Pfizer Inc will apply for emergency use authorization of its COVID-19 vaccine with the Food and Drug Administration today - a major step toward providing protection against the coronavirus for pandemic-weary Americans.
The application to the FDA comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95 percent effective in preventing COVID-19 with no major safety concerns.
Pfizer's shares rose 2% and BioNTech climbed 5% on the news that a vaccine could soon be available, raising hopes for the end of a pandemic that has claimed more than a quarter of a million American lives.
The companies expect the FDA to grant emergency use by mid-December and said they will begin shipping doses almost immediately.
Vice President Mike Pence and other officials said yesterday that the vaccine will be rolled out across the country within 24 hours of the FDA granting emergency use.
Officials have said they hope to have about 20 million of Pfizer's vaccine doses, which is enough to vaccinate 10 million Americans, by the end of the year.
Rival company Moderna is expected to be the next company to seek a emergency use nod for its COVID-19 vaccine. The US also expects to have 20 million doses of Moderna's vaccine available to distribute next month.
Pfizer Inc will apply for emergency use authorization of its COVID-19 vaccine with the Food and Drug Administration today - a major step toward providing protection against the coronavirus for pandemic-weary Americans
An FDA advisory committee will now determine if Pfizer's vaccine is safe enough to be given emergency authorization so it can start to be distributed. It is not yet clear how long the FDA will take to review Pfizer's vaccine findings.
The FDA, as well as UK's Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, have been doing a 'rolling review' of the vaccine. It means the approval process could be wrapped up in a matter of days and the high risk people could start getting their hands on it by the end of the year.
In a statement, Pfizer Chairman and CEO Dr Albert Bourla said: 'Filing in the US 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.
'We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.'
Dr Anthony Fauci sought to dispel concerns about the vaccines from Pfizer and Moderna during a rare briefing by the White House COVID-19 task force yesterday, saying that both were 'solid'.
'The process of the speed did not compromise at all safety nor did it compromise scientific integrity. It was a reflection of the extraordinary scientific advances in these types of vaccines which allowed us to do things in months that actually took years before,' he said.
The drugmaker, which developed its vaccine with German partner BioNTech SE, revealed on Wednesday that final tests revealed its shot was 95 percent effective.
Rival US company Moderna on Monday released preliminary data showing its own vaccine was 94.5 percent effective.
The better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA , have raised hopes for an end to a resurgent pandemic that has killed more than 248,000 Americans and wreaked havoc upon economies and daily life.
Officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December.
The first shots will be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.
An expert panel advising the CDC is meeting next week to determine the order of priority for vaccines distribution.
It will be months, however, before large-scale roll-outs begin.
Following the completion of its trial, Pfizer said only eight people out more than 20,000 who got the vaccine caught coronavirus in the study, compared to 162 who were given a fake jab. A total of 10 people got severe COVID-19, one of whom had been given the real vaccine.
The company said that efficacy of its vaccine was consistent across age and ethnicity demographics and that there were no major side effects, which is a sign that the immunization could be employed broadly around the world.
Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94 percent.
This diagram explains how Pfizer will manage its own cold chain while McKesson will assist in the distribution of Moderna's vaccine kits. It also shows how each vaccine will be sent to all states and territories within 24 hours of their emergency use authorizations
