Biologics
In a briefing document prepared for a 9/17 meeting of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, FDA does not take a position on whether there is a current need for a booster shot of the Pfizer Comirnaty Covid-19 vaccine. “Some observational studies have
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House Republican whip and Select Subcommittee on the Coronavirus Crisis ranking member Steve Scalise (R-LA) and House Committee on Oversight and Reform ranking member James Comer (R-KY) say they are concerned that the Biden White House is pressuring career FDAers to recommend Covid-19 vaccine booster shots before
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Two retiring senior FDA vaccine officials, CBER Office of Vaccines Research and Review (OVRR) director Marion Gruber and her deputy Philip Krause, have joined outside researchers to argue against requiring Covid-19 booster shots until data can show a necessary benefit. Writing in a 9/13 Lancet viewpoint article, the
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FDA has alerted Biden Administration officials that it may only be able to give the green light for those vaccinated with the Pfizer/BioNTech Covid-19 vaccine to begin receiving booster shots later this month. So far, only Pfizer has submitted full data to FDA on booster shots, and an
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Moderna says it has started its submission to FDA for the evaluation of a 50 microgram booster dose of its Covid-19 mRNA vaccine. A company statement says a Phase 2 study of the vaccine was amended to offer a booster dose at the 50 microgram level to interested participants
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FDA has announced a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTech’s supplemental BLA seeking approval for a booster dose of Comirnaty (Covid-19 vaccine, mRNA) in individuals 16 years of age and older. “The process for authorizing or approving the use of
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In the wake of the departures of two senior CBER vaccine officials (see earlier story), FDA acting commissioner Janet Woodcock has weighed in, pledging support and asserting confidence that she and the agency have in the Center’s ability to deliver safe and effective vaccines during the pandemic. CBER Office
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Two senior CBER vaccine officials are leaving FDA over the next couple of months — untimely departures that signal trouble with how the agency and Biden Administration are handling Covid-19 vaccine reviews and approvals. CBER Office of Vaccines Research and Review (OVRR) director Marion Gruber plans to retire 10/31,
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Moderna has completed a rolling BLA and requested a priority review for the submission seeking full licensure of its Covid-19 vaccine for use in individuals 18 years of age and older. The vaccine was granted an emergency use authorization by FDA 12/18/2020. The completed submission includes clinical
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FDA has approved the first Covid-19 vaccine — Pfizer-BioNTech’s vaccine that is now under the trade name Comirnaty — for use in individuals 16 years of age and older. The vaccine continues to be available under an emergency use authorization (EUA) for individuals 12 through 15 years of age
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Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) has three takeaways from the recent FDA final rule governing how the intended use of a distributed product is to be determined. First, he says in an FDA Law Blog post, the removal of the knowledge provision, which had seemed to problematically suggest
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A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) in Sandy, UT, has determined that the firm’s cell products StemVive and StemMaxx are unapproved. A just-posted Warning Letter says that agency investigators also documented evidence of significant GMP and good tissue practice deviations.
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CBER says it will not object to AstraZeneca’s decision to export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations
Biologics
Pfizer and BioNTech have submitted Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary
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FDA has amended the emergency use authorizations (EUAs) for both Pfizer-BioNTech’s and Moderna’s Covid-19 vaccines to allow for the use of an additional dose in certain immunocompromised individuals. The expanded use specifically covers “booster” doses for solid organ transplant recipients or those who are diagnosed with
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FDA has placed a clinical hold on Bluebird Bio’s Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected serious adverse reaction of myelodysplastic syndrome (MDS) in a trial involving the investigational gene therapy for treating cerebral adrenoleukodystrophy. The MDS event showed up in a patient in the
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The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Stem Cell Therapy of Las Vegas, Las Vegas, NV, and other online sources determined that the company markets to consumers cellular products derived from either human adipose tissue or umbilical cord. An 8/
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FDA has accepted for review two Merck supplemental BLAs for its anti-PD-1 therapy Keytruda (pembrolizumab). One submission was accepted for priority review for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney)
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FDA has approved a Genzyme BLA for Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients one year of age and older with late-onset Pompe disease. The intravenous enzyme replacement therapy helps reduce glycogen accumulation, according to an FDA news release. In Pompe patients, glycogen accumulation in skeletal
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The Bloomberg editorial board says FDA is undermining its credibility by not speaking out forcefully and completely as calls increase for full approval of the Covid-19 vaccines that have been granted emergency use authorizations. In an online post, the editorial board says FDA insists it is “working as quickly
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FDA is allowing Emergent BioSolutions to resume production of the Johnson & Johnson Covid-19 vaccine at the company’s troubled Bayview manufacturing facility. The company says that following an FDA order to halt vaccine production at Bayview, it worked closely with the agency and J&J to address
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FDA has released the transcript of a 5/6 virtual workshop on “Patient Engagement & Regenerative Medicine: A CBER Workshop for Patient Advocates.” The workshop was hosted by CBER’s Office of Tissues and Advanced Therapies (OTAT). During the session, OTAT deputy director Rachael Anatol said cell and gene therapy-