• Regulatory NewsRegulatory News

    FDA issued vaccine EUAs without facility inspections: GAO

    Manufacturers of COVID-19 vaccines currently authorized for emergency use did not undergo facility inspections before their vaccines were authorized by the US Food and Drug Administration (FDA), said the General Accounting Office (GAO) in a new report. However, most facilities had been inspected at least once previously in past 10 years, and the agency relied on a variety of other information sources including record reviews and on-site reviews.   The examination of th...
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    FDA authorizes Pfizer COVID vaccine for younger kids

    The first US emergency use authorization (EUA) for younger children to receive a COVID-19 vaccine has been issued, the US Food and Drug Administration (FDA) announced Friday afternoon.   The mRNA vaccine developed by Pfizer in conjunction with the German firm BioNTech is now authorized for use in children aged 5-11 years. The Centers for Disease Control and Prevention (CDC) will convene a meeting of its immunization advisory committee next week to review clinical param...
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    Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids

    Younger school-aged children in the US came a step closer on Tuesday to having a COVID-19 vaccine available, with a positive vote from the US Food and Drug Administration's (FDA's) vaccines advisory committee for a reduced dose of Pfizer’s mRNA vaccine.   The vote was near-unanimous, with just one abstention and no “nays” among the 18 voting members of FDA’s Vaccines and Related Biological Products advisory committee (VRBPAC). Overall, the committee judged that the ben...
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    European Commission identifies 10 ‘promising’ COVID treatments

    The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.   A panel of scientific experts selected the 10 drugs from a pool of 82 therapeutic candidates that are in late-stage clinical development.    “In selecting the 10 most promising candidates, experts focused on the product categories with the highest potential impact on the pandemic: produc...
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    FDA okays Moderna, J&J, 'mix and match' boosters

    The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizing heterologous booster doses for all populations eligible for boosters under today's expansion of the emergency use authorizations for COVID-19 vaccines.   A booster is recommended for all recipients of the one-dose Janssen vaccine, an...
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    FDA adcomm unanimous on J&J boosters for all

    The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19 vaccine made by Janssen, the vaccines arm of Johnson & Johnson, for all recipients of the single-dose primary vaccination.   The Vaccines and Related Biologic Products advisory committee (VRBPAC) recommended that FDA issue an emergency use authorization (EUA) for a booster to be given at least 2 months after the...
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    Unanimous thumbs up from FDA committee for Moderna booster

    An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of the mRNA COVID-19 developed by Moderna and the National Institutes of Health for those 65 years and older, and for certain younger populations at high risk of severe COVID-19.   Moderna has requested an emergency use authorization (EUA) for the 50 mcg booster dose for individuals who have already completed the two-dose series of the Moderna ...
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    ICMRA: Industry's commitment to quality can facilitate regulatory flexibility

    Frequent communication with industry and relying on assessments by other regulators have enabled the rapid scale-up of COVID-19 vaccines and therapeutics, asserted regulators and industry representatives attending a July workshop sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA).   The workshop explored how different regulatory tools are being deployed to increase manufacturing capacity for vaccines during the COVID-19 pandemic. The...
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    China’s data localization‒centric policies and their impact on human research

    This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting such research must be vigilant about complying with the complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance. The analysis includes review of various legal requirements issued by the People’s Republic of China ...
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    Vaccines Europe makes the case for vaccine-specific HTA

    A new position paper from Vaccines Europe calls for an EU-wide committee and effort to implement clinical health technology assessment (HTA) methodologies that are specific to vaccines.   The vaccine-specific initiative would be part of a broader effort by the European Commission (EC) to institute common HTA methodologies and tools throughout the EU. Vaccines Europe, together with the European Federation of Pharmaceutical Industries and Associations’ (EFPIA), is seekin...
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    Comirnaty booster gets adcomm thumbs up, for limited population

      An advisory committee to the US Food and Drug Administration (FDA) voted 16-2 on Friday against approval of a third booster dose added on to the 2-dose regimen for Pfizer’s COVID-19 vaccine Comirnaty. However, the committee voted unanimously in favor of an emergency use authorization (EUA) for booster doses for those aged 65 years and up, as well as health care workers and other individuals at high risk for COVID-19 because of occupational exposure.   The ball is n...
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    EC announces €120 million in Horizon Europe funding

    The European Commission (EC) has pruned the list of COVID-19-related research projects it plans to fund, announcing Thursday a short list of 11 projects that will receive €120 million in total.   Funding for the projects will come from Horizon Europe, a research and innovation program that launched in 2021 and is planned to sunset by 2027. The program supports “urgent research” into COVID-19 with a focus on the emerging threats of variants of SARS-CoV-2, according to...