• Regulatory NewsRegulatory News

    EU authorizes Pfizer-BioNTech COVID vaccine

    The European Commission on Monday conditionally authorized Pfizer and BioNTech’s COVID-19 vaccine after receiving a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use earlier in the day.   The fast-tracked decision shortened what is usually a two-month procedure to a matter of hours, spotlighting the dire need for a vaccine as much of Europe faces lockdowns and restrictions amid a winter resurgence of the virus. The c...
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    EMA bumps up Moderna vaccine review

    As it faces increasing pressure to authorize vaccines to prevent COVID-19, the European Medicines Agency (EMA) on Thursday said it would speed up its assessment of Moderna’s mRNA COVID-19 vaccine by nearly a week after receiving the last outstanding data it needed to decide on the application.   The agency had initially scheduled an extraordinary meeting of its Committee for Medicinal Products for Human Use (CHMP) to conclude its assessment of Moderna’s conditional mar...
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    FDA authorizes Pfizer-BioNTech vaccine for emergency use

    The US Food and Drug and Drug Administration (FDA) on Friday authorized Pfizer and BioNTech’s COVID-19 vaccine for emergency use in individuals ages 16 and older just one day after the agency’s advisory panel voted 17-4 in favor of the vaccine.   Now that the vaccine has been authorized just three weeks after Pfizer and BioNTech submitted their emergency use authorization (EUA) request, a nationwide rollout of the vaccine is set to begin. FDA Commissioner Stephen ...
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    EMA chief says Pfizer, Moderna data ‘very robust,’ defends vaccine review approach

    Emer Cooke, the European Medicines Agency’s (EMA) newly installed executive director, on Thursday told a European Parliament committee that data submitted in support of COVID-19 vaccines developed by Pfizer/BioNTech and Moderna are “very robust”.   The meeting occurred hours before the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee would meet to discuss authorizing the Pfizer/BioNTech vaccine for emergency use and ju...
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    Expected mistakes, the need for speed, and change to come: Marks looks ahead

    The US Food and Drug Administration’s (FDA’s) Peter Marks, MD, directs the agency’s Center for Biologics Evaluation and Research (CBER). In a wide-ranging 6 November discussion with the president and chief executive officer of the Friends of Cancer Research, Jeff Allen, PhD, Marks spoke to tempering public expectation, sustaining CBER staff despite a crushing workload during the coronavirus pandemic, and the possibility of more changes in 2021.   Under a new adminis...
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    FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

    With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.   In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine d...
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    TGA gives Pfizer COVID vaccine provisional determination

    Another vaccine against SARS-CoV-2, the virus that causes the novel coronavirus, has received provisional determination from Australia’s Therapeutic Goods Administration (TGA). Pfizer, doing business in Australia as Pfizer Australia Pty Ltd, received the determination on 14 October for its messenger ribonucleic acid (mRNA) COVID-19 vaccine candidate, BNT162b2.   The decision comes after a 9 October decision by TGA to grant provisional determination to AstraZeneca’s rec...
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    Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.   PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect ...
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    TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.   “[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due ...
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    TGA moves AstraZeneca's vaccine on first step toward approval

    The Australian Therapeutic Good Administration (TGA) has taken the first step toward provisional approval of the vaccine against COVID-19 being developed by AstraZeneca in collaboration with the University of Oxford. The decision was made after reviewing the firm’s clinical trial plan and weighing the threats of the pandemic, said TGA in announcing its decision.   On 9 October, TGA gave AstraZeneca’s recombinant chimpanzee adenovirus vector vaccine, ChAd0x1-S, a prov...
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    EMA kicks off rolling review of AstraZeneca COVID vaccine candidate

    The European Medicines Agency (EMA) has begun a rolling review of the COVID-19 vaccine being developed by AstraZeneca and the University of Oxford. This is the agency’s first review of a vaccine against SARS-CoV-2, the virus that causes COVID-19.   EMA’s human medicines committee (CHMP) has begun with an evaluation of non-clinical data, announced EMA on 1 October. The rolling review is meant to hasten the time to a decision on the safety and effectiveness of a therap...
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    Former commissioners call on administration to end FDA criticism

    Seven former commissioners of the US Food and Drug Administration (FDA) came together to call out the Trump administration for undercutting FDA’s credibility as the agency prepares to evaluate clinical trial data for vaccines against SARS-CoV-2, the virus causing the novel coronavirus pandemic.   Their comments, made in an opinion column published 29 September in The Washington Post , were welcomed by the FDA’s current vaccines chief, Peter Marks , MD, PhD, directo...