Nordic Life Science 1
f the ongoing studies are successful and the vacc
ine candidate receives regulatory approval, the two companies anticipate manufacturing up to 100 million doses by the end of 2020, and up to 1.3 billion doses by the end of 2021. “We are working with an ambition to share the vaccine in a fair and equitable way across the globe for the people with the most urgent needs. We have recently submitted our first clinical data for publication and shared the data on the MedRxiv open source server,” says Dolsten. across the globe are racing as never before to find treatments and a vaccine for the new coronavirus that has killed more than half a million people worldwide since it was first detected in China in late December 2019. Among the leading *contenders is a trial vaccine developed by global pharmaceutical company Pfizer, Inc., and the biotech company BioNTech, founded in Mainz, Germany. The trial vaccine has now entered a large-global Phase 2/3 clinical trial. If the candidate is found to be safe and effective, a vaccine could be available by the end of this year. “We are sharing data from our COVID-19 vaccine clinical trials with the U.S. Federal Drug Administration (FDA) in real time, so they can evaluate at the earliest possible time whether the safety and efficacy threshold has been met that would enable us to make the vaccine available,” says Sweden’s Dr. Mikael Dolsten, MD, PhD, Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer Inc. As of early August, there were 18,705,096 coronavirus cases worldwide and 704,385 reported deaths. While 11,922,692 people have recovered from the virus, doctors are now learning that many survivors have suffered permanent organ damage and could face long-term health effects from the virus’s ravages – and they could catch it again. About 165 vaccine candidates were in the pipeline towards the end of the summer, according to the World Health Organization (WHO), while more than 20 companies were striving to find treatments for the disease, either by tweaking existing anti-viral drugs or testing new ones. Pfizer has been going full-throttle on developing a vaccine, working on several candidates with BioNTech. The candidate the companies have selected to pursue is BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein. Named Project Lightspeed, the joint Pfizer/BioNTech BNT162 mRNA-based vaccine program began a stage three clinical trial with 30,000 participants at the end of July. The mRNA vaccine candidate consists of an initial dose and a booster dose given within a three-week interval. In an earlier study, by the 28th day (seven days after the second dose), according to Mikael Dolsten all subjects who received 10 or 30 µg of BNT162b1 had significantly elevated IgG antibodies against the viral key receptor binding domain (RBD) with levels corresponding to eight- and 46-times above the levels recorded in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2. “It has been reported that many patients who have contracted COVID-19 disease have protective antibodies, although these may be lasting just a few months. Hence, to demonstrate that we can exceed those antibody levels is very encouraging,” he notes. 46 NORDICLIFESCIENCE.ORG