HEALTH CARE BRIEFING: Pfizer Shot Gets FDA Advisers’ Nod

The first Covid-19 vaccine expected to be deployed in the U.S. won the backing of a panel of government advisers, a step that will likely help quickly clear the way for emergency authorization by the Food and Drug Administration.

A Food and Drug Administration advisory panel voted 17 to 4, with one abstention, that the benefits of the vaccine from Pfizer and BioNTech outweigh the risks for use in people ages 16 and older. The FDA doesn’t have to follow the recommendation, though often it does agree with its advisers.

An authorization could happen within days. After gaining clearance, shots will be distributed across the U.S. in a massive undertaking that will put health-care workers and long-term care facility residents at the front of the line.

Part of the discussion focused on whether there was enough data to support the vaccine’s use in 16 and 17 year olds, leaving some pediatricians on the advisory committee uncomfortable with voting in its favor. Other members said data from older trial participants could be extrapolated to younger people.

There isn’t enough data on children younger than 16 to determine whether it will work in pediatric populations, FDA staff said. Data is also insufficient to make any determinations about pregnant, lactating or immuno-compromised people.

Those who do get vaccinated will still need to wear masks and practice social distancing to prevent spreading the disease. FDA staff said the shot prevents symptoms of Covid-19 but may not be as good at preventing infections that don’t show symptoms, meaning significant transmission would still be possible without basic health measures. Read more from Anna Edney.

Cities Rush to Build Vaccine Trust, Infrastructure

The District of Columbia last month conducted a poll of 3,000 district residents to understand how many would be willing to take the vaccine.

The results suggested local public health authorities had a lot of convincing to do: Overall 44% of the survey’s respondents who identified as Black and African American said they would not accept a vaccine, along with 11% of those identified as Hispanic or Latino.

The results for healthcare workers also showed a trust gap, despite their greater vulnerability to the virus: 46% of healthcare workers who identify as Black or African American and 10% of those who are Hispanic or Latino would not take the vaccine, they said. Potential side effects, safety and the speed at which the vaccine was made were their biggest concerns.

The worst case scenario is that those disproportionately impacted by Covid-19 will continue to be “because of vaccine hesitancy,” said D.C. Community Health Administration official Ankoor Shah. Mistrust in health officials linger within Black communities, scarred by incidents like the Tuskegee syphilis atrocity and by racial biases that have negatively impact the health care that Black patients receive.

Undocumented people, those who are unhoused or those who lack health insurance could likewise fall through the cracks in the national vaccine roll-out. The job of overcoming these and other hurdles will fall in part to local officials and city leaders. Read more from Sarah Holder.

More on the Pandemic

Moderna Offers a Fail-Safe if Pfizer Falls Short: Moderna could offer a fail-safe option that will allow the U.S. to get enough coronavirus shots to vaccinate most Americans if the Trump administration can’t reach an agreement to quickly buy more doses from Pfizer, which plans to honor its contracts with other countries. The U.S.’s existing deals with Pfizer and Moderna are only enough for 100 million people. But Moderna has said the U.S. has the option to buy 400 million more at a fixed price of $16.50 a dose. Robert Langreth has more.

Window Closing for Also-Ran Vaccine Makers: Now that Pfizer and BioNTech are rolling out a coronavirus vaccine and Moderna not far behind, dozens of drug companies further back in the development pack are suddenly faced with a sobering possibility: The window to develop a successful vaccine before the field becomes crowded could be closing. That may leave some laggards hard-pressed to nab enough volunteers for trials needed to win regulatory approval. James Paton, Michelle Cortez, and Robert Langreth have more.

Risk of PFAS Sabotaging Covid-19 Vaccines’ Promise Spurs Research: The FDA’s anticipated approval of the first coronavirus vaccine enables scientists to kick off studies examining whether “forever chemicals” hinder the effectiveness of Covid-19 vaccines. But studies set to go when vaccines reach their local communities aren’t big enough to shed light on what the CDC has already said is an important question facing communities: how exposure to per- and polyfluoroalkyl substances may affect their risk of getting infected by Covid-19. Read more from Pat Rizzuto.

National Struggle of Getting PPE to Frontline Workers: The U.S. likely is producing enough masks, gowns, and other personal protective equipment. The supplies just aren’t getting to all the health-care workers who need them most. Federal money and real-time data sharing have helped manufacturers boost domestic production of gear seen as critical for essential workers during the coronavirus pandemic. But a lack of a national centralized database to track supply and demand—in particular, who needs what and where—many of those workers will continue to go without, lawmakers and policy consultants say.

“We never actually identified how much we need as a country, and how much we have as a country,” Rep. Andy Kim (D-N.J.), a member of the House Select Subcommittee on the Coronavirus Crisis, told Bloomberg Law. It’s difficult to know if the government is doing enough if that wasn’t accounted for, he said. Read more from Shira Stein.

More Headlines:

• White House Considers Reopening Travel With Europe, Brazil
• U.S. Dry Ice Plan Needed to Transport Vaccine: State Leaders
• U.S. Airline Workers Union Urge for Priority Spot for Vaccines
• Two-Dose Pfizer Vaccine 95% Effective: New England Journal
• Pfizer Reports Some Covid-19 Vaccine Records Accessed in Hack
• Walmart Says It Will Administer Vaccines After FDA Authorize

Happening on the Hill

Redfield Says He Told Staff to Ignore Trump Official: U.S. Centers for Disease Control and Prevention Director Robert Redfield said he told his aides to ignore an email by a top Trump administration health official who had sought changes to a scientific report on coronavirus’s risk to children. The email in question was written by Paul Alexander, a top adviser to Health and Human Services Secretary Alex Azar. The editor of the agency’s Morbidity and Mortality Weekly Report, Charlotte Kent, told lawmakers that she was instructed to delete the email. Read more from Kristen V. Brown.

International Mail May Be Disrupted by Opioid Law: A law meant to catch illicit shipments of synthetic opioids entering the U.S. may disrupt international mail starting in January, a U.S. Postal Service official warned lawmakers yesterday. The rate of inbound international packages tagged with identifying information, which assists Customs and Border Protection in flagging illicit mail carrying deadly shipments of the powerful synthetic drug fentanyl, stood at 54% in October, the USPS official testified to a Senate panel. Alex Ruoff has more.

• Meanwhile, Sens. Sheldon Whitehouse (D-R.I.), Amy Klobuchar (D-Minn.) and Rob Portman (R-Ohio) introduced the Comprehensive Addiction and Recovery Act (CARA) 2.0, which would increase funding authorization for opioid education, treatment and recovery programs and address new policies. In a statement the lawmakers said the bill will “serve as a marker for bipartisan progress” in the 117th Congress.

House Sends Two Health Measures to Trump: The House cleared two measures yesterday for President Donald Trump’s signature: an amended version of H.R. 1503, which would improve a Food and Drug Administration database of drug approvals and patents, particularly used to check the availability of generic drugs; and H.R. 5663, which would authorize the secretary of Health and Human Services to destroy counterfeit medical devices.

BGOV OnPoint: Marijuana Decriminalization, Research Bills: The House voted on legislation (H.R. 3884) Dec. 4 to decriminalize and tax marijuana at the federal level, marking the first time either chamber has acted to remove the long-standing federal ban on the drug. The latest BGOV OnPoint outlines the string of House-passed cannabis-related bills, reviews federal and state marijuana policies and explores how legislation could affect tax revenue, medical research, and cannabis use by veterans, among other issues.

What Else to Know

Faster Drug Coverage Decisions Expected Under New Proposal: Patients could get their medications faster under a Medicare agency proposal that tightens insurer response times for coverage decisions. Sometimes insurance plans demand to sign off on medications before they agree to cover them. In those situations, doctors have to explain to the insurance company why a patient needs a specific drug, as a way to encourage the use of cheaper, generic drugs. The process is called “prior authorization” or “step therapy” and it happens most often with expensive brand drugs.

Prior authorization eats up a lot of resources though and contributes to physician burnout, according to the Centers for Medicare & Medicaid Services. The proposal yesterday is meant to make the process more transparent and efficient. Read more from Jacquie Lee.

Abortion Pill Dispensing Rule Stays Suspended: The U.S. Food and Drug Administration lost another attempt to lift a ban against its in-person dispensing rule for mifepristone during the coronavirus pandemic, as a federal trial court judge said that circumstances haven’t changed enough to justify reimposing the rule. Mifepristone is one-half of a two-drug regimen used to induce abortions. Read more from Mary Anne Pazanowski.

High Court Upholds Law Reining in PBMs: The U.S. Supreme Court upheld an Arkansas law yesterday that regulates powerful pharmacy drug middlemen that employer health coverage plans hire to manage prescription drug benefits. In an 8-0 verdict, the court held the law isn’t preempted by the Employee Retirement Income Security Act. The Arkansas law was merely a form of cost regulation, Justice Sonia Sotomayor said. Lydia Wheeler has more.

More Headlines:

• Health Providers Seeking Drug Price Breaks Get Review Boards
• Patients May See to Health Records in 15 Days in HHS Proposal
• U.S. Medicare Office Seeks Small Business for Obamacare Audit
• Sanofi to Resume Dosing in U.S. Studies of Hemophilia Therapy
• FTC, State Again Bid to Halt Philly Hospital Deal Pending Appeal
• Defense Health Agency Outlines $2 Billion Tech Transition Plan

GAO Reports:

• Studies Suggest Biopsy Specimen Misidentification, Contamination Errors Are Infrequent
• Indian Health Service: Actions Needed to Improve Oversight of Provider Misconduct, Low Performance

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