22 July, representatives of Pfizer and BioNTech said that the US government ordered their initial batch of 100 million doses of vaccine from COVID-19 in the amount of $1,95 billion and may purchase up to an additional 500 million doses. U.S. residents should be vaccinated with this drug free, says BusinessWire.
July 22, Pfizer Inc. and BioNTech SE announced the signing of an agreement with the Department of health and human services and the Department of defense about the achievement of U.S. government objectives under the name Operation Warp Speed aimed to begin deliveries of the vaccine from COVID-19. In accordance with the agreement, the U.S. government will receive 100 million doses BNT162 of the drug candidate for a vaccine against COVID-19, co-developed by Pfizer and BioNTech, after Pfizer successfully produce the drug and get approval from Management on control over products and medicines USA (FDA).
The US government will pay the companies the $1.95 billion after the first 100 million doses approved by the FDA and can buy up to 500 million doses in addition. The Americans will get the vaccine for free, the newspaper reports.
“We strive to make the impossible possible, working tirelessly on the development and production in record time safe and effective vaccine to help end the global crisis in health care, said Dr. albert Burla, Chairman and CEO of Pfizer. — We have decided in advance to begin clinical work and large-scale production at your own risk to guarantee that the product will be available immediately if our clinical trials are successful and permission is granted for emergency use. We are honored to participate in these efforts to provide Americans access to protection from this deadly virus”.
“The expansion of the range of Operation Warp Speed by adding vaccines from Pfizer and BioNTech increases the likelihood that we will receive safe and effective vaccine by the end of this year, — said the Secretary of the Department of health and human services Alex Azar. Depending on the success of clinical trials, today’s agreement will deliver about 100 million doses of the vaccine to the American people”.
The drug BNT162 based on patented technology messenger RNA (mRNA) and BioNTech is supported by the global opportunities Pfizer for the development and production of vaccines. BNT162 now undergoing clinical study and not yet approved for distribution anywhere in the world. BioNTech holds all the trademarks for a potential product.
“We are delighted to have signed this important agreement with the U.S. government to supply an initial 100 million doses. This agreement is one of many steps to ensure global access to safe and effective vaccines against COVID-19. We have also engaged in extended discussions with many other government bodies and hope to announce additional supply agreements. Our goal still is to as quickly as possible to deliver a safe and effective vaccine COVID-19 many people around the world,” said Ugur Sahin, doctor of medical Sciences, CEO and co-founder of BioNTech.
Program of vaccine development Pfizer/BioNTech tests at least four experimental vaccines, each of which represents a unique combination of format messenger RNA (mRNA) and the target antigen. July 1, Pfizer and BioNTech has announced preliminary data on BNT162b1, the most advanced of the four formulations of mRNA. Early data show that BNT162b1 capable of producing neutralizing antibodies in people at or above levels observed in the plasma of patients who have recovered from COVID-19, and it was shown at relatively low dosages. Local reactions and systemic side effects were generally transient and ranged from weak to moderate. Serious side effects were reported.
Recently 2 of the 4 of candidate drugs companies (BNT162b1 and BNT162b2) obtained the right to expedited review from the FDA. This was granted on the basis of preliminary data of the phase 1/2 studies that are currently underway in the United States and Germany, as well as studies of immunogenicity in animals. Additional data will allow to choose the leading drug candidate and the dose level expected for a global study of safety and efficacy in the next phase, which could begin as early as the end of this month.
If current research is successful, Pfizer and BioNTech expect to be ready to obtain permission to use in emergency situations or some form of regulatory approval by the FDA in October 2020. Currently, the company plans to produce up to 100 million doses worldwide by the end of 2020 and, perhaps, potentially more than 1.3 billion doses by the end of 2021, after the final determination of the dose through clinical trials.