Booster Doses Will be 6 Months Apart, Not 8

The US federal government is planning to shorten the period of time between the second dose of the COVID-19 vaccine and the booster dose from the previously discussed 8 month period to 6 months, according to an unnamed source the Wall Street Journal reported.

“Data from vaccine manufacturers and other countries under review by the Food and Drug Administration is based on boosters being given at 6 months, the person said. The person said approval for boosters for all three Covid-19 shots being administered in the U.S.—those manufactured by Pfizer Inc. and partner BioNTech SE, Moderna Inc. and Johnson & Johnson —is expected in mid-September,” the paper reported.

Last week, public health officials from the Biden Administration had announced that booster doses would be available 8 months after people’s second dose of the mRNA vaccines.

That announcement was predicated on the decision that a booster shot would be needed because of waning immunity of the vaccines because of the Delta variant, which is the predominant variant in the US.

On the same day it was announced a joint statement from Department of Health and Human Services (HHS) public health officials was released. The statement was attributed to the following officials: Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention (CDC); Janet Woodcock, MD, acting commissioner, Food and Drug Administration (FDA); Vivek Murthy, MD, US surgeon general; Francis Collins, MD, director of the National Institutes of Health (NIH); Anthony Fauci, MD, chief medical advisor to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases (NIAID); Rachel Levine, MD, assistant secretary for Health; David Kessler, MD, chief science officer for the COVID-19 Response; and Marcella Nunez-Smith, MD, chair of the COVID-19 Health Equity Task Force.

“The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” the joint statement read. “Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

The plan is subject to the FDA approval, and Pfizer-BioNTech announced earlier today they initiated a rolling submission for their COVID-19 vaccine BNT162b2 (Comirnaty) to seek an FDA supplemental Biologics License Application (sBLA) that would allow for marketing and prescribing of a third booster dose of the vaccine for fully vaccinated individuals aged 16 years and older.

Moderna announced today it has submitted its formal BLA with the FDA for its COVID-19 Vaccine, mRNA-1273.

And Johnson & Johnson announced today positive data supporting a booster dose of their COVID-19 vaccine, Ad26.COV2.S.