After much discussion and debate, members from an independent Food and Drug Administration team unanimously decided to approve Moderna’s coronavirus booster injectable.
The Vaccine and Related Biological Products Advisory Committee voted for boosters for people older than 65, people with certain illnesses, and people who are exposed in the workplace.
The qualification group fully represents the booster Pfizer that was approved last month.
Moderna’s booster dose will be 50 micrograms. That is half of the main injectable volume. The booster can be administered at least six months following the last dose.
Moderna’s representative stated that the 50 mg dose is still very effective and may cause fewer side effect. They also plan to increase their supply.
The booster injection, according to the company will increase the immunity against variants of the virus and have similar side effects and safety as the second.
Moderna’s Dr. Jacqueline Miller told FDA consultants that there was a 36% drop in the incidence of breakthrough infections among people who had been vaccinated recently, compared with people who were vaccinated sooner.
Moderna stated in a Twitter statement: “We are thrilled to have the opportunity today to present our COVID-19 vaccine booster vaccine clinical data package the FDA Advisory Committee.” We thank the committee for its review and unanimous vote for the 50 µg booster EUA. Thank you.
While VRBPAC members voted unanimously for the motion, many people pointed out that it was still more important to vaccinate people who aren’t vaccinated than to increase vaccinations.
During the eight-hour meeting, many questions were not answered. Members were unsure if there was enough evidence to support low-dose boosters of vaccines.
Experts also noted that those with weak immune systems can get the third full dose. It is not clear if this group can receive boosters.
Moderna’s booster will not be allowed to enter the weapon without overcoming some hurdles. The FDA must approve the recommendation and then the Immunization Practice Advisory Committee, which is comprised of the Centers for Disease Control and Prevention, will meet to examine Moderna’s data.
After this, the director at the CDC will approve and make the photos public. This could happen next week.