UPDATED: FDA recommends Moderna, Johnson and Johnson COVID-19 boosters

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously yesterday to recommend booster shots of Moderna COVID-19 vaccine for many who’ve already received the initial doses.

According to a report from The New York Times,the panel approved an emergency use authorization for the half-dose of the Moderna vaccine to be administered six months after the initial two-dose regimen for those considered at high risk of severe COVID-19 infection; the same groups eligible for the Pfizer booster shot.

The committee also voted unanimously to recommend boosters of the Johnson and Johnson vaccine for all adults two months after the initial dose, according to the Times.

FDA officials have said they are considering regulatory changes to allow those patients who received the initial dose of the Johnson and Johnson vaccine to receive a Pfizer or Moderna booster dose. A timeline on such a move has yet to be established, the Times reports.

An official ruling from the agency is expected in the coming days.

Documents which the committee used to reach their determination show that, when administered six months after a second dose, the booster dose of the Moderna vaccine 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.

A Phase 3 ENSEMBLE 2 study found that a second dose of the Johnson and Johnson vaccine administered 56 days after the first provided 100 percent protection against severe or critical COVID-19, 75 percent protection against symptomatic COVID-19 globally, and 94 percent protection against symptomatic COVID-19 in the U.S. When the second shot is administered, it boosts antibody levels four to six times higher than what is observed after the initial dose.

When the booster shot was given six months after the initial dose antibody levels shot up nine-fold after a week and 12-fold after four weeks irrespective of the age of the patient.

The committee will reconvene on Nov. 30 to discuss the Merck investigational antiviral pill, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults.

As previously reported, a planned interim analysis of a Phase 3 MOVe-OUT trial in 775 at risk, non-hospitalized adult patients with mild to moderate COVID-19 found that the antiviral reduced the risk of hospitalization or death by 50 percent. No patients who received the pill died after 29 days compared to eight who died after receiving a placebo.

The company plans to produce 10 million courses of treatment by the end of the year and previously entered into an agreement with the federal government to supply about 1.7 million courses of molnupiravir upon receiving an EUA or approval from the FDA. Merck has struck similar deals with other countries.

Boosters on the market

Late last month the Centers for Disease Control and Prevention (CDC) recommended booster shots of the Pfizer COVID-19 vaccine Comirnaty for those over 65 and those at high risk of severe COVID-19 due to an underlying condition. CDC Director Rochelle Walensky went a step further and recommended the extra shots for those in high-risk occupations or institutions.

Specifically, the CDC recommends boosters for:

• people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
• people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.