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  • Regulatory NewsRegulatory News

    FDA reports rare complications with Pfizer COVID vaccine, updates J&J safety info

    A summary of results of near real-time monitoring of the safety of COVID-19 vaccines in  older individuals was reported Tuesday by the US Food and Drug Administration (FDA). The agency identified four potential health concerns associated with receiving one of the authorized vaccines.   Examining the database of Medicare health care claims for people aged 65 years and older who received the mRNA vaccine marketed by Pfizer/BioNTech, FDA identified four adverse events o...
  • Regulatory NewsRegulatory News

    EMA's PRAC weighs in on more vaccine side effects

    The European Medicines Agency (EMA) has weighed in on several rare adverse events for COVID-19 vaccines and one gene therapy for treating thalassemia in their latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting.   At its July meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found mRNA-based COVID-19 vaccines, like Pfizer’s Comirnaty and the Moderna vaccine marketed in the EU as Spikevax, carry a small risk of myocarditis and pericarditis....
  • Regulatory NewsRegulatory News

    EMA gives procedural guidance on variant COVID vaccines

    A new document from the European Medicines Agency (EMA) will give vaccine developers procedural guidance when the time comes for them to update COVID-19 vaccines to include protection against variant strains of SARS-CoV-2.   The procedural guidance was adopted by EMA’s human medicines committee on 24 June, and is meant to apply to vaccines against other human coronaviruses as well. Marketing authorization holders may submit a variation to change the composition of a CO...
  • Regulatory NewsRegulatory News

    Include cancer patients in COVID-19 vaccine trials, say ASCO and Friends of Cancer Research

    People with cancer should be included in COVID-19 vaccine clinical trials, according to a new joint position statement from the American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR).   “We’ve learned that patients with cancer are especially vulnerable to severe illness, hospitalization, or death due to COVID-19,” said ASCO President Everett E. Vokes in a joint press release announcing the position statement. “It is critically important...
  • Regulatory NewsRegulatory News

    EMA updates COVID-19 vaccine risk management plans to reflect variant safety

    The European Medicines Agency (EMA) wants companies to provide safety information on additional strains or variants in an update to its guidance on risk management plans (RMPs) for COVID-19 vaccines. In the update, EMA also discourages sponsors from using passive surveillance to evaluate vaccine safety due to a lack of robustness in these methods.   The plan should be read in conjunction with EMA guidance on good pharmacovigilance practices, including GVP Module V, Mod...
  • Regulatory NewsRegulatory News

    FDA panel split on approach to COVID-19 vaccines for younger children

    Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.   Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as th...
  • Regulatory NewsRegulatory News

    FDA may decline new COVID vaccine EUA requests

    The US Food and Drug Administration’s (FDA’s) updated emergency use authorization (EUA) for COVID-19 vaccines says the agency may decline EUA requests from developers that have not yet met with the agency to discuss their vaccines.   This announcement was made by the agency in a 25 May tweet from the account of FDA’s Center for Biologics Evaluation and Research (CBER). The revised guidance supersedes versions issued on 22 February 2021 and October 2020. All versions ...
  • Regulatory NewsRegulatory News

    EC advances amendment to speed adapted COVID vaccines

    The European Commission on Wednesday advanced a delegated regulation that would give the European Medicines Agency (EMA) the authority to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the virus.   “We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said European Commission President Ursu...
  • Regulatory NewsRegulatory News

    Updated: FDA issues EUA for J&J's one-shot COVID vaccine

    The US Food and Drug Administration (FDA) has issued an emergency use authorization for the COVID-19 vaccine developed by Janssen, a division of Johnson & Johnson. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD in a statement announcing ...
  • Regulatory NewsRegulatory News

    EU plan to tackle COVID variants features flu vaccine-like pathway

    The European Union’s plan to take on new and emerging COVID-19 variants came into focus Wednesday with the European Commission’s announcement of a new incubator tasked with scanning for and assessing variants, speeding regulatory approvals and boosting EU production of vaccines.   The incubator is said to lay the groundwork for the recently proposed European Health Emergency Preparedness and Response Authority (HERA), which the Commission has billed as a “central eleme...
  • Regulatory NewsRegulatory News

    Cyberattack: EMA says leaked documents ‘manipulated’

    Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the agency said on Friday.   EMA first disclosed the hack in December and said at the time it had launched a full investigation in cooperation with law enforcement and other authorities. Since then, vaccine frontrunners Pfizer and BioNTech and Moderna have released statements ack...
  • RoundupsRoundups

    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 ...