This Week at FDA: Bivalent COVID vaccines for children, new guidance, and more

This Week at FDAThis Week at FDA | 09 December 2022 |  By 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. FDA this week authorized the Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines for children as young as 6 months of age. We’re also reading up on several new and upcoming guidances and watching as Congress nears a critical government funding deadline.
 
“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so – especially as we head into the holidays and winter months where more time will be spent indoors,” said FDA Commissioner Robert Califf.
 
The updated emergency use authorizations enable children 6 months to 5 years of age to receive a single booster of the bivalent Moderna shot two months after completing their primary series of the monovalent Moderna vaccine and children 6 months through 4 years of age to receive the bivalent Pfizer-BioNTech vaccine as the third dose of their primary series. “Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time,” FDA writes, adding that it expects to have data in support of a bivalent booster dose for children who completed the three-dose primary series of the Pfizer-BioNTech vaccine in January.
 
We’re also watching the ongoing negotiations in Congress over a spending package to fund the federal government beyond the current continuing resolution, which expires on 16 December. Several FDA-related riders were stripped out of the user fee reauthorization package earlier this year, including the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which proponents have eyed passing as part of an end of the year spending package. Talks between Democrats and Republicans have reportedly broken down, with the two sides disagreeing on the non-defense spending level.
 
This week, Politico reported that several former FDA investigators have raised concerns that members of the agency’s Team Biologics are not getting enough training and are overworked amid the COVID-19 pandemic. An FDA spokesperson asserted that the inspectors are “highly trained professionals, and that the agency’s top priority is protecting public health.
 
Plus, we may soon see final guidance from FDA on quality considerations cannabis and cannabis-derived compounds. The agency’s final guidance on the topic was submitted to the White House Office of Management and Budget this week for review.
 
Drugs & biologics
 
FDA this week announced it will move forward with a risk-based approach to policing homeopathic products that has been years in the making. The agency describes its policy for prioritizing enforcement and regulatory action for homeopathic products – none of which have ever been approved by the agency – in a final guidance. The guidance was first issued in draft form in December 2017 and was revised in October 2019 to add a definition of homeopathic products, as well as new information about the safety issues that led to the guidance’s development. The newly finalized guidance contains “minor revisions for clarity and transparency,” FDA wrote in a Federal Register notice. The enforcement and regulatory priorities laid out in the final guidance are essentially unchanged from the 2019 draft.
 
On Monday, FDA finalized its version of the International Council for Harmonisation’s E19 guidance on selective safety data collection in late-stage pre-approval and post-approval clinical trial after the ICH document reached Step 4 in October.
 
The agency also issued an immediately effective guidance on recommendations to reduce the risk of transfusion-transmitted malaria that supersedes an earlier guidance issued in the early days of the COVID-19 pandemic.
 
Endpoints reports that drugmaker Oncopeptides may comply with FDA’s request that it withdraw its accelerated approval for its drug Pepaxto (melphalan flufenamide) to treat multiple myeloma, though the company hasn’t made a formal decision on the matter at this time.
 
In enforcement news, FDA sent a warning letter to sperm and egg bank Cryos International for donor screening failures. The agency also released Form 483s for its recent inspections of Lupin Limited Unit I in Madhya Pradesh, India and Aurobindo Pharma Limited’s Unit IX in Telangana, India. Additionally, FDA has issued an import alert for drugs made at Sun Pharmaceutical Industries’ Gujarat facility, though the alert lists more than a dozen drugs that may exempt from the alert under FDA’s enforcement discretion due to shortage concerns.
 
Reuters also reports that FDA staff have raised safety concerns in their review of Cytokinetics’s heart drug ahead of an advisory committee meeting next week.
 
The Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality has revised three manuals of policies and procedures (MAPPs): CMC Reviews of Type III DMFs for Packaging Materials, CDER Liaisons to Official Compendia and Standards Development Organizations – Selection Process, Roles, and Responsibilities, Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) and Acceptability of Standards from Alternative Compendia (BP/EP/JP).
 
Medtech
 
FDA this week shared a new page on its website that lists medical devices that feature augmented reality (AR) or virtual reality (VR) technology. The page currently lists 39 devices that have been cleared or approved, the majority of which are for orthopedic or radiology devices. FDA notes that the list is not meant to be exhaustive and is based on information gleaned from the summary description of the device included in each product’s marketing authorization document.
 
The agency also issued new draft guidance this week on the content of human factors information in medical device marketing submissions (we’ll have more coverage of that guidance next week) and its voluntary malfunction summary reporting (VMSR) program.
 
Earlier this week, FDA provided an update on the ongoing safety issues with Endologix’s Endovascular graft systems. FDA said it approved new labeling for the company’s AFX2 Endovascular AAA System “that includes information to better inform patients and healthcare provided of the risks of Type III endoleaks.” The agency added that it is requiring Endologix to conduct a postmarket safety study comparing its AFX2 device to other commercially available AAA endovascular grafts using real-world data.
 
FDA classified Remel Inc’s recall of Thermo Scientific Gram Negative IVD AST Sensititre Plate as a Class I recall due to the risk of false positive susceptible results. The test is used for clinical susceptibility testing of Enterobacterales, Pseudomonas aeruginosa and other non-Enterobacteriaceae to aid in the selection of antibiotics for treatment. The agency also labeled Dewei Medical Equipment Co.’s recall of unauthorized DNA/RNA preservation kits as a Class I event.

 

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