If the application is approved by Pfizer, the vaccine will likely be limited and phased in, with health workers, the elderly, and those with underlying health conditions receiving their first vaccinations. Key workers, teachers, and people in homeless shelters and prisons would likely be next, followed by children and young adults.
The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine was tentatively planned for early December. Some Americans might get their first dose of vaccine in about a month.
“The US filing is a critical milestone in our journey to deliver a COVID-19 vaccine worldwide. We now have a more complete picture of the effectiveness and safety profile of our vaccine and are confident in its potential,” said Pfizer CEO Dr. Albert Bourla said in a statement.
Friday’s announcement came two days after Pfizer said final data analysis showed its coronavirus vaccine with BioNTech was 95% effective against Covid, safe, and appeared to ward off serious illness.
The final analysis rated 170 confirmed Covid infections among the more than 43,000 participants in the late-stage study. The companies said that 162 cases of Covid were observed in the placebo group, while eight cases were observed in the group that received the two-dose vaccine. This resulted in an estimated vaccine effectiveness of 95%.
Pfizer is the first in the Covid vaccine race to file an emergency with the FDA. His vaccine contains genetic material called messenger RNA, or mRNA, that scientists expect to induce the immune system to fight the virus. The vaccine requires a storage temperature of minus 94 degrees Fahrenheit, which may pose a challenge to its widespread use. Compared, Modernas The vaccine must be stored at minus 4 degrees Fahrenheit.
Pfizer announced on July 22nd The US agreed to buy 100 million doses of its vaccine for up to $ 1.95 billion. The agreement, which is part of the Trump administration’s Operation Warp Speed vaccination program, allows the US to purchase an additional 500 million doses of vaccine. Bourla said Nov. 9 that the company is on track to produce up to 50 million doses of vaccine this year and up to 1.3 billion doses in 2021.
It has already initiated ongoing filings with several regulatory agencies around the world, including the European Medicines Agency and the UK Medicines and Health Products Regulatory Authority.
Dr. Anthony Fauci, the nation’s leading infectious disease expert, said a vaccine could be available to all Americans by April or July.