The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the COVID-19 vaccine developed by Pfizer and its partner BioNTech, the New York Times reported for the first time on Friday evening and was later published by the Wall Street Journal supported. This EEA follows a recommendation from an independent panel of experts hired by the FDA to review Pfizer's application and make a recommendation, which the panel unanimously endorsed earlier this week.
Once approved, shipping of the vaccine is expected to begin immediately, with 2.9 million doses in the first shipping order. Patients in the high risk category, which includes healthcare workers and seniors in long-term care facilities, are expected to receive doses within a few days if the EEA is not granted.
This approval is not a complete certification by the United States Medicines Agency, but it is an emergency measure that requires a thorough review of the information available from Pfizer based on its Phase 3 clinical study in which a panel of 44,000 volunteers participated. Pfizer found that its vaccine, which is an mRNA-based treatment, was 95% effective at the final analysis of the data from the previous study – and also found that safety data were not significant Showed safety problems in patients who received the vaccine.
In addition to the initial order of 2.9 million doses, the US intends to distribute around 25 million doses by the end of 2020, which could result in far fewer people being actually vaccinated as the Pfizer course requires two vaccinations for maximum effectiveness. Most Americans shouldn't expect the vaccine to be available until at least the end of the first or second quarter of 2021, given the pace of Pfizer manufacturing and US order volume.
However, this is a promising first step and a tremendous achievement in terms of vaccine development turnaround time, as it has been approximately eight months since work on the Pfizer vaccine candidate began. Moderna has also filed an EEA for its vaccine candidate, which is also an mRNA treatment (which instructs a person's cells to take effective countermeasures against the virus). This could follow shortly, meaning two vaccines under the EEA could be available in the US before the end of the year.