American pharmaceutical company Pfizer and its partner BioNTech shared that they have applied to the EMA or European Medicines Agency for the conditional marketing authorization of their vaccine for coronavirus.
According to BioNTech, if the authorization will be granted, the decision will enable using the vaccine in the European continent this month.
The EMA shared on their website that such authorization is granted to medicines that address patients' unmet medical needs based on less comprehensive data than the usually required.
The European Medicines Agency or the EMA also added that in the interest of public health, applicants might be granted conditional marketing authorization for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than typically required.
EMA also requires that the applicant should also be flexible in providing comprehensive clinical data in the future.
The CEO and Chairman of Pfizer, Dr. Albert Bourla, mentioned in a statement that their announcement made today marks another key milestone in their efforts to fulfill their promise to do everything they can to address the current dire crisis critical public health need, BioPharma-Reporter reported.
He also added that they have known since the beginning of the pandemic. The patients are waiting for the vaccine, and Bourla stated that they stand ready to ship Covid-19 vaccine doses as soon as potential authorizations allow us.
The recent news came about two weeks after Pfizer and BioNTech shared that their final data analysis from the late-stage clinical trial of their vaccine for coronavirus showed 95% effectiveness when it comes to preventing COVID-19 infection.
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In mid-November, the partner's drugmakers shared that the vaccine, called BNT162b2, became highly effective against the virus 28 days after its first dose had been administered. They showed consistency in terms of a patient's age, race, and ethnicity.
The companies also added that the elderly, who have a higher risk of experiencing severe illness after acquiring coronavirus, saw vaccine effectiveness of not less than 94%.
According to CNN, both companies also applied for an emergency use authorization from the United States Food and Drug Administration on November 20. However, the FDA process is expected to last at least for a few weeks, and an advisory committee meeting will about the vaccine is tentatively scheduled for early December.
Aside from the submissions to the EMA, the FDA and United Kingdom Medicines and Healthcare Products Regulatory Agency, BioNTech noted on Tuesday that the company and Pfizer had initiated rolling submissions across the globe which includes in Japan, Australia, and Canada, and even planning to submit applications to other regulatory agencies around the globe.
The rival drugmaker of both companies, Moderna, shared that they will request emergency clearance from the FDA and the EMA for its vaccine after the latest data confirmed that it was safe. It resulted in 94% effectiveness in preventing coronavirus, CNBC reported.
According to Reuters' latest report, the EMA mentioned that if its experts could receive enough data from Moderna and Pfizer regarding their candidate vaccines, they would accomplish its reviews by December 29 and January 12 at the latest.
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