EU’s drug regulator wants longer approval process for Pfizer vaccine

Europe’s drug regulator, the European Medicines Agency (EMA) has opposed to UK’s fast-track approval of Pfizer’s Coronavirus vaccine candidate, citing that a longer approval procedure based on more evidence and more checks was “more appropriate.” 

The UK became the first EU country to green-light a vaccine shot, a move that has been seen by many as an attempt by the country’s Prime Minister, Boris Johnson to salvage his reputation for his handling of the pandemic. 

On Tuesday, US company Pfizer and the German partner BioNTech applied for conditional market authorisation for their Covid-19 vaccine with EMA, which now has to assess the application. One day earlier, American pharmaceutical company also announced it would submit its vaccine candidate for approval by EMA and the United States Food and Drug Administration (FDA).

EMA said on Tuesday it would decide by December 29 whether to provisionally authorise the vaccine from US drugmaker Pfizer and its German partner BioNTech, as the safety and effectiveness of the vaccine jab first need to be assessed by the agency before they hit the bloc’s markets, with the Commission President stressing that “transparency here is crucial and of utmost importance.” 

During the parliament’s plenary session in late October, the Commission’s chief Ursula von der Leyen had told MEPs that the first European citizens could be vaccinated by the end of 2020 and urged member-states to start preparing for vaccinations, which she labelled as Europe’s “ticket out” of the Coronavirus pandemic.

While one of the Commission’s priorities is securing vaccines for its citizens, another priority is “to make sure that everyone has access to the vaccines, everywhere in the world,” von der Leyen has stressed. 

The EU Executive arm has also warned Hungary against damaging trust on the safety and efficacy of vaccines, after Budapest announced it would import and use Russia’s “Sputnik V” vaccine. The Kremlin-backed vaccine is not included in the EU’s vaccine portfolio, as it has faced acute criticism over its fast-track approval that skipped the third phase of trials.

According to the Union’s legislation, and in particular the Regulation on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19), “no medicinal product may be placed on the market in the Union or in a Member State unless a marketing authorisation has been granted by the competent authorities” under the relevant directives or regulations. 

However, some exceptions are foreseen, “in situations characterised by an urgent need to administer a medicinal product to address the specific needs of a patient, for compassionate use or in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm.”