The American Food and Drug Administration has given a green light to Pfizer’s Covid19 vaccine.
Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday 10th of December, 2020 when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.
The vaccine is said to be usable for children younger than 16, nursing mothers, pregnant mothers and others.
The arrival of the first vaccines is the beginning of a complex, monthslong distribution plan coordinated by federal and local health authorities, as well as large hospitals and pharmacy chains, that if successful, will help return a grieving and economically depressed country back to some semblance of normal, maybe by summer.
The U.S. authorization of Pfizer’s vaccine is expected to be followed soon by one for Moderna’s version, which uses similar technology and has also shown promising results in clinical trials. Operation Warp Speed, the Trump administration’s multi-billion-dollar program to fast-track vaccine development, pre-ordered 100 million doses of Pfizer’s vaccine in July and heavily backed the development and manufacturing of Moderna’s vaccine.
More than 100 F.D.A. employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data.
Some members asked about the likelihood for serious allergic reactions, given the news that regulators in Britain recommended this week that people with a history of anaphylactic allergic reactions to medicines and foods not get the vaccine while they investigate two cases of allergic reactions among health care workers. Pfizer officials said there were no cases of serious allergic reactions in the trial of 44,000 participants. People with a history of allergic reactions to vaccines were excluded from the study.
The F.D.A. said that it had asked Pfizer to include allergic reactions in its safety tracking plan and would include a warning in its instructions on the use of the vaccine.
Pfizer’s clinical trial will continue even after its vaccine is authorized by the F.D.A., and the company and F.D.A. will continue to watch for safety concerns.