US authorities order first 100 million doses of COVID-19 vaccine: vaccinated for free

On July 22, Pfizer and BioNTech said the US government had ordered an initial batch of 100 million doses of COVID-19 vaccine worth $ 1,95 billion from them and could purchase up to 500 million additional doses. US residents will be vaccinated with this drug for free, writes BusinessWire.

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July 22 Pfizer Inc. and BioNTech SE have announced that they have signed an agreement with the US Department of Health and Human Services and the US Department of Defense to meet the US government's Operation Warp Speed ​​goal to begin shipping a COVID-19 vaccine. Under the agreement, the U.S. government will receive 100 million doses of BNT162, a COVID-19 vaccine candidate co-developed by Pfizer and BioNTech, after Pfizer successfully manufactures the drug and receives FDA approval. ).

The US government will pay companies $ 1,95 billion after receiving the first 100 million doses approved by the FDA, and may purchase up to 500 million doses in addition. Americans will receive the vaccine for free, the newspaper said.

“We are committed to making the impossible possible by working tirelessly to develop and produce a safe and effective vaccine in record time to help end the global health crisis,” said Dr. Albert Bourla, Chairman and CEO of Pfizer. “We have made the decision early on to enter into clinical work and large-scale manufacturing at our own risk to ensure that the product will be available immediately if our clinical trials are successful and Emergency Use Authorization is granted.” We are honored to be part of this effort to ensure Americans have access to protection from this deadly virus.”

“Expanding Operation Warp Speed's pipeline with the addition of the Pfizer and BioNTech vaccine increases the likelihood that we will have a safe and effective vaccine later this year,” said U.S. Department of Health and Human Services Secretary Alex Azar. “Depending on the success of clinical trials, today’s agreement will allow approximately 100 million doses of this vaccine to be delivered to the American people.”

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BNT162 is based on BioNTech's proprietary messenger RNA (mRNA) technology and is supported by Pfizer's global vaccine development and manufacturing capabilities. BNT162 is currently undergoing clinical trials and has not yet been approved for distribution anywhere in the world. BioNTech holds all trademarks for a potential product.

“We are pleased to have signed this important agreement with the US government for an initial 100 million doses. This agreement is one of many steps to ensure global access to safe and effective COVID-19 vaccines. We are also in extensive discussions with many other government agencies and hope to announce additional supply agreements soon. Our goal remains to deliver a safe and effective COVID-19 vaccine to many people around the world as quickly as possible,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.

The Pfizer / BioNTech Vaccine Development Program is testing at least four experimental vaccines, each with a unique combination of messenger RNA (mRNA) format and target antigen. On July 1, Pfizer and BioNTech announced preliminary data for BNT162b1, the most advanced of the four mRNA compounds. Early data demonstrate that BNT162b1 is capable of producing neutralizing antibodies in humans at or above levels seen in plasma from patients who have recovered from COVID-19, and this has been shown at relatively low dosages. Local reactions and systemic side effects were generally transient and ranged from mild to moderate. No serious side effects were reported.

Recently, 2 of the company's 4 drug candidates (BNT162b1 and BNT162b2) were eligible for expedited review by the FDA. This entitlement was granted based on preliminary data from phase 1/2 studies currently underway in the United States and Germany, as well as immunogenicity studies in animals. Additional data will enable the selection of a leading candidate drug and dose level for the anticipated global safety and efficacy study in the next phase, which could begin later this month.

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If current research proves successful, Pfizer and BioNTech expect to be ready to receive emergency use or some form of FDA regulatory approval as early as October 2020. The companies currently plan to produce up to 100 million doses globally by the end of 2020, and potentially more than 1,3 billion doses by the end of 2021, following the final dose determination from a clinical trial.

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