This Week at FDA: Updated COVID vaccine guidance, Senate to hold user fee hearing

This Week at FDAThis Week at FDA | 01 April 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. This week, we look at updates to FDA’s guidance on developing COVID-19 vaccines and look forward to next week’s Senate hearing on reauthorizing FDA’s user fee programs.
 
The big news we’re closing out the week with is FDA’s latest update to its COVID-19 vaccine emergency use authorization (EUA) guidance. The agency said the guidance contains revised recommendations on the clinical data to support the effectiveness of vaccines that have been modified to target a different strain of the SARS-CoV-2 virus. The bulk of the revisions made to the guidance can be found in Appendix 2 in the section pertaining to clinical data. The big takeaway is that the sponsors of approved or authorized vaccines will be able to gain authorization for a modified vaccine targeting a variant of concern based on data from immunogenicity studies.
 
The agency also removed its recommendation for sponsors to continue placebo-controlled follow-up data collection after receiving an EUA due to the widespread availability of authorized and approved vaccines.
 
“In earlier versions of this guidance, FDA included language stating that it expected sponsors to continue to collect placebo-controlled data in an ongoing trial for as long as feasible after submission of an EUA request and issuance of an EUA. FDA has modified this language because access to safe and effective authorized or approved COVID-19 vaccine may preclude the ethical continuation of blinded, placebo-controlled follow-up in ongoing clinical trials,” FDA explains.
 
As we reported previously, FDA’s Vaccines and Related Biological Products Advisory Committee will meet next week on 6 April to discuss booster doses and strain selection for updated vaccines.
 
In other vaccine news, FDA announced on Tuesday that it has authorized a new presentation of Moderna’s COVID-19 vaccine for booster vaccination only. The new multi-dose vial presentation uses dark blue caps and labels with a purple border to differentiate them from the red capped vials meant for primary vaccination.
 
Next Tuesday, the Senate Health, Education, Labor and Pensions will hold its first hearing on the reauthorization of FDA’s user fee programs, following similar hearings in the House Energy and Commerce committee. Read more of our coverage of the hearings here, here and here, and look out for coverage of the Senate hearing.
 
We’re also reading STAT and Endpoints’ coverage of FDA Commissioner Robert Califf’s first public appearance since taking over as commissioner for the second time in February.
 
We also note that FDA is seeking candidates to fill two high-profile roles – chief medical officer and chief scientist.
 
Drugs and biologics
 
FDA announced that effective last Friday, all electronic certificates of pharmaceutical product (eCPPs) will include a unique QR code that will enable faster verification of the certificates’ authenticity. “Anyone, including foreign governments, that receives an eCPP for human drug products exported from the U.S. FDA verify the authenticity of these certificates,” using a smartphone or by visiting the agency’s FECV Portal.
 
The agency also issued a warning to patients and healthcare professionals advising against the use of products purported to be sterile made by North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding following a recent inspection of the company’s Richardson, TX facility. FDA said it has requested that the company recall all unexpired drugs and cease sterile operations, though the company has yet to initiate a recall.
 
In other safety-related news, FDA is advising that newborns and children through three years of age undergo follow-up thyroid monitoring within three weeks of receiving injections of contrast media containing iodine. The advice follows a review of recent scientific literature that convinced the agency that, while uncommon, the risk of decreased thyroid hormone levels require additional monitoring in infants and young children, particularly those with underlying medical conditions.
 
FDA, in partnership with the Federal Trade Commission, this week sent out warning letters to seven companies for marketing cannabidiol (CBD) products with misleading claims that they cure, mitigate, treat or prevent COVID-19.
 
Medical devices
 
FDA has issued a technical amendment to its regulations to change the requirement to submit three copies of postmarket surveillance plan or revised postmarket surveillance plan documents to instead require only a single copy be submitted.
 
COVID-19 test developers also got some new guidance from FDA, including clarification that test developers can leverage validation data that has been reviewed by the agency for another test. “If the data is applicable to the new developer's test, they would generally not have to repeat that validation for their submission to the FDA,” the agency writes. It also notes that it has reviewed validation data on the adequacy of pediatric self-swabbing for COVID-19 diagnostics from Emory University and Children’s Healthcare of Atlanta, which was conducted with support from the National Institute of Biomedical Imaging and Bioengineering and the National Center for Advancing Translational Sciences at the National Institutes of Health. The university has “granted a broad right of reference to leverage the performance data and specimen collection protocols from their study on pediatric self-swabbing,” though FDA says some additional data may be required.

 

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