The next step in finding a vaccine to combat the coronavirus pandemic has started.
Update 11:34 a.m. ET, Nov. 22: The first patients in the U.S. could receive immunizations for the coronavirus Dec. 12, health officials said.
The Food and Drug Administration advisory committee meets Dec. 10 and if Pfizer’s request for emergency use authorization is approved, its vaccine could begin shipment within 24 hours, The Associated Press reported.
Dr. Moncef Slaoui, head of Operation Warp Speed, the coronavirus program, expects vaccinations to start the second day after approval, CNN reported.
The Associated Press contributed to this report.
Update 3:14 p.m. ET, Nov. 20: Pfizer has formally asked the federal government to allow the emergency use of its COVID-19 vaccine, The Associated Press reported.
First inoculations could begin as early as next month.
The company is also submitting applications across Europe and the U.K.
Officials said they believe that their safety record and the protection the vaccine gives is enough to grant the emergency use, the AP reported.
It is estimated that there will be about 25 million vaccinations available in the U.S. in December, another 30 million in January and 35 million in February and March with those getting it needing two rounds, three weeks apart.
Overall the company plans on having 50 million doses by the end of the year worldwide.
The government is buying the vaccines and said the shots will be free.
Original post: Drugmaker Pfizer has announced that it will submit an emergency use authorization request to the U.S. Food and Drug Administration today for its COVID-19 vaccine.
The company, along with partner BioNTech, shared the update in a news release early Friday.
The submission “will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020,” according to the release.
“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” Dr. Ugur Sahin, BioNTech’s CEO and co-founder, said in a statement. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally.”
Pfizer and BioNTech “have already initiated rolling submissions across the globe, including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world,” the release added.
The news came days after the companies said a final analysis revealed that their COVID-19 vaccine was 95% effective in a clinical trial.
“After conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints,” the companies said Wednesday. “Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.”
In the trial, which enrolled more than 43,000 participants, researchers recorded 170 coronavirus cases, the companies said at the time. Of those cases, 162 occurred among placebo recipients, while just eight occurred in those who received the vaccine, Pfizer and BioNTech said.
Additionally, efficacy was more than 94% for adults over age 65, according to the companies. An independent Data Monitoring Committee also “has not reported any serious safety concerns related to the vaccine,” the companies said in a statement.
Pfizer’s vaccine wasn’t the only one making headlines this week. On Monday, another company, Moderna, said an early analysis found that its COVID-19 vaccine candidate was 94.5% effective in a clinical trial, according to The Associated Press.
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