German regulators have approved the first clinical trial of a coronavirus vaccine. Developed by BioNTech SE, an immunotherapy company, and Pfizer, a pharmaceutical company, the potential coronavirus vaccine has completed pre-clinical studies in Germany.
The German regulatory authority, Paul-Ehrlich-Institut, has given the green light to kick start the Phase 1/2 clinical trial for the BNT162 vaccine, which was developed jointly by the two pharmaceutical companies. The trial is the first of its kind to start in the country, which is part of a global development program.
The coronavirus disease (COVID-19) has ravaged through the globe, affecting most countries. The viral infection, which started in China, has now infected more than 2.7 million people and topping a death toll of 190,000. With the rapid spread of the virus and many countries in a standstill, finding a vaccine against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a race against time.
“Pfizer and BioNTech’s partnership has mobilized our collective resources with extraordinary speed in the face of this global challenge. Now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the U.S. soon,” Albert Bourla, Pfizer Chairman and CEO, said.
The vaccine
The BNT162 vaccine, a messenger-RNA (mRNA) vaccine, which was based on the research and development collaboration into which the two companies entered in 2018, in an attempt to develop mRNA-based vaccines to prevent influenza. Now, the vaccine they developed for coronavirus is ready to be rolled out in human clinical trials.
A messenger-RNA are molecules that help instruct human cells to produce antigen proteins, allowing the immune system to develop antibodies against future coronavirus infections.
The four vaccine candidates to be studied represent various mRNA formats and target antigens. The first two of the vaccines include a modified nucleoside mRNA (modRNA). The other two vaccines contain either uridine containing mRNA (uRNA), or the last vaccine candidate, the self-amplifying mRNA (saRNA). All of the vaccine candidates are mixed with a lipid nanoparticle (LNP) formulation.
Lipid nanoparticle (LNP) formulation loaded with an anticancer drug. Image Credit: Photos de Dodo / Shutterstock
The trial
The trial, which is the fourth across the globe for a vaccine that targets the novel coronavirus, is planned to be conducted on 200 healthy individuals. In the second part of the trial, more people will participate, including those who are at high risk for the infection.
The participants are between the ages of 18 and 55 and will be given a dose range of 1µg to 100µg to determine the optimal dose ideal for helping prevent the novel coronavirus infection. The dosing will also help evaluate the safety and immunogenicity of the vaccine.
“We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations. The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved,” Ugur Sahin, the Chief Executive Officer and Co-founder of BioNTech said.
The testing of the vaccine in the United States will commence as soon as the companies receive the approval of the U.S. Food and Drug Administration (FDA) for testing on humans. Two other companies are joining the race to find an effective vaccine against the SARS-CoV-2. Germany’s CureVac and the U.S. biotech Moderna, have developed their messenger-RNA vaccines.
If the human trials are successful, the vaccine can help combat the rapid spread of the virus, which has spread to 185 countries and territories. The hardest hit of the pandemic in the United States, with more than 868,000 confirmed cases and at least 49,000 deaths. Globally, the number of infections now stands at 2,708,885, with a death toll of 190,858.
Germany has reported more than 153,129 infections, and a death toll of at least 5,575. The other hotspots of the coronavirus pandemic include Spain, Italy, France, the United Kingdom, and Turkey, among others.
Source:
Pfizer. (2020). BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates https://www.pfizer.com/news/press-release/press-release-detail/biontech_and_pfizer_announce_regulatory_approval_from_german_authority_paul_ehrlich_institut_to_commence_first_clinical_trial_of_covid_19_vaccine_candidates
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