Pfizer Inc says it could have results from its late stage Coronavirus vaccine study already available in October.
On Thursday, during a pharmaceutical industry call sponsored by the International Federation of Pharmaceutical Manufacturers & Associations, CEO Albert Bourla said that 23,000 volunteers were enrolled in the Phase III study, which began in July.
The New York-based pharmaceutical company says if data shows the sting is safe and effective, it will work with its German partner BioNTech to file an application for approval immediately.
"We assume we should have enough to say whether the product is working or not by the end of October," said Bourla.
Pfizer is in a race with companies like AstraZeneca Plc, Johnson & Johnson, Moderna and Sanofi to make a vaccine as President Donald Trump promised his administration could be vaccinated before the November 3rd election.
However, the White House fervently denied any political pressure from the Trump administration on the U.S. Food and Drug Administration to approve a vaccine.
Pfizer Inc has enrolled 23,000 people in Phase III of its coronavirus vaccine study, which began in July. Pictured: The first patient enrolled in Pfizer's coronavirus vaccine clinical trial at the University of Maryland Medical School in Baltimore will receive an injection in May 2020
If the vaccine is found to be safe and effective, the company will apply for approval immediately, according to CEO Albert Bourla. Pictured: Pfizer headquarters in New York City, July 2019
Pfizer and BioNTech's vaccine candidate uses part of the pathogen's genetic code called messenger RNA, or mRNa.
It trains the body to recognize the coronavirus, which triggers an immune response when infected.
In July, the company released data from its early study that enrolled 45 people who received either a low, medium, or high dose of the vaccine in two shots or a placebo.
Volunteers given either the low or medium dose not only produced antibodies to the virus, but specifically neutralized antibodies, which means that they prevent the virus from infecting human cells.
The results showed that the concentrations of neutralizing antibodies were between 1.8 and 2.8 times higher than in recovered patients.
Pfizer hopes to enroll up to 30,000 participants. The process is expected to take place in 120 locations around the world, including 39 US states.
In July, the US government signed a contract with Pfizer for $ 1.95 billion in exchange for 100 million doses of their immunization.
The agreement was part of Operation Warp Speed, the Trump administration's plan to accelerate coronavirus vaccine candidates in America.
Pfizer plans to ship 100 million cans by the end of 2020 and about 1.3 billion cans by the end of 2021.
Dr. Anthony Fauci, the nation's leading infectious disease expert, said it was possible a vaccine could be ready by the end of October, but he didn't expect it.
"These are all estimates," Fauci told CNN when asked about Pfizer's plans, adding that most believe a vaccination will be ready by November or December.
"It is conceivable that you can have it by October, although I don't think that is likely."
The Centers for Disease Control and Prevention urged states to prepare for a vaccine distribution as early as November, and White House spokeswoman Kayleigh McEnany said there was no political pressure on the FDA to get a coronavirus vaccination quick to approve.
This has made public health experts concerned that Trump is pressuring regulators to put a stab in the market before enough data is available to review.
However, Pfizer says it won't apply for approval if the results don't prove the vaccine is safe and effective.
"We will never submit a vaccine for approval or approval ourselves until we feel safe and effective," said Bourla.
& # 39; We're not going to cut corners. Our phase three study will be the only one that will allow us to tell if we have a safe and effective vaccine. If we don't have results from a phase three study, we wouldn't submit them. & # 39;