Pfizer Inc announced it will likely apply for emergency use authorization (EUA) of its experimental coronavirus vaccine by late November.
In an open letter on Friday, the drugmaker said it is awaiting data from its late-stage human trials on the vaccine’s effectiveness, safety and ability to be consistently manufactured.
Provided the results are positive, Pfizer, along with its German partner BioNTech SE, says an application will be submitted by the third week of November.
This is the first time that any company developing a vaccine against COVID-19 has provided such a precise timeframe, and makes it clear that no jab will be available by Election Day as President Donald Trump has promised.
It also comes on the heels of a study published on Wednesday, which found that Pfizer’s shot left fewer than half of participants with side effects – even if they were over age 65 and prone to bad reactions.
In an open letter on Friday, Pfizer said it is waiting for data on its coronavirus vaccine’s effectiveness, safety and ability to be consistently manufactured. Pictured: The first patient enrolled in Pfizer’s COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 4
The data is expected by the third week of November and, if positive, the company will apply for emergency use authorization with the FDA. Pictured: Pfizer headquarters in New York City
The vaccine candidate from Pfizer and BioNTech uses part of the pathogen’s genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.
In the jab, known as BNT162b2, the mRNA encodes for all of the spike protein found on the outside of the virus that it uses to enter and infect cells.
For the trial of up to 44,000 participants, one group is given the vaccine and another groups is given the placebo.
Researchers then wait until several participants become infected with the virus. If the number of people infected is significantly higher in the placebo group, then the jab is considered effective.
Pfizer CEO Albert Bourla said the company presented the timeline to be as transparent as possible and make a very complex process easy to understand.
‘To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines,’ he wrote in the open letter.
The New York-based pharmaceutical company did not reveal whether or not it would apply for authorization in other counties.
Previously, Pfizer stated that it would know whether its jab was effective at preventing volunteers from contracting the virus by October.
However, earlier this month, the FDA said it would require two months of safety data before approving any vaccine.
In addition to the safety data requirements, vaccine makers must submit their manufacturing process and controls information no less than one month prior to submitting an EUA request.
This all but ensures that an immunization will not be ready before the November 3 presidential election as Trump had declared in the past.
‘The timelines above reflect our best estimates of when these important milestones could be achieved,’ Boula wrote in the letter.
‘I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.’
The federal government had already placed an order 100 million doses – enough for 50 million people – from Pfizer with the option to buy another 500 million doses.
Additionally, the European Union has ordered 200 million doses, Japan has ordered 120 million doses and the UK has ordered 30 million.
There are 10 companies around the world currently testing vaccine candidates, and Pfizer is one of four in the US.
The other three companies, Moderna Inc, AstraZeneca Plc and Johnson & Johnson, have all stated that they expect to submit for EUA later in the year.
AstraZeneca and Johnson & Johnson have both had to pause their trials in the US due to safety concerns, which could delay their applications further.
After the news, Pfizer’s shares increased one percent and BioNTech’s US-listed shares rose by 2.4 percent.