Days after announcing a 95 percent effectiveness rate for their COVID-19 vaccine, Pfizer and BioNTech are asking FDA regulators to approve the vaccine for emergency use in the US. If approved, the companies said shots could be available on a limited basis to high-risk individuals as early as mid- to late December.
Pfizer and BioNTech are asking for emergency approval on the grounds that the vaccine has proven both safe to use and highly effective in clinical trials. The trials included 38,000 participants globally, covering a range of ages, races, and ethnicities, and to date, the companies have not found “any serious safety concerns related to the vaccine.”
“Our work to deliver a safe and effective vaccine has never been more urgent as we continue to see an alarming rise in the number of cases of COVID-19 globally,” said Pfizer Chairman and CEO Albert Bourla, PhD, in the company’s press release. “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.” Pfizer is also seeking approval across the globe in countries including Australia, Canada, Japan, and in Europe and the UK.
While they await approval, the companies are moving forward with manufacturing and distribution plans, enormous undertakings requiring collaboration with regulatory agencies across the world. The mRNA-based vaccine will require two shots taken three weeks apart and, in just one hurdle that must be overcome, has to be stored at minus 70 degrees Celsius, or minus 94 degrees Fahrenheit.
Even as the Pfizer vaccine moves toward approval, officials have warned that it won’t be an immediate fix. The CEO of Moderna, which also announced promising results from its clinical trials, said this week that the vaccine shouldn’t be seen as a “silver bullet . . . we need surveillance to be stronger. We need public health measures.”
Anthony Fauci, MD, director of the National Institute of Allergies and Infectious Diseases, has estimated that both vaccines will be available to high-risk people by December and to the general public by spring 2021. In the meantime, staying safe, wearing a mask, and taking necessary precautions remains crucial as cases continue to rise around the country.
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