COVID-19 Vaccine: Moderna First Company to Announce Start of Phase 3 Trial Despite Adverse Reactions Reported

All participants in the Moderna vaccine clinical trial produced antibodies against the coronavirus.

The research results were published in the New England Journal of Medicine on Tuesday, July 14. The findings showed the levels of neutralizing antibodies appear during the trial were similar to those in COVID-19 patients who recovered.

Meanwhile, over half of those Moderna trial participants who got about three doses suffered some adverse reactions. These include chills, headache, muscle pain, and mild to moderate fatigue.

Outbreak of the coronavirus disease (COVID-19) in Tuebingen
Professor Gottfried Kremsner injects a vaccination against the coronavirus disease (COVID-19) from German biotechnology company CureVac to a volunteer at the start of a clinical test series at his tropical institute of the university clinic in Tuebingen, Germany, June 22, 2020. REUTERS/Kai Pfaffenbach/

Another 40% of this group suffered from fever after receiving the second shot. Meanwhile, among 14 patients who received the highest dose, three of them experienced severe reactions. However, such a high dose is not given in larger trials.

Although a vaccine that triggers antibody production does not prove its efficacy, it is still an important step in testing.

A doctor from Duke Human Vaccine Institute, Dr. Tony Moody said that despite having numerous side effects, the levels of antibody produced were "really encouraging."

National Institute of Allergy and Infectious Diseases Director Anthony Fauci told Bloomberg in a phone interview find the recent Moderna results as "quite promising" and that the side effects were typical as seen in other vaccine trials.

Fauci also noted that the vaccine triggered the production of neutralizing antibodies, which he believed is the good news.

Phase 3 trial on the way

While some patients experience side effects, the company plans to continue with its phase 3 trials on July 27, which brings good news to a pandemic-stricken country. This will determine whether it will be approved by U.S. regulators, so it can be released in the market.

Moderna Therapeutics seen during COVID-19 in Massachusetts
A sign marks the headquarters of Moderna Inc, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyde

"[We] expect participants will be able to register with clinical sites beginning July 21," Moderna spokesperson Ray Jordan told CNBC, confirming the trial start date.

The Cambridge, Massachusetts-based pharmaceutical company is the first U.S. company to announce a start date for its phase 3 trials. It was also the first to begin its human trials on March 16.

The recent results are from human trials on 45 patients who received two shots within 28 days. All participants produced antibodies against coronavirus after the first dose, but these could not neutralize the virus.

After 28 days after, they received the second shot and 42 of them have produced neutralizing antibodies.

For the third phase, Moderna aims to include 30,000 participants who will either receive the vaccine or a placebo. For two years, they will be supervised to see whether they would develop any adverse reactions or get infected by COVID-19. Researchers will also check the patients' antibody levels.

Moderna stocks

Last week, Gurofocus reported that Moderna Inc CEO Stephane Bancel sold 20,281 shares of MRNA at an average price of $63.85 a share for a total of $1.3 million. Moderna stocks gained 13.3%, which is more than three times growth in value, being traded for about $75, although the company has a market cap of $27.86 billion.

Experts see that with the phase 3 trials starting by the end of the month, Moderna's stocks will continue to surge. Starting next year, the company vows to deliver 500 million doses per year.

Read also: Bill Gates: Giving COVID- 19 Drugs to the Highest Bidders is a Deadlier Pandemic

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