HEALTH CARE BRIEFING: Vaccine Hiccups Raise Queries About Method

Two Covid-19 vaccines stalled by potential side effects have one key feature in common: Both are based on adenoviruses, cold germs that researchers have used in experimental therapies for decades with varying results.

Johnson & Johnson said last week it would pause its trial to investigate an illness, which it didn’t specify, in a study participant. Meanwhile, AstraZeneca’s U.S. trial of the vaccine it’s developing with the University of Oxford has been halted by regulators for more than a month after neurological symptoms arose in two volunteers.

With AstraZeneca in a pit stop, vaccines from Moderna and the Pfizer-BioNTech partnership have taken the lead in the race to be first out with a shot. Meanwhile, the two paused trials are reviving questions about adenoviral vectors, which have been used in laboratory, animal and human experiments for years. In some cases, the experiments have succeeded, but not always.

And this year, with Covid-19 vaccines entering strongly into the politics of the hour, trust and transparency are key to fighting a disease that’s hit more than 39 million people globally and hamstrung economies. If concerns about side effects in experimental vaccines in trials using adenoviruses are validated, it may boost skepticism in the general public and raise questions for other drugmakers.

“While it could be a coincidence,” Bloomberg Intelligence analyst Sam Fazeli said in a research note, “there’s still the possibility that adenoviral vector vaccines run a higher risk of rare side effects—such as autoimmune attacks like transverse myelitis—than those of Pfizer-BioNTech, Moderna or Novavax.” Read more from John Lauerman, James Paton, and Stephanie Baker.

Biden Hones Tactics to Win Vaccine Trust: Meanwhile,Joe Biden’s allies said the Democratic presidential nominee’s priorities in office would be to respond to the pandemic and restore public trust, leveraging the government’s power and scientists’ expertise to roll out a Covid-19 vaccine. The current lack of trust in government threatens to undermine the success of the federal response to the coronavirus. Americans’ willingness to be vaccinated against the virus fell 11 percentage points since July, a Gallup survey released last week found. Just 50% of respondents said they would agree to be vaccinated right now. Read more from Alex Ruoff.

CVS, Walgreens Can Give Covid Shots in Nursing Homes: CVS and Walgreens will provide a future coronavirus vaccines to residents and employees of long-term care facilities, the Trump administration announced Friday. The shots will be free to the facilities, according to a Health and Human Services Department statement. Operators will pick which pharmacy they would prefer to work with and will coordinate directly with them. Each chain boasts more than 9,000 locations across the country. Read more from Angelica LaVito.

Meanwhile, Pfizer said it could seek emergency-use authorization for its Covid vaccine in the U.S. by late November if the shot is shown to be effective in a large late-stage trial, putting to rest any notion that a vaccine could be cleared for emergency use in the U.S. before Election Day. Safety reviews will dictate the timeline, with the Food and Drug Administration requiring that at least half the people in the study be watched for side effects over two months. Read more from Naomi Kresge, Robert Langreth, and Emma Court.

More on the Pandemic

Pelosi Shifts Deadline for Stimulus: Speaker Nancy Pelosi (D-Calif.) set a deadline of tomorrow for more progress with the White House on a fiscal stimulus deal before the Nov. 3 election, while President Donald Trump renewed his offer to go beyond the dollar amounts now on the table. While Pelosi said a pre-election deal remains possible, her team sent conflicting signals after setting a 48-hour deadline for progress on Saturday night. Her spokesman, Drew Hammill, later said the timing of the deadline meant by the end of Tuesday, not Monday. At issue is wording “on the design on some of these things” that remain unresolved in the bill, Pelosi said on ABC’s “This Week.” Read more from Billy House.

U.S. Cases Top 8 Million: Total Covid-19 cases in the U.S. topped 8 million, according to data compiled by Johns Hopkins University. Cases across the U.S. have been rising since mid-September, after a summertime peak as the virus spread through the Sun Belt. The trailing seven-day average of cases rose by almost 9% this week compared to the prior week, illustrating the upward curve faced by the U.S. Read more.

Plans for Permanent Test Authorization in Works: The FDA committed Friday to create a plan for how devices distributed throughout the Covid-19 emergency will transition to the market after the pandemic ends. The promise of a transition is among the list of guidance documents the FDA said it plans to publish in the coming year. Ventilators, face masks and swabs would all theoretically fall under that category. Read more from Jacquie Lee.

Medicare Seniors Postpone Care Due to Covid: Medicare seniors are skipping needed care and struggling emotionally as the Covid-19 pandemic alters their lifestyles. New survey data from the Centers for Medicare & Medicaid Services found that 21% of beneficiaries reported forgoing health care due to the pandemic; 46% reported feeling more stressed and anxious. Nearly half of beneficiaries said they avoided care because they didn’t want to risk being in a medical facility and 23% said they’re feeling more lonely or sad. Read more from Tony Pugh.

Overdose Deaths Spiked Going Into Pandemic: The number of Americans dying from drug overdoses hit a record hit in March, according to a report by the Centers for Disease Control and Prevention. There were 73,860 overdose deaths reported in the 12 months before March 2020, the most of any year-long period in American history, according to the data. The record indicates that drug overdose deaths were increasing significantly leading into the spread of the coronavirus, which researchers have said may be exacerbating the drug addiction crisis gripping the U.S. Read the report here.

WHO Plans to Revise Guidance on Remdesivir: The World Health Organization will revise its guidance on the use of remdesivir in coming weeks following the results of the Solidarity trial in which it was found to not reduce the mortality rates, Chief Scientist Soumya Swaminathan said at a briefing. The review will take into account all studies on the drug. Read more.

More Headlines:

U.S. Influence in Asia Eroded by Pandemic as China Catches Up

NIH Starts Clinical Trial to Test Immune Modulators for Covid-19

China Says It Found Active Coronavirus on Frozen Food Packaging

Twitter Deletes Trump Health Adviser’s Claim Masks Don’t Work

OSHA Touts $1.2 Million in Virus-Related Fines for 85 Businesses

What Else to Know

Biden Health Agenda May Cost $2 Trillion Over 10 Years: Biden’s health care agenda could cost as much as $2 trillion over 10 years, while Trump’s would save as much as $1 trillion over that time period, according to a report by the Committee for a Responsible Federal Budget. Much of the savings from the Trump plan is based on a his “vision for health reform,” which lacks detailed policy provisions and assumes savings of $850 billion by cutting spending on Medicaid and insurance subsidies through the Affordable Care Act, according to the report. Costs tied to Biden’s agenda come largely from his goal of expanding Obamacare through a public option. Read the report here.

K Street Buzzes Over Possible Shift to Biden After Trump Era: Washington’s vaunted corps of lobbyists is bracing for the prospect of a win next month by Biden. All across the nation’s capital, companies and trade associations are laying plans for a potential Biden administration. They are strategizing on how to defend clients from an expected resurgence of regulation and marry their priorities with Biden’s expected focus on stimulating the economy, expanding health care and overhauling corporate taxes.

A stimulus bill alone could provide an opening for many corporate interests — and not just for a federal cash infusion. For instance, some companies anticipate an opportunity to remove barriers to telemedicine, potentially as part of an effort to strengthen health care. At the same time, drugmakers want to fend off measures to limit prices that they expect from House Democrats.

The prospect of a Democratic sweep of the Senate and White House is also driving some to cultivate closer relationships with moderate Democrats such as Joe Manchin (W.Va.), Jon Tester (Mont.) and Kyrsten Sinema (Ariz.), who would hold outsize influence to stop legislation, according to two lobbyists who asked for anonymity to detail strategy. Read more from Jennifer A. Dlouhy and Ben Brody.

Visa Renewal Proposal Risks Doctor Shortage: Hospitals in disadvantaged rural and urban areas could face physician shortages and operational chaos if a proposed change in federal immigration policy makes it harder for foreign-born doctors to remain in the country. Medical groups, including the American Hospital Association and the Association of American Medical Colleges, are sounding the alarm. They’ve called on the Department of Homeland Security to exclude foreign-national physicians in U.S. medical residency and fellowship programs from proposed requirements needed to extend their authorized stays. Read more from Tony Pugh.

More Headlines:

IRS Keeps $1,800 Yearly Cap on Health Reimbursement Arrangements

Maker’s Lawsuit to Force Medicare to Pay for Leg Massager Barred

Akero Therapeutics Lands EMA PRIME Designation for Efruxifermin

To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Alex Ruoff in Washington at aruoff@bgov.com

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