Moderna Will Evaluate Booster Shot for COVID-19 Vaccine in New Trial

Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in the works, the company disclosed last week.

The drugmaker plans to kick off the booster-shot trial in July. The study will enroll adults who previously took part in the initial phase 1 study led by the National Institutes of Health (NIH) and were given the full two-dose regimen of the vaccine.

The phase 1 trial began administering vaccinations to participants in March 2020, followed by second doses four weeks later. The booster shot study aims to assess the safety of an extra shot given a year after the second dose and the additional immune response it provides.

“We anticipate that an additional dose could further boost the levels of neutralizing antibodies, should such a boost be required, and that this is expected to be an advantage of mRNA vaccines,” a Moderna spokesperson told FDAnews.

Tal Zaks, the company’s chief medical officer, said that the company expects its two-dose vaccine to grant at least one year of immunity based on what’s been seen so far. Whether or not a third shot should be incorporated into the dosing regimen will be determined by reviewing the data the new trial is set to gather. — James Miessler