Friday, August 14, 2020

Two key COVID-19 vaccines enter the final stages of trials before FDA approval

U.S. company Pfizer and BioNTech (German biotech) announced Monday that they have begun late-stage human trials for their COVID-19 vaccine. The first “Phase 3” trial in the U.S. has also begun with biotech company Moderna and the National Institute of Allergy and Infectious Diseases (part of the NIH) announcing that they will begin their trials at nearly 100 U.S. research sites, CNN reports. Both vaccines will be submitted to the FDA for approval after successful final-stage trials.

Moderna and the National Institutes of Health

Moderna and the NIH are expected to bring in about 30,000 adult volunteers to conduct final analysis of the safety of the SARS-CoV-2 vaccine that they have been developing. The primary goal is to confirm that the vaccine can prevent COVID-19 cases after two doses of the vaccine.

Read Also: COVID-19 patients no longer infectious after 10 days, CDC guidelines say

The Phase 1 trials, published in the New England Journal of Medicine, showed that the vaccine initiated a response from the immune system and was generally safe. However, there were also side effects such as fatigue, chills, headache, muscle pain, pain at the injection site. Phase 1 and Phase 2 trials were conducted on a smaller level and a lower variety of characteristics of people. The Moderna/NIH vaccine is one of 25 clinical studies in the world, according to the WHO.

Pfizer and BioNTech

Pfizer’s and BioNTech’s vaccine trial is considered to be in Phase 2/3, CNBC reports. Kathrin Jansen, head of vaccine research and development at Pfizer, says, “The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic. Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”

This vaccine is an mRNA vaccine, meaning it uses the messenger RNA to initiate an immune response from the body. Pfizer’s and BioNTech’s vaccine trial is also expected to include up to 30,000 participants between the age of 18 and 85. This trial is spread across 120 sites globally. The companies hope to supply 100 million doses by the end of 2020, and around 1.3 billion doses by the end of 2021, if the trials complete successfully.

Other companies like Johnson & Johnson and AstraZeneca are also developing COVID-19 vaccines. Johnson & Johnson said that it expects to begin late-stage human trials near the end of September while AstraZeneca said they are looking for volunteers in their late-stage trial, which is currently ongoing.

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