- Pfizer and BioNTech expect to ask for emergency permission within a matter of days to distribute their COVID-19 vaccine.
- Other vaccine makers, including French company Sanofi, are also pursuing mRNA COVID-19 vaccines.
- The vaccine was tested for its effectiveness in protecting against symptoms of COVID, and not protecting against infection with the coronavirus.
Massachusetts (SK) — Pfizer and BioNTech expect to ask for emergency permission by the Food and Drug Administration within a matter of days to start distributing their COVID-19 vaccine, the companies said Wednesday. The Pfizer and BioNTech vaccine would be the first shot to use a new mRNA technology to receive FDA approval. Other vaccine makers, including French company Sanofi, are also pursuing mRNA COVID-19 vaccines. The vaccine was tested for its effectiveness in protecting against symptoms of COVID-19, and not protecting against infection with the coronavirus. Public health experts view vaccination against COVID-19 as an important part of getting rid of the virus. The drug maker New York-based Pfizer partnered with German BioNtech was the first to report results from a Phase 3 study of a pandemic vaccine. The results improve on an on 90% efficacy finding that was based on early data of the final-stage trial.
The agency will review the data and could make a decision quickly, based on the quality of data and the urgent need for a vaccine to address the pandemic. Pfizer and BioNtech's announcement included data from 94 cases of COVID-19 among both the vaccinated and placebo groups in the Phase 3 study. The company said its full report involved more than 43,000 study participants and logged 170 cases of COVID-19,162 of which occurred among people receiving the placebo shot. There was encouraging data that the vaccine also protected against severe disease, only one had received the vaccine from the 10 people in the study who had had severe COVID-19. Pfizer's vaccines need to be stored at 70° C (-94° F), much lower than most freezers. The company is planning to ship vials in special thermal containers that can maintain these temperatures for up to 15 days with dry ice.
Researchers then looked at those who were positive for COVID-19 and compared the vaccinated and placebo groups for whether they developed more symptoms of the disease.