Pfizer and BioNTech will be amongst the first pharmaceutical industry leaders to gain emergency authorization for a COVID vaccine in the United States. The latest coronavirus vaccine update has prompted US Health and Human Services Secretary Alex Azar to say that there is “light at the end of the tunnel.” The emergency-use authorization (EUA) could also mean that the Pfizer vaccine will be available on a limited basis within weeks.
The application to the US Food and Drug Administration (FDA) for emergency-use authorization comes days after Pfizer and its German partner BioNTech announced its COVID-19 vaccine is 95% effective. Early results from Pfizer’s phase 3 clinical trials showed that the two shots, given three weeks apart, prevent symptomatic COVID-19 in people aged over 65 years, with no major safety concerns.
"Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally," Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement.
Pfizer and BioNTech are also submitting for the “initiated rolling submissions” in Australia, Canada, Europe, Japan and the United Kingdom. The drugmakers will make 50 million doses available this year and 1.3 billion in 2021, using both facilities in the United States and Belgium.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," said Bourla.
Pharmaceutical leaders’ progress in developing a successful COVID-19 vaccine has brought much-needed hope since the outbreak in early March this year. Earlier this week, Moderna announced its COVID vaccine showed a high rate of efficacy.
The US FDA along with an independent advisory board will review Pfizer’s filing for emergency-use authorization before it is available to the common public. One major drawback of the Pfizer vaccine is its requirement for ultra-cold storage. The vaccine shots must be stored at minus 94 degrees Fahrenheit - which poses a huge logistics and storage problem at healthcare facilities across the United States and elsewhere worldwide.
Other drugmakers and research groups joining the race to develop a successful COVID-19 vaccine are AstraZeneca and Johnson & Johnson.