HEALTH CARE BRIEFING: No Vaccine Seen for Most Until Late Spring

Even if the most optimistic projections hold true and a vaccine to prevent Covid-19 is cleared for U.S. use in November, the vast majority of Americans won’t be able to get the shots until spring or summer next year at the earliest.

That likely timeline, based on interviews and remarks from top health specialists including Anthony Fauci of the White House Coronavirus Task Force, means that businesses, schoolchildren and families will continue to wait.

In an interview, Fauci, who’s also been involved with White House’s “Operation Warp Speed” vaccine program, said it may take until well into 2021 for vaccines to actually reach the much of the general public. “I would hope that by the time we get well into the second half of 2021 that the companies will have delivered the hundreds of millions of doses they have promised,” said Fauci.

The reasons are many. U.S. health regulators will have only a tiny sliver of the usual safety and efficacy data. The leading products require two doses, which will limit how many people early supplies can help. And federal health officials are still developing a plan for who will get the shots, how they’ll be distributed, and how their effectiveness and safety will be tracked afterward.

“For three to six to nine months, there will be more people wanting a vaccine than there are vaccines,” according to Stephane Bancel, CEO of Moderna, the biotechnology company developing one of the furthest-along inoculations.

Bancel said he expects his company’s shot may get an emergency authorization by the Food and Drug Administration for “a very narrow population at very high risk.” Vaccines for the general population will need full FDA approval, which will likely take significantly longer, he said in an interview.

Bancel’s comments run counter to the timeline portrayed by President Donald Trump, who’s said a Covid-19 vaccine may be ready by Nov. 3, Election Day. “If you had another president other than me, you wouldn’t be talking vaccines for two years,” he said. “I will push it very hard.” Read more from Anna Edney, Josh Wingrove, and Robert Langreth.

Where We Are on the Path to a Covid Vaccine: In a special Vaccine Issue, Bloomberg Businessweek looks at the biggest challenges, promising solutions, and the weirdest science, from the molecular level on up. Read more.

More from the issue:

• Most Coronavirus Vaccine Projects Are Taking Unorthodox Routes
• Moderna Wants to Transform the Body Into a Vaccine-Making Machine

Happening on the Hill

Trump Aid Orders Fail to Jolt Stimulus Talks: Days after Trump implemented scaled-down pandemic aid without congressional approval, there’s no indication the tactic will get Republicans and Democrats back to the negotiating table for a comprehensive coronavirus stimulus deal. Treasury Secretary Steven Mnuchin said that there are areas where a compromise over a massive aid bill is possible and a “fair deal” could be agreed upon. But in an interview on CNBC, he continued to dismiss Democrats’ request for nearly $1 trillion for aid to state and local governments as “absurd.” Laura Litvan and Erik Wasson have more.

• Read a breakdown of Trump’s four executive actions targeting evictions, unemployment benefits, employees’ payroll taxes and student loans in a BGOV OnPoint here. The presentation also compares House Democrats’ and Senate Republicans’ dueling stimulus proposals.

Assisted Living Operators Struggle for Attention: Senior living executives are lobbying Congress and the administration to make them a larger priority as they negotiate the next round of coronavirus relief, saying they’re in desperate need for money and preferential access to testing and personal protective equipment like gloves, masks and gowns. The assisted and independent living industry says it may lose upwards of $50 billion from higher costs imposed by the coronavirus over 12 months, forced to buy large amounts of gear and tests. Megan R. Wilson has more.

• Meanwhile, hospitals are having to make difficult financial decisions as they prepare to absorb roughly $120 billion in losses through the second half of 2020. Hospitals have begun resuming elective procedures that were halted through the earlier months of the pandemic and are slowly rebuilding lost patient volume and revenue. But they still face an unclear future, as ripple effects from the pandemic continue to force closures, job cuts, and service cutbacks. Read more from Tony Pugh.

Health Groups Call for Pot Policy Overhaul: More than a dozen public health and advisory organizations yesterday sent a letter to House Democratic leaders calling for a September vote on Judiciary Chairman Jerrold Nadler’s (D-N.Y.) bill to end the federal criminalization of marijuana. The Drug Policy Alliance and the Center for Effective Regulatory Policy and Safe Access, in addition to 12 groups and other health officials, requested a vote on the legislation (H.R. 3884) to remove marijuana from the federal government’s Controlled Substances Act list, Alex Ruoff reports. Read the letter here.

Bill Seeks to Halt Synthetic Drug Trafficking: Sens. Jeanne Shaheen (D-N.H.) and Rob Portman (R-Ohio) introduced a measure that would boost global cooperation in the fight against synthetic drug trafficking, they said in a statement. The bill would authorize two State Department programs aimed at detecting synthetic drugs and supporting an international exchange program for drug demand experts. Read more from Jameelah Robinson.

More on the Pandemic

Hospitals in Some Hot Spots Get Virus Respite: American hospitals are getting a reprieve as a spike of Covid-19 cases in the Sun Belt eases and the Northeast recovers, giving health-care workers a chance to prepare for what September and October may bring. For the first time in a month, fewer than 50,000 Americans are known to be hospitalized with Covid-19, according to data compiled by the Covid Tracking Project through Sunday.

In Arizona, one of several states to have suffered a brutal July, the coronavirus hospitalization figures have dropped by about half. In Florida, they’re down about a third from their peak last month, partly due to an easing of pressure on the Miami area. And in New York, where the pandemic hit hardest in its first onslaught, Gov. Andrew Cuomo (D) said yesterday that the numbers fell to their lowest of the pandemic — 535 hospitalized and 127 in the ICU statewide. Read more from Jonathan Levin.

Most N.Y.C. Students Opt for In-School Learning: New York City schools will be open next month, with their more than 700,000 students participating in a blended schedule of in-school and online instruction, Mayor Bill de Blasio said yesterday. Parents of about 74% of the city’s 1.1 million students have decided to send their kids to school for up to three days a week. They can opt out and switch to an all-remote schedule at any time. Read more from Henry Goldman.

• Coronavirus infections among U.S. children grew 40% in the last half of July, the American Academy of Pediatrics and the Children’s Hospital Association said in a report, as the country debated the risks of reopening schools. The study said 97,078 new child cases were reported from July 16 to 30, bringing the total number since the outbreak began to 338,982. That amounts to 9% of all infections. Read the report here.

Trump May Bar Citizens With Covid-19: Trump is considering rules that would permit border officials to temporarily block American citizens from returning to the U.S. from abroad if authorities believe they may have Covid-19, according to The New York Times. A draft memo says the rule would apply “only in the rarest of circumstances.” It’s unclear when the rule might be approved or announced, the Times reports. Read more from the Times.

Germany, France Balk at U.S. Bid to Revamp WHO: Germany and France are determined to prevent the U.S. from leading efforts to change the World Health Organization. A German government spokesman said it was the U.S.’s decision to pull out from the United Nations agency, and therefore neither Germany nor France see a mandate for the U.S. to steer the changes. The issue was discussed at an Aug. 6 call of the Group of Seven health ministers. Read more from Birgit Jennen and William Horobin.

More Headlines:

• Mass-Shooting Risk Is Growing on U.S. Virus Job Losses, Evictions
• Virus Safety Crackdown in Michigan Puts Small Farmers in a Bind
• WHO China Mission to Start in Wuhan to Investigate Virus Origins
• N.Y. Hospitalizations Hit Low; N.J. Transmission Rate Falls Under 1

What Else to Know Today

U.S. Wants Tariffs on Janssen HIV Drug: Imports of Janssen Ortho‘s darunavir ethanolate, a medicine for the treatment of HIV, should face U.S. import duties, the Justice Department told the Federal Circuit. The protease inhibitor interferes with the cleaving of viral proteins into mature proteins capable of propagating a viral infection. U.S. Customs and Border Protection classified the Prezista brand drug under a tariff provision for “sulfonamides,” which typically carry a duty rate of 6.5%. Read more from Brian Flood.

Trump Campaign Keeps Focus on Pre-Existing Conditions: Trump is vying to shore up his health care arguments by focusing on pre-existing conditions. The campaign posted a four-minute video on YouTube yesterday that consists of 20 clips of the president saying he will protect people with pre-existing conditions, as triumphant music swells. “We will always protect Americans with pre-existing conditions,” he says in one clip. “That’s a major part of what I’m all about.” Read more from Ryan Teague Beckwith.

More Headlines:

• Pandemic Lays Bare Fight Over Patent Strength, Innovation
• Juul Complaint Against Rival Vaping Cartridges to Get ITC Probe
• Humana Sues Teva Over Recalled, Tainted Blood Pressure Drugs
• Amarin Faces Another Generic Threat With Dr. Reddy’s Approval
• R.J. Reynolds Loses Bid to Dislodge L.A.’s Flavored-Tobacco Ban
• Ohio Men Get Another Shot at Disputing Air Ambulance’s Bills

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com