US FDA clears Pfizer-BioNTech COVID-19 Vaccine for emergency use

The United States FDA has approved the emergency use of Pfizer and BioNTech’s COVID-19 vaccine on Friday, paving the way for millions of vulnerable Americans to begin obtaining the vaccine within a day.

The FDA’s Emergency Use Authorization (EUA) is a crucial turning point in the global pandemic as the United States becomes the sixth country in the world to roll out the vaccine, following the United Kingdom, Bahrain, Canada, Saudi Arabia and Mexico. The UK was the first western country to approve the Pfizer-BioNTech vaccine for emergency use on the 2nd of December. The European Medicines Agency is expected to complete its reviews of the Pfizer-BioNTech vaccine application by December 29.

The COVID-19 pandemic has claimed 296,000 lives in the US to date and has seen hospitalisation rates over the last month reach record highs. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine ( BNT162b2) to be distributed across the US and supports the vaccine’s use in millions of people 16 years of age and older.

Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research stated:

“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States.”

Albert Bourla, Chairman and Chief Executive Officer of Pfizer stated:

“Pfizer’s purpose is breakthroughs that change patients’ lives, and in our 171-year history there has never been a more urgent need for a breakthrough than today with hundreds of thousands of people continuing to suffer from COVID-19. As a U.S. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”

The first vaccine to be administered within 24 hours

US President Donald Trump released a video statement on Twitter saying that the vaccine will be free for American citizens and that the first vaccine will be administered within 24 hours. The President explained that they wish for senior citizens, healthcare workers and first responders to be first in line to receive the vaccine.

The Pfizer-BioNTech COVID-19 Vaccine met all criteria for the issuance of an FDA Emergency Use Authorisation

In a press release, the FDA announced it has found that the Pfizer-BioNTech COVID-19 Vaccine has met all statutory criteria for the issuance of an Emergency Use Authorisation. According to the FDA, based on the available data there is clear evidence that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the potential benefits outweigh the risks.

The FDA has assured the public and the medical community that in reaching its decision, it has carried out a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The FDA Commissioner Stephen M. Hahn, M.D. stated:

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.”

“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

The US FDA Pfizer-BioNTech COVID-19 Vaccine Evaluation

The FDA has based the emergency use authorisation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published this week in The New England Journal of Medicine. The Phase 3 data showed that the BNT162b2 vaccine has an efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose.

Pfizer-BioNTech RNA based COVID-19 Vaccine – BNT162b2

The Pfizer-BioNTech COVID-19 vaccine, named BNT162b2, contains messenger RNA (mRNA), which is genetic material. The vaccine “contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein”, the FDA explained. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause the COVID-19 disease but triggers the immune system to teach the body to react defensively, producing an immune response against SARS-CoV-2.

About the Phase 2/3 Study

The ongoing Phase 3 clinical trial involves approximately 44,000 participants from almost 150 clinical research sites in the US, Germany, Turkey, South Africa, Brazil and Argentina. The Phase 3 study is designed as a 1:1 vaccine candidate to placebo, a randomized, observer-blinded study to collect data on safety, immune response and efficacy data required for regulatory approval. The primary endpoints of the trial are COVID-19 protection of people that were not infected with SARS-CoV-2 prior to immunization as well as COVID-19 prevention, irrespective of whether the patients were already infected with SARS-CoV-2. Secondary key endpoints are focused on prevention of severe COVID-19 in these groups.

Complex logistics effort to see 100 million doses distributed in the US at ultra-low storage temperatures

The FDA authorisation has kicked off a complex logistics effort by Pfizer, private shipping firms, state and local health agencies, the military, hospitals and pharmacy chains to distribute three million doses of the first week’s batch to health care staff and nursing home residents as quickly as possible, all while holding the vaccine at ultra-cold (minus 70 degrees Celsius / 94 F or below) temperatures. Pfizer has struck a deal with the US government to supply 100 million doses of its messenger RNA (mRNA) vaccine by March 2021. Notably, under that agreement, the shots will be free of charge to the US public.

To ensure the quality of the vaccine, the companies have developed specially designed, temperature-controlled shippers, which can maintain the recommended storage temperature (-70°C ±10°C) for 10 days when unopened. This allows for transportation to markets on a global scale. Once open, a vaccination center may use the shippers as a temporary storage solution to maintain the recommended storage temperature up to 30 days with re-icing every five days. Each shipper contains a GPS-enabled thermal sensor to monitor the location and temperature of each vaccine shipment 24/7. Once thawed, the vaccine vial can be kept safely for up to five days at refrigerated (2-8°C) conditions.

Rapid manufacturing of vast quantities of the vaccine

Pfizer and BioNTech trust their capability to supply the COVID-19 vaccine to people in the United States. The companies are leveraging the advanced vaccine manufacturing and distribution capabilities of Pfizer to rapidly scale, produce and deliver vast quantities of the vaccine at high quality, complementing the BioNTech mRNA manufacturing experience developed over almost a decade. Pfizer will be using three of its US manufacturing facilities to produce the COVID-19 vaccine – Saint Louis, Missouri, Andover, Massachusetts, and Kalamazoo, Michigan. The Pfizer Pleasant Prairie, Wisconsin and Puurs, Belgium plants are also being utilised.

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