Pfizer ‘Within Days’ From Requesting COVID Vaccine Approval From FDA

Just over a week after it announced that its COVID-19 vaccine had a 90% efficacy, Pfizer (PFE) and BioNtech (BNTX) have said that their vaccine has now shown 95% effectiveness.

The drugmakers said they plan to submit a request for U.S. Food and Drug Administration Emergency Use Authorization “within days” based on the safety and efficacy data of the COVID-19 vaccine.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Dr. Albert Bourla, Pfizer chairman and CEO, said in a statement.

“We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world. With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

The news comes just two days after Moderna announced that its COVID-19 vaccine was 94.5% effective, giving the U.S. two leading candidates to help combat the raging coronavirus across the country.

Pfizer said that it found the 95% efficacy after conducting their ongoing Phase 3 study of their COVID-19 vaccine (BNT162b2). The vaccine indicated an effectiveness of 95% in study participants without COVID-19 infection and also in participants with and without prior COVID-19 infection, which was a secondary goal for the drugmakers.

In participants without COVID-19, the study was based on 170 cases, of which 162 were observed in a placebo group with eight cases receiving the vaccine. Efficacy was consistent across age, gender, race, and ethnicity, the drugmakers said. This includes a 94% effectiveness rate in adults over 65.

In total, there were 10 cases of COVID-19 infection observed, with nine of the cases receiving a placebo to only one receiving the vaccine.

Pfizer and BioNTech said no serious safety concerns were reported related to the COVID-19 vaccine. The vaccine was well tolerated, with adverse effects resolving shortly after vaccination. Minimal side effects occurred after the first or second dose, including fatigue (3.8% of participants) and headache (2% of participants).

“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” Ugur Sahin, CEO and co-founder of BioNTech, said.

“These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.”

The Phase 3 clinical trial of the vaccine began on July 27 with 43,661 participants to date in 150 clinical trial sites throughout the U.S., Germany, Turkey, South Africa, Brazil, and Argentina. The trial will continue to collect effectiveness and safety data for another two years.

Pfizer and BioNTech said they project that they will produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

The vaccine will be produced at Pfizers facilities in St. Louis, Andover, Massachusetts, and Kalamazoo, Michigan, as well as in Puurs, Belgium. BioNTech’s German sites will be used for global supply.

To maintain the temperature of the vaccine, Pfizer said it has developed temperature-controlled thermal shippers that will utilize dry ice to maintain temperatures of minus 94 Fahrenheit (minus 70 degrees Celsius) where the vaccine can be stored for 15 days by refilling the dry ice. Tracking and temperature control will be provided by thermal sensors.

Shares of Pfizer were trading at $37.06 as of premarket open, up $1.02 or 2.83% while shares of BioNTech were trading at $92.58, up $5.65 or 6.50% at the same time.