Moderna's COVID-19 Vaccine Deemed Safe and Effective. When Can You Get It?

By Dani O. Jul 14 2020, 22:00 PM EDT

Massachusetts Based Biotech Company Moderna Receives FDA Approval To Continue Coronavirus Vaccine Trials — A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts. Moderna was given FDA approval to continue to phase 2 of Coronavirus (COVID-19) vaccine trials with 600 participants. Maddie Meyer/Getty Images

A coronavirus disease 2019 (COVID-19) vaccine, developed by Moderna Inc. and the U.S. government, was deemed safe and effective against the virus, according to data released Tuesday.

Research data released by the biotech company showed the candidate vaccine successfully triggered the body's immune response. The neutralizing antibody levels produced during the clinical trials matched those seen in patients who recovered after getting infected with the coronavirus.
Additionally, the vaccine did not generate an immune cell that has made vaccinated people worse off when faced with other diseases.

However, the experts who reviewed the results said it is still unclear whether the immune response is enough to protect someone from contracting the virus. Moderna's chief medical officer, Dr. Tal Zaks, said the findings indicate that the mRNA-1273 vaccine would most likely be safe and effective.

While several patients suffered side effects - with some severe, the team of researchers will move into a more extensive phase three trial this month. The late-stage testing will determine whether the coronavirus vaccine will get approval from U.S. regulators.

Possible COVID-19 Vaccine Side Effects

According to a report by the National Institute of Allergy and Infectious Diseases (NIAID), the side effects reported by the scientists were not severe enough to require further testing.

More than half of the patients who received three doses experienced mild to moderate side effects, including fatigue, chills, and muscle pain. Forty percent of people from the same group also developed a fever after receiving the second dose.

Among the 14 patients who receive the highest dose, three reported severe side effects. The group decided to drop the 250-micrograms dosage in the more extensive trials, the USA Today reported.

Late-Stage TrialsModerna Inc. collaborated with the Vaccine Research Center to hold the clinical trial. The experimental drug, which is being produced at lightning speed, was launched in early March.

The vaccine will now be tested during the late-stage trial that may involve over 30,000 participants. The highly anticipated trial is set to begin on July 27. The study is expected to run for three months.

According to The Motley Fool, each participant would be given one dose of either 100-micrograms of the mRNA-1273 vaccine or a placebo on the first day of trials. Another dose would be delivered on the 29th day.

Trial to be Held Across 87 Locations in the United States

The news comes after much speculation that the final phase of the trial would face delays after the company modified its testing protocol.

Multiple reports also claimed the biotech company and government health officials had disagreed over many aspects of the trials. However, both parties said that was not the case.

Moderna Inc. is relatively new compared to other companies that are also developing COVID-19 vaccine candidates. The drugmaker has never held a clinical trial of this size. It has also never received approval for a single product.

However, numerous health experts and industry observers believe the research results may give Moderna a strong chance of becoming the first company to market a COVID-19 vaccine.