FDA panel discussing Moderna COVID-19 boosters

A Food and Drug Administration (FDA) advisory committee will decide today whether the agency should recommend booster shots of the Moderna COVID-19 vaccine.

As part of a two-day meeting, the FDA Vaccines and Related Biological Products Advisory Committee will discuss whether to recommend the third half-dose of the vaccine at least six months after completion of the initial regimen.

Documents which the committee will use to reach their determination show that, when administered six months after a second dose, the booster doses raise antibody titers 15 times a month after the additional shot and provides protection against the now-dominant Delta variation of the disease.

The documents also show that the booster shots appear safe, with the reactogenicity and adverse event profile similar to that seen after the second dose of the vaccine.

Moderna is seeking an expansion of the drug’s emergency use authorization similar to that given to the Pfizer COVID-19 vaccine, Comirnaty.

Last month, the committee authorized a third dose of the Pfizer vaccine to be administered at least six months after the primary doses in patients 65 years of age and older, patients between 18 and 64 who are at high risk of severe COVID-19, and in patients who work in close proximity to the virus which leaves them at risk for severe COVID-19.

A day later, the Centers for Disease Control (CDC) and Prevention’s Advisory Committee on Immunization Practices recommended the extra doses only for those over 65 and those with underlying conditions. CDC Director Rochelle Walensky went a step further and recommended the extra shots for those in high-risk occupations or institutions.

The World Health Organization has called for a moratorium on the additional shots pushing for at least 10 percent of the population of every country to have been vaccinated before nations turn to further dosing those who’ve already received the shots.

“To make that happen, we need everyone’s cooperation, especially the handful of countries and companies that control the global supply of vaccines,” WHO Director General Tedros Adhanom Ghebreyesus said in an Aug. 4 briefing.