicion among some public health experts, who wonder whether the Trump administration is hyping the possibility or intends to rush approval.

The skepticism comes amid growing questions about the scientific credibility of the Food and Drug Administration and the Centers for Disease Control and Prevention, and their vulnerability to political pressure from Trump.

White House spokeswoman Kayleigh McEnany, meanwhile, gave assurances that Trump “will not in any way sacrifice safety” when it comes to a vaccine. And executives of five top pharmaceutical companies pledged that no covid-19 vaccines or treatments will be approved, even for emergency use, without proof they are safe and effective.

The concerns were set off by a letter dated Aug. 27 in which CDC Director Dr. Robert Redfield asked the nation’s governors to help government contractor McKesson Corp. set up vaccine distribution facilities so that they are up and running by Nov. 1. Redfield did not say a vaccine would be ready by then.

Some longtime scientific advisers to the government said the CDC’s preparations for a possible early vaccine do not necessarily mean that an answer will come sooner or that there will be a rush to judgment about whether one works.

“Being prepared for early success … is actually prudent,” said Dr. Steven Nissen, a Cleveland Clinic cardiologist. If a vaccine is working, “you want to be prepared to act on the information.”

Senate Democratic leader Charles Schumer of New York questioned the Trump administration’s motives.

“Too much of the evidence points to the Trump administration pressuring the FDA to approve a vaccine by Election Day to boost the president’s reelection campaign,” he said in a statement. “This raises serious safety concerns about politics, not science and public health, driving the decision making process.”

EXECS: NO SHORTCUTS

Three covid-19 vaccines are undergoing final-stage, or Phase 3, clinical trials in the U.S. Each study is enrolling about 30,000 people who will get two shots, three weeks apart, and then will be monitored for coronavirus infections and side effects for anywhere from a week to two years.

The FDA will not be able to even consider a vaccine until certain key steps occur.

First, independent experts on what are known as data safety monitoring boards, or DSMBs, will have to rule that they have collected enough information to draw firm conclusions about a vaccine’s performance. Then the experts will make the data available to the manufacturer, which will decide whether to submit it for FDA approval.

Whether and when to stop a study early is up to a DSMB, whose scientists see a study’s results as they are accumulating. The company does not.

“We will not cut corners,” Pfizer CEO Albert Bourla vowed Thursday in a call with reporters, hosted by a pharmaceutical industry group. Chief executives from Merck, Roche, Eli Lilly and Gilead Sciences agreed, adding that extra transparency on the test results and approval process is needed.

Bourla said that as of Wednesday, the company’s late-stage study, which started at the end of July, had enrolled about 23,000 people, some of whom had already received the second dose. He said he expects by the end of October to have enough participants infected by the virus to tell whether the vaccine works.

Countries around the world are racing to develop a vaccine. Russian President Vladimir Putin announced Aug. 11 that his country had become the first to approve one, but scientists reacted skeptically because the shots had been tested on just a few dozen people.

Alex Azar, secretary of Health and Human Services, gave assurances that any decision to release a vaccine in the U.S. would be based on the data and the “FDA’s gold standards.”

And he accused those questioning the Nov. 1 date of partisanship.

“I think it’s very irresponsible how people are trying to politicize notions of delivering a vaccine to the American people,” he told CBS. “We already have a significant challenge in this country with vaccine hesitancy. And efforts to undermine confidence in a vaccine … hurt in terms of people being willing to take a vaccine once it comes through.”

Information for this article was contributed by Vivek Shankar of Bloomberg News; and by Linda A. Johnson, Michelle R. Smith, Marilynn Marchione, Zeke Miller, Matthew Perrone and Ricardo Alonso-Zaldivar of The Associated Press.