The Food and Drug Administration on Wednesday said Pfizer will begin testing for the tuberculosis vaccine as early as 2018.
The vaccine is expected to be available by mid-2019, but not until 2021, when the company is allowed to test it on more than 3 million people.
“We believe that the vaccine is safe and effective,” Dr. Paul L. Smith, Pfizer’s vice president for vaccine development, said in a statement.
“We are committed to continuing to expand access to the vaccine and look forward to the continued progress of this important vaccine in our community.”
Pfizer is a major drugmaker and maker of antibiotics, and its vaccine is one of the few to have been approved by the FDA.
The vaccine is designed to prevent tuberculosis in humans, which kills an estimated 6 million people each year in the United States.
The first batch of vaccine is now in the hands of pharmacies, with more than 7 million doses already delivered.
Pfizer is not disclosing the price of the vaccine, but estimates that it will cost about $60 per dose.
The company also said that its vaccine will contain a strain of tuberculosis called Listeria monocytogenes, which has been linked to several serious infections and deaths in humans.
Pfizers vaccine has not been tested for the bacteria.
The drugmaker said the Listeriosis vaccine is available through pharmacies for $120 to $140 per dose, and will be available for $200 to $300 per dose over the next two years.
Pfisers vaccines are manufactured by a consortium of three companies, including Gilead Sciences, and are approved for sale by the U.K. Medicines and Healthcare Products Regulatory Agency.