Analysis | The Health 202: Here's what is next for coronavirus vaccine approvals - The Washington Post

with Alexandra Ellerbeck

Coronavirus vaccines are now readily available to American adults and teenagers. 

But for the Food and Drug Administration, the job is hardly wrapped up. The agency is still facing the prospect of fully approving the shots beyond just emergency approval and giving them a nod for use among younger children.

Here’s how additional vaccine approvals might unfold through the fall and winter:

Full approval of the Pfizer and Moderna vaccines is likely just around the corner.

So far, all 195 million Americans who have received coronavirus vaccines have done so under emergency-use approval granted by the FDA. 

But the companies have continued submitting data to the FDA from large, ongoing clinical trials, and both Pfizer and Moderna have applied to the agency for full approval; Pfizer submitted its “biologics license application” on May 7 and Moderna began a rolling submission in June.

The Post’s Laurie McGinley recently explained the agency’s typical timelines: “While each vaccine review is unique, the FDA aims to complete priority vaccine reviews within eight months of receiving an application for approval and standard reviews within 12 months of receipt.”

Under that maximum time frame, the latest the agency would decide on full approval would be January for Pfizer and February for Moderna.

But Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which regulates vaccines, told Laurie that the agency is pursuing “an all hands-on-deck” strategy to accelerate an already expedited effort to grant full approval. He said the agency was essentially “in a sprint” to complete the process for Pfizer’s vaccine.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, gave a similarly optimistic prediction over the weekend.

“I hope — I don’t predict — I hope that it will be within the next few weeks. I hope it’s within the month of August,” Fauci said Sunday on NBC’s “Meet the Press.”

“If that’s the case, you’re going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that,” Fauci continued. “The time has come … we’ve got to go the extra step to get people vaccinated.”

Johnson & Johnson hasn’t yet applied for full approval.

This vaccine was used far less than either Pfizer or Moderna, with just 13 million Americans receiving the one-shot dose. The vaccine also stumbled momentarily in April, when the Centers for Disease Control and Prevention temporarily paused its use over concerns about rare and severe blood clots that appeared in a handful of recipients.

But the company is pushing onward, expected to apply for full approval later this year.

The other big thing: approving coronavirus vaccines for children under 12.

A federal official told our Post colleagues that authorization for children 5 through 11 might come by late October or early November. Pfizer and Moderna, which are both testing the shots in younger children, have been asked by federal regulators to expand their trials to include several thousand school-age kids before seeking authorization.

“The changes to ongoing pediatric trials run by Moderna and Pfizer and its German partner, BioNTech, could delay the availability of the vaccines to children between 5 and 11 beyond the hoped-for timeline of early fall, although it is unclear by how much,” Laurie wrote, along with Carolyn Y. Johnson and Yasmeen Abutaleb. 

“As the country faces a surge fueled largely by cases in unvaccinated people and the school year approaches, pediatricians and families have impatiently awaited shots of protection.”

The American Academy of Pediatrics isn't enthused about the FDA's request to expand the trials.

The association, which represents more than 67,000 pediatricians, asked FDA acting commissioner Janet Woodcock to “strongly consider” authorizing the vaccines for children 5 to 11 based on data from the initial trial enrollees, instead of waiting for all the safety data from the expanded cohort.

“While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group,” the AAP wrote in a letter dated Aug. 5. “In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children.”

When the vaccines are initially approved for children — whenever that happens — it will likely be an emergency-use authorization rather than full approval, said Ronny Gal, a financial analyst with investment research firm Sanford C. Bernstein and Co. And the FDA might approve a smaller dose for children. The agency is facing particularly weighty questions around how to address vaccine side effects for children and for whom pediatricians should recommend them.

“Obviously the biggest nightmare scenario for the FDA is this vaccine kills a couple of kids,” Gal said. “They have to think through what they’re going to tell parents and physicians.”

Don’t forget about the three other potential coronavirus vaccines.

The federal government has contracted with three other vaccine makers — Novavax, AstraZeneca and Sanofi — to buy coronavirus vaccine doses if they're ever approved by the FDA.

Novavax — whose president of research told us in February that the plan was to apply for EUA in the second quarter — has delayed its plans over and over. The company again pushed back the timeline last week, announcing it now plans to seek authorization in the fourth quarter. 

“It's a matter of getting validation work done” to demonstrate consistency in the vaccine's manufacturing process to the FDA, CEO Stanley Erck told Reuters.

AstraZeneca has also delayed plans, initially expecting to seek authorization in the United States in April but now looking at later this year. And Sanofi is way behind both companies; it is expecting interim results of its Phase 3 clinical trial of an mRNA vacccine in the third quarter.

Ahh, oof and ouch

AHH: Democrats released a $3.5 trillion budget blueprint.

The budget resolution calls for an expansion of Medicare to cover dental, vision and health benefits; the creation of a new federal health program that would provide healthcare in states that refused to expand Medicaid; and the extension of Affordable Care Act subsidies first introduced on a temporary basis this spring. 

“The resolution, which sets up a process to craft full legislation in the weeks ahead, is expected to gain the support of only the chamber’s 50 Democrats — forcing the party to rely later on a legislative move known as reconciliation to bypass Republican opposition and avert a likely filibuster,” The Post’s Tony Romm reports.

Democrats have said the package would be financed through tax increases on profitable companies and wealthy families. The summary of the proposal also calls for reducing drug prices to “save taxpayers millions of dollars.” Senate Finance Committee Chairman Ron Wyden (D-Ore.) has said Democrats will seek to empower Medicare to negotiate drug prices.

Chip Kahn, head of the Federation of American Hospitals, praised the proposals to extend Affordable Care Act subsidies and provide coverage in Medicaid non-expansion states.

“The budget resolution framework released today by Senate Democrats contains several promising proposals that will expand coverage and increase access to care for millions of Americans,” Kahn said in a statement. “However, as always, ‘the devil is in the details’ so we look forward to reviewing the reconciliation bill when it becomes available.”

OOF: The Pentagon will mandate vaccination for active-duty military personnel by mid-September.

Defense Secretary Lloyd Austin will seek a mandate requiring all service members to get a coronavirus vaccine by mid-September, or even sooner if the vaccine receives full approval from the Food and Drug Administration, The Post's Dan Lamothe reports.

“The intervening few weeks will be spent preparing for this transition,” Austin said in a memo circulated to the Defense Department workforce. “I have every confidence that Service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion. We will have more to say about this as implementation plans are fully developed.”

Defense Secretary Lloyd Austin will seek a mandate to require that all service members get a coronavirus vaccine by mid-September, according to a Aug. 9 memo. (Reuters)

President Biden praised the decision, saying that the United States was on “still on wartime footing” against covid-19 as the delta variant spreads rapidly through unvaccinated populations. 

“Secretary Austin and I share an unshakable commitment to making sure our troops have every tool they need to do their jobs as safely as possible. These vaccines will save lives. Period,” Biden said.

OUCH: Workplace disputes over vaccine mandates have moved to the halls of Congress.

Nineteen House Democrats have sent a letter to the Capitol physician urging him to require proof of vaccination or at least twice-weekly testing for members and staff in the U.S. Capitol. But such a mandate would likely face fierce backlash from Republicans, many of whom are already railing against mask requirements. 

“Democrats worried they could expose themselves to the virus through their work — and then transfer it to vulnerable family members — are angry with Republicans who refuse to be vaccinated or wear masks,” the Hill’s Cristina Marcos reports. “The boiling anger and distrust has led to lawmakers getting into shouting matches over masks, refusing to board elevators with each other and outright avoiding some colleagues on the House floor.”

“After nearly six months without any reported COVID-19 cases among members of Congress, at least five lawmakers have tested positive in the last three weeks. That number included four who said they were fully vaccinated, highlighting the threat of relatively rare but still possible breakthrough cases,” Cristina writes.

A total of 2.5 million people enrolled in marketplace health coverage during this year's special enrollment period.

Vice President Kamala Harris will announce the sign-ups at an event in D.C. this morning. The sign-ups – which come on top of 11.3 people who were already enrolled – reflect a roughly 22 percent increase in people obtaining coverage through Healthcare.gov and the state-run marketplaces, during an expanded, pandemic-related enrollment period that ends on Sunday. 

Harris will also tout more-generous subsidies available on the marketplaces, as well as President Biden's agenda to permanently expand the subsidies, expand Medicare and Medicaid coverage and lower drug costs. The expanded subsidies – which were provided through a March coronavirus relief plan – allowed more than one-third of new and returning Healthcare.gov customers could find a plan costing a premiums of $10 or less per month, according to a release from the White House.

More in coronavirus news

• Arkansas reported a new record for the number people in the state hospitalized with covid-19, the Associated Press’s Andrew DeMillo reports. With 509 covid-19 patients in intensive care units across the state and 286 on ventilators, the Department of Health reported that there are only eight open ICU beds. Arkansas ranks third in the country for coronavirus cases per capita. Only 37 percent of the state’s population is fully vaccinated against the virus.
   
• Dallas school leaders announced that students and teachers will be required to wear masks in defiance of Texas Gov. Greg Abbott. The governor signed an executive order last month that bars government entities, including public schools, from requiring masks of vaccines, The Post's Annette Nevins and Laura Meckler report. The move comes as virus cases surge in the state. Abbott on Monday called on hospitals to voluntarily postpone elective procedures in order to free up beds for covid patients. 

• The latest surge in coronavirus cases is complicating Democrats’ midterm strategies. For months, Americans gave Biden high approval on his handling of the pandemic, but that popularity is starting to erode. Democratic politicians worry that they will be blamed if the country doesn’t return to normal, The Post’s Sean Sullivan and Marianna Sotomayor report.

Elsewhere in health care

The U.S. health-care system ranks last among 11 high-income countries.

A report by the Commonwealth Fund found the United States spent the highest proportion of its gross domestic product on health care, but it ranked dead last when it came to performance, The Post’s Claire Parker reports.

“We’ve set up a system where we spend quite a bit of money on health care but we have significant financial barriers, which tend to dissuade people from getting care,” said Eric Schneider, senior vice president for policy and research at the Commonwealth Fund, which conducts independent research on health-care issues.

Researchers compared the health-care systems in Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom and the United States. They looked at 71 performance measures related to access to care, the care process, administrative efficiency, equity and health-care outcomes.

The United States ranked well when it came to the care process — which measures preventive care and engagement with patients — but did poorly in the other categories. Researchers found large inequities in health care among income groups, which contributed to poor health outcomes. The United States has the highest infant mortality and the lowest life expectancy of any of the countries surveyed.

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Analysis | The Health 202: Here's what is next for coronavirus vaccine approvals - The Washington Post
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