A volunteer is vaccinated on September 24, 2020, at a research center in Florida, USA, at a research center for coronavirus disease (COVID-19).
Marco Bello | Reuters
LONDON – US pharmaceutical giant Pfizer and its German partner Bioentech say they have applied to the European Medicines Agency (EMA) for conditional marketing authorization of their coronavirus vaccine.
If approved, it could potentially use Pfizer and Bioentech vaccines in Europe before the end of 2020, Bioentech said in a press release.
The EMA says on its website, “Such authorizations, known as CMAs, are given to drugs that take into account patients’ medical needs based on less comprehensive data than is usually needed.”
“In the public health interest, applicants may be granted conditional marketing authorization for such drugs where the benefit of immediate availability increases the risk of less comprehensive data than is usually required.” However, the applicant should be in a position to provide comprehensive clinical data, in the future.
Dr. Albert Borla, Chairman and CEO of Pfizer, said in a press release that today’s announcement is another important goal in our efforts to fulfill our commitment to do everything we can to address this dire crisis given the serious need for public health.
“We know from the start of this trip that patients are waiting, and potential authorizations will allow us to say that we are ready to send Covid-19 vaccine doses as soon as possible.”
The news comes almost two weeks after Pfizer and Bioentech that final data analysis of a late-stage clinical trial of their coronavirus vaccine showed it was 95% effective in preventing Covid-19 infection.
The vaccine, called BNT162B2, becomes highly effective against the virus 28 days after the first dose, drug manufacturers said in mid-November, and its effectiveness was consistent across all ages, races and species.
In addition, the elderly, who are at increased risk of serious illness from Covid-19, saw more than 94% in vaccination effectiveness, the companies said.
Pfizer and Biontech launched the U.S. market on November 20. Applied for emergency use authorization from the Food and Drug Administration, the FDA was expected to take a few weeks to process, and an advisory committee meeting to review the vaccine, scheduled for early December.
In addition to the introduction of the EMA, the U.S. The Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) noted on Tuesday that it and Pfizer have started rolling submissions worldwide, including in Australia and Canada. The plan is to submit the application to Japan, and other regulatory agencies around the world. “
Rival drugmaker Moderna said Monday it would request immediate approval from the FDA and its European counterpart (EMA) for a new confectionery vaccine that is more effective and safe than the Covid-19 vaccine.
– CNBC’s Berkeley Lovelace contributed to this story report.
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