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Pharma & biotech companies are in testing phase for a COVID-19 vaccine

Many Pfizer/BioNTech sites are in diverse communities that have been disproportionately affected by COVID-19.

Susan Morse, Managing Editor

Several pharmaceutical and biotech companies are in the testing phase for a COVID-19 vaccine.

Pfizer and BioNTech said they have been chosen to lead the mRNA vaccine candidate against COVID-19. The vaccine consists of an mRNA strand that codes for a disease-specific antigen.

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review as early as October and, if regulatory authorization is obtained, plan to supply up to 100 million doses by the end of this year and approximately 1.3 billion doses by the end of 2021, according to Pfizer.

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Also this week, Moderna, a clinical stage biotechnology company, announced a Phase 3 trial in the United States of its experimental vaccine against COVID-19, mRNA-1273.

A study has shown that a two-dose vaccination schedule of mRNA-1273 leads to a robust immune response and protection against SARS-CoV-2 infection in the upper and lower airways in nonhuman primates, without evidence of vaccine-associated enhanced respiratory disease, Moderna said.

WHY THIS MATTERS

A vaccine is seen as the best hope of controlling the spread of COVID-19, which has infected more than 16 million people worldwide and killed more than 661,000, according to Johns Hopkins University. The U.S. death rate is approaching 150,000.

Seventy-two percent of adults would be willing to get the vaccine, while 27% said they would not, according to a Pew Research Center study done in May.

This falls short of the estimated 80% needed to develop herd immunity, in which a majority of the population has been exposed to the virus or has become immune, as is what is believed to have finally halted the spread of the 1918 Spanish flu. Without a vaccine, that deadly pandemic is thought to have infected a third of the world's population and killed an estimated 675,000 people in the United States, according to the Centers for Disease Control and Prevention.

The number of people willing to get vaccinated is important as pharmaceutical companies are in the testing stages for a vaccine that could become available by the end of the year.

Pfizer said it could be ready for regulatory review as early as October.

WHAT ELSE YOU NEED TO KNOW

This Phase 2/3 Pfizer and BioNTech study involves up to 30,000 participants ages 18–85. By the end of the trial, the Phase 2/3 study is expected to be active at approximately 120 clinical sites around the world, including 39 states across the U.S. and countries including Argentina, Brazil and Germany. 

The companies plan to enroll a diverse population, including participants in areas where there is significant expected SARS-CoV-2 transmission. Many of the sites are in diverse communities that have been disproportionately affected by COVID-19, so individuals who have been most impacted have the opportunity to participate, Pfizer said. 

THE LARGER TREND

Pfizer and BioNTech recently received U.S. Food and Drug Administration Fast Track designation, after four BNT162 RNA vaccine candidates, BNT162b1 and BNT162b2, emerged as strong candidates based on assessments of safety and immune response. 

Pfizer and BioNTech selected BNT162b2 as the candidate to progress to a Phase 2/3 study, but are continuing to collect data from the Phase 1/2 trials for all four vaccine candidates. They expect to submit data on BNT162b2 for peer review and potential publication in the near future. The companies also intend to post the manuscript on a preprint server at that time.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com