On July 22nd, the US Department of Health and Human Services announced an agreement with Pfizer Inc. for the mass production and nationwide delivery of 100 million COVID-19 vaccine doses. The agreement also reserved an additional 500 million doses for the US.
Pfizer and its partner, BioNTech, must still complete a phase 3 clinical trial to prove their vaccine’s efficacy. Given approval by the FDA, which would likely come in the form of an EUA, nationwide delivery is set to begin in the last quarter of 2020.
The deal with Pfizer is part of Operation Warp Speed (OWS), a federal effort to collect various COVID-19 vaccines. The program's goal is to have at least one safe and effective defense against the virus readily available for the American public by January of next year.
According to the WHO, 24 vaccines are currently being evaluated in clinical trials around the globe. Many countries are scrambling for a vaccine. According to Johns Hopkins, COVID-19 has infected more than 15 million people worldwide, 4 million of which are American.
Pfizer and BioNTech received the FDA’s Fast Track designation at the beginning of July for two of their four experimental COVID-19 vaccines. The designation is meant to speed up the regulatory review process for unauthorized treatments and vaccines in the face of an unmet medical need.
The designation was granted following the release of preliminary Phase 1/2 data from studies conducted in the United States and Germany. The leading vaccine was shown to generate antibodies against SARS-CoV-2, the virus responsible for COVID-19. Some of these were neutralizing antibodies, meaning they appear to interfere with the virus’ core functions.
While the vaccine spurred immune responses, mild side effects—especially fever—were common among participants and exacerbated at higher doses. Levels of neutralizing antibodies were 1.8 to 2.8 times higher in vaccinated patients that recovered.
It should be noted that the relationship between antibody levels and immunity is still unclear. While antibodies contribute to the immune response, a vaccine that targets antibody levels only may not be enough to effectively halt the spread of COVID-19. Pfizer's phase 3 study aims to prove that vaccinated individuals are 50% less susceptible to becoming infected.
For public health organizations everywhere, now is the time to invest in life sciences training. Staying prepared means more than staying updated. What are you doing to keep your workforce COVID-ready?
Invest in new skills while refreshing those that are out of date with professional training and certification courses from the Center for Professional Innovation and Education (CfPIE). We offer a wide selection of pharmaceutical training programs and more.
Make sure your organization follows best practices, maintains compliance, and offers the skills that are necessary to tackle an unprecedented public health emergency.
Questions? Get in touch with a member of the CfPIE team today by calling 1-610-648-7550 or emailing [email protected].
Stay Informed
Since 2001 CfPIE has
Need help finding the right life sciences training courses? We can help you make the right choice based on your company's needs.
All Rights Reserved | CfPIE Inc. | Our courses and materials are copyrighted by CfPIE, Inc. and may not be used or reproduced without the written permission of CfPIE, Inc. management. | In partnership with CCC