20.08.2021 · Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or …
23.08.2021 · Peter Doshi, senior editor, The BMJ. Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.
08.12.2021 · Early hopes. The Novavax vaccine candidate, NVX-CoV2373, is based on a technology already used in a few approved products. It contains a protein derived from moth cells, and its Matrix-M1 adjuvant is based on a saponin extracted from the Chilean soapbark tree (Quillaja saponaria).Hamid Merchant, professor of pharmacology at the University of …
02.11.2021 · Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their …
25.08.2021 · We must have realistic expectations of how much influence FDA approval will have on vaccine hesitant populations, says Peter Hotez. The announcement of the Food and Drug Administration’s (US FDA) full regulatory approval of the Pfizer-BioNTech covid-19 vaccine is an important development for the US vaccination programme.
08.06.2021 · Approving a covid-19 vaccine now risks setting a precedent of lowered standards for future vaccine approvals. The “FDA approved” seal must represent a high bar—and premature licensure of a covid-19 vaccine could seriously damage public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure.
24.08.2021 · The US Food and Drug Administration has granted full approval to the two dose Pfizer-BioNTech vaccine to protect against covid-19 for people aged 16 and above. The vaccine’s previous emergency use authorisation will continue for 12 to 15 year olds.1 President Biden used the approval to urge hesitant Americans to get vaccinated and called on businesses and local …
08.11.2021 · More recently, Doshi published more misinformation in The BMJ about COVID-19 vaccines, claiming that there was “no biodistribution data” (even though there was and biodistribution data aren’t required for vaccines anyway) and insinuating that the trials had been unblinded earlier this year not out of ethical concerns about leaving the subjects in the placebo …
23.11.2021 · Valneva’s covid-19 vaccine looked set to be another effective tool in the fight to end the pandemic. But the UK’s sudden decision to cancel the company’s main order of 100 million doses threw a major spanner in the works. Elisabeth Mahase asks what this means for the company and the vaccine In September, UK health secretary Sajid Javid said that the country’s …
18.05.2021 · After rollout under emergency authorisation, manufacturers of covid-19 vaccines now have their sights on regulatory approval. But what’s the rush, asks Peter Doshi , and is just six months of data from now unblinded trials acceptable? In April 2021, Pfizer and Moderna announced efficacy results at the six month mark from the phase III trials of their respective …