This is the first coronavirus vaccine to seek regulatory clearance in the United States.
Albert Burla, CEO of Pfizer, said in a video shared on Friday: “It is with great pride and happiness, and even with a little bit of relief, I can say that our application for an emergency use permit for our Covid-19 vaccine is now in the hands of the Food Administration. And drugs. ” “This is an historic day, a historic day for science and for all of us. It took only 248 days from the day we announced our plans to collaborate with BioNTech until our FDA filing day.
“We worked extraordinarily quickly on our clinical development program, from concept to regulatory filing, always keeping our focus on safety.”
Pfizer and BioNTech said in a statement earlier Friday that the vaccine, known as BNT162b2, may be available for use in high-risk groups in the United States from mid to late December. The vaccine requires two doses a few weeks apart, and protection is achieved 28 days after the first shot.
The submission to the FDA is based on results from the Phase 3 clinical trial of the Pfizer vaccine, which began in the United States on July 27 and has registered more than 43,000 volunteers.
The latest analysis from the trial concluded that the coronavirus vaccine was 95% effective in preventing infection, even in the elderly, and did not cause serious safety concerns, Pfizer and BioNTech said this week. The submission also includes safety data on 100 children between the ages of 12 and 15.
The companies said in a press release that about 42% of global respondents and 30% of US participants in the Phase 3 study have ethnically and ethnically diverse backgrounds, 41% of global respondents and 45% of US respondents are between the ages of 56 and 85.
Emergency use, or EUA, permission from the U.S. Food and Drug Administration (FDA) is not the same as full approval. The EUA permits the use of products under certain conditions before all evidence is available for approval. As for the EUA, the agency says it will determine whether “the known and potential benefits of the product outweigh the known and potential risks”.
“ While encouraging data from the Pfizer / BioNTech COVID-19 vaccine trial indicate a welcome possibility for an important new tool to combat the pandemic, a comprehensive and transparent review of the data, including evidence that the vaccine has been studied in diverse populations, remains essential. Dr Barbara Alexander, Chair of IDSA, said in the statement that it is assured of its safety, effectiveness and acceptability.
“If permission is granted for emergency use, clinical trials and data collection must continue. Measures including wearing masks, frequent hand washing, maintaining effective distance, and restricting the size of gatherings will remain necessary,” the statement said in part. “Finally, new federal funding must be provided for a widespread, fair and equitable distribution of a vaccine, as well as campaigns to build confidence in the vaccine.”
what happened after that
Moderna, another drug company, announced on Monday that results from early clinical trials show its vaccine is 94.5% effective, and is planning to apply to the FDA for permission after it collected more safety data later this month.
The FDA has scheduled a meeting of the Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9, and 10, a source familiar with the process told CNN this week. The source said the agency may make a decision at the end of the meeting on Dec. 10 about issuing emergency use permits.
The source said, “It would make sense for the FDA, in all likelihood, to study both applications together,” bearing in mind that both the Pfizer and Moderna vaccines use the same technology and appear to have very similar safety and efficacy outcomes from broad clinical. Trials.
If the U.S. Food and Drug Administration approves vaccines, they can be distributed immediately to states, according to a presentation given last month at the U.S. Centers for Disease Control and Prevention.
However, no one can be vaccinated until the Centers for Disease Control and Prevention Advisory Committee reviews data, recommends a vaccine, and decides which groups will receive the vaccine first.
If the FDA approves vaccines, the CDC’s Immunization Practices Advisory Committee, an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesperson.
At that meeting, the committee will decide whether everyone should get the vaccine, or whether some people should be excluded.
“We have all been alerted about the ACIP, we have to be flexible with our calendars because there will likely not be a lot of advance notice for this meeting. It will take place very, very quickly,” Dr. William Schaffner, a committee member, told CNN this week.
Once ACIP issues its recommendations, vaccinations can be given.
“We have a plan the moment the Food and Drug Administration concludes that the vaccine is safe and effective, we have a system to start, within 24 hours, shipping this vaccine to hospitals and healthcare facilities and 24 hours after that, Vice President Mike Pence said during a briefing to the task force.” Coronavirus at the White House on Thursday The vaccine has literally been injected into Americans.
Countries are currently working on preparing details for managing vaccination clinics. The Pfizer vaccine is particularly complex, because it must be stored at minus 75 degrees Celsius, and physicians’ offices and pharmacies usually do not have very low freezers.
The first groups expected to receive the vaccine are health care workers, the elderly, basic businesses such as police officers and those with underlying medical conditions.
CNN’s Elizabeth Cohen and Jacqueline Howard contributed to this report.