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Parents are mad.  While grown-ups have been eligible for COVID-19 vaccines for almost a year, there currently aren’t any options for children under 12.  This is especially concerning for many parents as the kids return to school amid a nationwide surge in cases.

A Different Process

On September 20, Pfizer/BioNTech released data showing its mRNA vaccine is safe and effective in children aged 5-11.  As the Food and Drug Administration (FDA) has fully approved the vaccine for individuals aged 16 and older and Pfizer/BioNTech vaccine is still available to individuals aged 12 to 15 through emergency authorization, why is the approval process taking so long for children?

• More data.  Earlier this year, FDA asked Pfizer/BioNTech and the other vaccine developers to provide six months of follow-up data for all clinical trial participants.  In comparison, the approval process for adults only required two months of follow-up data.
• More scrutiny.  Unlike the emergency use authorization (EUA) for adults, FDA doesn’t just rely on a company’s summary of the clinical trial data for children’s vaccines.  The agency looks at individual reports from every child, including data on side effects and blood tests.
• Biological differences.  Kids aren’t simply smaller adults.  Children have more active immune systems than grown-ups, which means scientists need to ensure they’re providing the right dosage.  Pfizer/BioNTech has specifically been testing children aged 5-11 with a two-dose regimen administered three weeks apart.  Each dose contains 10 micrograms, which is about a third of the dosage used for individuals aged 12 and up.

Pressure Grows for FDA to Speed Up Timeline

Earlier this year, it appeared that FDA would be able to approve vaccines for children aged 5-11 by early fall, just in time for the start of school.  However, signs that the approval timeline would extend first appeared in July when FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation.  These changes caused many health experts to revise their predictions on a timeline for approval for EUA, with some saying that the FDA would not make a decision until winter 2021 or early 2022.

The prospects of a longer timeline combined with a nationwide surge in cases sparked panic among many parents of younger children.  While COVID-19 poses a low risk for healthy kids, there is a justifiable concern about immunocompromised children as well as the ability for kids to pass the virus onto vulnerable adults.  As a result, some parents are even looking for doctors to skirt the rules and vaccinate their children, while others are signing their kids up for clinical trials, even though it’s unknown whether their child will be receiving the vaccine or a placebo.

Pressure from Pediatricians: The American Academy of Pediatrics (AAP) urged the FDA in an August 5  letter to “continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible” due to the threat posed by the Delta variant.  Specifically, AAP indicated that a two-month follow-up period to collect safety data is sufficient, as opposed to the six-month period FDA initially requested.  AAP also noted that reported cases of myocarditis in children who are receive mRNA vaccines like Pfizer/BioNtech’s are “extremely rare.”

The FDA is listening and took the rare step of publicly responding to the concerns around approving a COVID-19 vaccine for children on September 10. .  In addition to vowing to adhere to strict safety standards, FDA stated clinical trials are required to have a “follow-up period for safety data of at least about two months,” indicating a change from the previously requested six-month follow-up period.

The Timeline, Revised

With the FDA apparently open to a shorter follow-up period for safety data, what does the approval timeline look like now?  At the the Morgan Stanley Global Healthcare Conference 2021 on September 14, Pfizer CEO Albert Bourla laid out a new estimated approval timeline for children aged 5-11.

• Pfizer to have all safety and immunogenicity date in late September (topline results were released on September 20).
• Pfizer to file for EUA in early October.
• FDA to approve EUA within 3-6 weeks, meaning children aged 5-11 could get their shots as soon as late October or early November. 

Bourla also said Pfizer will likely have enough data on how well its vaccine works on children under 5 years of age as early as the end of October, putting that vaccine on the path for EUA by the FDA by the end of the year.

This is reassuring news for parents of kids aged 5-11, to potentially have a vaccine available by Halloween than, say, early 2022.  But let’s not get our hopes up as COVID-19 has proven itself to be an incredibly unpredictable virus, and changing conditions could cause scientists and regulators to shift their approval considerations once again.

Ahead of a September 17 meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), Food and Drug Administration (FDA) staff declined to take a position on whether to back third-dose “booster” shots of the Pfizer COVID-19 vaccine in a meeting briefing document.  While FDA staff acknowledged that some observational studies have pointed to declining efficacy of the Pfizer vaccine over time, much of the data presented in these studies has yet to be verified independently.  FDA staff also wrote that overall data indicates all currently authorized COVID-19 vaccines still offer protection against hospitalization and death.  Alongside the briefing document, FDA released data from Pfizer’s application for booster shots on September 15 that offers the company’s case for a third, immunity-restoring dose that VRBPAC will consider during its Friday meeting.  Separately, Moderna announced on Wednesday new data that points to benefits of a third “booster” dose of its vaccine.

House Dems’ Drug Pricing Plans on Thin Ice after E&C Markup

On September 15, three moderate House Democrats – Reps. Scott Peters (D-CA), Kathleen Rice (D-NY), and Kurt Schrader (D-OR) – blocked passage of a measure to allow the government to directly negotiate on drug prices during the third day of the Energy and Commerce (E&C) Committee markup.  Even though the drug pricing measure passed the Ways and Means Committee later that day, the push-back from the three moderate House Democrats signifies the challenges Speaker Nancy Pelosi (D-CA) faces in securing near-unanimous support among House Democrats to advance the $3.5 trillion “human” infrastructure plan. Reps. Peters, Rice, and Schrader believe the sweeping price negotiation plan would hurt drug innovation and has no chances of passing the Senate.  Instead, they are pushing for a more modest proposal that would subject price negotiations to a limited number of drugs, which progressive Democrats consider to be a non-starter.

CMS Proposes to Repeal Medicare Breakthrough Device Coverage Rule

On September 13, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal a Medicare breakthrough device coverage rule that was finalized in the waning days of the Trump administration in January 14, 2021.  Under the initially established pathway,  Medicare would cover a breakthrough medical device for four years beginning on the date of FDA authorization.  However, under the Biden Administration, CMS feels the rule needs to be withdrawn because FDA’s approval standards do not necessarily mean a product is safe for Medicare’s patient population.  The proposed rule is considered a win for the insurance industry, which felt the coverage pathway would result in “premature coverage of unproven devices for the Medicare population.”  And, if CMS finalizes the rule, it  would be bad news for medical device manufacturers, which saw Medicare coverage as payoff for taking the risk to develop breakthrough devices.

Pompeo, Christie Named Co-Chairs of Republican Redistricting Group

Former Secretary of State Mike Pompeo and former New Jersey Governor Chris Christie were named national co-chairs of the National Republican Redistricting Trust (NRRT), an organization aimed at providing resources to support Republicans in the post-2020 census redistricting process.  NRRT was launched in 2017 as a counterweight to the National Democratic Redistricting Committee, which is being led by former Attorney General Eric Holder during the Obama administration.  The announcement comes as both parties prepare for a redistricting process that is likely to face numerous legal challenges.  As discussed in an August 10 blog post, Democrats’ razor-thin majority in the House means redistricting could have an outsize effect on which party controls the lower chamber after the 2022 midterm elections.

ICYMI: Congressman Gets Mistaken for an Intern

Overheard DC, a Twitter account that shares interesting exchanges heard around the nation’s capital, posted an exchange  on Tuesday of a congressional intern asking an individual at the Subway in the Rayburn House Office Building who he worked for.  The individual replied, “I’m a member,” meaning he’s a member of Congress. The member in question turned out to be Rep. Gregory Meeks (D-NY), who currently chairs the House Foreign Affairs Committee.  Meeks later commented “glad I still blend in with the cool kids” when resharing the Overheard DC tweet.  The tweet also saw engagement from Rep. Abigail Spanberger (D-VA), who said she had previously experienced a similar case of mistaken identity.