The mission of the Food and Drug Administration (FDA) is to protect and promote public health by ensuring the safety of products on the market. These products include vaccines. Typically, the testing and approval process for a potential vaccine can take many months or even years. Now the FDA has placed a COVID-19 vaccine developed by the company Moderna Therapeutics on the Fast Track status.
What is the Fast Track Status?
According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get treatments to the public faster. A company must request Fast Track status. A drug or treatment that receives Fast Track designation has greater access to the FDA, a shortening of the review process from ten months to six months, a rolling review of the New Drug application rather than waiting for the entire application to be completed, and other advantages. So far, the FDA has approved of over 150 emergency authorizations related to COVID-19, although the majority have been related to testing.
In May of 2020, pharmaceutical company Moderna Therapeutics requested Fast Track designation for its potential COVID-19 vaccine. Moderna hopes to test its COVID-19 vaccine on 30,000 people at the beginning of July. This is the final trial stage before a vaccine can receive approval from the FDA. It is believed that approval may come as soon as November. Meanwhile, the United States plans to manufacture the vaccine while it awaits approval in the hopes of having millions of doses available as soon as approval is received. There are also other vaccine trials that will begin during the summer.
There is some fear that Fast Track approval for a vaccine could be dangerous to the public. It is essential that any vaccine is rigorously tested to ensure that it is safe and effective. There are allegations that the White House is putting pressure on government agencies to get a vaccine out as soon as possible to align with President Trump’s promise to have a vaccine by the end of 2020.
Contact a Dangerous Drug Attorney
If you’ve been injured by a dangerous drug, you should have your case evaluated by an experienced product liability attorney. Gregg Goldfarb has been helping the victims of dangerous drugs for over 20 years. Contact us online or call us at 305-374-7000 to schedule a free consultation.