By Otto Rodriguez
Miami-Dade Health
The U.S. pharmaceutical company Moderna announced Monday that is ready to submit its coronavirus vaccine for regulatory approval after clinical trials showed effectiveness close to 95 percent.
In a statement issued after the trials, the company said that there has not been any serious clinical or medical concerns in the use of its vaccine, with the most common side effects being fatigue, headaches, and joint and muscle pain.
The results, Moderna said, were standard across all age, race, and gender categories. The company’s shares have been climbing steadily on Wall Street after positive news related to the possible fast approval of the vaccine.
The US Federal Drug Administration (FDA) committee in charge of reviewing Moderna’s vaccine results is set to meet Dec. 17, when it will review the submissions of other candidates developed by pharma giant Pfizer and its German partner BioNTech. Both vaccine have shown high levels of efficacy.
The Moderna and Pfizer-BioNTech treatments involve inserting a special code, called mRNA, designed to develop an immune response. No mRNA-based vaccine or drug has ever won approval before.
An early vaccine candidate developed by European pharmaceutical AstraZeneca in conjunction with Oxford University that showed promising results a few months ago has had some recent setbacks, and the company said that will probably run more clinical trials to collect additional effectiveness data.
Concerns about the efficacy of AstraZeneca’s vaccine were voiced recently by experts in the United States, scientists from Oxford University, and representatives of the World Health Organization.
Shares of AstraZeneca dipped this week after the company announced interim results that showed an effectiveness of around 70 percent.
It was also announced last week that Pfizer has finalized an agreement with a U.S.- based airline to create an extensive operation to fly millions of vaccine doses from Brussels, in Belgium, to the United States.
