Two experimental coronavirus vaccines manufactured in Michigan have received “rapid” certification from the US Food and Drug Administration.
These vaccines were jointly developed by American pharmaceutical giant Pfizer and German biotechnology company BioNTech.
The initial clinical supply of the BNT 162 vaccine was produced in Germany, but Pfizer and BioNTech plan to expand production in the United States, including the factory in Michigan.
Pfizer said that the initial production in the United States will be carried out in Pfizer̵
The FDA’s fast-track process has accelerated the review of new drugs and vaccines, and the name was awarded based on preliminary data from initial clinical studies in the United States
Peter Honig, Pfizer’s Senior Vice President of Global Regulatory Affairs, said: “The FDA’s decision to award these two COVID-19 vaccine candidates as fast-tracks marks the importance of developing a safe and effective vaccine against SARS-CoV-2. Milestone.” said in the press release.
Pfizer and BioNTech announced in May that it will start clinical trials in Germany and the United States.
According to the press release, the first phase of the US clinical trial divided as many as 360 healthy subjects into two age groups: 18-55 years old and 65-85 years old.
Clinical trial of Pfizer’s Michigan coronavirus vaccine
The press release said the two companies will receive regulatory approval and are expected to start Phase 2b/3 clinical trials later this month, and are expected to recruit up to 30,000 subjects.
If the ongoing research is successful and the candidate vaccines are approved by the regulatory authorities, these companies currently expect to produce up to 100 million doses of vaccines by the end of 2020 and more than 1.2 billion doses of vaccines by the end of 2021.
For more statewide data, please visit the MLive Coronavirus Data page.
COVID-19 Prevention Tips
In addition to washing your hands regularly and not touching your face, officials also recommend social evacuation to prevent someone from carrying the virus.
Health officials say that if possible, you should stay at least 6 feet away from others and work from home.
Use disinfectant wipes or spray cleaner on frequently contacted surfaces (door handles, faucets, countertops) in shops, etc., and carry hand sanitizer with you.
The governor of Michigan, Gretchen Whitmer, also issued an executive order requiring people to wear masks on their noses and noses when they are in closed public places.
For additional information, please visit Michigan.gov/Coronavirus and CDC.gov/Coronavirus.
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