BioNTech and Pfizer have submitted an application of their Covid-19 vaccine to the European Medicines Agency (EMA) that could enable its use before the end of the year, according to a news release.
"If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA (Conditional Marketing Authorization) that could potentially enable use of BNT162b2 in Europe before the end of 2020," said the release from German company BioNTech.
This submission completes a rolling review process that began on October 6. The vaccine candidate will now be assessed according to EMA’s normal stringent standards for quality, safety and efficacy, the drug makers said.
“Today’s announcement marks another key milestone in our efforts to fulfil our promise to do everything we can to address this dire crisis given the critical public health need,” said Albert Bourla, Pfizer Chairman and CEO. “We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us.”
Ugur Sahin, CEO and co-founder of BioNTech, said it was an important step "as we continue to seek to enable a worldwide supply upon potential approval" of the vaccine.
Earlier this month, BioNTech and drug giant Pfizer submitted their mRNA coronavirus vaccine candidate to the US Food and Drug Administration (FDA).
The companies have now submitted to the EMA, FDA and UK Medicines and Healthcare Products Regulatory Agency, and have initiated rolling submissions in countries including Australia, Canada and Japan.
Drugmaker Moderna yesterday announced it will become the second pharmaceutical company to apply to the FDA for emergency use authorization of its Covid-19 vaccine.