Pfizer, Inc., in conjunction with its partner BioNTech, have submitted their COVID-19 vaccine candidate to the U.S. Food and Drug Administration (FDA) for what is called an “Emergency Use Authorization” (EUA). The vaccine, which recently completed its Phase 3 testing on over 44,000 participants, has been shown to be 95% effective in preventing the contraction of the virus.
The application for Pfizer’s EUA will be reviewed in the upcoming weeks, but it is possible the approval could come sometime in December. And Pfizer says it will be ready.
“We have ramped up manufacturing capabilities across the globe in an effort to meet the high demand due to the COVD-19 pandemic,” Pfizer announced in a press release. “Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.”
The U.S. death toll alone from the novel coronavirus has now surpassed 250,000, and the current spike in cases, hospitalizations and fatalities means that this vaccine, and others like Moderna’s that are not far behind in the testing and approval process, can’t come soon enough.
As the name implies, the Emergency Use Authorization is not the typical kind of FDA approval, which can sometimes take years to complete in evaluating a new drug or vaccine. But in a pandemic where people are dying every day, and there is currently no effective alternative, the rules change a little.
But safety – not just urgency – governs how the FDA goes through the process of granting an EUA. There are three basic requirements that must be met, according to Pfizer:
– “Based on available scientific evidence, including data from clinical trials, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2 (the virus that causes COVID-19).
– “The identified and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the identified and potential risks of the product.
– “There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.”
Both Pfizer and Moderna have an interesting challenge to meet when it comes to shipping their vaccines worldwide. Pfizer’s vaccine must be kept at -70 degrees Celsius, and Moderna’s at -20 degrees Celsius. Pfizer has created special GPS-tracked coolers with dry ice to facilitate safe shipment of the vaccine.
The next question facing government authorities will be deciding who gets vaccinated first. Healthcare workers, first responders and vulnerable populations will have to be prioritized in the early months of the vaccine’s limited availability.
Gallup reports that in a poll conducted October 19 – November 1, 58% of Americans say they will take the vaccine, up from 50% in September. That was before Pfizer and Moderna both reported a 95% success rate with their vaccines, and also before the COVID infection rate and fatalities took a serious spike upward. Look for even more public acceptance and demand for the vaccine in the next few weeks.
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