On Tuesday, Mr. Trump is hosting an event at the White House to promote the role of the program and plans to adopt an executive order that will apply his «America First» philosophy to the pandemic, announcing that other nations will not receive U.S. shipments of his vaccine until Americans are vaccinated. Recently, two of the company`s four vaccine candidates (BNT162b1 and BNT162b2) were given the fast-track name of the U.S. Food and Drug Administration . This term was given on the basis of preliminary data from phase 1/2 studies currently underway in the United States and Germany, as well as on animal immunogenicity studies. Further data from the ongoing Phase 1/2 clinical studies of the four vaccine candidates will be used to select a primary candidate and dose level for a large overall safety and efficacy study of Phase 2b/3 expected, which may begin this month until no marketing authorization is available. October 28: HHS announced a $375 million agreement with Eli Lilly and Company to purchase the first doses of the control antibody COVID-19 Bamlanivimab, also known as LY-CoV555. Bamlanivimab is currently being evaluated in Phase 3 clinical trials funded by Eli Lilly, in addition to clinical studies conducted as part of ACTIV`s public-private partnership.

The FDA is investigating bamlanivimab as a possible treatment for COVID-19 in outpatient patients. Monoclonal antibodies mimicking the human immune system bind to certain proteins in a virus, reducing the virus`s ability to infect human cells. August 4: Grand River Aseptic Manufacturing Inc., (GRAM) Grand Rapids, Michigan, obtains, in response to the COVID-19 pandemic, a fixed-price contract of $160 million for national filling and final manufacturing capabilities for critical and therapeutic vaccines. Although Pfizer`s contract includes the option to purchase an additional 500 million doses of its vaccine, this transaction would require a separate agreement and the price would change, the contract said. August 11: HHS announced up to $1.5 billion in funding to support the large-scale production and delivery of the candidate for Moderna`s anti-denki vaccines. Under the agreement, the U.S. government will own the resulting 100 million doses of vaccines and have the opportunity to purchase more vaccines. The vaccine, called RNA-1273, was developed jointly by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

NIAID continues to support vaccine development, including non-clinical studies and clinical trials. In addition, BARDA has supported Phase 2/3 clinical studies, upgrading vaccine production and other vaccine development activities. The Phase 3 clinical trial, which began On July 27, is the first state-funded Phase 3 clinical trial for a COVID-19 vaccine in the United States. Asked whether the Trump administration missed a crucial opportunity to release more doses for Americans, a spokeswoman for the Department of Health and Human Services said, «We are confident that we will have 100 million doses of Pfizer vaccines, as agreed in our contract, and in addition, we have five other vaccines, including 100 million doses on the way to Moderna.» After Pfizer signed its federal contract at the end of July, Pfizer sealed contracts with other governments, including the European Union, which last month reached an agreement to acquire 200 million doses from Pfizer and its German partner BioNTech.